Quality & Regulatory Jobs in Pharma & Biotech

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...

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...

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 Manager of Quality Systems Metrics and Management Review is responsible for overseeing and refining enterprise performance review processes, driving effective metric reporting, and leading the automation and modernization of data review mechanisms and data consumption. This role enables leadership teams to make informed decisions through clear, timely, and actionable insights while advancing digital transformation in operational processes. This position defines, implements, and monitors the performance of systems related to quality assurance across global internal manufacturing sites, third-party manufacturers, suppliers, and/or affiliates. Designs effective quality systems, procedures, and/or processes to ensure compliance as well as efficiency throughout the global network....

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,...

Regulatory Affairs Strategy Lead POSITION SUMMARY Plays a key role in supporting the development of regulatory strategy on behalf of the regulatory affairs team across Natera’s products and services. Combines strong technical knowledge and understanding of regulatory requirements within at least one regional expertise, e.g. US FDA, CAP/CLIA/NYS, EU, or Japan to support the approval and registration of Natera’s products and services. Represents the RA team to internal and external stakeholders through written and verbal communication within at least one product line. May represent RA in different core teams and change control initiatives. Maintains product registrations, change assessments and post-market...

GENERAL POSITION SUMMARY The Senior Manager, RDQ Compliance is responsible for leading quality assurance and compliance activities in support of Compliance and Issues Management. This role requires expertise in overseeing investigations, root cause analysis, CAPA development, and effectiveness checks, as well as the ability to educate and guide stakeholders in performing effective root cause investigations. The ideal candidate will have experience in linking issues and risks, conducting data analysis, performing spot checks, and leveraging data trending to identify patterns and drive continuous improvement. This individual will work closely with Quality Leads, Study Team members, and other stakeholders while exemplifying Vertex...

The External Manufacturing Director – Quality Control (ExM-QC) will lead the strategic and technical oversight of Quality Control (QC) activities to ensure the highest standards of product quality and compliance for Vertex’s biologics and combination device product across development, PPQ, launch, and commercial lifecycle. This role is pivotal in driving QC excellence, fostering collaboration with internal and external stakeholders, and ensuring adherence to cGMP regulations. Reporting directly to the head of ExM-QC small molecule and biologics, the Director will play a critical role in shaping QC strategies, managing external partnerships, overseeing investigations and supporting regulatory submissions. Key Duties and Responsibilities...

This position, Sr. Specialist, Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. 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. What You’ll Work On We are seeking a highly knowledgeable individual to combine expertise in scientific,...

Laboratory Supervisor Quality Control This position works out of our Gretna, LA location in the Toxicology , 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 Laboratory Supervisor Quality Control will oversee a small team and assist in preparing calibrators and controls, performing annual verifications, overseeing proficiency testing, assisting in method development and QC review, and other duties for which the individual is qualified...

Johnson & Johnson is recruiting for a Director, Bioresearch Quality Process Management , located at one of the identified Johnson & Johnson Medtech sites New Brunswick, NJ; Mountain View, CA; Cincinnati, OH; Jacksonville, FL; Miami, FL; Raritan, NJ; Irvine, CA; Palm Beach Gardens, FL; Santa Clara, CA and 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 Director, Bioresearch Quality Process Management, is a highly experienced and strategic...

Associate Director – Global Compliance Platform (C3) What you will do In this vital role you will be responsible for the strategic oversight, governance, and optimization of Amgen’s global compliance platform (C3). This role ensures the platform effectively supports the execution of Amgen’s global healthcare compliance framework and enables compliant business operations across regions. The Associate Director leads platform strategy, drives process improvement and system optimization, and partners closely with Technology, Compliance, and business stakeholders to ensure the platform evolves to meet changing regulatory and operational needs. Serving as the business product owner for the C3 platform, this role...

USE YOUR POWER FOR PURPOSE Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. WHAT YOU WILL ACHIEVE In this role, you will Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications. Conduct rigorous sampling and statistical process control procedures to identify deviations from standards. Approve investigations and change control activities to maintain compliance...

ROLE SUMMARY Our Global Cybersecurity Governance, Risk, and Compliance team provides comprehensive blueprints for cybersecurity excellence by embedding governance, risk management, and compliance into every layer. The team is responsible for ensuring risk-based decision-making is used and that security, privacy, and regulatory compliance is integrated seamlessly with Pfizer’s organization. We are seeking an experienced Senior Director, Security & Compliance to lead the Security and Compliance Business Partners function within the Cybersecurity GRC organization. This role partners closely with R&D, PGS Manufacturing, Commercial, Digital, Enabling Services and corporate functions to ensure cybersecurity, data protection, and regulatory compliance requirements are understood, implemented,...

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. Join Lilly’s Technological Revolution A Gateway to Innovation and Global Impact...

The Senior Quality Engineer – Combination Products External Quality is responsible for the quality of assigned suppliers/contract manufacturers to ensure business objective are me with regards to on time delivery of product while assuring compliance to AbbVie requirements, applicable external regulations, and standards. Products include injection molded components, and critical device components used to manufacture AbbVie On Body Injection Delivery Systems. Responsibilities Support supplier quality development projects and continuous improvement activities. Investigate/coordinate supplier quality issues resolution with the appropriate department, including the dispositioning of non-conforming product, event, deviation, and market complaints. Initiate and follow up on Supplier Corrective Action...

The Senior Manager, Quality (IQA/SQA) provides leadership and direction to the Quality Function they are responsible for within Operations. This Sr. Manager role is responsible for the effective implementation of AbbVie Quality Systems for which they are responsible for. This could include Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Quality Control, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives. The Sr. Manager of Quality leads a team of quality professionals who are responsible for compliance and quality oversight for the plant and/or strategic initiatives. Expectations that the...

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...

Will be an onsite position at our Irving, TX office. Traveling up to 10%. Our Core Lab team is looking for a Quality Operations Engineer out of our Irving, TX office. They will be responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. Heavy focus on the operation side, mostly with quality inspections. Responsibilities Responsible for implementing and maintaining the effectiveness of the Quality System. Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation. Assist...

