Quality & Regulatory Jobs in Pharma & Biotech

GENERAL POSITION SUMMARY The Associate Director, GCP Compliance is responsible for the quality assurance and compliance activities in support Quality Issues Management and other activities within RDQ . This role will support GCP related events and escalation of these events to Senior Management and other key stakeholders . This individual will work closely with Quality Leads, Study team members, and other pillars in the Quality organization and will d emonstrate Vertex Core Values. RESPONSIBILITIES Assist in the continuous improvement of the Issue Management process- handling of QEs, trending , and updating processes. M anage or assist in (internal and external)...

An engineering professional that works with project owners, automation engineers, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified automated systems equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The primary objective is to design and execute robust evaluation, testing, and documentation strategies that support risk management, commissioning, and validation in alignment with product, regulatory, and quality requirements. The role also contributes to optimizing automated systems, process controls, and related technical workflows...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

About This Role As a Senior Associate II, Technical Quality, you will play a critical role in ensuring quality and compliance across manufacturing, laboratory, engineering, and quality operations. You will lead and support investigations, change controls, quality oversight activities, and continuous improvement initiatives that strengthen operational performance and regulatory compliance. This position serves as a key technical quality subject matter expert, partnering cross-functionally to solve complex problems, assess risk, and implement effective quality solutions. You will provide quality assurance oversight for quality control activities, technology transfers, material management, and regulatory inspection readiness. This role helps drive a culture of quality,...

The Sr. Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development. Responsibilities Launch and stabilize new product launches through concept, design, development, and steady-state processes. Drives the development of product requirements, verification strategies, and validation strategies. Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction. Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical support...

Johnson & Johnson is recruiting for a Manufacturing Quality Engineering Manager , located in Danvers, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Manufacturing Quality Engineering Manager is responsible for leading manufacturing quality engineering activities that support regulatory compliance, production quality, and manufacturing and supply chain operations. This role provides leadership to a team of quality engineering professionals, supports robust quality systems and data-driven decision making, and partners...

Johnson & Johnson is currently recruiting a Sr. Program Manager Quality Systems . This position will be located in Santa Clara, CA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Sr. Program Manager Quality Systems will be responsible for leading multiple Quality System programs and projects that optimize processes and support business objectives while enhancing compliance. This role will ensure overall execution to meet project objective and timelines. Key...

Abiomed is recruiting for a Sr Manufacturing Quality Engineer located in Danvers, MA . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our facilities expansion. In this role, you will have the unique opportunity to contribute to manufacturing life-saving medical devices....

USE YOUR POWER FOR PURPOSE Candidate will be responsible to provide leadership for will be responsible for managing a team of Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity within the Rochester Quality organization. Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Job Summary The Associate Director, Patient Safety-Virology provides strategic pharmacovigilance leadership for one or more products, compounds, or indications across the development...

Job Title Associate Quality Engineer This position works out of our Caguas location in the SH Division as a global leader we focus on innovative technologies that can improve the way doctors treat people with heart. As the Associate Quality Engineer, you will provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. The Associate Quality Engineer will work with line supervisor, manufacturing engineer, and other team members, to address all opportunities found in the assigned manufacturing line and will...

Quality Engineering Manager This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Altavista, Va. , is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you...

Job Title Associate Quality Engineer This position works out of our Arecibo location in the CRM division as a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. As the Associate Quality Engineer, you will provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. The Associate Quality Engineer will work with line supervisor, manufacturing engineer, and other team members, to address all opportunities...

Quality Engineer II This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Quality Engineer II, you’ll have the chance to provide process/quality engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Also provide process/quality engineering support to product development teams, helping to ensure development of highest quality new products. What...

The GMP Quality Operations Manager is recognized internally as an expert in the principles and application of quality assurance, compliance, and AI-enabled quality operations. The Quality Manager will provide QA support of manufacturing operations for the external manufacture of Cell & Genetic Therapeutic programs. This role will drive, review, and support activities related to product disposition, including review of batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation, while advancing intelligent digitized solutions for backlog triage, metrics generation, records reconciliation, and archiving to improve operational efficiency, compliance, and data integrity. Key Duties...

The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. This position performs and leads activities “on the floor” in support of batch records review and disposition while ensuring compliance with cGMPs policies and procedures. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. Key Duties and Responsibilities Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions Lead root-cause analysis and product impact assessment for investigations as a result of deviations,...

A Day in the Life In this meaningful role as a Quality Engineer II supporting Cardiac Ablation Solutions (CAS), you will play a vital part in ensuring product quality, safety, and reliability through post‑market activities. You will perform complaint investigations, partner closely with engineering teams to identify and escalate risk file signals, and support data‑driven decisions that protect patients and clinicians. This role supports the development and continuous improvement of procedures, processes, tools, and techniques used for product analysis and returned product evaluation. You will devise and implement inspection and testing methods for returned product, support test method validation efforts,...

This position is located in Lafayette, CO and supports the Acute Care & Monitoring (ACM) operating unit. The Principal Regulatory Affairs Specialist (Pr. RAS) provides regulatory leadership and strategic direction for the Core Respiratory product portfolio within ACM. This role is responsible for collaborating with cross-functional partners to develop, plan, and execute global regulatory strategies across early development, commercialization, lifecycle management, and business transition activities. This position is suited for a high-performing individual contributor who operates with a high degree of autonomy on moderately to highly complex programs. With limited supervision, the Pr. RAS sets objectives aligned with broader business...

Information Systems Sr. Manager – Technology Regulatory Compliance Lead Live What you will do In this vital role, you will lead the delivery of high-quality, robust, and reliable digital technologies and services within the Technology Organization, ensuring seamless support for business, project, and daily operations. You will be accountable for the computer systems compliance framework of the technology function, ensuring adherence to global regulatory requirements and Amgen procedures. You will lead the strategy for computer system validation (CSV), regulatory compliance, and inspection readiness for the technology team, proactively driving a culture of quality and continuous compliance. Serving as the...

Quality Compliance Associate Director - Microbiology What you will do In this vital role, you will serve as a Quality Compliance microbiology subject matter expert supporting contamination control, QC microbiology, manufacturing microbiology, inspection readiness, and technical consistency across Amgen Operations. This role partners with Quality, Manufacturing, Process Development, Regulatory Affairs-CMC, Cellular Sciences, site laboratories, and global technical networks to ensure science-based, compliant, and practical microbiology decisions. This is a full-time remote position Specific responsibilities include but are not limited to Serve as a microbiology and contamination control subject matter expert for Quality Compliance, QC laboratories, manufacturing, and site teams....

Quality Compliance Associate Director – Aseptic Processing What you will do In this vital role, you will serve as a Quality Compliance microbiology subject matter expert supporting contamination control, QC microbiology, manufacturing microbiology, inspection readiness, and technical consistency across Amgen Operations. This role partners with Quality, Manufacturing, Process Development, Regulatory Affairs-CMC, Cellular Sciences, site laboratories, and global technical networks to ensure science-based, compliant, and practical decisions. This is a full-time remote position Specific responsibilities include but are not limited to Serve as a aseptic processing and contamination control subject matter expert for Quality Compliance, Manufacturing, and site teams. Support...

Drug Substance Quality Assurance Specialist What you will do In this vital role within the Plant Quality Assurance organization, the Drug Substance QA Specialist provides quality oversight and compliance support for Drug Substance manufacturing operations at Amgen. Under minimal supervision, this role ensures adherence to cGMP requirements, quality systems, and regulatory expectations while partnering closely with Manufacturing, Facilities & Engineering, and other cross-functional teams to support safe, compliant, and reliable operations. The Drug Substance QA Specialist will be a member of the Drug Substance Plant QA team and provide Quality oversight for Drug Substance Manufacturing and supporting Facilities &...

