Quality & Regulatory Jobs in Pharma & Biotech

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, North America Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Raritan, NJ; or Titusville, NJ. Remote work options may...

The Associate Director, Quality Control is responsible for overseeing and managing the quality control operations to ensure compliance with GMP and regulatory standards. This role involves driving continuous improvement initiatives, and will develop, execute, and periodically evaluate QC practice and processes to ensure that QC operations are efficient, timely, and safeguard data integrity. The role will author, review and/or approve QC documents such as test methods, SOPs, validation protocol/reports, reference standard qualification protocols/reports, stability protocols/ reports, quality records and investigations (deviations, change controls, CAPAs), regulatory filings, specifications/justification of specifications, and APQR. In addition, this role will develop and validate new...

We are currently looking for a Senior Program Manager - Quality and Regulatory to join our Program Management Office (PMO) within our Ear, Nose, and Throat (ENT) Operating Unit (OU). In this exciting role as a Senior Program Manage r, you will engage with multiple Product Development teams within the ENT OU. You will manage projects that are strategic to the business and work cross functionally with various functional managers while driving program execution. Also, this role will engage with the OU leaders through steering meetings, monthly leadership meetings and daily project execution. The ideal candidate can work a hybrid...

Reporting to the Vice President, Corporate Quality, this role provides strategic and tactical direction for the GPS divisional audit program for product development, clinical supplies, manufacturing, and product distribution across all modalities including CMOs, CLOs, material suppliers and service providers, inclusive of IT systems and services. Leads inspectional readiness activities across the network inclusive of biologics, small molecule and cell therapy as well as distributors and local markets inclusive of global regulatory agencies worldwide. Serves as consultancy to sites/functions with regulatory inspections including Pre-inspection readiness. Key Responsibilities · Responsible for development of risk-based process for assessment of sites, suppliers and...

Senior Regulatory Writer, Remote “This position can be based remotely anywhere in the U.S. Please note that this role would not provide relocation as a result. The expectation of working hours and travel will be defined by the Hiring Manager. This position will require minimal travel” Purpose To write, review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide documentation related consultancy to other line functions. To coach/mentor and/or train less experienced writers. #LI-Remote Key Responsibilities 1. To author, review and manage high quality clinical and...

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

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...

The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell & Gene Therapies. This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Senior Director, CMC-CGT Regulatory Affairs. Responsibilities Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams. You will partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / BLA/ Master Files, amendments, annual reports) and...

Objective / Purpose A dvance the objectives and vision of the Head of Regulatory Ensure project management support and facilitation of the Regulatory Leadership Team meetings and offsites including the coordination of the preparation of the meetings and tracking of required actions until completion Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that Regulatory is on track to meet or exceed its performance targets . Provides insight into evaluating overall Regulatory performance over time and for future planning Accountabilities Responsible for overseeing and consolidating input for the decision support resource(s), including tracking resource utilization ,...

About the Role Assist in the development of lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities. How you will Contribute Assist in the development of lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities. Work under minimum supervision. Assist with the installation and validation of sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of microbiology and chemistry principles. Complete all testing,...

We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM). In this role you will play a key role in the lifecycle management of Medtronic products that get integrated with our strategic partners. You will be responsible for engaging with strategic partners in integration projects, preparing and submitting regulatory filings for the U.S. and EU market and managing global compliance. You will collaborate closely with engineering, marketing, clinical, quality as well as the regional and international teams working with integration partners to support the submission process and ensure regulatory requirements are...

Responsible for supporting regulatory strategy execution for development programs. Works closely with the Director of Regulatory Affairs to prepare regulatory submissions (strategy, authoring, timeline planning, etc.) and to maintain department regulatory processes. Coordinates, prepares, and contributes to the development of document packages for regulatory submissions including IND/CTA, NDA/BLA. DSUR/Annual Reports, clinical protocols, clinical study reports, application amendments and postapproval activities. Ensures submission compliance with local and regional regulatory requirements, company policies, and internal quality and compliance standards. Provide regulatory representation on cross-functional teams as directed. Collaboratively develop regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs....

Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Process Quality Specialist to be located in San Angelo, TX. 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...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Engagement Compliance, Manager to be in Spring House, PA. Purpose IHEA organization is seeking to hire a solution oriented, innovative and engaging member in their Patient Engagement Strategy team who will...

Johnson & Johnson is currently recruiting for a Senior Manager, Quality Control, Stability Operations. This position will be located in Titusville, NJ. At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Associate Director, Quality Assurance, GoSolo Site Deployment will play a pivotal role in helping to design and execute the future...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Manager, Quality System Innovation, GoSolo Site Deployment will play a pivotal role in helping to design and execute the...

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Primary Responsibilities Employee must show ability to perform routine assignments and develops competence by performing structured work assignments Ability to use existing procedures to perform routine testing Requires knowledge and exposure to fundamental laboratory instrumentation, theories, principles, and concepts Receives instruction, guidance, and direction from others and also...