Johnson & Johnson Med Tech is recruiting for a Vice President of Global Regulatory Affairs, Heart Recovery located in Danvers, Massachusetts! 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 Cardiovascular Are you passionate about improving and growing the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of...

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....

Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. The Reg ulatory Affairs Specialist ( RAS) develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to the market. The RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required . Primary responsibilities include developing global regulatory strategies; preparing US,...

Digital & Data Quality (DDQ) GMP AI Compliance Director We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and contribute to our mission of using the power of leading-edge science to save and improve lives around the world. Responsibilities Keep abreast of emerging regulatory trends pertaining to AI use in GMP/GDP operations. Define and implement standards for GMP/GDP use of AI-based tools and applications, including data management, quality risk management, vendor assessment, human-in-the-loop role,...

USE YOUR POWER FOR PURPOSE Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those who rely on our products. WHAT YOU WILL ACHIEVE In this role,...

Biologics Quality Control Incoming Materials Associate The Biologics QC Incoming Materials Analyst is responsible for the receipt, testing, and release of raw materials used in biologics manufacturing. This role supports laboratory operations and contributes to the Smart-QC initiative aimed at enhancing digital and operational efficiency across QC functions. Key Responsibilities Raw Materials Testing Receive and process incoming raw material samples in accordance with SOPs and regulatory requirements. Perform analytical testing (e.g., identity, purity, and quality assessments) using validated methods. Review Certificates of Analysis (CoA) and Certificates of Testing (CoT) from Contract Testing Labs (CTLs) and ensure accurate data...

Provide Quality oversight and approval regarding qualification and validation in compliance with regulatory regulations/guidelines. Administer and control the Validation program which includes equipment, processes, utilities, facilities, computers, cleaning procedures, laboratory equipment, and analytical methods to demonstrate that product will perform consistently as intended. Responsibilities Responsible for the audit, pre-approval and post-approval of all process validations protocols, cleaning protocols and analytical test method protocol as the QA signature. Maintain and control the Validation Change Control Program for the validated/qualified systems and the Validation Management System (VMS). Review and approval of Validation Master Plan. Create validation documents, such as Soltraqs Change Plans,...

Role Summary The Manager, US Regulatory Advertising and Promotion (US RAP) provides regulatory guidance and strategic support for the review of promotional communications, ensuring regulatory requirements and business needs are met in a manner compliant with regulatory standards and Pfizer internal policies. The Manager may interact with the Office of Prescription Drug Promotion (OPDP) or the Advertising and Promotional Labeling Branch (APLB) on routine matters, under the direction of more senior personnel. The Manager may mentor or provide guidance to more junior personnel within the group. Role Responsibilities Operate in collaboration with the lead US RAP Reviewer(s) to develop the...

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 and Position Overview Lilly recently announced a $4.5 billion investment...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – Eye Care 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 shares knowledge and expertise with others in support of team activities and analyzes broad scope implications...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – Eye Care 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 shares knowledge and expertise with others in support of team activities and analyzes broad scope implications...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – Eye Care 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 shares knowledge and expertise with others in support of team activities and analyzes broad scope implications...

Position Manager, Quality Assurance Shop Floor Support, Cell Therap The Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at the Devens Cell Therapy Facility in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs). In the capacity of QA Shop Floor Support, the Manager shall be responsible for handling Quality Assurance Shop Floor internal compliance and documentation tasks, routine communication to front line employees, and metrics/monitoring for key QASF processes. The incumbent will be considered a local process owner for core...

Provides senior-level Quality Engineering leadership across the medical device product lifecycle, ensuring compliance with regulatory standards and effective risk management in development and manufacturing activities. Serves as a subject matter expert and partner to cross-functional teams, leading complex investigations, supplier quality oversight, and quality system improvements. Drives data-informed quality strategy and operational excellence through KPI monitoring, risk mitigation, and continuous improvement initiatives supporting device constituents. _ Your Contributions (include, but are not limited to) Provide Quality Engineering leadership across the product lifecycle, ensuring effective quality oversight for medical devices and combination products Lead and facilitate complex risk management activities (e.g.,...

We are seeking a Principal 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 work. We’re working 5 days a week onsite as part of our commitment to fostering a culture of professional...

This position is located in Lafayette, CO as part of the Acute Care & Monitoring (ACM) group. The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Bispectral Index™ (BIS™) monitoring product portfolio within the Acute Care and Monitoring operation unit. This role is fit for an established, productive individual contributor and leader who works independently on moderately to highly complex projects or programs with limited general supervision. In the position, you will set objectives for your own work to align with broader project goals and actively contribute to key milestones....

At Medtronic, we A career at Medtronic is purposeful, mission-driven, and unlike any other. We are committed to alleviating pain, restoring health, and extending life for millions worldwide. 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 a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned. Develops...

The Principal Radio Regulatory Affairs Specialist is responsible for managing global RF/Wireless regulatory compliance activities for RF enabled devices within the Acute Care and Monitoring (ACM) Operating Unit. The Principal Radio Regulatory Affairs Specialist is dedicated to the Acute Care and Monitoring (ACM) Operating Unit. In this role, the specialist supports both New Product Development (NPD) programs and lifecycle maintenance activities across the RF enabled device portfolio. The specialist collaborates closely with Regulatory Affairs colleagues, cross functional partners at all levels, external test laboratories and certification bodies, and International Regulatory Affairs teams to ensure ongoing compliance with global RF, wireless,...

We are searching for the best talent for a Design Quality Engineer II, Lifecycle to be based in Danvers, MA. Purpose This person will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products! Activities will include risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support statistical analysis and more! This role’s emphasis will be in support of Abiomed’s existing single-use heart pumps. You will be responsible for Support and lead Design Assurance engineering activities in support of Abiomed’s Life Cycle processes including design controls,...