Key Responsibilities Strategic Leadership & Sterility Assurance Governance Embed control contamination and aseptic assurance strategy and aseptic-by-design principles into future processes and product development programs Lead remediation plans following regulatory observations, ensuring proactive installation of appropriate aseptic assurance standards (QMS and standard work) across the business Champion continuous improvement initiatives including KPI trending and capability development in aseptic and sterility assurance domains and process confirmations Own and periodically review BMS's Global CCS as a living document, ensuring it reflects current regulatory requirements Establish, own, and govern BMS's global sterility/aseptic assurance and CCS performance metrics framework, including KPI definitions, network-level escalation...

Key Responsibilities Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management. This will involve collecting all the relevant inputs from the RBM framework (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections. As part of the upstream protocol authoring process, partner with Drug Development, in particular the CORM function, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure...

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by playing a crucial role in Quality Control Operations including sample management, equipment management and reagent management in the AstraZeneca Quality Control Laboratory. This position is essential for ensuring that the laboratory meets the high standards required for CGMP Quality Control Operations. This position operates on the following shift, and is subject to change Monday to Friday, 5X8, 9AM-530PM Responsibilities The candidate will be primarily responsible for...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – US Specialty combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – US Specialty combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – US Specialty combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications...

The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as a very knowledgeable in their discipline expert and in regulatory affairs submission management. Responsibilities Manages medium to high impact (with respect to internal...

The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as a very knowledgeable in their discipline expert and in regulatory affairs submission management. Responsibilities Manages medium to high impact (with respect to internal...

The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as a very knowledgeable in their discipline expert and in regulatory affairs submission management. Responsibilities Manages medium to high impact (with respect to internal...

The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as a very knowledgeable in their discipline expert and in regulatory affairs submission management. Responsibilities Manages low to medium impact (with respect to internal visibility, risk, complexity and...

The Senior Quality Engineer, Risk Management has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending,...

The Principal Quality Engineer – Automation and AI Enablement is responsible for ensuring that AbbVie's IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role provides leadership in defining, implementing, and optimizing quality systems through digital enablement and AI-driven solutions, collaborating directly with cross-functional teams. Focusing on modernizing communications, metrics management, SLC monitoring activities, and providing end-to-end audit and Corrective and Preventive Action (CAPA) support, the incumbent leverages automation and AI to strengthen cross-functional integration and quality oversight. They drive improvement initiatives, support audit readiness, ensure effective issue tracking and resolution, deliver actionable insights...

The Senior Quality Engineer, Risk Management has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending,...

The Senior Quality Engineer, Risk Management has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending,...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

In this exciting role as a Senior Supplier Quality Engineer in CardioVascular Surgery (CVS), you will work on supplier quality deliverables and lead supplier control activities for new product development programs for the Aortic portfolio. You will be responsible for supporting supplier quality excellence to enable the successful development and launch of programs supporting the Aortic portfolio of the business. This role collaborates with cross-functional teams and suppliers to ensure effective component development, qualification, and release processes that align with program timelines and regulatory requirements. The ideal candidate will have strong experience managing supplier changes during NPD programs, effectively communicating...

Join us as a Director Quality Assurance , where you will lead and direct the Site Quality Assurance Operations at our Cell Therapy 9950 MCD Rockville manufacturing site. This role offers an opportunity to develop strategic and operational plans, lead high-level projects, and define innovative solutions within complex areas of the business. You will be working on diversified tasks with a global team, providing you with exposure to new ways of thinking and helping us grow collectively and as individuals. What you will do Lead the new Quality Assurance team at the Commercial Cell Therapy Facility, supporting facility start-up and...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Overview At Lilly, we unite caring with discovery to make life...

Director, Product Quality Complaints Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that...

The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational excellence initiatives across Global Regulatory Affairs (GRA). The role is responsible for identifying, designing, and implementing process improvements that enhance efficiency, consistency, and quality across GRA processes. As a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. The Director applies deep subject-matter expertise and hands-on operational excellence experience to shape objectives and drive transformation aligned with GRA and corporate goals. This is a Boston based, hybrid position requiring 3 days/week onsite....

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of . Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements. What You’ll Work On Contributes to the development, maintenance and improvement of division supplier development quality program...

This is not a remote opportunity Traveling up to 5% Our team is looking for a Customs and Trade Compliance Analyst to be based out of our office in Irving, TX. Responsible for providing technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws including, 19CFR, 15CFR, FDA, USDA, other PGAs and data metrics. FTZ Operations and Compliance Administer and maintain FTZ operations in compliance with CBP regulations (19 CFR Part 146) and FTZ Board guidelines. Manage FTZ admissions, withdrawals, transfers, and inventory movements within the...

This role with lead CRM global Quality System Management and Audit, as well as CRM global Microbiology & Sterilization oversight, including direct oversight of the Sylmar Microbiology/Sterilization based team and operation for production manufacturing. WHAT YOU’LL WORK ON Organizing, hosting, and executing regulatory audits across the global CRM network. Develop and drive audit strategies and plan across CRM global network/sites, in alignment with increasing complexity from global regulatory agencies. CRM network microbiology and sterilization oversight, as well as direct leadership responsibility over Sylmar based micro/sterilization team and production operation. Drive sterilization acceptance approaches / compliance with appropriate standards across the...

The Senior Specialist, QA Investigations , is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines. Responsibilities Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems. May author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the...

About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

General Information Position Manager Quality Control Department Name Quality Operations Physical Location of Role Malvern, PA or Spring House, PA Manages all aspects of Quality Control (QC), in support of designated Innovative Medicine Supply Chain (IMSC) sites and supports Malvern Clinical Operations in full compliance with established cGMP and IMSC requirements. Activities include managing in-process testing, raw material testing, environmental monitoring sample testing, utility sample testing, validation sample testing, stability sample testing, method transfer and method validation sample testing, testing of reagents, media, and buffers, and other samples as appropriate. Other non-testing activities include sample management, equipment lifecycle...

We are searching for the best talent for a Director, Health Care Compliance Officer, Global Functions, for the Innovative Medicine business with responsibilities for areas within the Global Commercial Strategy Organization (GCSO) and Global Business Development. This role will primarily be based in Raritan, NJ. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. The candidate will audit/inspect/release all incoming company Animal Health pharmaceuticals, third party pharmaceuticals, medical devices, third party biologic and diluents...

Senior Specialist, Quality Risk & Governance What you will do Let’s do this. Let’s change the world! At Amgen, quality is more than compliance — it is a strategic capability that enables innovation, operational resilience, and trust across the product lifecycle. We are seeking a Senior Specialist, Quality Risk & Governance to help strengthen and evolve our enterprise GxP Quality Management System through proactive risk management and effective governance practices. This role combines a strong emphasis on Quality Risk Management (60%) with strategic and operational support for GxP Governance (40%) , helping ensure enterprise-wide visibility, escalation, decision-making, and continuous improvement...

About This Role As the Head of Quality for Device and Combination Products, you will lead the development and execution of the global quality strategy, focusing on devices and combination products. This role involves establishing cross-functional roles and serving as the primary quality representative for drug-device combination engagements. You will oversee the Global Quality Device organization, ensuring quality management across all stages from design to lifecycle activities. Your role is critical in ensuring inspection readiness and aligning regulatory regulations within Biogen's quality system, integrating engineering design and risk management. Your leadership will drive compliance with regulatory and quality standards while...

Principal Specialist, Software Quality Assurance This position works out of our Lake Forest, IL location in the Core Lab , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. As the Principal Specialist, Software Quality Assurance , you’ll be the division subject matter expert for the non-product software lifecycle, Data Integrity, and cybersecurity compliance. This position reviews and assesses software activities (e.g., suppler evaluations, lifecycle...

Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QA Site Director. Responsibilities Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities Member of the Laboratory Center of Excellence (COE) Serves as the standalone laboratory systems and site Maximo administrator Reviews and approves raw materials and commodities including ERP approval Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs...