Location Upper Gwynedd, Pennsylvania ( preferred ); Rahway, New Jersey Employee Status Regular Full Time A part of the Ethics and Compliance Organization (ECO), the Compliance Program Oversight team (the “Team”) designs and helps implement our company’s global compliance program, including compliance standards and processes (collectively, the “Program”). The Program is designed to mitigate enterprise risk and to empower employees and business partners to act with integrity while fulfilling our company’s mission of helping to improve and save lives. Reporting to a Director of the Team, the Associate Director supports the implementation and maintenance of the Program. 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. At Lilly, we unite caring with discovery to make life better...

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

Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination Products will lead a team responsible for device regulatory activities associated with Sanofi’s combination product and medical device portfolio in the Specialty Care R&D and commercial product ranges. The team is comprised of direct reports and matrix team members. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. The incumbent will work closely with key stakeholders including clinical, medical affairs, R&D, Manufacturing & Supply (device development, manufacturing,...

An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility. Responsibilities...

POSITION SUMMARY Sr. Software Quality Engineer is responsible for complete end-to-end verification of Natera software systems and services using both manual and automated test strategies. PRIMARY RESPONSIBILITIES Perform software verification, define and execute test cases and scenarios required for software quality assurance and regulatory compliance. Perform system analysis, assess risk, and develop strong test strategies by analyzing product design and technical specifications, and by collaborating with product managers and developers. Participate in building and maintaining test automation framework using automation tools and libraries. Perform debugging and root cause analysis of product issues or defects. Evangelize new testing methodologies, best...

Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. The unit focuses on providing innovative solutions for ENT conditions, including surgical and therapeutic products designed to improve patient outcomes in ear, nose, and throat health. We are currently offering an excellent opportunity to join the ENT Quality team as a Senior Software Quality Engineer. This position is based onsite in Jacksonville, FL. In this role, you will serve as an individual contributor with responsibilities in our technical functions to advance existing technology or introduce new technologies and therapies. You will be tasked with formulating, delivering,...

Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of...

Description The Associate Director position’s core responsibilities are to oversee our Company's compliance related to customs country of origin. In the origin space, responsibilities are to oversee our company’s customs country of origin program and lead efforts related to global customs origin reviews. CIT is primarily responsible for determining trade compliance requirements and processes, as well as executing select trade compliance functions that are best performed on a global and/or cross-divisional level. Among other centralized trade compliance activities, CIT implemented and continues to manage and monitor compliance with the Trade Agreements Act (TAA). CIT is also responsible for the management...

Associate Regulatory Affairs Director Introduction to role 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 all collaborators and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives globally. Accountabilities Lead and/or contribute to the planning, preparation, and...

Purpose The Senior Quality Engineer is responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc. Responsibilities Perform QA activities related to Combination Product and Medical Device Design Transfer and Change Management Ensure compliance with company policies and procedures. Perform design control and risk management activities according...

The Director will provide strategic support and compliance oversight for business initiatives within the US Allergan Aesthetics business with a focus on Plastics and Regenerative Medicine (PRM), Body Contouring and digital/social media. Responsibilities Partners with US AA Leadership for PRM, Body Contouring and digital marketing to provide moderate to complex OEC and functional policy interpretation and provide guidance on the requirements. Active contributing member of the PRM Leadership Team, bringing compliance insights, governance and strategic solutions to support business goals and improve compliance. Conducts compliance risk assessments, trend analysis and provides recommendations for novel, creative and compliant business activities to...

Medtronic – Milwaukee, WI manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. In this role, the Quality Engineer II is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life...

Are you passionate about serving patients with quality products? Within our Research and Development Division, the Global Clinical Supply (GCS) organization is accountable for the end-to-end supply chain (planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites and patients) across the product portfolio to enable the execution of Phase I-IV clinical trials in 60+ countries in accordance with worldwide GxP regulations as set by the US cFR, EU eudralex, and all applicable jurisdictions as well as Sarbanes-Oxley (SOX) financial, and Environmental Health & Safety agency guidelines. GCS operates in close collaboration with Discovery Sciences Clinical Supply (DSCS),...

The Compliance Engineer will be involved in projects that require obtaining agency approvals for both new and existing products. This role requires experience in securing certifications from agencies such as the FCC, CE, EMC/RED, IC, and safety organizations. Familiarity with relevant standards and directives from UL, CSA, FCC, IEC, and EN is essential. Additionally, experience with environmental regulations such as RoHS, WEEE, REACH, and Proposition 65 is a valuable asset. The Compliance Engineer will create and execute a compliance test plan addressing EMC, EMI, safety, environmental, and other product compliance requirements. Key Responsibilities Read, interpret, and communicate changes in technical...

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 An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for a Quality Review Specialist to be in Danvers, MA . Duties and Responsibilities Perform reviews of Device History Records (DHR) on the production floor for compliance to procedures, including good documentation practices (GDP), documented test results within specification, and...