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. Develops and implements long-term strategy, and execution of Quality Control programs. Ensures department staff complies with all J&J, IMSC and government-issued environmental, health, safety, quality and regulatory policies and guidelines,...

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...

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 We are searching for the best talent for Software Design Quality Engineer II role to be located at Danvers, MA. The ideal candidate for the Software Design Quality Engineer II position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. The engineer should have the ability...

Manages Johnson & Johnson Vision Care's (JJVC) External Regulatory Requirements Management process and manages JJVC's process to assess new/revised J&J quality standards. Collaborates with various functional areas, partners with subject matter experts (SMEs) and regional regulatory affairs, to ensure assessments are initiated, actions are identified and completed, where needed, to ensure alignment with new/revised external standards, global regulatory requirements, and internal J&J quality standards applicable to JJVC's quality management system and JJVC's products. Monitors external requirements through various sources of information to ensure new/revised regulatory requirements applicable to JJVC are identified and evaluated. Provides support to quality system, quality system...

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 serve an extraordinary purpose. We make a difference...

This position works out of our Plymouth, MN 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. Hours 200PM-1100PM Monday-Friday What You’ll Work On Receive incoming materials and perform visual and dimensional inspections prior to production use Retrieve inspection schedules from SAP and prioritize work based on FIFO requirements Pull materials from the warehouse and transport them to the inspection lab for evaluation Perform the Receiving Inspection Process (RIP) following...

Quality Engineering Technician II (Second Shift) 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 Engineering Technician II (Second Shift) 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...

Working at Abbott 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. 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 will also have access to Training and career development , with onboarding programs...

Senior Manager Quality Operations The Senior Manager, Quality Operations is responsible for ensuring consistently high product quality while driving operational efficiency, leading the Quality Assurance function in alignment with Corporate and Divisional policies and regulatory requirements. This role develops, executes, and oversees quality systems and processes that strengthen controls, improve quality performance, and drive cross‑plant consistency across the organization. In addition, the Senior Manager provides strategic leadership for global QA initiatives and serves as the final authority for all product‑related decisions, including acceptance, release, and post‑production assessments, investigations, and complaint management. What You’ll Work On Effectively manage/develop the department...

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 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. This is an exciting opportunity with responsibilities for leading global regulatory submissions, which include but not limited to premarket submissions, pre-submissions and clinical trial applications, which include medical hardware and digital health technology solutions to address the spectrum of customer needs. This individual has department level influence...

The Director, Quality Assurance will be responsible for team leadership and subject matter expertise in Quality Operations, Facilities and Validation at the our Company's Rahway, New Jersey site. This position will serve a critical role in supporting the expansion of clinical development activities at the site with responsibilities including, but not limited to the following Execute GMP quality assurance activities directly related to facilities, equipment, and automation for clinical trial material supply capabilities. Support the design phases and operational readiness of multiple significant cross-modality capital projects that are aligned with the expanding site mission. Drive quality from design through qualification,...

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly,...

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly,...

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly,...

This position works every day on site out of our Carlsbad, CA location in the Cardiometabolic Division in Abbott Rapid Diagnostics. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is 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. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. In addition...

The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager, this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level. The Validation Engineer responsibilities may include the review of commissioning and validation documentation completed by others, leading, authoring or reviewing investigations and implementation of preventive and corrective action, review and authoring of plant standard operating procedures, review and approval of critical planned maintenance...

Purpose The Compliance Manager is responsible for the management and coordination of project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates in maintaining quality system documentation including but not limited to Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and participates in quality system management review. Oversees Global Product Surveillance CAPA program and is responsible for the site’s internal audits. Oversees internal, supplier and regulatory audits and preparation activities....

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, Label Operations and Warehouse Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This position is a people manager position, leading a team of individual contributors in the Quality Assurance Shop Floor Organization. Shift Schedule Wednesday to Saturday - 12-hour shift (every other Wed off) 5 a.m. to 530 p.m. Duties/Responsibilities Oversee performance of QA shop floor activities. Supervise Quality Assurance...

Quality Assurance Senior Associate, Drug Substance Plant What you will do Let’s do this! Let’s change the world! In this role as Senior Associate QA, you will be responsible for providing quality oversight to Drug Substance (DS) Cell Bank Manufacturing and Process Development (PD) laboratories at Amgen Thousand Oaks. Under general supervision, you will support and ensure compliance for Manufacturing, Facilities, and Engineering staff in their processes, procedures, and use of quality systems. You will engage directly with a diverse range of partners, establishing effective working relationships with production operators, line leads, shift supervisors, warehouse staff, facilities, maintenance, and engineering...

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Quality Control - Nights What you will do In this vital role you will...

Associate Quality Control What you will do Let’s do this! Let’s change the world! The Associate Quality Control will provide analytical testing support for the Quality Control Microbiology laboratory at Amgen, Thousand Oaks. The QC Microbiology lab supports testing from the beginning to the end of a product’s lifecycle, from Process Development to final Drug Product. Some of the tests that the Associate may perform on a routine basis include Total Aerobic Count, Sterility, Biological Indicators, and Polymerase Chain Reaction, among other tests. Responsibilities include Execution of QC Microbiology assays following assigned procedures Analysis of analytical test results and reporting...

Quality Technician This position of Quality Technician works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine Division. The Quality Technician is responsible for bioanalytical and/or platform quality testing within the WWLIMS or QIMS system and SAP system. Provides inputs to facilitate CAPA investigations as required. Maintains product and testing inventory and complies with the quality system. Undertakes the role of a Quality Technician with minimal supervision. Redline documents and reviews operating procedures when needed. Execution of daily activities with minimal supervision. Accountability/Scope Individuals execute daily testing in a high-paced laboratory environment. Identify and...

CAPA 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 feel...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Senior Clinical Quality Specialist is part of the clinical affairs team, which is responsible for planning, executing, managing, and closing projects associated with the company clinical study plans. The Senior Clinical Quality Specialist will partner with the...