This position ensures products meet safety, regulatory, and quality standards throughout the product lifecycle, from design and development to post-market surveillance for medical devices within combination products. Responsibilities include risk management, participation in root cause analyses, process validation, and maintaining Design and Development Files (DDF) related to medical devices. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products. Maintain and improve risk management files (ISO 14971) and Design...

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. The role works with a high degree of independence to provide QA Analytical support for commercial product stability programs and executes routine tasks and activities in support of QA Analytical function. Key Duties and Responsibilities Provides QA review of the GMP data in support of commercial product stability as required. Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support...

Join Genentech in South San Francisco, CA as a Principal Healthcare Compliance Manager, Advisory! Seeking a highly experienced senior compliance professional for a strategic role with significant organizational impact. As a Principal Healthcare Compliance Advisor, you will serve as the primary consultant for multiple business units, advising on and developing policy, guidelines, and training for complex risk areas. This role holds full strategic responsibility for understanding business priorities and advising across the compliance ecosystem. You will proactively research evolving regulations, influence the development of long-range plans and overall objectives for Genentech, and represent the department on high-impact cross-functional committees. Decisions...

The Counsel, AI Governance, Law & Compliance provides day-to-day legal and compliance support for the design, development, deployment, and ongoing oversight of AI systems across the enterprise. Sitting within the AI, Data and Privacy Law and Compliance department and reporting to the Head of AI Governance, Law and Compliance, this role partners closely with Business Insights and Technology (BI&T), Privacy, Data Governance, and business stakeholders to operationalize the company's global AI governance framework. The Counsel translates evolving AI laws, regulations, and standards (e.g., EU AI Act, OECD Principles, NIST AI RMF, ISO/IEC 42001, CPPA ADMT, China PIPL) into practical guidance,...

Position Responsibilities In close partnership with the regional strategists / liaisons and/or GRL Team leader, develop strategic and operational plan for the development and the registration of assets across Therapy Area. Lead development of strategy and content for US dossier in partnership with marketing application submission teams for indications that are at the regulatory filing stage; Develop contingency plans in conjunction with the GRL or Team Leader for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRT Develop and execute approaches to resolve regulatory issues and appropriately drive speed to patients. Develop predictions for expectations and...

We are searching for the best talent for a Director, Health Care Compliance Officer (HCC) supporting the U.S. Innovative Medicine (Pharmaceutical) business to be based in Titusville, NJ. This role provides strategic leadership for healthcare compliance within a highly dynamic and regulated environment, enabling compliant growth while advancing a modern, risk-based, and principles-driven compliance program. Purpose The Director, Health Care Compliance Officer will set strategic direction, provide compliance oversight, lead complex risk management initiatives, and drive operational excellence across the U.S. Innovative Medicine organization. This leader will serve as a trusted advisor to senior business and functional leaders, exercising sound...

This position works out of our Atlanta, GA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Quality Engineer II partners with Manufacturing, Operations, Engineering, and Quality teams to ensure products consistently meet quality, regulatory, and customer requirements. This role provides quality engineering support for manufacturing operations through investigation, analysis, risk assessment, continuous improvement, and quality system activities. The Quality Engineer II independently manages routine and complex quality activities while driving timely resolution of...

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input...

Quality Technician I This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. The Quality Technician I provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions. Assists engineers in developing methods and procedures to control or improve manufacturing processes. What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Assists engineering in...

Inspector II Quality Control This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. T he inspector provides an independent, unbiased evaluation of materials or the work of others. The results of the Inspector's evaluation is documented and communicated to organizational stakeholders with an interest in the evaluation's outcome - typically, this is supplier development and/ or manufacturing. The Inspector's approval certifies the...

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. We are recruiting for a Senior Regulatory Affairs Manager to join our team on-site in Alameda, CA. In this role, you will combine knowledge of scientific, regulatory and business issues...

This position works out of our Atlanta, GA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Senior Quality Engineer serves as the quality leader for assigned manufacturing operations and provides technical leadership across quality engineering activities. This role drives quality strategy, mentors quality engineers, leads complex investigations and improvement initiatives, and serves as a key partner to Operations leadership in achieving quality, compliance, and business objectives. What You’ll Work On Strategic Quality Leadership...

Manager Quality Engineering. This position will support the Structural Heart business and will be based in Caguas, Puerto Rico. On-site position. This position will provide support to our Medical Devices / Structural Heart business . Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of...

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. We are recruiting for a Senior Manager, Quality Systems to join our team on-site in Alameda, CA. In this role, you will ensure effectiveness of the quality system and consistent...

This position will support the Surgical Needles’ Manufacturing business within Medtronic’s Surgical Innovations group located in North Haven, CT. We are seeking a Senior Quality Engineer to join our team in North Haven, CT. This role is integral to ensuring the highest standards of quality and compliance in our medical device manufacturing processes. As a key member of our Quality team, you will collaborate cross-functionally to enhance product reliability, optimize processes, and uphold regulatory compliance. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our...

Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes worldwide....

The Associate Director is responsible for the review and approval of all US promotional materials and serving as the promotional regulatory expert with legal, medical and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company's policies, and support business objectives. Serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB, including complex regulatory questions and submissions for advisory comment. Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. Provide regulatory consultation in the development and implementation of US marketing strategy...

Quality Assurance At - the - Source Specialist, Cell Therapy Are you ready to foster an attitude of excellence? Join AstraZeneca's Global Quality Operations team as a Quality Assurance At-the-Source (ATS) Specialist , Cell Therapy at the Rockville Manufacturing Center (RMC) facility, the newest addition to our global supply network. We aim to make a direct impact on patients by delivering life-saving cell therapies. This is your chance to break new ground and leave a collective legacy! We are investing in internal capabilities across our R&D and manufacturing organizations to help us realize our ambition to discover and deliver next-generation...

Employer Shockwave Medical, Inc. Senior Quality Engineer Job Code A011.10369 Job Location Santa Clara, CA Job Type Full-Time Rate of Pay $145,205 - $155,369 Job Duties Provide Design Quality Assurance to efficiently deliver safe and effective medical device designs for manufacturing. Provide Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP and other applicable regulations, Work closely and partner with internal departments to ensure designs are aligned with company policies and procedures. Participate in design reviews and...

Johnson & Johnson is currently recruiting for a Staff Supplier Design Quality Engineer! This position will be located in West Chester, PA. The Staff Supplier/Source Design Quality Engineer supports new product development and design transfer activities by ensuring Supplier and Strategic Collaborator processes meet quality, regulatory, and TECA business requirements. This role leads process and test method validation, risk analysis (i.e. PFMEA), supplier qualification, and inspection planning, while applying statistical and quality engineering tools to decision-making. The position also provides quality system leadership across areas such as CAPA, nonconforming materials, complaints, inspections, and risk management, and works cross-functionally with...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be based in Titusville, NJ. Purpose The Senior Manager, Health Care Compliance Officer serves as a strategic healthcare compliance partner to Johnson & Johnson Innovative Medicine teams, enabling compliant growth through risk-based, principles-driven guidance and decision support. This role operates within a dynamic and highly regulated environment, translating evolving legal, regulatory, and policy requirements into clear, practical, and actionable guidance that supports both business objectives and ethical standards. Consistent with the Innovative Medicine compliance strategy, this position helps advance the evolution from a rules-based...

Johnson & Johnson is recruiting for a Senior Manager, ERP Quality - Global Product Lead , located in New Brunswick, JN or Raynham, MA! About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose The Senior Manager will be a part of the MedTech Supply Chain Digital organization, a transformation office aiming at modernizing our end-to-end Supply Chain digital capabilities by harmonizing our disparate ecosystem of 40+ major global MT ERP...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find...

Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionizing the way we do R&D. We’re uniting science, technology and...