About the Role The Quality Operations, Analyst II is responsible for ensuring the quality of processes and product outputs by adhering to established policies and procedures. This role involves auditing, monitoring, and determining the quality of processes or outputs against defined internal and regulatory standards, contributing to Takeda's mission of delivering high-quality products. How you will contribute Leads ongoing, daily departmental operations. May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner Interview/hire, evaluate, train and develop direct reports Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective...

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. Opportunity Overview Lilly is on the cusp of a transformative expansion,...

Reporting to the Executive Director, RIIM , this role will be accountable to ensure a holistic Regulatory centric D ata M anagement ( R DM) capability and related data centric submissions within GRACS , are implemented and maintained . This role has broad accountabilities for the following Regulatory Data Management ( RDM) Strategy & Regulatory Data Standards Governance Regulatory Compliance and Risk Management for Regulatory Data Direct and Indirect (e.g., partnering with CMC, Labeling, etc ) e xecution activities that support Data-based Submissions ( e.g. XEVMPD, IDMP, PQCMC, SPL etc . ) Internal & External Stakeholder Engagement and Change Management...

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

In this exciting Sr Quality Engineer role, you will be responsible with engineering and manufacturing functions to ensure quality standards are in place among other responsibilities. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality...

In this exciting Sr Quality Engineer role, you will be responsible with engineering and manufacturing functions to ensure quality standards are in place. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and...

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...

POSITION SUMMARY Software Quality EngineerIII, Production Bioinformatics Pipelinesis responsible for complete end-to-end verification of Natera software systems and services using both manual and automated test strategies. PRIMARY RESPONSIBILITIES Perform software verification, define and execute test cases and scenarios required for software quality assurance and regulatory compliance. Perform system analysis, assess risk, and develop strong test strategies by analyzing product design and technical specifications, and by collaborating with product managers and developers. Participate in building and maintaining a data-driven test automation framework using automation tools and libraries. Perform debugging and root cause analysis of product issues or defects. Evangelizenew testing methodologies,...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Supplier Development Quality Engineer II position drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You'll Work On Upholds Division approval requirements to supplier...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Supplier Development Quality Engineer II position drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You'll Work On Upholds Division approval requirements to supplier...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Supplier Development Quality Engineer II position drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You'll Work On Upholds Division approval requirements to supplier...

Are you ready to make a significant impact in the pharmaceutical industry? As a Quality Systems Specialist II, you will play an essential role in supporting quality system activities that are vital to our site processes. Your focus will be on documentation and training process support, ensuring that our operations align with best practices and deliver excellence every time. Join us in this dynamic role where you'll collaborate with subject matter experts, improve processes, and contribute to the continuous improvement of our quality systems. Accountabilities In this role, you will be responsible for managing documentation issuance, including procedures, test methods,...

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 Quality Operations Leader to be in Manatí, PR. Under the direction of the Site Quality Lead and with the objective of maintaining high quality standards for the product manufacturing process and in compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations and Quality Assurance. Provide guidance during the design, development,...

The Quality Systems Manager serves as a senior technical expert in the principles and application of quality assurance and compliance within a regulated environment. This role leads and supports cross-functional quality initiatives, drives continuous improvement, and ensures robust compliance across Quality Systems. The Quality Systems Manager may also lead and mentor a team to execute department and business objectives. Key Duties and Responsibilities Collaborate with internal stakeholders and external partners to resolve quality issues and deliver compliant, risk-based solutions. Identify and lead initiatives to close compliance gaps and strengthen cross-functional Quality Systems. Act as a subject matter expert and Quality...

The Manager of Quality Control will be responsible for supporting the oversight of QC external contract labs. The position will manage GMP release and stability activities in support of clinical and commercial programs, while ensuring compliance with SOP’s, policies and industry guidances. In addition, this role may support transferring/validating GMP analytical methods, establishment of internal Quality Control systems, processes and procedures in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations. This role will interact with internal cross-functional teams and Vertex network of external CMOs/contract labs to ensure that all GMP analytical methods for lot release and...

GSK is currently looking for a Quality System & Data Associate Director to join our team in Rockville, MD. The Quality System & Data Associate Director provides leadership to a team of Quality professionals and is critical in overseeing data integrity and governance, document control, training compliance, Quality Management System (QMS) deployment, as well as defining and driving the site Quality Improvement Plan. The role also includes responsibility for driving GPS for Quality, Quality Culture and embedding Digital Strategy into the Quality organization. The Quality System & Data Associate Director reports to the Site Quality Director and is part of...

GSK is currently looking for a Quality Technical and Validation Associate Director to join our team in Rockville, MD. The Quality Technical and Validation Associate Director provides leadership to a team Quality professionals and is responsible for ensuring the highest standards of GxP compliance in the validation and qualification activities, ensuring robust and compliant validation and change control efforts, providing GMP oversight on Continuous Process Verification process and GMP oversight on facilities and utilities (including maintenance, calibration and pest control programs).This role is pivotal in overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless introduction of...