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 Verve Therapeutics, a wholly owned subsidiary of Eli Lilly...

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 Senior Director/Executive Director, Clinical Development Safety Leader, is a...

About the role This position supports the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. How you will contribute Lead the execution of CD/PQ/CV/PV/RV activities. Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts. Supervise and manage contractors or consultants as needed. Participate in change control review board. Track and trend...

This position will work on pre-market and post-market changes for the Pelvic Health Operating Unit. SENIOR REGULATORY AFFAIRS SPECIALIST Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance , foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value...

This is a seasoned individual contributor role responsible for developing, implementing, and maintaining rigorous quality standards and protocols during the sustaining and post-market phases of the product lifecycle. The Specialist serves as a key technical expert, working with limited supervision, who must demonstrate substantial expertise in risk management (e.g., assessing product risk and supporting field actions). This role involves providing design-quality oversight for product changes (including design change analysis and DHF maintenance), and using advanced inspection, testing, and statistical analysis methods to ensure product precision, accuracy, and compliance with all required standards and documentation. A successful candidate will drive process...

As part of the Clinical Manufacturing Validation team, you will support GMP‑compliant validation activities for clinical manufacturing operations. Responsibilities include coordinating and executing validation deliverables, supporting IQ/OQ/PQ activities, managing validation schedules, and reviewing and completing validation documentation. You will work closely with Validation, Manufacturing, Quality, and SME partners to assess execution status, ensure timely completion of assigned activities, and respond to validation-related requests. Your technical rigor, attention to detail, and continuous improvement mindset will help ensure compliant, reliable clinical manufacturing processes and support the delivery of high‑quality medicines to patients worldwide. How You Will Achieve Plan and coordinate the validation...

The Senior Asset Quality Lead, Inspections (AQL) is responsible for driving GCP Quality by maintaining ‘quality’ line-of-sight for assigned asset/franchise The Senior Asset Quality Lead /TA. With this focus, the sAQL role brings deep knowledge of GCP quality and risk management principles to asset and study teams. In partnership with the cross functional study team and functional lines in Clinical Development & Operations, the sAQL will ensure asset and/or franchise quality oversight, drive quality risk management and inspection readiness activities and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS. The...

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 deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized...

Position Overview We are seeking a strategic leader to establish and lead our new Regulatory Intelligence organization. The Sr. Director, Head of Regulatory Intelligence will set the strategic direction for the team, define and implement a multi-year strategic roadmap for regulatory intelligence, and oversee the integration of proactive regulatory insights into organizational decision-making. Our vision is to transform proactive regulatory intelligence into a strategic competitive advantage by anticipating the GxP risk landscape, safeguarding product quality and patient safety, and enabling the compliant growth and supply of J&J's medicines and medical devices. This role is pivotal in shaping our regulatory intelligence...

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 deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized...

This position works out of our Tech Center St. Paul, MN location in the EP Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What to expect an 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 work or...

This is a full time, on-site position with a schedule of 12 noon to 12 midnight on a rotating 2-2-3 schedule About This Role The QA Associate III has the working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures in order to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems. The QA Associate III has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The QA Associate...

Location Gaithersburg or Boston Hybrid 3 days a week online At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re...

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 Sr Principal (R4+) – Global Quality Systems Lead will...

Purpose Describe the primary goals, objectives or functions or outputs of this position. AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board. Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture. The...

The Senior Administrative Assistant will support the Global Regulatory Affairs Strategy organization. The Senior Administrative Assistant is responsible for all administrative functions of the department answering phones, managing calendars, scheduling travel, managing correspondence and scheduling couriers, processing expense reports, planning meetings/events, creating or revising business documents, preparing presentations from source materials, handling teleconference, Web Ex and Blackberry/iPhone setups, managing billing, compiling meeting materials and other similar matters. Responsibilities Provides advanced administrative support to VP level or equivalent. May provide backup support to other staff as needed. Monitors and prioritize executives’ email, highlights actions and routinely authors responses. Coordinates and maintains...

The Senior Validation Engineer/Analyst functions as the lead for maintenance, engineering, and validation activities within the assigned site/area of responsibility. Equipment, facility, utilities and cleaning are within the scope of responsibility. The incumbent is the primary liaison with the Operations, engineering services, and third party vendors for executing activities within area of responsibility. All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations. Responsibilities Manage departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services....

The Opportunity We areseekinga highly motivated and strategic leader to direct analytical development and quality control strategies in support of drug substance and drug product development across all stages of development. In this role, you willestablishand lead the analytical strategy for our small molecule programs and serve as a key partner across CMC, Regulatory, and Quality functions. You will work closely with internal stakeholders and external partners, including CMOs and CROs, to ensure robust analytical methods and quality systems are implemented to support development, manufacturing, and regulatory submissions. This is a highly visible leadership role with responsibility...

Employer Johnson & Johnson International Manager, Compliance & Technology Integration Job Code A011.3437 Job Location New Brunswick, NJ Job Type Full-Time Rate of Pay $150,000 - $175,000 Job Duties Lead and manage HealthCare Compliance projects for data management, business and data analytics. Identify, develop, and implement innovative solutions that enhance user experience, improve process efficiencies and enable significant automation. Responsible for creating and maintaining a suite of critical dashboards using Tableau Desktop and other Front End Development related tools like Plotly wherever necessary. Use Alteryx Designer software for analyzing trends, seasonality, and correlation in critical Healthcare Compliance Data. Partner...

The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets. This role will also work on new product development, as well as work on sustaining/post-market regulatory activities for Class II robotic devices. Devices that are part of the Robotics Surgical Technology Business are inclusive of hardware and software components. The senior principal specialist will work directly with new product development and sustaining teams to develop the global regulatory strategy and support regulatory activities throughout the product lifecycle. The senior principal specialist has primary responsibility...