Beam is seeking an experienced Clinical Quality professional at the Associate Director / Director level to join our grown Quality Team. Reporting to the Senior Director, Clinical Quality Assurance, this role will provide strategic and operational leadership for inspection readiness, program quality oversight, and vendor oversight as Beam advances toward its first regulatory submission and potential associated inspections. Responsibilities Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans. Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities. Support health authority inspections, including document review, response coordination, and follow-up remediation activities. Serve as the...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including antibody-drug conjugates (ADCs), complex biologics and small molecules. Our goal is to accelerate access...

Johnson & Johnson is currently recruiting for a Senior Analyst- Data Quality & Automation to to be based in Raritan, NJ. Consideration will also be given to Mexico and Bogota. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) Mexico City, Mexico- Requisition Number R-081827 Bogota, Columbia - Requisition Number R-081827 Remember, whether you apply to one or all of...

Under General Direction and in accordance with all applicable federal, state, and local laws/regulations and company procedures and guidelines, this position Implements methods and procedures for inspection, testing and evaluation. Supervise and train Quality Technicians. Evaluates performance and provides opportunities for growth. Communicates department objectives and metrics. Implements changes in methods, tooling and equipment, space allocations, workforce utilization, production schedules, lines and other factors required to maintain or improve compliance with quality standards of existing products and to establish initial and continuing compliance. Supervises the timely evaluation of complaints and returned product. Provides input to budget planning process. Responsible for...

Johnson & Johnson is searching for a Senior Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, FL. The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. Our rapidly growing Velys Enabling Tech Operation is in need of a Senior Quality Engineer who provides overall quality assurance...

US Analytical Technology Solutions (US-ATS) supports all Animal Health sites globally in analytical method development, improvement, validation, transfer as well as in all kinds of analytical investigations This position will lead and oversee all aspects of analytical life cycle management activities for in-line licensed products including collaboration with cross-functional teams to ensure that deviations are resolved in a timely manner, and that corrective actions are effectively implemented. The Analytical Technical Solutions (ATS) Site Lead provides strategic, scientific, and operational leadership for analytical development activities across US sites. The role ensures compliant, efficient, and innovative analytical support for biologics, vaccines, and...

The Senior Device Quality Engineer provides quality and compliance leadership for manufacturing and packaging equipment at the Zebulon, NC site, ensuring systems and processes used to produce respiratory and solid dose medicines operate in full compliance with FDA, ISO 13485, GxP and GSK Quality Management System (QMS) requirements. This role supports new product introductions and site expansion , owns key elements of the device/equipment quality lifecycle (qualification, validation, change control, deviations, CAPA), and acts as a primary quality interface with Engineering, Production and Technical teams to maintain a strong safety and quality culture and inspection readiness. This role will provide...

The GRS-CMC Director is responsible for overseeing management of multiple development and life-cycle management projects of varying priorities and complexities. Represent GRS-CMC on cross functional teams, governance committees, and due diligence /in-licensing projects. Represent BMS at Health Authority meetings. Serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities. Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external regulatory engagement for themselves and/or members of their team. Duties/Responsibilities Develop and communicate strategic direction based on global regulatory guidelines and experience Prepare or oversee preparation of CMC submissions while ensuring...

The Director, Operational Excellence – Internal Quality is a people leader who owns the vision, strategy, and operating model for Operational Excellence across Internal Quality. This role ensures strong strategy‑to‑execution alignment, delivering sustained improvements in compliance, efficiency, cycle time, cost, and right‑first‑time outcomes across Quality Assurance and Quality Control while maintaining inspection readiness and patient safety in a GxP environment. The role serves as the enterprise Operational Excellence leader for Internal Quality, aligning priorities to Quality and enterprise strategy, governing delivery, enabling the OE network, and ensuring measurable value realization across a portfolio of initiatives. This role will sit in...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will report to the Associate Director, Quality Assurance within the PDM External Quality...

About this role The Sr. Manager, Compliance provides strategic, tactical, and operational leadership for compliance across the RTP Drug Substance Manufacturing site. This role is responsible for ensuring the site always remains inspection-ready, maintaining adherence to global regulatory requirements, and driving continuous improvement across quality systems. As a key member of the Site Quality Leadership Team, this leader partners closely with cross-functional stakeholders to strengthen compliance oversight, risk management, and data integrity while fostering a strong quality culture. What you’ll do Lead site-wide compliance programs, including inspection management, regulatory interactions, and response coordination Oversee data integrity compliance across computerized and...

About this role The Sr. Manager, Plant Quality Assurance plays a critical role in ensuring the quality and compliance of manufacturing operations. This position is responsible for leading material and batch disposition activities across multiple manufacturing platforms, supporting both clinical and commercial supply. Working cross-functionally with Manufacturing, Quality Control, Supply Chain, and MSAT, this role ensures decisions are accurate, timely, and aligned with Biogen’s Quality Management System, while driving a strong quality and compliance mindset across operations. What you’ll do Lead material and batch disposition activities, including review of batch records, test results, and supporting documentation Make compliant, risk-based decisions...

About This Role The Sr. Associate II, Compliance plays a critical leadership role in ensuring the RTP Drug Substance Manufacturing site maintains a strong state of compliance and inspection readiness. This position partners closely with Site Leadership and Quality teams to oversee inspection management, data integrity, and quality systems, while driving continuous improvement across local and global processes. This role is instrumental in ensuring adherence to regulatory requirements and strengthening a culture of quality and compliance across the organization. What You’ll Do Lead site compliance and inspection management activities, including planning, execution, and regulatory response coordination Ensure the site remains...

About this role The Sr. Associate III, Compliance - Data Integrity is a key leadership role supporting the RTP Drug Substance Manufacturing site, with a strong focus on ensuring data integrity, compliance, and inspection readiness. This individual partners across Quality, Manufacturing, and Site Leadership to strengthen data integrity practices, oversee quality systems, and ensure adherence to global regulatory standards. The role plays a critical part in driving a culture of compliance, continuous improvement, and operational excellence across the site. What you’ll do Lead data integrity compliance initiatives across manufacturing and Quality Control environments Ensure compliance with global regulatory requirements including...

About This Role As the Head of IT Quality, you will spearhead the strategic direction for ensuring that Biogen's digital systems meet global quality and compliance standards, while facilitating efficient and cost-effective delivery. You will lead enterprise-level quality oversight of business-critical IT systems, including governance of GxP processes, system validation, and IT change control in line with regulatory expectations such as FDA guidance and EU standards. Your role will also establish oversight of quality policies related to Artificial Intelligence, ensuring compliance with emerging global frameworks and industry best practices. Moreover, you will be responsible for defining and driving the enterprise...

About This Role As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality oversight of design control and risk management activities for combination products and medical devices. This senior-level position requires you to work closely with device development teams, medical device suppliers, and testing partners during the design and development phases, extending your support throughout the device lifecycle. Your expertise will drive the development, implementation, and continuous improvement of device-related quality processes and procedures, ensuring compliance with relevant standards and regulatory requirements. By providing strategic guidance and oversight, your role will be integral...

About this role The Sr. Associate III, Compliance – Risk Management provides operational leadership for Biogen’s RTP drug substance manufacturing site, with a focus on quality risk management (QRM), inspection readiness, data integrity, and compliance systems. This role is responsible for ensuring the site always remains in a state of control and inspection-ready, supporting both domestic and international regulatory expectations. As a key member supporting site leadership, this individual will drive continuous improvement across quality systems while promoting a strong compliance culture aligned with cGMP and Biogen Quality Management System standards. What you’ll do Lead and manage the site Quality...

The Complaint Investigation Engineer role is critical to ensuring product quality, patient safety, and regulatory compliance. This position is responsible for leading and managing complaint investigations, performing thorough root cause analysis, and driving effective Corrective and Preventive Actions (CAPAs). The role also oversees risk management activities through the Internal Investigation Assessment (IIA) process to ensure that potential risks are properly evaluated and mitigated. Additionally, this position is responsible for analyzing and trending complaint data to identify systemic issues and opportunities for continuous improvement. Effective management of complaint investigations and CAPA activities is essential to maintain compliance with quality system regulations...