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...

Shire Human Genetic Therapies, Inc. is seeking a Sr. Cleaning Validation Engineer II with the following duties manage validation programs and projects. Develop validation strategies to test equipment and processes in compliance with domestic and international GMP regulations. Create and maintain validation life cycle documentation, including IQ/OQ/PQ protocols and reports, risk assessments, and traceability matrix. Provide technical assessments for Corrective and preventive actions (CAPA’s), deviation, and change control management. Troubleshoot cleaning and steam sterilization issues to ensure smooth manufacturing operation. Collaborate with stakeholders to establish project timelines and scopes. Review and approve validation deliverables including project plans, protocols, reports, risk...

About the role The Associate Director of Quality Control will lead the establishment of a state-of-the-art quality control laboratory. Responsibilities include overseeing its design, construction, qualification, and regulatory approval. Collaborate with global teams to align with Takeda’s laboratory-of-the-future strategy, focusing on automation and paperless systems. Hire and train the Quality Control team, eventually overseeing lab operations to support a 24/7 pharmaceutical manufacturing site. How you will contribute · Lead the planning and execution of a new Quality Control Laboratory startup, ensuring full compliance with regulatory standards. · Design and implement efficient lab processes and workflows to optimize operational performance and...

OBJECTIVES Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ Partner with teams across CPMQ to proactively assess the needs for functional processes and system enhancements Lead the development of internal functional processes and training and ensure alignment with global processes and regulatory requirements and expectations. Drive the implementation and change management of processes and systems across CPMQ Create mechanism to monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans Engage with CPMQ teams to foster a culture of learning and continuous improvement Lead CPMQ...

Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate...

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 Manager, Supply Chain Quality EndoMech and Energy to be in Guaynabo, Puerto Rico. The Sr Manager, Supply Chain Quality EndoMech and Energy will support the Ethicon-Endo Surgery LLC (EES) Supply Chain Quality organization to transform the way we serve customers and patients with high-quality and compliant products each and every day into the...

In this exciting role as a Senior Supplier Quality Engineer, you will be responsible for ensuring the quality and compliance of materials we procure at our Medtronic Tempe Campus (MTC). This specific role will support the procurement of electronic components, indirect materials, and services needed for the design and manufacture of our Cardiac Rhythm Management and Neuro Implantable Medical Devices. Responsibilities may include the following and other duties may be assigned. Ensure that suppliers deliver quality parts, materials, and services. Drive Quality rigor for New Product Development decisions, Capability & Reliability with Suppliers, ensuring new products and components are manufactured...

This position – Specialist, Global Trade Standards & Controls (GTSC) – provides enterprise-wide support for compliance with laws, regulations, and policies related to restricted parties. In this role, which is part of the Company’s Manufacturing Division Compliance organization within the Ethics & Compliance Office, the Specialist, GTSC will conduct restricted party screenings on third parties to identify potential compliance risks, ensure business partners meet international trade laws, and support informed decision-making. This position is ideal for a detail-oriented, mission-driven individual eager for a career in global trade compliance within the pharmaceutical industry. Key Responsibilities Conduct Screenings Perform daily screening of...

Janssen Supply Group, LLC, a member of Johnson & Johnson Innovative Medicine, is recruiting for a Sr. Specialist, External Quality (Small Molecules) . The preferred location for this position will be in Horsham, PA or Titusville, NJ . However, the role can also be located in Athens, GA. 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...

Director of Validation, Cell Therapy Technical Operations reports to the Senior Director, Cell Therapy Technical Operations within the Cell Therapy Development and Operations (CTDO) organization. This Technical Leadership role will provide Technical oversight to drug product and vector sites, covering process validation for commercial cell therapy products manufactured globally via internal and external manufacturing sites. This role will serve as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy the standards to site MS&T at internal and external sites. The validation lead is accountable for developing...

The Director, Regulatory Strategy will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects within the Vertex cell and gene therapy portfolio. This position will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring effective integration of broad regulatory ideas/tactics supporting program strategy. This role's assignments may be global or regional depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy. Key Duties and Responsibilities Leads the development of regulatory strategy for assigned projects/regions...

Senior Specialist - Regulatory Affairs -Transfusion Our location in Lake Bluff, IL, currently has an opportunity for a Senior Specialist - Regulatory Affairs . As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for on-market regulatory affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit...

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...

In this vital role, you will support establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. The lead will also specifically develop and implement regulatory strategies and processes for in vitro diagnostics (IVDs)/companion diagnostics (CDx’s). Key responsibilities Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning and decision-making Developing clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of both therapeutic and diagnostic products by regulatory health authorities Providing regulatory leadership and input to internal teams involved with IVD/CDx development planning, including Diagnostic Development teams and joint project...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, Innovation, Expertise. Are you ready to shape the future of Quality Audits? As Global Quality Auditor - Technology Audit &...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was...