The Senior Asset Quality Lead, Inspections (AQL) is responsible for driving GCP Quality by maintaining ‘quality’ line-of-sight for assigned asset/franchise The Senior Asset Quality Lead /TA. With this focus, the sAQL role brings deep knowledge of GCP quality and risk management principles to asset and study teams. In partnership with the cross functional study team and functional lines in Clinical Development & Operations, the sAQL will ensure asset and/or franchise quality oversight, drive quality risk management and inspection readiness activities and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS. The...

The Director of Quality Excellence and Governance is responsible for driving a culture of quality excellence across R&D Quality (RDQ) operations and ensuring robust governance of quality systems, processes, and performance. This role will lead strategic initiatives to harmonize quality standards, embed proactive and predictive quality principles, and oversee governance frameworks that enable compliance, operational efficiency, and continuous improvement. The position serves as a key partner to senior leadership, ensuring transparency, accountability, and alignment with global regulatory expectations and enterprise objectives. The role supports data-driven decision-making, fosters cross-functional collaboration, and promotes ongoing innovation. Additionally, this position advocates for a culture...

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly,...

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...

In this key role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans Conduct the formal review and approval of authored documents, following applicable standard operating procedures With limited supervision,...

Sr. Supplier Quality Engineer 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. Our location in Temecula, CA , currently has an opportunity for a Senior Supplier Quality Engineer . This role will serve as liaison between internal Abbott third party manufacturers and Abbott Vascular. Ensures effective implementation of quality and compliance requirements between multiple quality systems and sites. THIS IS AN ON-SITE DAILY ROLE. WHAT YOU'LL DO Position Responsibilities...

Director, Payor Relations & Regulatory Affairs The Opportunity Acelis Connected Health’s (ACH) DME & IDTF businesses operate across all states in the US with several hundred payor plans to serve it’s 80,000+ patients on service. This Director, Payor Relations and Regulatory Affairs will be accountable to develop strategies and drive ongoing activities that maintain and expand payor coverage while ensuring ACH remains compliant standards required by The Joint Commission, state agencies, and CMS (Medicare/Medicaid). These activities include leading the development, implementation, and monitoring of processes related to commercial payor contracting, state licensing, and CMS enrollments. These processes span across all...

QA Ops 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...

This position works out of our St. Paul, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer I , you will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, sustaining products, manufacturing, or system/services support. What You'll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet...

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. Organization Overview The Quality engineer facilitates and enforces compliance with Good...

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 an Associate Director, Quality Assurance Compliance at Gilead you will have the following responsibilities Inspection Operation and Logistics (Foster City) Manages...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager,...

The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) Post Approval Change (PAC) is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will also ensure proper communication with all key partners in the functional departments in support of regulatory filings. Responsibilities Independently manage, compile, and author CMC sections of marketed product variations. Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines as needed....

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality assurance background to join our Quality Assurance (QA) team. The successful candidate will contribute to the advancement of our product pipeline by performing QA batch record review, label review and verifications, document archival of records, and other assigned tasks. You will also be expected to independently organize and manage timelines for batch record reviews. You will be expected to provide support for both the Santa Monica, CA and Tarzana, CA sites as needed. Responsibilities include, but are not limited to Reviews routine manufacturing batch documentation and quality control...

Quality Engineer I This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer I , you will be responsible for supporting and maintaining quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency regulations. Uses problem solving, technical writing, and communication skills to gather cross functional buy in for improvements...

This Regulatory Affairs Manager – APAC position will work on-site at 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. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products...

This Principal Regulatory Affairs Specialist – APAC position will work on-site at 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. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market. What You’ll Work...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week at our Jacksonville Florida facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This This position has the responsibility and authority to support the development and implementation of the overall objectives and long-range regulatory strategies that impact both the introduction of new products and the market status of existing products. The Principal Regulatory Affairs Specialist will exercise a leadership role and serve as a mentor...

REGULATORY AFFAIRS SPECIALIST Onsite Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release. Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls....

The Brooklyn Center facility also known as Medtronic Electronics Components Center (MECC) supports the production of components used in devices for a variety of Medtronic Operating Units (OUs). The Senior Quality Engineer serves as the Quality decision‑making partner on cross‑functional development and sustaining engineering teams at the MECC site. This role leads risk‑based quality planning across design, manufacturing, and supplier interfaces, providing strategic quality guidance throughout the product lifecycle. The Senior Quality Engineer is accountable for ensuring quality readiness prior to MECC Decision Points (MDPs) and market release, proactively identifying and mitigating risks to ensure compliance and product integrity. It...

The Engineering Specialist is a key role within Our Company’s Research Labs Pharmaceutical Sciences – Pharmaceutical Operations Engineering group (Pharm Ops Engineering), responsible for Commissioning, Qualification, and Validation (CQV) and broader engineering support across non-sterile operations, including formulation, filling, and packaging of Oral Solid Dosage and Inhalation products. The position leads CQV development and execution for new and modified processing equipment, systems, and critical utilities. Author and execute protocols aligned with cGMP and develop Validation Master Plans, Project Execution Plans, and schedules to support capital projects. Primary responsibility will be to provide ongoing commissioning/qualification/validation related to changes and new equipment...

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Supply Chain/Warehouse Operations. This position will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shift NIGHT shift, 6 PM – 6 AM, Panama schedule (12-hour shift patterns with a 2-2-3 work cycle, including weekends and holidays) The Specialist, QA Shop Floor, is accountable to own quality decision making as it relates to unexpected events on the production floor, including deviation triage and determination,...

About the role This Quality Compliance Specialist is responsible for managing external regulatory inspections and responding to regulatory observations while leading GMP compliance projects. How you will contribute Manage external regulatory inspections, lead local inspection readiness efforts, oversee inspection and support rooms, escorting regulatory agents, and serve as a subject matter expect during inspections. Draft responses to regulatory inspection reports, collaborating with multiple departments under short deadlines to ensure accurate and appropriate responses. Editing skills are important. Promote on-time completion of corrective action commitments made to regulatory authorities. Coordinate efforts associated with GMP re-certification and product licensing. Lead projects to...