Are you a people leader who thrives at the intersection of quality, rigor, and impact? Medtronic is seeking a Business Process Improvement Manager focusing on Clinical Quality to lead and elevate how clinical quality and compliance show up across daily work and deliverables within the Surgical organization. This role offers a unique opportunity to lead a team that plays a critical role in protecting patients, strengthening trust, and ensuring operational excellence in a highly regulated environment. In this leadership role, you will develop and empower a high performing team through clear prioritization, coaching, and readiness for training and inspections—while proactively...

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. MAIN PURPOSE OF THE ROLE The Quality Control Inspector I p erforms inspection and testing of purchased materials, components and products in accordance with policy and procedures MAIN RESPONSIBILITIES Performs visual, dimensional and functional...

ROLE SUMMARY Our Global Cybersecurity Governance, Risk, and Compliance (GRC) team defines the blueprint for cybersecurity excellence by embedding governance, risk management, and compliance into every layer of the organization. The team enables consistent, risk‑based decision‑making and ensures that security, privacy, and regulatory requirements are seamlessly integrated across Pfizer’s global operations. We are seeking an experienced Director to serve in a strategic leadership role within the Security GRC organization, acting as the primary security representative for mergers, acquisitions, and divestitures. This role is accountable for ensuring security risk identification, regulatory alignment, and secure integration across the full transaction lifecycle—from diligence...

Manager QA What you will do In this vital role you will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support GMP Manufacturing and to manage change in an effective, efficient and compliant manner. This individual will be responsible for overseeing our Day shift Plant Quality Assurance teams, who work 7am-7pm. Additional Responsibilities Independently determine approach to managing daily operations; guided by general policies and management guidance Develop or contribute to the development of procedures and standards by which others will operate. Interpret and execute standards and procedures directly affecting work activities Develops...

The Senior Quality Engineer – IVD Devices is a senior subject matter expert responsible for ensuring the quality, safety, and regulatory compliance of IVD devices across the full product lifecycle—from early development through commercialization and lifecycle management. Partnering with the Senior IVD Director, this role requires deep technical and regulatory expertise including EU IVDR, FDA 21 CFR Part 809/812/820, ISO 13485, ISO 18113, and ISO 15189. The incumbent serves as a strategic quality partner to cross-functional teams including R&D, Regulatory Affairs, Manufacturing, Clinical, and Laboratory Operations, providing expert guidance on design controls, analytical validation, clinical performance evaluation, and post-market quality...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly is seeking a Senior Director of Global Cyber Compliance to...

R-246261 Senior Associate - Regulatory Affairs What you will do In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements. To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions To assist the Global Regulatory Lead to manage GRT interactions Key responsibilities include Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities Covers all GXP audit in areas of current, Good Clinical Practices (GCP),...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. The Senior Quality Systems Specialist will serve as the primary interface between Medtronic and external customers for a designated business, while owning and optimizing the Quality Management System (QMS) processes that support customer-related activities. This role combines hands-on customer support (orders, changes, complaints, RMAs)...

In this exciting role as a Senior Quality Engineer on the Plymouth Nathan Lane sustaining and project quality engineering team, you will be responsible for being the quality voice and executing on a broad range of projects. Projects supported in this role to support the Peripheral Vascular Health (PVH) platform can span from capacity expansion, equipment end of life replacement, yield improvement, technology change implementation, quality improvement, and lean transformation initiatives. This role will collaborate with a wide cross-functional group both inside and outside the facility. This is an in-person/on-site role with very limited travel required. At Medtronic, we bring...

The Cardiac Rhythm Management operating group is a division within Medtronic focused on developing and manufacturing medical devices and solutions for the management of cardiac arrhythmias and heart failure. This group’s product portfolio includes implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. CRM’s mission is to improve patient outcomes and quality of life by providing innovative therapies for the detection, prevention, and treatment of abnormal heart rhythms. The group collaborates closely with healthcare professionals and leverages advanced technology and data-driven insights to drive improvements in cardiac care. At Medtronic, we bring bold ideas forward...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative...

The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams. This On-Site...

DePuy Synthes is recruiting for a Director, Analytics & Compliance, located in Raynham, MA The Director, Analytics & Compliance serves as a senior leader responsible for shaping and executing analytics strategies that strengthen business performance while ensuring compliance with regulatory, legal, and internal governance requirements. This role provides strategic leadership across analytics, data‑driven decision‑making, and compliance monitoring, partnering closely with cross‑functional stakeholders to enable innovation, transparency, and risk‑aware growth. The role offers a unique opportunity to influence enterprise‑level analytics capabilities while reinforcing a strong culture of integrity and compliance across DePuy Synthes. Key Responsibilities Provide strategic leadership for analytics and...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Quality Assurance Senior Supervisor to be located in Athens, GA . Purpose The Quality Assurance Senior Supervisor is responsible for the effective supervision and operation of the site Quality Investigation Unit,...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Quality Control Investigation Analyst to be located in Athens, GA . Purpose Assists with data analysis, and lab investigations. Supports data review and metrics reporting. The Investigation Analyst is responsible for...

Johnson & Johnson is currently recruiting for a Manager – Data Quality and Automation to be based at Raritan, NJ. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at About the Role This role will own strategy, governance, and execution of data quality across J&J’s global supply chain data ecosystem with key focus on forward-looking AI implementation and efficiency gains via automation. The role will ensure that data powering supply chain...

We are searching for the best talent to be a Senior Counsel, Regulatory Law, MedTech. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Johnson & Johnson Global Legal Organization (“GLO”) is recruiting for a Senior Counsel, Regulatory Law, MedTech to support Johnson & Johnson MedTech. This position can be based in New Brunswick, New Jersey, Washington, D.C., Santa Clara, California, or Danvers, Massachusetts . Purpose This Senior Counsel position...

DePuy Synthes is recruiting for a Director, Quality (NA) located in Raritan, New Jersey, West Chester, Pennsylvania, Palm Beach Gardens, Florida, Raynham, Massachusetts, Warsaw, Indiana. The Director, Quality (NA) – IT provides strategic leadership for quality, validation, and testing across North America–based information technology solutions supporting DePuy Synthes. This role is accountable for ensuring technology platforms, systems, and processes meet regulatory, compliance, and business quality standards while enabling speed, reliability, and scalability. The Director partners closely with IT, Digital, Cybersecurity, and business leaders to embed quality into the full technology lifecycle and to drive continuous improvement across enterprise systems. Reports...

We are searching for the best talent for Design Quality Engineer II role to join our MedTech Quality organization located in Danvers, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The ideal candidate for the Quality Engineer position will lead various New Product Development activities as well as play a role in product risk management, manufacturing qualifications, and design controls. This engineer should excel in an environment that embraces...

We are searching for the best talent for Sr. Validation Engineer. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Responsibilities Take charge of the validation efforts for new manufacturing processes, guaranteeing consistency...

DePuy Synthes is recruiting for a Manager, Regulatory Intelligence located in Raynham, Massachusetts, Palm Beach Gardens, Warsaw, NJ RARITAN The Manager, Regulatory Intelligence is responsible for leading the global identification, monitoring, and interpretation of evolving regulatory requirements, health authority expectations, and industry trends. This role translates external signals into actionable insights and structured intelligence that inform regulatory strategy, enable proactive risk management, and support compliance and market access across the product lifecycle. Key Responsibilities Regulatory Intelligence & Surveillance Lead end-to-end global monitoring of regulatory changes, guidance, and enforcement trends across key health authorities. Establish and execute structured surveillance processes across...