About the Role As the Quality Systems Analyst II, you will participate in the daily Quality System department activities for Thousand Oaks including Change Control, Deviations, CAPA, and Quality Documentation. This is an on site position and you will report to the Quality Systems Manager. How you will contribute Support Change Control, Deviation, CAPA and continuous improvement initiatives. Review quality related documentation and approval of Deviations/CAPA and Change Control including evaluating the impact to the process and product as applicable. Complete and approve nonconformance investigations and change control requests in accordance with Quality system requirements. Revise SOPs and forms to...

About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis, and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit Acadia.com and...

The Manager, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across various communication channels. This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic regulatory guidance on advertising and promotional activities. The ideal candidate will have expertise in FDA regulations, OPDP (Office of Prescription Drug Promotion)/Advertising and Promotional Labeling Branch (APLB) guidance, and industry best practices. Here's What You’ll Do Regulatory Compliance & Review Review and approve promotional materials, corporate communications, and disease awareness campaigns to ensure compliance with FDA...

Purpose Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market. Responsible for assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetics Devices, etc. Responsibilities Primary driver for the quality and compliance aspects of Design transfer and on-market change management. Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and...

The Opportunity The Therapeutic Data Manager Lead will contribute to the company's Clinical Data Management organizational and Therapeutic Area Data strategies, lead and deliver on complex projects, and interact with external partners. Responsible for global and broad organizational high impact deliverables. Responsibilities will include Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies and projects. Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones. Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements...

Position The Quality Assurance Specialist role is responsible for providing guidance and support to implement, execute, and oversee compliance and quality-related processes in accordance with applicable GMP requirements and our company's Animal Health Quality Systems. The position will assist engineering, material management, supplier quality management, and warehouse areas, and will provide overall support with quality audit (internal and external). Other expectations include Knowledge and experience in assessing quality impact and GMP requirements applicable to qualification and validation of highly complex engineering and IT projects related to pharmaceutical product Manufacturing and Quality Control. Work experience in supporting engineering and maintenance-related...

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 Associate Vice President for Global Quality Systems plays a...

This position works out of our Tipp City, OH 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. Tipp City, Ohio, is one of Abbott’s newest nutrition manufacturing facilities with technology that enhances production efficiency and product quality. Join us and you’ll be part of...

Johnson & Johnson is currently recruiting for a Senior Analyst, Trade Compliance in Raritan, NJ. The Senior Analyst Trade Compliance is responsible for facilitating data extraction, collection, cleansing and preparation to support the Segment’s trade compliance and operation’s needs. This position works closely with Trade Controls and Trade Operations to address data needs to enable maturity of the Segment Trade Compliance program, with an initial focus on export controls and trade sanctions. Key Responsibilities Collaborate with Regional Trade Operations, Global Trade Controls, Health Care & Compliance and Global Legal Organization on identification structured and unstructured trade data needs. Implement...

Your skills could be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports. In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice...

Your skills could be critical in helping our teams accelerate progress. The Chemistry, Manufacturing and Controls (CMC) regulatory team is accountable for the global regulatory strategy for development and marketed products within GRA. The team responsibilities include but are not limited to global regulatory CMC strategies, submission dossiers and approvals, direct contact/liaison with FDA/EMA for new and marketed chemical entities. The team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Industrial Affairs, Regulatory Health Authorities, and others. The team demonstrates behaviours that live and...

Purpose To provide Quality oversight and approval for Quality Engineers on qualification/validation activities and documentation. Responsibilities Provide interpretation and guidance regarding qualification and validation requirements in GLP-, GCP- and GMP-regulated areas of an R&D organization. Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision. Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.). Support CAPA activities related to validation and qualification Provide guidance, direction, and support to peers. Provide assurance that applicable national and international regulatory requirements are adhered to...

Purpose Primarily responsible for quality assignments related to batch records, quality approvals, exception reports, metrics, and other documentation. Responsibilities Review/approve/release batch record packets and associated documentation Provide quality approvals of materials in the materials management system as defined by procedures Write/review/approve exception documents and corrective actions/preventive actions (CAPA) and ensure they meet timeliness requirements Review/approve clinical documentation and specifications, as applicable Write/review/approve policies/processes/procedures and related documents Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, R&D GxP Compliance Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality...

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. AstraZeneca’s pipeline of industry-leading innovative medicines is consistently growing, and we are investing in our capabilities to become leaders in the delivery of next-generation cell and gene therapies. At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about...

Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory guidance to cross-functional partners in support of various programs. What You’ll Work On Prepares robust regulatory applications to achieve departmental and organizational objectives. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise on complex worldwide strategies with the help of international regulatory affiliates. Compile,...

We are seeking a strategic and experienced Senior Manager, Quality Systems to lead our global internal audit and compliance programs across multiple divisions and global sites. This role is pivotal in ensuring consistent adherence to external laws, regulations, guidance, and standards (LRGs Local and Reginal Governments Standards), while driving continuous improvement in quality systems, regulatory compliance, and operational excellence. You will lead a team of professionals responsible for internal audits, investigations, audit execution, and quality system enhancements. This role is pivotal in mitigating risk, supporting external audits, and fostering a culture of compliance and performance across Abbott’s global operations. This...

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide. Medtronic's Endoscopy Operating Unit (OU) is seeking a strategic and accomplished Sr. Director of Quality Assurance and Regulatory Affairs (QA/RA) to lead and evolve the global quality and regulatory function. This individual will be responsible for overseeing all aspects of quality compliance, regulatory strategy, product approvals, and post-market surveillance...

Johnson & Johnson MedTech is recruiting for a VP, Quality & Compliance for the joint reconstruction business. The position can be located at the following sites Raynham, MA Boston, MA West Chester, PA Palm Beach Gardens, FL Warsaw, Indiana Leeds and Blackpool, United Kingdom Cork, Ireland About the Company 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...

The primary purpose of this position is to perform routine basic and mid-level laboratory procedures with minimal guidance for the testing of veterinary biologicals according to strict government and company-imposed guidelines. Preparation/sterilization/maintenance of media/solutions/glassware/equipment. Perform basic and complex laboratory techniques and procedures. Perform quality control procedures including titrations, bacterial counts and observations, cell culture and virus testing. This position requires an understanding of the principles underlying the testing procedures used in the areas of assignment. In addition, a thorough understanding of the material being evaluated (virus, bacteria, cell line) is also required. Enter test results in the appropriate tracking system...

We are seeking a skilled privacy professional to help drive our privacy strategy, implement our global privacy program, ensure compliance with global data protection laws, enable innovation in an evolving and highly regulated digital landscape, and foster a culture of responsible data stewardship across the organization. The Deputy Chief Privacy Officer reports to the Chief Privacy Officer and will manage a team of professionals located globally. The Global Privacy Office is comprised of two teams. One team is responsible for counseling internal stakeholders on privacy matters, as well as engaging with external organizations, data subjects, and regulators. The other team...

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. Position Brand Description Lilly is entering an exciting period of growth,...

We are seeking a Principal Regulatory Affairs Specialist to join Abbott’s Electrophysiology Division on-site in Plymouth, MN or St. Paul, MN. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. The individual may execute tasks and play a consultative role by partnering across business functions....

About the Role The primary responsibility is to serve the operations support group by ensuring compliance with procedures and regulatory requirements on the floor. You are responsible for investigations and escalation on the floor promptly to continue un-interrupted production. You are responsible for sample management (sterility, stability, etc.) and preparing shipments of those samples. Additional responsibilities incudes and are not limited to Triage, Deviation/CAPA initiation and investigation, raw material investigations, QOTSF, online batch documentation review, and serve as a Subject Matter Expert for processes. How you will Contribute Sample Management Manage sterility, stability, and retention samples, ensuring proper storage and...

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 At Exact Sciences, we are cancer fighters. We are united by our mission to change lives by providing earlier, smarter answers. Through advances in cancer detection and treatment guidance, we will help eradicate the disease and the suffering...

Johnson & Johnson is recruiting for a Head of Quality and Compliance (Q&C) Leader for our Ottava platform. This role will report to Global VP of Q&C Robotics and Digital and located in Santa Clara, California. About MedTech Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare...

Your skills could be critical in helping our teams accelerate progress. The position will be based in either our Morrsitown, NJ or Cambridge, MA site as part of the Sanofi North America Regulatory Affairs Organization within GRA and will be responsible for providing US regulatory support for both development and marketed products in the Sanofi-Genzyme GBU. As a key member of the Global Regulatory Team (GRT) for the Innovation Franchise and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) will play a pivotal role in shaping regulatory strategy for novel therapies. The RS leverages their regulatory...

Purpose Establish, Implement, lead, and manage an effective Global GxP Data Integrity Program supporting Global Operations. Lead business ownership for Quality Operations global enterprise IT systems ensuring system applications support and manage the business effectively. Build an effective strategic business process improvement plan to ensure business processes associated with each respective enterprise system is managed to reflect a best-in-class quality operating system. The role is responsible for ensuring Quality Centers of Excellence associated with global enterprise systems and associated quality system processes are effectively operating to optimize business processes. Responsibilities Lead the Data Integrity program for AbbVie Operations Engage with...

Purpose An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility....

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

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

Reporting to our Company’s Global Supply Chain Director, the Specialist will support the development and implementation of global trade compliance policies, procedures, and related training. The Specialist will interface with internal customers, external vendors, and service providers as needed. This role is a key part of the team driving global trade compliance policies and procedures within our Company Animal Health. Additionally, the Specialist will assist the Director in conducting audits of our Company Animal Health import and export operations globally. The Animal Health Trade Compliance Team is primarily responsible for identifying trade compliance requirements, supporting various our Company Animal Health...

Johnson & Johnson is hiring for a Principal Supplier Quality Engineer – Shockwave Medical 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 Fueled...

This position works out of our Westfield, IN location in the Structural Heart division. 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 Sr. Quality Engineer, you’ll have the chance to support product development teams, helping to ensure development of highest quality new products as well as providing support to manufacturing teams, helping to ensure delivery of highest quality product to the customer. What You’ll Work On Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints)...

We anticipate the application window for this opening will close on - 23 Jul 2025 Position Principal Quality Engineer for Medtronic, Inc. located in Northridge, CA. Responsible for product quality of devices within the Diabetes Business Unit. Collaborate with manufacturing, operations quality, regulatory and research & development to ensure therapy continuity for Diabetes patients. Provide Quality Engineering support for Diabetes products ensuring all devices meet necessary compliance, performance, and safety requirements. Navigate the complexity of government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, and European Union Medical Device Regulation (EU MDR)....

Our location in Lake Forest, IL has currently an open position for a Sr. Manager, Customs and Trade Compliance in the Core Diagnostics Division supporting Immunoassay, Clinical Chemistry, Transfusion Medicine, Hematology, and our instrument and automation product families. This role will provide divisional leadership and support to ensure compliance with all relevant US customs regulations and trade laws and regulations, including 19CFR,15CFR, FDA, USDA, and other US regulatory agency requirements. Responsible for supporting the development and implementation of division-level policies and strategies and ensuring that appropriate actions are taken by the sites. It will be the responsibility of this position...

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our...

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities This role reports into the Assoc. Director of Compliance and will report to a cluster lead for the EMEA / AP or US region....

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The senior specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities This role reports into the Assoc. Director of Compliance and will report to a cluster lead for the EMEA / AP or US...

Surgical Quality leader for NPD systems quality, hardware quality and reliability. Responsible for setting direction for functional development and program execution to achieve portfolio quality goals. A quality functional director has strong leadership in both people leadership and functional development to support the new product development portfolio. This position will require setting a strategic direction for developing the reliability engineering competency and for elevating the talent and competency within systems and hardware quality. Accountability for program execution, resource planning, talent development, hiring, and functional excellence. This role requires the ability to navigate the matrix organization and engage with program and...

This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Mechanical Development Quality Engineer I assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs What You’ll Work On Execute and support on-time completion of Design Control Deliverables. Support...

Senior Manager Software Compliance Nourish the world and your career as part of the Nutrition team 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®, Glucerna® – to help get the nutrients they need to live their healthiest life. WHAT YOU’LL DO MAIN RESPONSIBILITIES Lead team responsible for software quality assurance validation efforts and system compliance to federal regulations (e.g. 21 CFR Part 11, cGMP,...

Johnson & Johnson is hiring for a Regulatory Affairs Specialist – Shockwave to join our team located in Santa Clara, CA . Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Provides leadership and technical engineering expertise for quality processes, procedures, troubleshooting, investigations, improvement projects, capas and change controls. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career,...

As the Sr. Clinical Quality Assurance Manager at Neurocrine, you will be a pivotal leader in ensuring the highest quality standards are upheld across our diverse clinical research portfolio. Leveraging your deep expertise in Quality Assurance, you will spearhead CQA activities that support the development and commercialization of transformative therapies, primarily in neurology with support for psychiatry therapeutic areas. Your QA leadership and training will be instrumental in driving adherence to all relevant regulatory requirements and internal policies and procedures. You will partner closely with cross-functional teams to implement robust quality systems and processes that mitigate risks and position our...

ModernaTX, Inc. seeks a Specialist, Quality Assurance for its Norwood, Massachusetts location. Here’s What You’ll Do Provide quality on-the-floor support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues and change overs. Assist with troubleshooting equipment. Participate, support, review, and approve the authoring of quality systems records such as investigation, deviations, change controls, Corrective and Preventative Actions (CAPAs) and Stability program support. Support quality decisions that may impact operations, ensuring appropriate escalation. Review data entry and support Stability trending data. Collaborate with Manufacturing to support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping, managing and stocking...

Director, Devices & Combination Products Complaints QA We are seeking a highly motivated and experienced Director of Combination Products Complaints QA to join our team. This role is responsible for leading and supporting the complaints management processes for combination products with a focus on auto-injectors, pre-filled syringes and other innovative drug delivery systems. The ideal candidate will have a strong background and deep expertise in complaint management systems, regulatory reporting and post-market surveillance for combination products. The ideal candidate should also have a proven track record of establishing and managing compliant, scalable complaint processes across pharma, biotech or medical device...

The SOX Compliance team is part of the Controllership group at Gilead and is responsible for the SOX internal controls over financial reporting. This is an audit advisory role with cross-functional involvement with U.S. and international finance teams and business partners. The Associate Director, SOX Compliance and Controls key area of responsibility include design of key controls (business processes, interfaces, and IT application controls), identification of audit process improvements, financial reporting risk mitigation, and remediation of control deficiencies. As part of this unique business structure, the SOX PMO group works closely with external auditors and Gilead Internal audit teams to...

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

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

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. Preference for software-based regulatory experience or familiarity with software regulations and requirements. The Principal Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostics products and External Pacemaker to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval....

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 assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. You will support new product development projects as...

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Our company's Animal Health Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and...

Associate QA What you will do In this vital role you will conduct routine checks, assist in quality audits, and support in implementing corrective actions based on QA findings Responsibilities General inspection of received shipments of raw materials, components, and labels Sampling of chemical raw materials and preparation of sample shipments Quality inspection and dimensional analysis for component and label batches Review of GMP shipment paperwork GMP controlled document review Initiation of deviation records What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek...

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 Associate Director, Quality Control, will serve as site-based...

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...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. This position works out of our Columbus, Ohio plant 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. The...

Our location in Santa Clara, CA currently has an on-site opportunity for a Senior Regulatory Affairs Manager - Transcatheter Mitral Valve Replacement within Abbott Ventures . This new team member is responsible for the management and leadership of Regulatory Affairs activities for an early stage Transcatheter Mitral Valve Replacement device. This individual will lead and coordinate global Regulatory Affairs activities including regulatory strategies, submissions to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals and acts independently to identify and resolve problems. This individual applies advanced regulatory expertise to guide cross-functional partners and...

As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory approval, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and product market entry. What You’ll Work On Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Reviews and provides input on device labeling. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory...

The Senior Director, GMP Operational Quality Assurance will be responsible for the oversight of Site Quality Operations for the Manufacturing of Cell & Gene products . The role will be responsible for leading the Quality on site operations team across multiple shifts for internal clinical and commercial manufacturing operations . Responsibilities include day- to-day operational quality oversight for internal batch record review, batch disposition and manufacturing operations across the end-to-end manufacturing processes for the manufacture of clinical and commercial intermediates and drug product batches. Responsibility includes ensuring all shift quality operational activities are completed in time by identifying technical risk...

The Senior Manager, Quality Assurance Contamination Control and Sterility Assurance is recognized as having expertise in the principals and application of sterility assurance and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing. This role will partner with stakeholders to define strategies for contamination control activities in key areas that include facility and equipment design and qualification (e.g. cleanroom, isolators, autoclaves, etc.), environmental qualification and monitoring programs, and operational practices (e.g. gowning, cleaning and sanitization, etc.). This individual will interface with internal manufacturing sites to support the maintenance of critical cGMP contamination control activities and...

Regulatory Affairs Global Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Global Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely...

The Associate Director, Regulatory Affairs Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters....

We are enhancing our US Oncology Office of Ethics and Compliance (OEC) team to deliver exceptional results and support our business growth. This is your opportunity to be part of AbbVie’s US Oncology Therapeutic Area (Oncology TA), which boasts multiple assets in commercialization and development, along with a mission-focused and inclusive culture. Your ideas and experience matter. We value driven individuals who thrive in a fast-paced environment, can lead initiatives from start to finish, see the promise before us, anticipate risks and opportunities, and are willing to learn and adapt to change. As the Associate Director, OEC, you will foster...

The Senior Manager, RA Global Regulatory Strategy, US & Canada position is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development within the Oncology TA. Assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. Additional Responsibilities...

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

Sr. Cleaning Validation Engineer Job Responsibilities · Serve as the Cleaning Validation lead of cross functional team and able to provide guidance during planning, designing and development of projects. · Write and review technical documentation (cleaning cycle development reports, SOPs, system lifecycle documentation, protocols & reports for engineering and validation testing, cleaning validation master plans) · Creation, execution of Cleaning Validation Protocols, including identification and resolution of non-conformances/deviations. · Assist in preparation of regulatory submissions and presents validation in respective SME areas to regulatory authorities during regulatory inspections. · Manage contractors performing system qualifications, ensure the quality of completed deliverables....

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . Senior Manager of Regulatory Project Management will plan, execute and oversee regulatory submissions and projects and manage cross-functional relationships to achieve on-time completion of submissions. This position will report to Head of Regulatory Affairs. Responsibilities Essential duties and...

Senior Manager Quality Control What you will do Let’s do this! Let’s change the world! In this vital role, you will lead the Amgen Thousand Oaks, Quality Control Microbiology Laboratories. This is a unique opportunity to learn about and support testing of Amgen products through various stages of the product lifecycle. The QC Senior Manager will report directly to the Director of Quality Control and as a member of the QC leadership team will contribute to fostering and further developing a culture of safety, quality and compliance. The QC Senior Manager will be accountable for the following functions in support...

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. About the Role The Director – Manufacturing & Quality, Training Globalization...

Senior Specialist Quality Assurance This position works out of our Alameda, CA location in the Diabetes Care division where 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. As the Senior Specialist Quality Assurance you will be responsible for interpreting applicable internal and external requirements and translate to produce documents such as procedures and partnership agreements that are inline with the Quality System. Define process improvements to ensure consistent implementation of internal requirements...