Onsite 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 4 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. In this exciting role as Quality Engineer II, you will be a part of the Americas Service & Repair team at our Louisville, CO site. Service of medical devices is crucial to ensuring their safe and effective operation, which ultimately allows healthcare professionals...

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 We are searching for the best talent for Sr. Design Quality Engineer role to be located at Danvers, MA. The ideal candidate for the Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. This engineer should excel in an environment that embraces...

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 currently seeking a Quality Director to join the Quality Team in Wilson, North Carolina. While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both...

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 is currently seeking a Quality Systems Manager to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina. This role will support the construction, operational start-up and end state of the DS site operations...

The Associate Director, Clinical QA is responsible for developing and implementing a strategy for proactive quality oversight of clinical development programs within their responsibility. This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations. The role assures inspection readiness within the scope of a Clinical Development program/system. Provide consistent and aligned consultation to R&D team members from multi-functional interactions and delivering a comprehensive QA perspective. Influencing the decision-making process to ensure quality requirements are included within improvement initiatives. This position is accountable to the Director of Clinical Quality, RDQA. The decisions and recommendations...

Role Overview The Senior Director, Category Management and Procurement– Development is a global leadership role responsible for setting and executing category strategy across Development. This position owns end-to-end category management and portfolio execution for Development R&D spend, ensuring speed, rigor, and scalability while enabling scientific innovation. As a key member of the R&D Procurement leadership team, this role serves as the single point of accountability for all Development categories, partnering closely with R&D leaders, the Chief Procurement Officer, and cross-functional stakeholders. The Senior Director leads a global team of category professionals and plays a central role in transforming procurement into...

The Senior Validation Engineer for Facilities Utilities & Equipment (FUE) Qualification is responsible for leading, planning, executing, and maintaining qualification/validation activities at AbbVie’s manufacturing site. This role ensures that all systems are installed, commissioned, qualified, and maintained in compliance with regulatory requirements, internal quality standards, and industry best practices. The successful candidate will serve as the subject matter expert (SME) for equipment, facility and utility validation, lead cross-functional projects, and drive continuous improvement in validation strategies and lifecycle management. This position is fully onsite Monday-Friday. Open to considering non-local candidates; relocation required. Responsibilities Lead and execute qualification activities for facility...

The Associate Director, Clinical QA is responsible for developing and implementing a strategy for proactive quality oversight of clinical development programs within their responsibility. This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations. The role assures inspection readiness within the scope of a Clinical Development program/system. Provide consistent and aligned consultation to R&D team members from multi-functional interactions and delivering a comprehensive QA perspective. Influencing the decision-making process to ensure quality requirements are included within improvement initiatives. This position is accountable to the Director of Clinical Quality, RDQA. The decisions and recommendations...

The Associate Director, Clinical QA is responsible for developing and implementing a strategy for proactive quality oversight of clinical development programs within their responsibility. This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations. The role assures inspection readiness within the scope of a Clinical Development program/system. Provide consistent and aligned consultation to R&D team members from multi-functional interactions and delivering a comprehensive QA perspective. Influencing the decision-making process to ensure quality requirements are included within improvement initiatives. This position is accountable to the Director of Clinical Quality, RDQA. The decisions and recommendations...

Leads the Branchburg Quality Control Laboratories and serves as integral member of the Quality leadership team. The role is accountable for ensuring compliance with all applicable regulatory and compliance requirements and must ensure the site is anticipating and building capabilities in-line with regulatory expectations and trends. Provides strategic, scientific, and operational leadership for all QC testing activities supporting the commercial manufacturing of tissue products. This role oversees laboratory functions, personnel and budget management, method validation and transfer, regulatory compliance, and continuous improvement initiatives. The Senior Manager will partner cross-functionally to maintain reliable product quality and throughput. Responsibilities Lead a team...

The Associate Director, Clinical QA is responsible for developing and implementing a strategy for proactive quality oversight of clinical development programs within their responsibility. This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations. The role assures inspection readiness within the scope of a Clinical Development program/system. Provide consistent and aligned consultation to R&D team members from multi-functional interactions and delivering a comprehensive QA perspective. Influencing the decision-making process to ensure quality requirements are included within improvement initiatives. This position is accountable to the Director of Clinical Quality, RDQA. The decisions and recommendations...

The Quality Services and Improvement team, within Quality Assurance, partners with internal Data, Digital & Technology (IT) & Business Excellence teams to drive innovative initiatives. These initiatives, both digital and non-digital, continually enhance capabilities and improve overall operational efficiencies, and add value to our stakeholder functions. We are seeking a highly motivated and detail-oriented Quality Improvement Intern to join the Quality Services and Improvement team at our Libertyville office. This internship offers a unique opportunity to gain hands-on experience with a broad range of Quality initiatives in the pharmaceutical industry, including but not limited to digital transformation, process optimization, and...

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 Ready to lead at the forefront of innovation? Learn more and apply today! The role will drive the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices. The incumbent is...

WHY JOIN US? Evinova is a health-tech business focused on accelerating better health outcomes by advancing digital transformation across the life sciences sector. By combining science-based expertise, evidence-led rigor, and deep human insight, we design digital solutions that enable healthcare to work better for everyone. Operating at the intersection of healthcare, technology, data, and analytics, we are helping unlock the full potential of digital health, transforming how clinical research is conducted, how care is delivered, and how patients experience healthcare. Our solutions are built to scale, driving efficiency, improving decision-making, and ultimately delivering better outcomes for patients worldwide. At Evinova,...

Compliance Specialist uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within Engineering & Maintenance operations. Engineering & Maintenance Compliance Team is responsible for managing change controls, CAPAs and deviation intake and closure across GMP activities in the following areas - Metrology, Engineering, Facilities, Utilities, Validation, Automation and Capital Projects. The responsibilities of the team primarily extend to owning deviations relating to facilities, equipment and utilities and their associated systems. The Senior Compliance Specialist is responsible for developing programs and metrics to ensure all aspects of engineering and maintenance are compliant. About Sanofi We...

The Vice President, Chief U.S. Regulatory Counsel & Chief Compliance Officer is responsible for providing regulatory and commercialization legal support, advice, and counsel in connection with planning, tactics, and strategies in the U.S. undertaken primarily by the Regulatory and Commercial departments of the Company. This role also will be responsible for leading our global compliance program, as well as partnering closely with our Head of Legal International on ex-U.S. regulatory and commercialization activities The Opportunity to Make a Difference Regulatory & Compliance Leadership Serve as principal advisor to the Executive Team on compliance, regulatory, and commercialization risk, providing clear, pragmatic,...

SENIOR REGULATORY AFFAIRS SPECIALIST Onsite Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release. Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product...

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 Associate Director – Quality Assurance - Operational Readiness is a...

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 Quality Control Manager – Animal Testing is responsible for providing leadership, oversight, and regulatory compliance for in-vivo animal testing...

Johnson & Johnson is hiring for a Sr Design Quality Engineer – Shockwave Medica l to join our team located in Santa Clara, CA. 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 deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at...

This position works out of our NorthPoint Westfield, IN location in the S t ructural 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. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and...

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 plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a...

Join AstraZeneca as a Lead Quality Advisor, Site Quality (Development Quality). At AstraZeneca, quality is how we deliver on our mission to transform patients’ lives. We’re seeking a Lead Quality Advisor to provide GMP leadership across our development value chain—from internal Drug Substance and Drug Product to Pack & Label and clinical trial supply. In this high‑influence role, you will Build and translate robust, risk‑based cGMP standards into practice across Development Provide QA oversight of manufacturing documentation, deviations, risk assessments, and SOPs Release internal Drug Substance, Drug Product, and IMP for clinical trials (DevQ release) Lead/host regulatory inspections and contribute...

This position works out of our Abbott Park IL (preferred) or any Abbott's manufacturing location. What You’ll Work On Our location in Lake Bluff, IL currently has an opportunity for a Program Quality Manager in Complaints, Vigilance and Product Actions. The function of the Quality Program Manager is to provide corporate-level leadership and guidance for Quality Systems matters related to complaint management, medical device reporting/vigilance and product actions (corrections and removals), as well as supporting other Abbott Quality System elements as it relates to post market surveillance. This includes but is not limited to providing global support to Abbott Businesses/Divisions,...

The Director, Cell Therapy Quality Automation will play an important role in shaping the future of our organization's quality processes. This global position is responsible for the planning, execution, and implementation of next-generation quality processes to support high volume manufacturing processes. The Director will provide quality oversight of projects in supply chain, manufacturing, Quality Control, etc. The Director will be a core member of critical cross-functional teams which identifies the future state cell therapy value stream in conjunction with automated processing. This person will lead projects which integrate advanced technologies and methodologies, ensuring our quality systems are robust, efficient, and...

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly,...

Software Quality Director Careers that Change Lives Transforming Patient Management with Smart Technology! The Software Quality Director will lead our software quality organization within CRDN supporting both current products in the markets, ensuring ongoing reliability, performance and customer satisfaction as well as new product development and release initiatives. This role is accountable for managing and developing a high-performing quality Engineering team, defining the long-term quality strategy, and ensuring the delivery of reliable, high-quality software across our product portfolio. The Software Quality Director will balance strategic vision with operational excellence- driving quality initiatives across the organization while overseeing day-to-day...

Employer Auris Health, Inc. Primary Software Quality Engineer - Ottava Job Code A011.4396 Job Location Santa Clara, CA Job Type Full-Time Rate of Pay $110,000 - $130,000 Job Duties Support computerized system validation activities for various platforms' Non-Product software in Surgical Robotics product development. Identify and implement necessary changes to ensure and maintain the continued suitability and effectiveness of the quality management system (QMS) using quality policy, quality objectives, audit results, and analysis of data. Apply a risk-based approach for QMS processes. Provide direction and support for verification and validation (V&V) of product software, non-product software, software tools, and...

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. Join our Rare Disease and Rare Blood Disorders Regulatory Team as Global Regulatory Lead and you’ll be responsible for the development & execution of global regulatory strategies for your products in Sanofi’s diversified portfolio. Our team is involved in developing regulatory product strategies for the Rare Disease and Rare Blood Disorders therapeutic area, leading regulatory efforts in the development stage of drug products. Main Responsibilities As Global Regulatory Affairs Lead (GRL), you...

Lead and manage Computer System Assurance (CSA) and IT qualification efforts for systems and applications in core GxP functions – primarily Research, Commercial and Cell Therapy functions. Supervise junior to mid-level team members assigned to IT and Compliance programs to ensure effectiveness, efficiency, consistency, quality of work and compliance with external regulations and internal procedures. Collaborate with cross functional and multi-location IT Delivery teams, business users and internal Global Quality compliance staff to ensure that CSA activities are planned and executed in accordance with internal procedures. Work with one-up manager and peers to propose effective and efficient quality strategies. Evaluate,...

OBJECTIVES/PURPOSE Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information, Data and Systems (GRIDS) is responsible for developing and implementing a comprehensive GRIDS strategy. This pivotal role ensures Takeda’s regulatory data integrity while driving the adoption and efficiency of Regulatory systems globally. This role involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the enterprise. Additionally, the role leads accurate and timely reporting for both common and ad hoc...

The Senior Director Regulatory Portfolio Management is accountable for providing program and project management support across the Regulatory Affairs (RA) organization. This includes project management in support of all Global Regulatory Product Teams (GRPTs), as well as the management of the portfolio of initiatives to drive process improvements and operational efficiencies across Regulatory. As part of the Regulatory Operations Leadership Team, this strategic role drives substantial organizational influence internal and external to RA at the executive level. Liaises with partners and stakeholders to inform, develop, and execute the RA and RQS business strategies. Manages various personnel to include exempt, non-exempt...

The Regulatory Specialist will participate in the preparation of documentation packages for global regulatory submissions. Primary Responsibilities Able to prepare documentation packages for global regulatory submissions (including IND, CTA, Briefing Books, Scientific Advice, etc.) to the FDA and global regulatory agencies. Compiles documentation for submissions to FDA and global regulatory agencies. Support the development of regulatory strategies, risks and key issues in an evolving regulatory landscape. Support the develop regulatory processes and procedures of regulatory submissions. Develops and maintains collaborative partnerships with key internal and external stakeholders. Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain...

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...

J&J MedTech is recruiting for a Senior Quality Engineer, New Product Development , located in Cincinnati, OH! 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 deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at In this role you will be responsible...

Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you’ll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We’re passionate about innovation, inclusion, and supporting your growth—inside and outside the lab. Why Vertex? Real Projects You’ll work on assignments that...

Vertex is entering a new phase of data-driven innovation where trusted, observable, and governed data is foundational. The Associate Director, Data Quality Platform is a senior technology and product leader within the Data & Software Engineering organization, reporting to the Director, Data Governance. This role owns the enterprise Data Quality (DQ) platform strategy and execution, with an explicit mandate to build AI-first, scalable and embedded data quality capabilities across the enterprise. The role partners closely with data stewards, data product owners, date engineering, analytics, compliance, privacy and security to translate data quality policies and standards into automated, measurable, and continuously...

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 and introduce new innovative analytical technologies. 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 biotherapeutics while enabling cross‑functional alignment, regulatory readiness, and business continuity. This position is in Millsboro, Delaware-US...

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. Accountabilities/Responsibilities Understand the regulatory framework, including regional trends, for various types of applications and procedures for small...

REGULATORY AFFAIRS SPECIALIST Onsite Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release. Review regulatory issues with the manager as necessary and support resolution of submission issues with engineering partners, geography regulatory partners, and regulatory agencies. Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls. Provide...

SENIOR REGULATORY AFFAIRS SPECIALIST Onsite Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release. Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product...

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 of which you dream. 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 plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting...

About the role The Global Ethics & Compliance Investigations Head, Americas, senior director level, leads the team that reviews and investigates allegations of misconduct and/or potential violations of laws, regulations, or Company policies across North and South America. This role involves leading, managing, and developing talent on the Americas investigations team; planning and conducting thorough investigations; preparing and presenting detailed findings to senior stakeholders; and collaborating cross-functionally to identify, mitigate, and remediate identified risks. As part of the Global Ethics & Compliance team, this role will report to the Global Head of Ethics & Compliance Investigations. How you will contribute...

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...

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...

Quality Engineer II This position works out of our Plymouth, MN location in our Structural Heart Division. In Abbott’s Structural Heart (SH) business, 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. As the Quality Engineer II , you'll be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Lead the investigation, resolution, and prevention of product and process non‑conformances by applying systematic problem‑solving methodologies, driving effective...

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together expert teams and industry‑leading technologies to support diagnostic testing that provides important information for the treatment and management of diseases and other conditions. Diagnostic testing serves as a compass, offering information that aids in the prevention, diagnosis, and treatment of a wide range of health conditions. Abbott’s tests and diagnostic tools deliver accurate, timely information to help you better manage your health. We are enabling smarter medical and economic decision‑making to help transform how people manage their health throughout life. Each day, more than 10 million tests...

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly,...

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 Lilly is currently constructing a cutting-edge facility for the...

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 a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Quality Technician III supporting the Cardiac Ablation Solutions organization, you will have responsibility for the inspection and testing of returned products as part of the complaint handling process. The Technician will be capable of supporting...

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 a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Open to our Newton, MA or Mounds View, MN offices. Join Medtronic as a Software Reliability Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll...

As a Senior Quality Engineering Manager in the Cardiac Surgery Post Market Quality organization, you will lead quality strategy and execution for a complex, global commercial portfolio. You will be accountable for ensuring patient safety, product performance, and regulatory compliance for released products, while leading a high‑performing team responsible for post‑market surveillance and risk management. This role requires deep technical expertise in risk management, design controls, and root cause investigation, along with proven leadership capability to drive change, strengthen quality culture, and deliver results in a fast‑paced environment. At Medtronic, we bring bold ideas forward with speed and decisiveness to...

The Reliability Engineer is responsible for ensuring medical devices meet lifetime, safety, and performance expectations through rigorous testing, data analysis, and cross-functional collaboration. This role focuses on identifying early-life failures, improving product robustness, and supporting design and manufacturing teams with data-driven reliability insights. Responsibilities Execute reliability engineering activities across the product lifecycle, including Design for Reliability (DfR) in R&D and post‑market support. Perform early‑life testing using engineering methodologies to identify components at risk of premature failure. Conduct reliability tests such as environmental, thermal, shock, vibration, and lifecycle testing; develop test methods as needed to evaluate component and system durability. Apply...

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...

The Director, Legal (Regulatory and Quality Counsel) will serve as a senior legal advisor within Illumina’s global legal regulatory practice, providing high-level legal support on complex regulatory matters impacting medical device, diagnostics, and RUO (Research Use Only) product lifecycle. This position plays a critical role in enabling business objectives while ensuring compliance with applicable laws and regulatory frameworks, including the U.S. Food, Drug, and Cosmetic Act (FDCA), FDA medical device regulations, the European Union In Vitro Diagnostic Regulation (IVDR) and other similar regulations. This position requires a hands-on, business-oriented, and solutions-focused legal professional with deep in-house experience, ideally within the...

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...

Validation Program Manager – Nutrition Manufacturing, Casa Grande, AZ This position works out of our Casa Grande, Arizona 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. Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment...

Job Title Manager Supplier Quality We currently have an opening for a Manager Supplier Quality for the Vascular division. This role can be located at our St. Paul, MN location. This is a fully onsite role. 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 MAIN PURPOSE OF ROLE Manages the development and administration of departmental activities of Supplier Assurance while maintaining compliance to, and driving continuous...