About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

DePuy Synthes is recruiting for a Quality/Compliance Analyst – Customer Service , located in New Brunswick, NJ, West Chester, Pennsylvania, and Raynham Ma . Remote locations may be considered. This role is responsible for executing and supporting regional operations in the areas of Document Management, Quality, Compliance, and SOX Reporting and for providing superior advisory and analytical support to internal and external customers enabling the compliant execution of critical customer focused operations. Key Responsibilities Day-to-Day Activities 70% Support and continually work within the parameters established by a risk-based Quality Management System framework. Serve as the Customer Service (CS) Subject...

DePuy Synthes is recruiting for a Compliance DS Director, located in Massachusetts, US. The DPS Compliance Director is responsible for overseeing the entire DPS GS Compliance team, including governance of outsource SOX testing provider. The role will be based in DPS headquarters and will lead a team in GS hub footprints in Manila & Bogota . Key Responsibilities and Deliverables People & Org Change Management Coordinate cross ‑ functional workstreams and dependencies to deliver a fit for purpose L2 Compliance Organization Hire, Lead, coach and engage finance compliance team members assigned to DPS Support organizational design inputs and staffing decisions...

The Senior Quality Systems Specialist – Data Integrity and Risk Management proactively contributes to risk identification, assessment, mitigation, governance, and reporting. Ensures communication and reporting efforts follow global and local requirements to produce value-added, actionable risk analytics and governance information. Oversees the local risk assessment periodic review program and ensures site adherence to periodic review schedules. Manages the local risk register and maintains active involvement in reporting out and up to the platform and risk management Community of Practice forums. Assists in the es and implementation of Risk Management Systems designed to identify, eliminate or reduce, and insure against potential...

As the Global Regulatory Lead on our Global Regulatory Affairs, Oncology Team, you’ll be fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi’s diversified portfolio in order to meet corporate and business objectives. The GRL is the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT). Ready to get started? Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions....

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

This position is located in Lafayette, CO as part of the Acute Care & Monitoring (ACM) group. The Associate Regulatory Affairs Specialist (RAS) is responsible for collaborating, planning and executing regulatory activities related to the Nellcor™ pulse oximetry monitoring and digital solutions HealthCast™ remote patient monitoring product portfolios within the Acute Care and Monitoring operation unit. This is an ideal opportunity for someone early in their career who is excited to learn, collaborate, and build a strong foundation in regulatory affairs within a highly technical, fast-paced environment. As an Associate Regulatory Affairs Specialist, you’ll support regulatory strategy and execution for...

PURPOSE AND SCOPE OF POSITION The QC Senior Scientist is responsible for supporting the analytical testing at QC Analytical Testing department at the CAR T manufacturing facility during clinical and commercial phases. This department is responsible for flow-cytometry and molecular based testing for stability, validation, critical reagent qualification, training, and other critical support as needed. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. This is Wed-Sat day shift. REQUIRED COMPETENCIES (Knowledge, Skills, and Abilities) Advanced hands-on experience with various analytical techniques including flow-cytometry, molecular techniques and scientific knowledge in...

Manager , Quality Control Analytical , Cell Therapy Sunday - Wednesday (4x 10 hour day shift) Role Overview The Manager , QC A nalytical , provides managerial , operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability testing . The role focuses on right ‑ first ‑ time analytical assay execution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell ‑ based assays) and end ‑ to ‑ end laboratory readiness, including people and equipment oversight . Responsibilities span management of a routine testing team, testing execution, laboratory operations management,...

Manager , Quality Control Analytical , Cell Therapy Wednesday - Saturday (4x 10 hour day shift) Role Overview The Manager , QC A nalytical , provides managerial , operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability testing . The role focuses on right ‑ first ‑ time analytical assay execution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell ‑ based assays) and end ‑ to ‑ end laboratory readiness, including people and equipment oversight . Responsibilities span management of a routine testing team, testing execution, laboratory operations management,...

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. We are seeking an experienced, high caliber Quality Engineer I for our Liberty, South Carolina location. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new...

Senior Regulatory Affairs Specialist This position works out of our Itasca or Chicago, IL (Willis Towers) location in the Abbott Molecular Division . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, North America Regulatory Liaison. This position is a hybrid role and will be located in Spring House, PA. The Senior Manager, North America Regulatory Liaison will serve...

Johnson & Johnson is currently recruiting for a Quality Operations Manager! This position will be located in Cornelia, GA. Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals. Implement and lead the quality operations organization for the Ethicon Cornelia, Georgia site by Planning, coordinating, and directing quality assurance programs designed to ensure continuous production of products...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Responsibilities The Principal Associate QA-FUME is responsible for providing oversight to...

The Batch Record Reviewer audits manufacturing and packaging batch records for accuracy and compliance to AbbVie policies and procedures and performs transactions in inventory systems to release the batch for further processing. Responsibilities Review and audit the data and records generated by Manufacturing and Packaging Operations in the processing of a material or product batch Ensure any batch record errors are corrected, all batch record components are present, and exception documents are referenced and approved Ensure all in-process and release testing is complete and all Quality holds are released Interface with various electronic databases/systems to interpret data pertinent for release...

Performs functions associated with cGMP manufacturing operations within the drug product manufacturing and packaging facility, including performing visual inspection of both finished and in-process materials, verifying manufacturing data in the batch record system, and conducting testing on in-process materials. Uses sophisticated programs (such as POMS and SAP) to evaluate operating data, which can be used to determine acceptable quality limits and product release requirements. Responsibilities Responsible to enter test results in manufacturing systems such SAP, POMS, and LIMS. Interprets experimental data for conformance with product and material specifications. Perform in-process laboratory tests such as Karl Fischer and Torque removal testing,...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

About This Role As the Director of Quality Risk, Auditing and Governance, you will lead a dynamic team dedicated to developing and executing Biogen’s comprehensive Quality Risk Management, Auditing, and Governance programs. This pivotal role involves creating and maintaining a robust quality risk management framework that integrates seamlessly with Biogen’s Quality Management System and other risk management processes. You will oversee internal and external quality audits, ensuring that manufacturing and testing sites, distributors and suppliers meet the highest standards. Your leadership will be critical in establishing and continuously improving Biogen’s quality governance framework, driving transparency and accountability through metrics and...

About This Role As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence. Leading the charge in designing, implementing, and sustaining the enterprise Quality Risk Management (QRM) capabilities, your role is pivotal in aligning with ICH Q9 and global regulatory expectations. Reporting to the Director of Quality Risk Auditing & Governance, you will be the primary enterprise lead for the execution of QRM, ensuring that risk-based thinking is interwoven into our Quality Management System (QMS), operational decision-making processes, and organizational culture. Your leadership will drive the standardization of QRM methodologies,...

The Cardiovascular Surgery Operating Unit is a specialized clinical environment designed to support complex surgical procedures involving the heart and major blood vessels. Equipped with advanced imaging systems, precision surgical instruments, and integrated patient monitoring technology, the unit enables surgical teams to perform procedures such as coronary artery bypass grafting, valve repair or replacement, and aortic surgery with high levels of accuracy and safety. The space is typically designed to facilitate multidisciplinary collaboration among surgeons, anesthesiologists, perfusionists, and nursing staff, while maintaining strict sterile protocols and efficient workflow to optimize patient outcomes. At Medtronic, we bring bold ideas forward with...

The Executive Director, Microbiology Quality Sterility Assurance (MQSA) is a pivotal global leadership role within BMS's Corporate Quality organization. This position brings critical expertise in sterility assurance, microbiological controls, and contamination control strategy across BMS's internal and external commercial and PD manufacturing sites — spanning pharmaceutical, biopharmaceutical, cell therapy and radiopharmaceuticals. This role is responsible for defining, owning, and governing BMS's enterprise-wide Contamination Control Strategy (CCS) as a living, risk-based framework — ensuring alignment with EU GMP Annex 1, FDA, and all applicable global regulatory standards. The Executive Director serves as the global Single Point of Contact (SPOC) for all...

Perform method transfer/ validation/verification and routine testing of materials and lead retain sample management activities. Anticipate and perform routine troubleshooting and problem solving with minimal guidance. Perform data verification, data review and review of GMP documentation for general and complex methods. Perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts. Train and mentor others on QC test methods, processes, and procedures. Perform other tasks as assigned. Specific Knowledge, Skills, Abilities Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Demonstrated technical writing skills. High problem-solving ability/mentality, technically...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Senior Director, Quality Control (QC Head) at Gilead, you will be responsible for providing strategic leadership and end-to-end oversight of...

The Manager, Quality Control is a key position that provides oversight of a variety of analytical functions that occur in the QC department supporting testing, and reporting of in-process, release, and stability samples. This role also ensures activities occur in an efficient and cGMP compliant manner. The role will have formal people management responsibilities Key Duties and Responsibilities Manages various laboratory program(s)/processes within the department (assay readiness, training, sample management, data review and reporting) and serves as QC representation at triage and QC of contact for Quality Events. Coordinates and facilities laboratory activities to meet commitments on-time Ensure lab personnel...

Are you ready to steer US promotional regulatory strategy in a way that accelerates responsible growth and earns patient and prescriber trust? This role translates science into clear, compliant communication across healthcare professionals, consumers, and payers—so that what we say is as strong as the medicines we deliver. As Director of Promotional Regulatory Affairs, you will set the regulatory guardrails that enable confident brand execution and speed. You will partner closely with Medical, Legal, Commercial, and Corporate Affairs to shape claims early, guide labeling implications, and ensure promotional materials meet the highest standards across all channels—from print and broadcast to...

Manages subordinate QA management and experienced QA specialist employees who exercise significant latitude and independence. Often heads one or more departments. Establish operating policies and procedures that affect departments and subordinate sections and work units. Interprets companywide policies and procedures. Develops budgets, schedules and performance standards. Assignments are objective oriented. Work is reviewed in terms of meeting the organization's objectives and timelines. What You’ll Work On Interacts frequently with internal and external management and senior-level representatives concerning projects, operational decisions, regulatory requirements, scheduling requirements and or contractual clarifications. Leads briefings and technical meetings for internal and external representatives....

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. May serve as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. O rganization Overview At Lilly, we serve an extraordinary purpose. We...

The Principal Regulatory Strategy Specialist is an individual contributor within Global Regulatory Affairs responsible for supporting and partnering with Regulatory teams across the organization as they shape and advance regulatory strategies aligned with Medtronic’s business goals and objectives. This role will partner closely with operating unit teams to provide additional expertise and guidance on complex, novel, and strategically important regulatory questions across the product lifecycle, including supporting effective due diligence for acquisitions. This role will help teams assess options, anticipate obstacles, and develop practical, risk-based pathways for innovative technologies across Medtronic, including but not limited to software-enabled products. The role...

The Senior Design Quality Engineer, supporting Released Product Engineering (RPE) within the Acute Care & Monitoring (ACM) Operating Unit, drives product quality, reliability, and regulatory compliance through technical expertise and cross‑functional leadership. This role partners with R&D, regulatory, manufacturing, and program teams to ensure design changes and sustaining engineering activities meet internal quality standards and global regulatory requirements. The Senior Design Quality Engineer plays a critical role in applying Design Controls, Risk Management, and Change Control processes to evaluate, implement, and release product improvements across the ACM product portfolio. If you are passionate about solving complex technical problems, improving product...

Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. SENIOR REGULATORY AFFAIRS SPECIALIST - Global Markets (High-Risk Devices) Neuromodulation Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life. Check...

CardioVascular Surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac Operating Room by offering an unparalleled depth and breadth of portfolio. Key Technologies Surgical heart valves Cardiac OR solutions (e.g., blood management, cannulae) Extracorporeal life support Coronary artery bypass grafting (CABG) solutions Advanced endovascular therapies across the entire aorta The Senior Engineering Program Manager role is for a Quality Core Team Member directly supporting new product development in CardioVascular Surgery. The role is responsible for managing the extended...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors, you will provide leadership for the development and implementation of innovative pure device and combination product regulatory strategies particularly pertaining to the development, registration, commercialization and life cycle management with a focus on Human Factors,...

The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex procedures. This is an individual contributor role focused on GCP quality assurance oversight for clinical trials, including risk-based audit strategy, quality risk identification, issue escalation, CAPA support, compliance trend analysis, and inspection readiness. The role partners closely with clinical study teams and external stakeholders, including CROs, vendors, and investigator sites, to support quality outcomes across Vertex clinical programs. The ideal candidate brings direct, hands-on GCP...

The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This role requires a demonstrated ability to shape and drive end-to-end regulatory strategy across all phases of product development, from early-stage planning through post-market lifecycle optimization. This individual will provide tactical and strategic input and leadership across regulatory and cross-functional teams with the objective of delivering...

In this role, you will support routine microbiological quality control activities such as Rapid Sterility, Mycoplasma, Bioburden, Endotoxin, Growth Promotion, and Cell Aliquoting under approved methods and cGMP/GDP expectations. You will also perform environmental monitoring in classified GMP spaces, including non-viable and viable air sampling and surface viable sampling , while supporting aseptic processing areas. Additional responsibilities include incubation and enumeration of media plates and samples , processing plates for microbial identification through external laboratories, operating laboratory instruments in accordance with SOPs, and documenting data accurately in electronic systems following ALCOA+ principles. This position also supports lab housekeeping, inventory management,...

Are you passionate about Regulatory Writing? Would you like to have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us! Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science....

Are you ready to steer US promotional regulatory strategy in a way that accelerates responsible growth and earns patient and prescriber trust? This role translates science into clear, compliant communication across healthcare professionals, consumers, and payers—so that what we say is as strong as the medicines we deliver. As Director of Promotional Regulatory Affairs, you will set the regulatory guardrails that enable confident brand execution and speed. You will partner closely with Medical, Legal, Commercial, and Corporate Affairs to shape claims early, guide labeling implications, and ensure promotional materials meet the highest standards across all channels—from print and broadcast to...

That’s what makes us Roche! The Opportunity Are you ready to shape the future of quality management in healthcare? As an Associate Quality Lead within our Pharma Development Quality (PDQ) function, you will play a vital role in supporting the delivery of quality-focused strategies that reinforce trust in our Quality Management System (QMS). Working with a high degree of independence, you will collaborate with cross-functional teams to ensure our clinical and safety data meets rigorous global regulatory standards. In this dynamic position, you will have the unique opportunity to champion a culture of continuous improvement and innovation. By leveraging data...

As we are building out our Data Strategy and Operations organization, we are creating this role as part of our Master Data Process and Capability team. Our key accountabilities include design and maintenance of master data management governance policies and procedures that are aligned with business objectives and regulatory requirements. Our team enables End-to-End Master Data Management workflows, ensuring standardized global MDM processes that leverage technology for automating and orchestrating timely master data set-up. We coordinate master data management processes, maintain key data elements, resolve master data issues, and monitor data quality. By working closely with key partners, we manage...

Job Title Process Quality Engineer This position works out of our St. Paul, MN (New Brighton) location in the Abbott Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. What You’ll Do Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Support the investigation, resolution and prevention of product and process nonconformances...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose The purpose of the Associate Director / Director, Global Medicines...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Site Compliance Leader plays a critical role in managing compliance...

Global Regulatory Product Planning Senior Manager – Obesity What you will do The Regulatory Science and Patient Safety organization is seeking a Global Regulatory Product Planning Senior Manager to support a key strategic asset within the Obesity and Related Conditions Therapeutic Area, spanning multiple indications and global regulatory activities. This role serves as the integrated regulatory planning lead for the product, driving alignment, visibility, and execution readiness across multiple indications and all global regulatory activities. The individual will be responsible for maintaining a comprehensive view of regulatory priorities, milestones, risks, and dependencies to support predictable regulatory execution throughout the...

We anticipate the application window for this opening will close on - 12 Aug 2026 Position Principal Reliability Engineer- Software Quality for Covidien, LP. Responsible for various software quality assurance functions during the Product Development Process (PDP) development lifecycle of complex medical devices to identify software problems and their causes in partnership with Software Developers and Testers. Provide coordination to cross functional groups to ensure software quality objectives are met for product software, manufacturing software, quality system software and software technologies included or used in the creation or production of medical devices. Coordinate Medical Device Product Development (MDPD) and...

PSA is a global function responsible for the nonclinical safety strategy for the Vertex portfolio & therapies at all stages of discovery and development. Vertex Pharmaceuticals uses cutting edge science, technology, and novel therapies for the treatment of the most serious diseases with unmet medical need. The Exploratory and Regulatory Safety Sciences (ERSS) head leads a major functional area within PSA and plays a pivotal role in the development and implementation of the preclinical safety and risk management strategies for the Vertex portfolio (small molecule & VCGT) from VXc, FIH to Registration and loss of Exclusivity (LoE), ensuring that the...

Associate Director, Cell Therapy Trade Compliance Operations Introduction to role Are you ready to build a world-class trade compliance engine that keeps life-changing cell therapies moving on time to patients who are waiting? In this role, you will turn complexity into clarity—designing the operating model, shaping standards, and setting the pace for compliant, reliable import/export and FTZ execution across a growing cell therapy network. You will own the execution cadence and first-line escalation framework that safeguards chain of identity and chain of custody while meeting strict regulatory expectations. Your leadership will ensure patient materials, critical manufacturing inputs, intermediates, and finished...

Within Oncology Regulatory Affairs, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and optimally as possible. As an industry leading Oncology Regulatory function, we’re growing fast, and we’re as passionate about and committed to the development of our people as we are our business – providing an open and encouraging space to explore, learn, grow and develop across all roles and levels. At AstraZeneca, we share and are motivated by the same...

Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About AstraZeneca At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Oncology Regulatory Science and Strategy Within Oncology Regulatory Science and Strategy (ORSS) we bring...

AstraZeneca - Infectious Diseases At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of people, where the burden of disease is greatest. During the COVID-19 pandemic, we played an important role as part of a truly global effort to respond to a new and unprecedented challenge. We will continue to advance science in infectious disease therapies and work with partners to drive improvements in public health and ensure our science reaches millions more people. Role The Senior Regulatory Affairs Director (SRAD) leads the global regulatory strategy for complex products. They aim...

This position serves as the Medical Devices Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps MD RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process . WHAT YOU’LL DO Global Regulatory Operations is seeking a Regulatory Affairs Intelligence Specialist to join our team in St. Paul, MN. This position is focused on new and changing regulations that enable global market access for new and innovative medical devices and supports compliance continuity for marketed devices. Assisting in the process to evaluate proposed regulatory changes in...

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply....

This position serves as the Structural Heart (SH) Regulatory Affairs (RA) Global Regulatory Compliance process lead; collaborates cross-functionally as needed and keeps SH RA informed of key global regulatory changes and status of assessment / implementation for compliance via the QMS Process . Main Responsibilities Acts as SH RA representative for RA compliance related tasks in cross-functional team. Actively participates in all meetings and discussions and track assessment and implementation to completion Act as RA point of contact , and vendors. Provides mentoring and leadership to Regulatory Specialist I and II team members Required Qualifications Bachelors...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Site Quality Leader is primarily responsible for overseeing the execution...

Ensure GxP compliance to AbbVie policies/processes/procedures, global regulatory requirements, and industry guidelines. Remain current with major compliance trends and their application within the biopharmaceutical industry. Proactively evaluate organizational compliance needs and opportunities to improve efficiency and productivity. Responsibilities Adhere to codes of conduct and ethical principles and ensure compliance with applicable AbbVie policies and procedures. Utilize systems, documents, and tools to provide compliance support for centralized business function processes Manage compliance and process improvement initiatives to enhance efficiency and compliance. Anticipate and respond to unexpected occurrences and business needs with suggested solutions. Identify and appropriately escalate potential compliance risks, and...

Purpose AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients. Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie’s evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the...

About the Role We are seeking a highly skilled Senior Manager to join our dynamic team supporting biologics regulatory submissions. In this role, you will serve as the lead author for key Module 3 Common Technical Document (CTD) sections. You will apply your analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory submissions. You will be an integral member of cross-functional teams, collaborating closely with Quality Control, Quality Assurance, Regulatory, Analytical Research and Development, and Chemistry, Manufacturing and Controls (CMC) colleagues to deliver submissions to support commercial approval. The ideal candidate will have extensive analytical...

Ensure GxP compliance to AbbVie policies/processes/procedures, global regulatory requirements, and industry guidelines. Remain current with major compliance trends and their application within the biopharmaceutical industry. Proactively evaluate organizational compliance needs and evaluate opportunities to improve efficiency and productivity. Responsibilities Adhere to codes of conduct and ethical principles and ensure compliance with applicable AbbVie policies and procedures. Utilize systems, documents, and tools to provide compliance support for centralized business function processes Manage compliance and process improvement initiatives to enhance efficiency and compliance. Anticipate and respond to unexpected occurrences and business needs. Identify and appropriately escalate potential compliance risks, and recommend practical...

The Director of Financial Compliance and US Transparency Reporting (FCT) leads a high-performing team responsible for ensuring the integrity, accuracy, and effectiveness of AbbVie’s US Enterprise Federal ‘Sunshine’ and State Reporting program. With a strong focus on analytics and insights generation, data accuracy, process controls, and systems governance, this role oversees financial data monitoring and reporting for Health Care Professional (HCP) and Health Care Organization (HCO) interactions across all US Commercial Therapeutics business units and all US Aesthetics business units. Responsibilities Lead, coach, develop, and motivate a team of 20 financial professionals, providing strategic direction and fostering a culture of...

Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications. Influence the regulatory strategy of Recursion’s development programs by attending team meetings, providing drug substance or drug product recommendations for US, EU and Rest of World (ROW) regulatory requirements/guidance interpretation, and best practices for CMC submissions and meetings. Strategize , plan, write, manage internal and external contributors and review region specific investigational stage CMC summary submission documents (Module 2, Module 3, IMPD, etc.) and agency requests. Deliver high quality regulatory US, EU and ROW submissions, strategy and advice....

Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data, and superlinearly scaling our efforts to accelerate the delivery of high-potential drug candidates to the clinic. We are seeking an Associate Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks for the assigned programs. Collaborate with cross-functional leads to support the development of regulatory strategies and implementation for all jurisdictions as applicable to the program. Plan and perform critical reviews...

About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. Please note that this position is based...

We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. We have an exciting opportunity within US Medical Affairs for a Senior Manager in our Patient Access and Quality of Care (PAQ)...

The Principal RA Specialist will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes. This is an exciting opportunity with responsibilities for US submissions for new product introductions, which include breakthrough advancement in diabetes management and digital health technology solutions to address the...

Associate Manufacturing Line Quality Engineer (2nd Shift Position) This position works out of our Scarborough, ME location in the Infectious Disease , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Associate Manufacturing Line Quality Engineer (2nd shift position) is within our Infectious Disease business unit located at all sites under Abbott Diagnostics Scarborough Quality Management System (QMS). In this role you will provide...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we unite caring with discovery to make...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose The purpose of the Senior Director, Global Regulatory Affairs, Global...

About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing...

About the Role As a Quality Control Analyst I, you will execute routine in-process, drug substance, and stability test methods. Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower).Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal). How you will contribute Demonstrate a functional understanding of a laboratory setting and Standard Operating Procedures (SOP’s). Work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials...