Quality & Regulatory Jobs in Pharma & Biotech

Lead or co-lead for one RA CMC development and/or marketed product and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. Works closely with subject matter experts within CMC technical operations and QA working within a CMC sub-team structure and serving as a member of the GRT. Contributes to the development of fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences) to support global Health Authority interactions. May oversee activities of junior regulatory personnel. Builds/maintains relationships globally and cross-functionally to ensure effective communication & efficient implementation of regulatory activities for assigned programs. Applies and further...

This position Medical Director, Patient Safety and Compliance, works out of our Lake Forest, IL location in the Infectious Disease Business Unit in Abbott Rapid Diagnostics. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. What You’ll Work On This position will manage Patient safety to provide medical risk and sexual transmitted diseases (STD) guidance for the business group, including support to maintain focus on product performance and safety, product/program development and customer education. The director hired will work cross functionally to support lateral flow technology (LFT) in sexual transmitted diseases (STD), and provide input...

Use Your Power for Purpose The Manufacturing Quality Operations Senior Associate provides Quality Assurance (QA) support to all modalities manufactured on site including clinical, commercial, and contract manufacturing operations providing QA Operations Floor oversight. The role ensures adherence to regulatory expectations, safety, and GxP (i.e., Current Good Manufacturing and Documentation Practices). Duties include, but are not limited to, Aseptic Observations, Acceptable Quality Limit (AQL) testing, batch record review, line clearance approvals, alarms evaluation, on the floor triage, and on the floor real time batch record review. The Senior Associate will work cross-functionally with manufacturing and support groups to investigate manufacturing...

Purpose The Manager Quality Systems is responsible for providing quality assurance support for pharmaceutical products, cosmetics, and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of support may include Training, Manufacturing Quality Assurance, Compendia Management and CAPA. This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations. Responsibilities Ensure proper integration and support of quality regulations...

Our growth story at AZ is based on our core therapeutic areas of Oncology, Respiratory, Cardiovascular/Renal/Metabolics (CVRM), Vaccines, and Immunotherapy (V&I) and investment in China, Japan, and emerging markets. Within our Biopharmaceuticals Business Unit, our global Respiratory, CVRM, V&I, and Medical teams are at the intersection of drug development, formulation and manufacturing, commercialization, and evolving standards of medicine in primary and specialty care; developing and driving our TA strategies to bring new medicines to patients across the globe. In addition to the challenge of different local regulatory regimes, our business is constantly evolving with new innovations in digital/AI, personalized medicine,...

The Site Analytical Science team within Global Quality- Large Molecule Analytical Sciences (GQ-LMAS) team provides support of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support. The position will work closely with partners with Large Molecule Analytical Science (GQLMAS), Sterile Quality Assurance Center of Excellence, Technical Operations, Operations and our manufacturing division Quality to provide site microbiology support. The successful candidate will have the opportunity to apply his or her enthusiasm and microbiological skills in the operation and improvement of a manufacturing facility. This role requires the ability to manage multiple complex projects, activities, and/or...

Our location in Plano, TX currently has an opportunity for a Supplier Quality Engineering Manager in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. This position provides leadership and guidance for the supplier quality engineering department; responsible for developing goals, objectives, procedures, policies and systems that are in line with company goals and objectives, mission and vision and FDA/ISO regulations. Daily responsibilities include managing the resolution of supplier...

We are seeking a Quality Engineer for our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. The Quality Engineer I is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What...

The Manager, Quality Control supports Tech Ops objective on GMP compliance and is a key member of the QC team. Key Responsibilities Include Work closely with contract partners to ensure timely release testing and stability programs of Apellis drug substance and commercial drug product. Author well written quality records (change controls, deviations, investigations, etc.) to implement method changes and/or to investigate non-conformances, OOS/OOT, and CAPA primarily for commercial stage drug product/drug substance. Critically review commercial stage/late-stage analytical data packages (release, stability, validation, etc.) generated for GMP manufacturing and testing of in-process samples, starting materials and key intermediates, drug substance and...

In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Support the development, communication, implementation, and maintenance of regulatory strategic plans Lead and/or support health agency engagements Lead and/or support filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions Perform change control regulatory assessments Develop and support implementation and maintenance of internal regulatory processes Perform...

As a Sterile Operations, Validation Leader, you will provide guidance and direction to a team of Validation Professionals supporting the construction, start up, commissioning, and qualification of an R&D, clinical manufacturing, Drug Product filling facility. The new DP facility as well as this position will be located in Marietta, Pennsylvania. After the facility is released for GMP manufacturing, the role will include routine validation support of the facility including, but not limited to validation maintenance, Change Control management, new equipment / system introduction, decommissioning, and other validation life-cycle requirements. This role requires consistent and continuous on-site presence. Although the role...

The Associate Director, Therapeutic Area Audit Strategy Lead will be mainly responsible for developing the TA audit strategy and overseeing the planning, conduct and reporting of internal and external audits of clinical trial investigator sites. Key Responsibilities Design , develop and implement the Clinical Audit Strategy for various Therapy Areas (ICN & HOCT) . Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and process/systems, including for- cause and directed activities. Provide input in the global audit plans based on identified signals/trends/risks/gaps . Partner with R isk, G overnance, O perations (RGO)...

Position Responsibilities Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers. Ensure consistent positions are presented in responses to global Health Authority (HA) queries. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration...

Position Executive Director, Head of Quality, Cell Therapy Manufacturing Facility Location Summit, NJ BMS Cell Therapy Quality Operations is seeking a Head of Quality at the Cell Therapy Manufacturing Facility in Summit, New Jersey (USA). This role will be responsible for leading the day-to-day Quality operations at the Cell Therapy site including Quality Control, Quality Assurance Operations, and Quality Systems and Compliance. The role will also be a key contributor to the implementation, execution and monitoring of BMS’s quality systems in support of manufacturing, testing and release of BMS’s commercialized Cell Therapy products. This includes but not limited to...

This role will be onsite in Mounds View, MN The Associate Regulatory Affairs Specialist working under the guidance of more senior regulatory specialists/manager will provide support for Cardiac Surgery products. Emphasis is on the post market sustaining activities which includes maintaining regulatory approvals and assessment of device changes for registration. A Day in The Life Contributes to product registration maintenance, including FDA 510(k)s and EU MDR Technical Documentation Collaborates with engineering and cross-functional team to compile materials required for device changes and their corresponding submissions Becomes an SME on various products within the Cardiac Surgery portfolio Monitors and improves global...

The Associate Director, Clinical Supplies Quality, is a dynamic position that will have responsibility for support of US quality operations and disposition, global distribution planning and management, and requires organizational skills and leadership to work effectively and proactively on global functional teams. Primary Responsibilities Responsible for operational and technical support of Clinical Supply Chain for clinical development programs for the company's portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced Development and execution of Quality and key stakeholder strategies, improvement initiatives in line with business drivers and objectives whilst streamlining processes and...

This position works out of our Livermore, California 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. This position provides regulatory compliance leadership for the business, ensuring the policies, procedures, and practices of the business remain compliant to regulatory and contract requirements. What You’ll Work On Directly manages team responsible for following CMS enrollment, Medicaid enrollment, state licenses, Joint Commission accreditation, payor contract review, and quality systems Develops and participates in setting compliance strategies and...

Sr. Director, U.S. Medical Affairs Ethics and Compliance Advisor to US Medical Affairs. This position reports to the Executive Director, U.S. Ethics & Compliance Advisor. Essential Duties and Job Functions Act as the key point of ethics and compliance support for relevant US Medical Affairs activities Partner with leaders across Legal, Commercial, Medical, Clinical Development to build and integrate the compliance program into the US Medical Organization. Advise and provide guidance on Ethical Medical-Commercial interactions Participate in activity reviews consistent with established policies and processes, advising on ethics and compliance insights and recommendations, including outreach to relevant stakeholders or...

The Compliance / Audit Program Manager will have responsibility for developing and executing global strategic internal audit and compliance improvement initiatives. This person should be a well-rounded individual who thrives in fast-paced, technically advanced, and collaborative settings. Responsibilities may include the following and other duties may be assigned. Plan, perform and implement process improvement initiatives (using Lean, DMAIC or Six Sigma processes to understand existing processes through to improvement). Organize, lead and facilitate cross-functional project teams. Develop metrics that provide data for process measurement, identifying indicators for future improvement opportunities. Collect data to identify root cause of problems. Take initiative...

Medtronic – Warsaw, IN 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. The Quality Engineer II role 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 of our...

Our location in Sylmar, CA, Santa Clara, CA or Maple Grove, MN currently has an on-site opportunity for a Senior Staff Auditor, Quality Systems professional. This new team member will be a leader and mentor responsible for implementing internal audits required for compliance with global regulatory standards and collaborating with Abbott Medical Device Business Units for external inspection preparation and support. What You’ll Work On Internal audit planning, developing audit schedules and plans, performing and documenting audits and managing related following up activities including related KPI and metrics reporting. Support the development, training, and supervision of auditors to improve their...

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Temecula, CA, currently has an opportunity for a Quality Engineer. THIS POSITION IS AN ON-SITE DAILY REQUIRED ROLE. What you'll do Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer and provide support to product development teams, helping to ensure development of highest quality new products. The Quality Engineer is expected...

Our company is expanding its global recombinant vaccine production network by investing and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the vaccine, comprised of fermentation, microfiltration/ultrafiltration, purification and chromatography steps. The Director will be responsible for managing the Quality organization and overseeing the daily operations of the Operations Integrated Product Team (IPT). This role ensures that the production facilities and the operations conducted within them are maintained in compliance with Good Manufacturing Practices (GMP). Additionally,...

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...

Specialist , External Capabilities Validation & Compliance (Stability & Sample Management) , Analytical Research & Development The Analytical Research & Development (AR&D) Stability Operations & Compliance department of our company is seeking applicants for a specialist position available at the West Point, Pennsylvania research facility. The Stability and Sample Management Specialist will work as a part of the integrated Stability and Operations team and drive a culture of quality and operational excellence across the global AR&D network. The Stability and Sample Management Specialist will oversee and support GMP stability sample management and logistics in collaboration with our AR&D scientists....

About the Job Are you ready to empower the future of Regulatory Affairs with purposeful digital adoption and innovation leadership? Join Sanofi’s Regulatory Data, Digital, and AI (DDAI) team as Head of Engagement & Innovation , where you will turn vision into momentum—bringing new solutions to life and ensuring they are adopted, loved, and continuously improved across the GRA community. In this strategic and hands-on role, you will lead a global team that blends product mindset, user experience, and value realization. You will manage a flat, multidisciplinary team that includes Portfolio Management, Innovation Leads, Change Management & Adoption Lead, and...

As a Quality Engineer, you will be developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. WHAT YOU’LL DO Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Lead, coach, and mentor non-exempt and entry level exempt personnel Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Design and conduct experiments for process...

Project Leader Design Quality Assurance Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to Career development with an international...

This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. We are seeking a highly knowledgeable individual to combine expertise in scientific, regulatory, and business issues...

We have an immediate opportunity for a MANAGER, GLOBAL COMPLIANCE AUDIT in our ABBOTT PARK, IL OR CHICAGO, IL location. Join Abbott as a Manager, Global Compliance Audit and play a pivotal role in ensuring the integrity and effectiveness of our global compliance program. In this dynamic position, you will lead the planning and execution of comprehensive sales and marketing compliance audits across Abbott’s global operating divisions and Affiliates. You will identify and mitigate compliance risks and provide actionable insights to enhance internal controls. Your work will provide critical assurance on the robustness of our compliance efforts, directly contributing to...

This is a Pipeline requisition for future opportunities in 2025. Associate Quality Engineer for Vascular, this position is based in Barceloneta, Puerto Rico. This position works out of our Barceloneta, PR location in the Vascular Division. ur medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks . Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. As the Associate Quality Engineer will p rovide Process/Quality...

The Director, Regulatory CMC leads a cross-functional team in the execution of global regulatory CMC strategies for investigational and marketed cell and gene therapy products. This role is accountable for the preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and marketed products. Key Duties and Responsibilities Oversees the preparation and review of CMC sections of regulatory submissions, and leads the interactions and responses with regulatory agencies Leads the...

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. The Sr. Manager, IT – GxP Computer Systems Validation & IT Process Lead is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Exec. Director, IT...

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...

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...

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. Quality Control Microbiology (QCM) is responsible for testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. Quality Control is also responsible for assisting...

Production Quality Associate Location Virginia, Brisbane 12 x month FTC Endless growth and development opportunities About the job We deliver consumer-inspired, science-based products and solutions to our consumers worldwide, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. Your job, as Production Quality Associate (FTC) within our Production and Quality Team will be to develop and manage Quality related activities within the Production business to ensure robust processes are in place and are supported by Quality Systems. Reporting to the Production Lead, this position is responsible for the timely alignment & embedding of...

Purpose The Quality Site Head is responsible for the effective operation of QA functions at the manufacturing plant including Incoming Quality Assurance, quality control testing of the product, Manufacturing Quality Assurance of in-process and finished product including batch record auditing and disposition. Validation of product, processes and equipment. Leads a team of quality professionals who are responsible for compliance and quality oversight for the plant operations. Responsibilities Responsible for all aspects of quality assurance and quality control related to product(s) produced at the plant. Represents the decision-making authority on all aspects of the Quality and Regulatory compliance program...

The Director, Regulatory Labeling manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC and Rest of World (RoW) labeling. Provides labeling expertise to the Labeling Working Group and other relevant stakeholders, carrying out responsibilities independently. Leads development of labeling strategies and is responsible for the management of marketed or pipeline products, across the product lifecycle. Responsible for coordination of labeling strategies across program-specific deliverables and junior labeling team members. In this role, a typical day might include Managing the Regulatory labeling process throughout the product lifecycle. Leading the Labeling Working Group and...

Engineer - Compliance System Owner – Inspection What you will do In this vital role you will be the system owner responsible to oversight all compliance aspects at the Inspection lines. Key Responsibilities Lead or support deviations, CAPAs, change controls, technical assessments, and audits (internal and external) Conduct root cause analysis and document findings Lead implementation and effectiveness verification of corrective and preventive actions Develop and execute equipment testing protocols and analyze data to support investigations Review and update documentation such as validation protocols, design documents, SOPs, and data integrity assessments Collaborate across functions to ensure quality, compliance, and...

The Senior Engineering Manager - AME and Program Support Quality will lead a team of talented engineers at our Twin Cities Campus manufacturing sites (Rice Creek, Brooklyn Park, Plymouth-Annapolis, Plymouth-Cheshire). This role is pivotal in driving new product introductions and supporting significant projects across multiple sites. The Senior Engineering Manager will play a key role in mentoring and coaching engineers, ensuring successful project execution, and contributing to the Quality Leadership team. Responsibilities may include the following and other duties may be assigned. Lead and manage AME engineers focused on New Product Introductions, developing and commercializing manufacturing processes for combination products....

We have an immediate opportunity for a Manager Quality Assurance in our Lake County, IL location. What You'll Work On Primary Job Function The function of the Manager, Quality Business Support – Technical Design Quality is to provide corporate-wide support of Abbott’s Quality System and product submissions. The candidate must possess a working knowledge of Quality System requirements, design controls and risk management, as well as an understanding of the US IVD regulatory submissions process and required contents. The candidate must have experience in product design quality and technical (R&D, Technical Support, or manufacturing) roles. The primary activities and responsibilities...

The Senior Manager 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. Responsibilities Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new...

In Pharma Technical Regulatory (PTR) we develop and maintain our licenses globally and influence Health Authorities in their thought processes to develop regulations. In the role of Head of Pharma Technical Regulatory , you will be a member of the Global Pharma Technical Operations (PT) Leadership team and report directly to the Head of Global Pharma Technical Operations. You will lead a global, multilayered organization of about 350 FTEs with approximately 8 direct reports, with a budget responsibility of approximately 100m CHF. As a member of the PT leadership team, you will work collaboratively as part of a team to...

Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. #LI-Hybrid Key Responsibilities Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions. Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions. Determines requirements and...

The Director- QA Compliance, will report to the Executive Director of Supplier Management and Auditing. This key position will be the acting Global Process Owner for External Audits and conduct GMP audits of Gilead’s global suppliers with a primary focus on external biologics manufacturing, contract packaging and contract testing labs. This position will lead audits to support the effectiveness of the global audit program and will work closely with cross functional partners and internal stakeholders. Lead the development, implementation, and maintenance of procedures and templates to assist in the evaluation of and in improvement of the auditing process. Develop strategy...

The Associate Director- QA Compliance, will report to the Director of Supplier Management and Auditing. This key position will conduct GMP audits of Gilead’s global suppliers with a primary focus on external biologics manufacturing, contract packaging and contract testing labs. This position will lead audits to support the effectiveness of the global audit program and will work closely with cross functional partners and internal stakeholders. Primarily conduct global vendor audits for contract manufacturing of Gilead Biologics Support and/or conduct audits of providers of raw materials, product contact consumables, contract manufacturing or testing, software, warehouse / distribution in support of Gilead’s...

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

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

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

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. Sanofi Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. By driving its own transformation, Global MSAT fulfils an important function...

We’ve been on a three-year journey to modernize our U.S. distribution network and transform how we distribute our products. The Woolwich Distribution site is one of two new U.S. distribution hubs opened within the last year to enhance and streamline our delivery operations. We’re aiming to elevate the customer experience and generate cost savings with state-of-the-art technology and standardized processes. But none of it can happen without you – the people who power our operations and ensure that our customers receive our life-saving therapies when they need them. Responsibilities may include the following and other duties may be assigned. Provide...

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation...

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 Overview The PR&D Quality System Associate Director provides critical leadership,...

Be trusted and empowered to be the best you can be! Here at AstraZeneca , we thrive in our inclusive and ambitious environment. We draw on our knowledge to take smart risks and uncover creative ways to better deliver for our patients and our business. Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and own the regulatory strategy for the development, manufacturing and testing of all of our medicines. With our expertise we interpret, anticipate and craft global Health Authority expectations to build CMC and Device Regulatory Strategies. We are seeking a Director, CMC RA...

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Under the direction of the Associate Director, is responsible for providing guidance and supervision to hourly employees to complete testing and testing support activities. Responsible to motivate, train and resolve problems for his/her team while maintaining a compliant and safe environment. Uses team work and good communication skills to administer personnel policies in accordance with the local bargaining agreement. Additional Responsibilities Activities involved in conducting testing and/or assaying of, validation, raw material, process intermediates and finished product samples,...

Our Quality Operations group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. At least 1 year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations. Evidence of good oral and written communication skills (i.e., effective presentation of concepts and...

Medtronic leads the health care industry to provide solutions that benefit the daily lives of people across the globe. Our organization contributes directly to this mission through our rich software system, which include Mobile applications combined with scaled infrastructure and advanced analytics. Become part of our team and you will be challenged to build these amazing software products, and in the process, make a real difference. The Medtronic Diabetes Operating Unit is on a mission to deliver the power of our Automated Insulin Delivery (AID) algorithm and its proven benefits and to give people with Diabetes a choice in the...

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve As a Sr. QA Associate – Validation, the successful candidate will play an integral part in the QA oversight of Validation and Qualification activities conducted within the Pfizer Groton, CT site as well as provide remote support for our RCMF operation...

Our location in Lake Forest, IL has currently an open position for Quality Systems, Regulatory Compliance Manager . This person will be responsible for quality systems and/or quality subsystems and/or key process(es). Incumbent may be a Key Process Owner for a key process(es) or provides managerial oversight, examples include but not limited to QMS Monitoring, Nonconformance/ CAPA, and PRRC (Person Responsible for Regulator Compliance). Directs multi-site, Division-wide activities to accomplish quality system objectives and goals. The incumbent is the Subject Matter Expert and is the primary representative during internal and external inspections such as FDA, ISO, and AQR. What You’ll...

We have an immediate opportunity for a Senior Auditor, Global Finance Audit in our Chicago, Willis Tower, or Abbott Park, IL location. As the Senior Auditor, Global Compliance Audit, you will have the primary responsibility of conducting global sales and marketing compliance audits for all of Abbott’s global operating divisions and Affiliates. Compliance audits provide assurance on the effectiveness of the key elements of Abbott’s Ethics & Compliance Program. Auditors will conduct sales and marketing compliance audits and formulate recommendations for improvement in operating performance and controls over the course of an 18-36 month rotation in Corporate Audit. The individual...

Senior CAPA Quality Engineer Personalized healthcare is the future. Bio-wearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Diabetes is a growing problem worldwide, and at Abbott Diabetes Care (ADC) we are helping people with diabetes lead healthier, happier lives. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, and we‘re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. ADC is responsible for the development and launch of new digital products based on the FreeStyle Libre platform, the world’s...

Senior CAPA Quality Engineer Personalized healthcare is the future. Bio-wearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Diabetes is a growing problem worldwide, and at Abbott Diabetes Care (ADC) we are helping people with diabetes lead healthier, happier lives. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, and we‘re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. ADC is responsible for the development and launch of new digital products based on the FreeStyle Libre platform, the world’s...

Your skills could be critical in helping our teams accelerate progress. Sanofi has established an mRNA Center of Excellence (CoE) and is actively developing mRNA-based vaccines which have the potential to be first and best-in class products in Influenza, Acne, Chlamydia and Respiratory Syncytial Virus (RSV). The Regulatory Affairs mRNA team is responsible for developing and executing cutting-edge regulatory strategies that enable successful product development and market access, while ensuring compliance with evolving global regulations specific to mRNA technologies. The team serves as the critical interface between R&D, manufacturing, and Health Authorities to navigate the unique regulatory challenges of this...

Purpose This individual will be responsible for supporting activities for Combination Products, Pharmaceutical products and medical devices, support the strategic direction to ensure business objectives are met to support and sustain the quality system in Combination Products, Pharmaceutical products, and medical devices and complete quality assurance activities to develop, implement and sustain required regulations to comply to global regulations. Responsibilities Assure proper integration and support of device, drug and Biologics regulations. Areas of direct responsibility include development and maintenance of QA procedures for risk management that support AbbVie’s business objectives, functional area strategies, and the overall quality system. Coordinate quality...

About This Role Biogen is seeking a dynamic professional to oversee all activities related to external Quality testing, with a focus on managing Contract Laboratory Organizations (CLOs). This role drives the development and upkeep of key agreements—including Quality Agreements, MSAs, and SOWs—while leading RFPs, purchase orders, budget tracking, and timeline oversight for outsourced testing. You’ll be the project manager across multiple teams, ensuring alignment on testing status, resolving deviations, and contributing to strategic initiatives like Annual Product Reviews and business performance evaluations. Reporting into Quality Control leadership, you’ll collaborate cross-functionally with Procurement, Finance, Quality, Supply Chain, and more, playing a...

We are currently hiring a Regulatory Affairs Operations Specialist I to work on-site at our Sylmar, CA location. This new team member will perform 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. Additionally, will support necessary regulatory activities required for product market entry. What You’ll Work On Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives. Responsible for following SOPs for managing GTS...

This position works out of our Plano, TX location in the Neuromodulation Division . Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. Lead in the implementation of quality system processes and CAPA systems designed to meet or exceed internal and external requirements....

About the role Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management and serious breach process. This role focuses on defining activities, processes, and standards to meet quality requirements relevant to deviation management and serious breach. This position supports Takeda's mission by maintaining high standards of quality and compliance in clinical trials. How will you contribute Drive the implementation of clinical deviation management and Serious Breach process across Clinical Program Quality. Acts as Subject Matter Expert (SME) for clinical deviation management, and Serious Breaches investigation and reporting to regulatory agencies. Act as strategic partner...

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. RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer...

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 seeking a motivated and detail-oriented Quality Control Summer Intern to join our Quality Control team. This internship provides hands-on experience in pharmaceutical Quality Control operations, supporting our mission to bring the miracles of science to life through high-quality products. We are an innovative global healthcare company with one...

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...

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. The Senior Quality Engineer is involved in developing, modifying, and maintaining quality standards for processing materials into finished products. The role collaborates with engineering and manufacturing to ensure quality standards, devises inspection methods, conducts quality assurance tests, and performs statistical analysis...

In this exciting role as a Quality Engineer II in Medtronic’s Post Market Surveillance (PMS) and Trending within the Risk Management organization, you will play a vital role in ensuring product safety and regulatory compliance. In this role, you will contribute to the Post Market Surveillance report writing process to ensure compliance to regulations, investigate and disposition adverse trending signals, partner with cross-functional team across Quality and Reliability, Clinical Research, Regulatory Affairs, Product Development, Medical Safety, and Statisticians for data-driven decision making process. A Day in the Life Responsibilities may include the following and other duties may be assigned. Draft...

Careers That Change Lives In this exciting role as a Post Market Quality Senior Engineering Manager, you will lead the Aortic Post Market Product Assurance and Quality Sustaining team based in Santa Rosa, CA for all commercial Aortic products for our Structural Heart and Aortic business. Manages a team of Reliability Engineers that are responsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product Manage a team responsible for all Design Assurance activities supporting changes to commercial products. Coach team members through technical problem solving including CAPA investigations and triaging issues. Provide technical knowledge and...

Amgen is searching for a Regulatory Affairs Manager to work in our Global Regulatory Affairs group. This Manager will report to the Senior Director Regulatory Affairs and will work remotely with as needed work out of our campus in Thousand Oaks, CA. In this vital role you will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), the Manager will achieve the desired labeling by developing and implementing regional regulatory strategies and managing effective agency interactions. Responsibilities for the Regulatory Affairs Manager include Ensure that Amgen acquires and maintains all...

Quality Assurance Manager What you will do Let’s do this! Let’s change the world! Amgen is searching for a Quality Manager site lead who will be responsible for Quality and Compliance oversight of contract manufacturing/testing sites. This Quality Manager will have significant responsibility working with supplier quality and manufacturing. The Quality Manager will also provide support to Quality Senior Manager site leads. The Quality Manager will report into External Supply Quality's North American regional team. This role can be filled in multiple locations in the United States. Key responsibilities for this role include Be an integral quality partner of Amgen’s...

The Associate Director, Large Molecule (LM) Development and Commercialization Team (DCT) Quality Support role will reside within our Research & Development Division Global Development Quality Operations (GDQ Ops) organization. This role is a unique opportunity to demonstrate/develop diverse skillsets in providing strategic and tactical support to the LM DCT QL CoE Center of Excellence, as well as the broader GDQ Quality Operations organization in the following areas Support the LM DCT CoE Quality Leader (QL) in defining and delivering on priorities for the continued evolution of the LM DCT CoE model (i.e. building infrastructure for QL training and onboarding, building...

The Associate Director of QC Raw Materials manages and directs the Vertex cell and gene therapy raw materials team. This position will provide leadership and technical expertise in Quality Control Raw Materials Program Management. The role is responsible for leading other QC personnel, optimizing Department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values Key Responsibilities Develop and execute the QC Raw Materials program strategy for in-house manufacturing of Vertex Cell and Genetic Therapies. This position requires strong partnerships with process development(PD), Supply Chain...

Responsible for management and leadership of regulatory activities for assigned commercial and/or development products. Accountable for ensuring alignment and compliance with local and regional registration requirements as well as with company policies. Oversees the development and implementation of global regulatory strategies, ensures timely preparation, review and submission of documents to regulatory authorities, collaborates with development partners, and drives compliance with applicable regulatory requirements. Provides leadership and direction to program teams on the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and lifecycle management. _ Your Contributions...

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 The Quality Assurance Floor Support Specialist works as a...

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

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. Key Objectives/Deliverables Responsible for adhering to safety rules and maintaining...

We are seeking an experienced and detail-oriented Sr. Manager Quality Systems – CAPA to lead and manage our Corrective and Preventive Action (CAPA) program. This role is critical in ensuring that all preventive actions, non-conformances, deviations, and quality issues are addressed effectively and that systemic improvements are identified and implemented. The ideal candidate will have a strong background in quality systems, regulatory compliance, and root cause analysis within regulated industries such as medical devices, pharmaceuticals, biotechnology, or manufacturing. This position reports to the Director of Quality Systems for the Operating Unit (OU) and will be responsible for the CAPA team....

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 us at...

Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Lead for one or more RA CMC development and/or globally marketed products and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. Works closely with subject matter experts with responsibility for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Provides product strategy and direction to commercial and clinical teams. Facilitates risk identification & mitigation strategies. Oversee activities of junior regulatory personnel. Manage contractual and budgetary responsibilities with best...

Take the lead or co-lead role in RA CMC development and/or marketed product initiatives, providing essential support for Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs. Collaborate closely with subject matter experts in CMC technical operations and QA, working within a dedicated CMC sub-team and serving as a key member of the GRT. Play a pivotal role in crafting high-quality, fit-for-purpose documentation (such as INDs, CTAs, NDAs, reports, and correspondences) to facilitate interactions with global Health Authorities. You may also oversee the activities of junior regulatory personnel, fostering their growth and development. Build and maintain strong relationships across global and cross-functional...

The Quality Engineer is responsible for providing ongoing product quality engineering support throughout the product life cycle for multiple product platforms. The individual is responsible for ensuring compliance to 21 CFR 820, ISO 13485, EU IVDR and other applicable international / local regulatory requirements. What You’ll Be Doing Conduct comprehensive reviews of batch records to ensure compliance with cGMPs and company procedures. Identify and investigate potential discrepancies or anomalies in batch records. Perform statistical analyses on batch data to assess product quality and identify trends. Prepare and maintain statistical reports to document findings and support quality decision-making. Contribute to the...

This Regulatory Affairs Project Manager position is an onsite opportunity working out of our St. Paul, MN location in the Abbott Vascular Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. In collaboration with the Regulatory leadership, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets. Additionally,...

You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned a portfolio of products or projects or key Gilead assets to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact...

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 QC Sample Management Technician facilitates the movement of QC...

The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible for implementation of strategic plans for development of diagnostics, including companion diagnostics (CDx), as they pertain to the Novartis innovative medicines portfolio, including its marketed products. The RDM works with oversight of senior members of the Regulatory Affairs Precision Diagnostics Team including the TA and Diagnostics Lead on strategies and submissions including companion diagnostics, in close collaboration with internal RA Disease Unit associates, associates of Digital, Data and Clinical Innovation (DDCI) at Novartis as well as Partner Companies that develop diagnostics and ensures adherence to regulatory requirements. The RDM will...

Quality Compliance Analyst II Location Thousand Oaks, CA About the Role As a Quality Compliance Analyst II, you will play a key role in supporting inspections, leading GMP compliance initiatives, and completing investigations and assessments. This is an on site role that reports to the Quality Compliance Manager. How you will contribute You will Support external regulatory inspections and local inspection readiness efforts and serve as a Quality Council Coordinator, Product Complaint Evaluator, and Gap Assessment Coordinator. You will act as Lead Auditor for self-inspections and supplier audits. You will coordinate efforts associated with GMP re-certification and product licensing. You...

The Medical Quality Assurance Physician plays a critical role in ensuring patient safety and product effectiveness within a pharmaceutical setting. This multifaceted position involves collaboration with the Product Safety Team to author and approve Health Hazard Assessments and Medical Opinions concerning potential product-related issues. The Medical Quality Assurance Physician is essential for maintaining high standards of product quality and safety, protecting patient well-being across all stages of product lifecycles. Major Responsibilities Design of product life cycle strategy, where key Quality System areas are underpinned by medical knowledge commensurate with the potential risk to patient safety e.g. risk assessment, manufacturing /...

Director, Global Patient Safety Physician, US About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AZ, we’re proud to have an exceptional workplace culture that encourages innovation and collaboration. Here, employees are empowered to express diverse perspectives – and made to feel valued, energized and rewarded for their ideas and creativity. AZ is a place where passionate people can immerse themselves in their work and make significant contributions...

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...

Responsibilities The Regulatory Affairs CMC Senior Manager at Gilead is responsible for providing strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. Responsible for guiding and overseeing the preparation of complex regulatory CMC submissions for investigational and commercial products with solid scientific foundations, in compliance with ICH and regional requirements, and in alignment with company policies and procedures. Works collaboratively in cross functional matrix teams to develop a CMC submission plan in accordance with business objectives. Actively collaborates with internal teams (including Technical Development and Manufacturing, Supply Chain and Quality) to identify and rank...

Position Overview This role provides an exciting opportunity to contribute to the operational excellence of our microbiology and sterility assurance laboratories. You will work closely with a dedicated team, drive quality improvements, and play a key role in ensuring compliance and robust laboratory practices. We are seeking a skilled Quality Control Specialist to join our team. This position will work directly with Laboratory Managers to ensure the safe, compliant, and efficient operation of our Quality Control microbiology and sterility assurance laboratories. As an individual contributor, you will support deviation management, problem-solving initiatives, and drive process and operational improvements to achieve...

The Executive Director, Companion Diagnostics/ In Vitro Diagnostics, reporting to Vice President, Global Regulatory Affairs and Clinical Safety (GRACS) Oncology Therapeutic Area, is responsible for overseeing the development and implementation of worldwide regulatory strategy for Companion Diagnostics/In Vitro Diagnostic projects within their portfolio. The individual functions with a high degree of independence and provides oversight for assigned products. They directly manage a team of regulatory strategists and are recognized as an expert in Companion Diagnostics/In Vitro Diagnostic development and they provide technical and professional leadership to staff handling multiple projects. Their subject matter expertise is leveraged internally to provide advice...

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 &...

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

And as the world evolves, so do we. For over 125 years, we have tackled some of the most sophisticated challenges in healthcare. Are you eager to join a team dedicated to bringing new medicines to patients? We are seeking a Technical Regulatory Program Director to join our Pharma Technical Regulatory (PTR) department. This position plays a crucial role in developing new medicines and making them accessible worldwide. We provide strategy, expertise, and mentorship to offer top-tier technical regulatory support for the chemistry, manufacturing, and controls (CMC) components of clinical trial licensure applications, new market applications, and post-approval changes. We...

This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A2 Shift (6pm to 6am), you will lead a team of 4-8 Specialists. The Shop Floor Quality Assurance team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational teams to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The Manager, Shop Floor Quality Assurance, Cell Therapy is responsible for quality activities for the Cell Therapy Facility in accordance...

The Shop Floor Quality Assurance team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with Operational Areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. **6p-6a, with rotating weekends** Provide Quality on-the-floor oversight to [Manufacturing/ QC/ Warehouse/ packout] operations. Identify departures from approved procedures & responding to minor issues or escalating to senior members. Perform and document operational verification per approved procedures Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques...

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of . Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree....

Compliance Manager What you will do In this vital role you will promote and support adherence to all U.S. Healthcare Compliance requirements. Responsibilities Include Assist US Compliance Leads in implementing and administering Amgen’s Corporate Compliance programs & policies Understand Compliance and Business strategy, and advocate for Compliance within the business Provide advice, guidance and support to staff and management on interpretation and implementation of Amgen policies & procedures Maintain awareness of applicable laws and regulatory guidance that may affect Amgen’s Compliance program Develop training programs, materials and workshops aligned with Amgen procedures & policies and deliver to appropriate audience...

About the role The primary responsibility is to ensure compliance with procedures and regulatory requirements in the manufacturing facility. You are responsible for quality support and oversight of manufacturing operations, which includes presence on the floor and for performing Acceptable Quality Limit (AQL) sampling of finished product. Additional responsibilities include assessment for potential issues on the floor, raw material investigations, Quality on the Shop Floor (QOTSF), online batch documentation review, sample management, kitting of batches, and raw materials release. How you will contribute Perform Acceptable Quality Limit (AQL) sampling of finished product. Identify and assess quality risk in production operations...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will p rovide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. How you will contribute Defines, develops, and leads global strategies to maximize global...

Sr Manager, Quality Assurance As the Sr. Manager, Quality Assurance, you will oversee the team responsible for initiating and executing Field Action related activities and is a key contact with national regulators. Responsible for leading projects with cross functional teams such as Commercial, Regulatory Affairs and Project Management as the point of contact during Field Actions and continuous process improvements. What You’ll Work On Provide oversight on team responsible for completing field action documentation and tracking Field Action responses and updates to national regulators, ensuring timely submission to the appropriate regulatory authorities. Responsible for reviewing Field Action packages and...

This position works out of our Santa Clara, CA, 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. We are seeking a skilled Quality Engineer to assume primary responsibilities in test method validation. The ideal candidate will possess extensive knowledge in this area. Additionally, the QE may be tasked with equipment/tooling logistics responsibilities, contingent upon their expertise and organizational needs. The role also encompasses supporting receiving inspections, in-house manufacturing inspections, and managing nonconformance reports....

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...

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 Manager – QA will be responsible for quality support for...

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. The Senior Compliance Specialist uses knowledge of Compliance and GxP to manage investigation and improvement initiatives within Engineering. This position is responsible for performing a variety of tasks under minimal guidance and in accordance with current GMP’s. We are an innovative global healthcare company with one purpose to chase the...

Role Summary The Associate Director, Healthcare Quality Improvement (AD, HQI) is a core member of the Healthcare Quality Improvement team within Global Medical Proficiency and External Affairs (GMPEA), that serves as an internal expert on implementation science methodologies and partners cross-functionally to support the development of implementation science strategies contributing to the adoption of evidence-based interventions. The AD HQI reports directly to the Healthcare Quality Improvement Center of Excellence Team Lead and provides expert guidance on the design and execution of implementation science research, and advises on the dissemination of findings to advance evidence-based healthcare policy and practice. Responsibilities and...

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. 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 ensure that the global SOX audit program...

PREREQUISITES Bachelor’s degree in life sciences with a minimum of 5 years of clinical lab operations, quality and/or compliance; experience in pharma, biotech, CRO, or medical device preferred. MS in relevant life sciences field preferred. Previous lab supervisor experience preferred. Strong knowledge in CLIA/CAP lab requirements and/or ISO13485 Quality Management System Regulation (QMSR). Knowledge of global quality standards and regulations (GCP, GLP, GDP, and ICH GCP), and ALCOA+ principles. Knowledge in various diagnostics technologies and platforms (e.g., PCR, NGS, IHC/pathology, Flow Cytometry, Mass Spectrometry, Imaging, etc.). Experience in diagnostic lab operations, biomarker assay verification/validation, material qualification, and monitoring of quality...

Position Manager, Cleaning Validation, Validation Engineering Location Devens, MA careers.bms.com/working-with-us Manage the development and maintenance of the cleaning validation and changeover cleaning verification program elements for a fully automated, multi-product, biologics manufacturing facility to assure readiness for intended use and to meet all policy and compliance requirements. Key Responsibilities Responsible for implementing the design, implementation and maintenance of a robust cleaning validation lifecycle for process equipment and systems, that includes a bench-scale cleaning program, an efficient cleaning validation philosophy, a cleaning monitoring program, and a cleaning verification changeover program for a fully automated, multi-product biologics manufacturing facility....

Senior Quality Manager This position works out of our San Diego, CA location in the Rapid and Molecular Diagnostics, Infections Diseases business . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As the Senior Quality Manager , you’ll be responsible for managing the Design Quality group supporting development of diagnostic products such as instrument, software, reagents and commodities...

Our location in Irving, TX has an open opportunity for a Principal Design Quality Engineer, Risk Management. This person will be responsible to review and participate in all aspects of product risk characterization, prioritization and management for On-Market and New Product Development activity. It is expected to have a firm understanding of risk management best practices & tools comprehending the identification, analysis, mitigation, tracking and controlling of risks as applied to hardware and software product development. Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products. Secondary function is to...

Lead Design Quality Engineer – Software Validation This position works out of our San Diego, CA location in the Rapid and Molecular Diagnostics, Infections Diseases business . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As the Lead Design Quality Engineer – Software Validation , you’ll reviews documentation for accuracy, clarity, consistency, completeness and compliance for multiple projects....

EM Technician, Quality Operations Evidence of good oral and written communication skills (i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills). Attention to detail, flexibility and an awareness of production and attendant quality control problems. Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields. Ability to sit, stand and move within workspace for extended periods, ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling; ability to lift up to 50 pounds. The candidate must pass a varicella...

We are currently looking for a Project 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 Project 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 schedule with...

GSK is currently looking for a Global Quality Control Lead to join our team. In this role, you will be accountable for maintaining reference standards and critical reagents for all commercial products within the GSK network. They ensure that all the reference standards and critical reagents remain qualified, maintained per regulatory and Quality requirements, inventory is actively managed to ensure no impact to product supply and long-term availability of reference standards and critical reagents to GSK sites, CMOs and LoC. KEY RESPONSIBILITIES Maintain Biopharm critical reagents and reference standards supporting commercial or late phase projects to ensure uninterrupted supply across...

Job Purpose The role is responsible for the leadership of a team focused on defining and driving the US regulatory policy, advocacy and intelligence activities to ensure optimal advancement and life cycle management of GSK’s biopharmaceutical portfolio. Actively shape the evolving US regulatory environment and enable GSK to influence and respond to strategic regulatory changes in the external environment (including coordination and alignment globally) in a compelling, science driven manner. Utilize their extensive external and internal stakeholder network to enable GSK advocacy activities. Key Responsibilities Lead a team and direct the development and maintenance of the US regulatory policy, advocacy...

This position works out of our St. Paul, MN 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 Quality Engineer I , you will be responsible for supporting and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. You will use problem solving, technical writing, and communication skills to gather cross functional buy in for improvements ranging from...

The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. This is an onsite role based in Santa Rosa, CA. In this exciting role as a Principal Quality Systems Compliance Specialist you will have responsibility for compliance to Quality System processes including External and Internal Audit processes to Medical Device regulations and requirements. Role...

Your skills could be critical in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions. The RS provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives....

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 serve an extraordinary purpose. We make a...

This position is a full-time on-site role (M-F business hours) About This Role The Site Investigations Lead (SIL), Quality Assurance, is responsible for championing the overall investigations processes to ensure execution of an effective and compliant process with global and site procedures for the Biogen, RTP, Bio facility. The SIL will have leadership experience and capabilities to influence, impact, and collaborate with all levels of the organization to achieve meaningful outcomes. Responsibilities include but are not limited to providing quality direction to the business to ensure efficient and effective execution of the exceptions processes, support review and approval of deviations,...

Position Supplier Quality Manager Location Devens, MA. Key Responsibilities Oversees the qualification and management of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) vendors. This includes identifying and assessing new vendors, developing and revising Quality Agreements, and maintaining the Approved Vendor List. Act as a support team member during external audits, providing assistance under the supervision of the lead auditor as needed. Manage the lifecycle starting materials used for the manufacture of drug substances/products, which involves material qualification, maintainance, reduced testing, and direct dispensing. Conduct quality assessment of supplier change notifications and ensure actions are driven to completion...

Career Category Regulatory The CMC Regulatory Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The CMC Regulatory Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The CMC Regulatory Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The CMC Regulatory Senior Manager may...

Validation Project Engineer - Casa Grande, AZ - Nutrition Plan This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our...

THE OPPORTUNITY The Director Supplier Quality leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies. WHAT YOU'LL WORK ON Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially in the area of supplier management. Builds strategic partnerships with internal and external stakeholders to...

About the role The Quality Compliance and Systems, Senior Manager is responsible for ensuring the quality of processes and product outputs by defining activities, processes, and standards. 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 quality products. How will you contribute Partner with key stakeholder group(s) to execute strategy to achieve and maintain the desired high state of quality on an ongoing basis to understand, communicate and mitigate compliance risks. Assist in the development and maintenance of quality standards that are compliant with...

You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You...

The Pre-Market Quality Program Manager will join the Medtronic Energy and Component Center (MECC) team and will be responsible for managing various Quality projects. The Program Manager will work cross-functionally with the OU and GO&SC functions as necessary to plan and execute initiatives across the site such as First Time Quality (FTQ), Quality First Reviews, QMS Development Process Improvements, manage and report on KPIs, and more. The Program Manager requires cross-functional operations knowledge, business management skills, and the ability to provide direction and leadership to a variety of functions at the site. This role is on site 3-4 days a...

The Plymouth Nathan Lane site is looking for a Quality Technician that will be responsible for supporting DHR Review and Mfg. Assessment activities and coordination. The ideal candidate will be highly self-motivated and able to effectively communicate with cross-functional teams to achieve the goals of the broader Quality organization. Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. Performs...

The Plymouth, MN site is looking for a Quality Technician that will be responsible for supporting the Operations Quality Technician team in the day to day production support. This position will support the production lines directly. The ideal candidate will be highly self-motivated, able to effectively communicate with cross-functional teams to achieve the goals of the broader Quality organization, and proficient with computers and relevant programs such as SAP, Excel, Word, IQS, and more. Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or...

This individual will work with a team engaged in providing technical services on cell-based assays (Potency assay, Infectious titer TCID50 assay). The individual will support the optimization of cell and molecular biology assays being conducted in Andover, MA and conduct laboratory support processes such as maintaining cell cultures. The candidate must have hands-on experience in cell culture techniques, in vitro Potency, Western blot (automated preferred), protein extraction, and protein quantification methods. Experience with qPCR, and/or ddPCR are also desired skills. The work involves performing assays in a QC-GMP BSL-2 environment and the individual will work alongside other team members to...

Responsibilities may include the following and other duties may be assigned. Provide regulatory support for both new and currently marketed products. This includes developing regulatory strategies, reviewing submission deliverables, preparing submissions for regulatory agencies, reviewing changes to existing devices and recommending strategies for earliest possible approval for regulatory change submissions. Leads or compiles all materials required in submissions, license renewal, and annual registrations. Supports internal audits and external inspections. Assists team members to support worldwide licenses and registrations as needed. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures, regulatory guidance, and regulations. May direct interaction with regulatory agencies...

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. 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 Execution plays a key role in providing regulatory strategy and expertise to drive operational excellence in end-to-end processes for RA labeling, translations and artwork,...

Position Manager, Validation Engineer, Cell Therapy Location Devens, MA Key Responsibilities Supports equipment qualification and validation activities by providing technical impact assessments and developing sound validation strategies. Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls. Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Applies strong technical skillset to investigate and resolve complex challenges. Investigate and resolve Validation Deviations, CAPA investigations and other potential issues Works with Automation/IT partners to ensure configuration and documentation of computerized systems to meet the requirements of CFR21 Part 11....

Your skills could be critical in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions. The RS provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives....

Purpose The Quality Engineer IV performs as QA specialist in the area of quality assurance oversight of operations, production, process and equipment systems and computer validation as well site specific projects related to process improvement and optimization. Responsibilities Provide Quality Assurance oversight and assessment of operational activities in Production, Compliance, Validations, and Technical Services projects. Serve as the QA representative on Validation and Technical Services projects. Liaison to process and equipment validations for QA/QC laboratories, BT, Manufacturing, and Engineering. Ensure process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits...

Purpose To provide strategy for Quality staff by managing daily activities with consideration to the LRP. Strong decision making and communication for issue resolution within the Quality System. Responsibilities Responsible for ongoing compliance with and understanding of applicable policies and procedures, including cGMP Defines strategy for staff to manage daily activities for planning and implementing the LRP. Manages direct reports including hiring, setting performance expectations, reviewing performance and developing staff to support the Quality needs of the plant. Quality oversight of drug product manufacturing and finished good packaging, as well as batch record review and batch release. Supports internal and...

As a Quality Engineer II supporting manufacturing operations, you’ll work at the front lines of product quality and compliance. You will collaborate closely with production, engineering, and quality teams to support daily operations, drive process improvements, and ensure that all products meet Medtronic’s high standards and regulatory requirements. Your focus will be on ensuring consistent quality of manufactured products and resolving production challenges efficiently and effectively. Responsibilities may include the following and other duties may be assigned. Serve as the quality point of contact for manufacturing lines, providing guidance on quality issues and helping ensure day-to-day compliance. Monitor and analyze...

SAP GRC SOX Compliance Analyst What you will do In this vital role you will be a vital part of the Governance, Risk and Compliance (GRC) team within Cybersecurity and Digital Trust (CDT). This team is part of Amgen's Technology team. In this position you are responsible for enabling Information Technology Sarbanes-Oxley (SOX) Compliance. You are required to collaborate with the IT SOX Compliance Manager, service owners, engineers, and other Amgen internal partners such as Finance, Compliance, Corporate Audit and Law department to develop, maintain, and improve Amgen’s Information Compliance. Key responsibilities You will bring forth out of the...

The Regulatory Affairs Manager CMC Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; re ports issues to RA CMC...

Job Summary We are seeking a highly motivated and experienced individual to serve as a Manager on our Regulatory Affairs team. This position will report to the Senior Manager, Regulatory Affairs, Labeling Operations and Compliance. The position will work in close collaboration with the Regulatory Affairs and Pharmacovigilance (PV) teams to develop, implement, coordinate, and execute global regulatory and PV activities. Essential Functions Oversight, planning, tracking, and execution of all regulatory submissions of PV documents to global regulators (e.g., responses to health authority requests, periodic safety update reports, periodic benefit-risk evaluation reports, summary safety reports, etc.) in collaboration with cross-functional...

Our location in Alameda, CA currently has an opportunity for a Senior Compliance Manager. What You’ll Work On Primary Job Function Abbott is currently seeking an experienced professional who will Provide direct oversight for moderately complex elements of Abbott’s compliance program at the franchise, business unit, regional, divisional, or corporate level. Be responsible for directing the development and administration of OEC education and training, and development and implementation of divisional monitoring plan. Identifies compliance risk areas and recommends action plans to ECO. Be responsible for direct compliance support of key business activities involving legacy and new business units. Be responsible...

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses. It brings together exceptional teams of experts and industry-leading technologies to support diagnostic testing, which provides important information for the treatment and management of diseases and other conditions. The position of Manager Quality Assurance is within our Cardiometabolic business based out of Carlsbad, CA. As a Manager of Quality Assurance, the person would be responsible for leading a team of Quality supervisors/engineers/technicians to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. Directs projects to ensure the manufacture of high-quality products and to facilitate...

Senior Project Leader TPM (Third Party Manufacturing) Quality Assurance Our location in Columbus OH currently has an opportunity for a Senior Project Leader TPM (Third Party Manufacturing) Quality Assurance. This individual will serve as the primary account manager for all things quality for multiple suppliers that manufacture nutritional products on behalf of Abbott Nutrition. The primary duties within this role include (1) event management and responsibilities for the Abbott CAPA system, (2) project management as it relates to new product launches, trials, rebranding, etc., and (3) compliance within the Abbott quality system as it relates to our supplier...

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...

The Senior Specialist, Rahway Drug Product Disposition, Global Development Quality is responsible for independent approval of documentation to support GMP clinical supply drug product manufacture, testing, release and maintenance in support of our Company's clinical supply programs. This person will also independently approve documentation accompanying the disposition of excipients, components and critical supply items to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or regulatory inspections independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs),...

Our Irving, TX location is looking for a Sr. Software Design Quality Engineer. This person will be responsible to review and participate in all aspects of product design control for On-Market and In-Development activity in the Medical Device space. It is expected to have a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to software product development. Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products. What You’ll Work On Responsible for implementing and maintaining the effectiveness...

The Sr. Director, Talent Acquisition is an experienced Talent Acquisition expert who will provide strategic leadership and business partnership to a highly complex/ large client group(s). As part of the senior Talent Acquisition Leadership team, s/he would provide vision, leadership and team management for Regulatory & Quality and G&A organizations. This role will report into the VP of Talent Acquisition, Talent Intelligence & Early Career and sit on the Talent Acquisition Leadership Team (TALT). This role will execute efficient and effective talent acquisition programs and practices which include developing a recruiting strategy to support the business strategy for assigned client(s)...

Validation Engineer – Casa Grande, AZ Nutrition Plant This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment 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. Organization Overview At Lilly, we unite caring with discovery to make...

The Rahway based Senior Specialist, Global Development Quality Operations - API , is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials (including new modalities such as ADCs) to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory inspections. Independently performs audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard...

Working in the Finished Goods Platform, TPQM (Third Party Quality Management) within our Research & Development Division, the position will be responsible for serving as the key representative for the quality oversight of Clinical Finished Goods Contractors. The role will also lead GMP/GDP activities supporting the production of clinical supplies, on behalf of our Company. Key responsibilities include Managing the quality oversight of Third-Party Vendors for Clinical Finished Goods (FG). This dynamic position would also play a role in the review and certification of batches intended for use in clinical trials. Play a role in supporting Health Authority Inspections, participating...

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. Summary The Associate Director of Chemistry, Manufacturing & Controls (CMC) - Quality Assurance develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in Development (radiopharmaceuticals). The emphasis of...

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...

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

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. As the Quality Engineer II Risk Management, you will Works closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation. Perform risk assessments and evaluations for products that conform to established standards and agency regulations. What You’ll Work On Perform risk evaluations associated with post market data, give guidance to...

Our location at Lake Forest, IL is looking for a Principal Regulatory Compliance Specialist. This person will be responsible in working with a global team of Quality Specialists to ensure effectiveness to the Core Dx Quality System and Key Processes and support continuous improvement projects and metrics to ensure compliance with regulatory requirements. They will be responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of the quality system to ensure that standards of quality are being met as well as continuously improved upon. What You’ll Work On Responsible for application of quality...

The Compliance Specialist is responsible for maintaining and strengthening the Quality management system. The Compliance team manages the documentation system, systems for food safety and laboratory quality, internal and external audit programs, pest control and sanitation program and stakeholders for governmental law and legislation. The Compliance Specialist develops and keeps all Quality management systems in line with relevant laws & regulations through audit reporting and corrective actions, validation and verifications and sanitation program administration. The Compliance Specialist focuses on quality system compliance, including coordination and implementation of new and existing processes. This position works out of our Casa Grande,...

Global Regulatory Policy and Intelligence Manager What you will do The United States Regulatory Lead (USRL), Sr. Manager is assigned to one or more Amgen products, and plans and executes the Regulatory strategies for that product(s) in the United States. The product(s) assigned have complex programs/strategies and high impact to Amgen. Strategic and Execution Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team. With minimal supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable. Ensures regulatory submissions are made on time and meet Amgen’s corporate and local...

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. The role involves supporting quality control and project management at the Pearl River site, ensuring compliance with regulatory standards for environmental and microbiological contamination control. This is a Monday to Friday, first shift position. We are an innovative global healthcare company with one purpose to chase the miracles of science...

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...

Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs by providing Regulatory Strategy Operational Support to a variety of project teams. Responsible for completing and tracking of requested activities while in compliance of SOP timelines and/or timelines specified by RA leads. Actively supports RA project leads with Regulatory activities associated with the preparation and submission of agency questions, periodic submissions, INDs, NDAs and BLAs. Completion of work must be in compliance with SOPs and GRA best practices. The Opportunity to Make a Difference Ensures accurate planning & tracking of activities requested by various project teams...

We anticipate the application window for this opening will close on - 11 Jun 2025 Position Principal Quality Engineer for Medtronic, Inc located in Billerica, MA. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Navigates the complexities of working in a quality position in the biomedical/medical device industry. Navigates various government and industry regulations to...

Responsibilities The Quality Control Technician position is available at our Animal Health facility in Elkhorn, Nebraska, located on the West end of Omaha. Under general supervision, this position assists professional laboratory personnel by performing routine test media preparation, test sample distribution, laboratory equipment cleaning/sterilization, instrument calibrations, laboratory notebook maintenance and other duties as assigned by QC Manager. Reviews internal documents against regulatory requirements for accuracy and compliance. The equipment used includes but is not limited to microscopes, centrifuges, dry ovens, pipettes, pipette aids, syringes, laminar flow hoods, balances, autoclaves, freezers, coolers, liquid nitrogen, etc. Education Minimum Requirement...

The Regulatory Affairs Director (RAD) , Global Regulatory Strategy will be responsible for the development and implement ation of global regulatory strategies for all assigned products and therapeutic areas, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Program and/or Medicine Teams (GPTs/GMTs) deliverables . The individual will also ensure effective communication and constructive working relationships with business partners and representatives of...

Quality activities for the Service & Repair organization - onsite minimum of 4 days per week in Plainfield, IN In this exciting role as a Quality Engineer II, you will be a part of the Americas Service & Repair team. Service of medical devices is crucial to ensuring their safe and effective operation, which ultimately allows healthcare professionals to deliver reliable and high-quality care to their patients. You will be an integral part of the team that supports the company’s quality policy to Put Patients First. This team collaborates with global teams to support products across several portfolios in Medtronic....

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...

Senior Manager, GxP IT Quality Assurance & E-Compliance, Bristol-Myers Squibb Company, New Brunswick, NJ. Oversee computer system validation and software development to assure regulatory compliance across the end-to-end product lifecycle (Research & Development). Ensure the research and development is conformance to current GxPs, guidance documents, applicable industry accepted standards and requirements. Review and approve the key computer software life cycle (SLC) deliverables. oversee key software development life cycle (SDLC) process such as problem, incident, change, release, etc. Ensure adequate and timely regulatory compliance support. Report on key metrics across the ITQA tower. Oversee the qualification BMS infrastructure that support regulated...

Job Summary We are seeking a VP, Global Quality Operations to oversee the global quality operations of Novavax. The responsibilities of this position include, but are not limited to, managing Novavax and external CMOs quality operations and the batch release process of commercial and clinical stage products. Additionally, the individual is expected to establish and maintain a robust quality system at all manufacturing sites to support production of safe, effective and quality commercial and clinical products. This strategic leader is also expected to hire, mentor and develop the global quality operations team. This position reports to the Global Head of...

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 Quality Assurance Representative for the Parenteral team (preparation, formulation,...

Job Title Regulatory Compliance Specialist This position works out of our Livermore, CA office in the Abbott Heart Failure, Acelis Connected Health business. Our Heart Failure solutions are helping address some of the World’s greatest healthcare challenges. As the Regulatory Compliance Specialist, your primary responsibility is to maintain and obtain state durable medical equipment licensing, including supporting accreditation activities. This position will support the day-to-day operations for various regulatory activities including regulatory change management, audit preparation, submissions to regulatory bodies, correspondence, and record keeping. What You’ll Work On Maintain and obtain durable medical equipment licenses and other state licenses...

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. In 2021, Abbott’s NeuroSphere Virtual Clinic was named one of Time Magazine's 100 Best Inventions. In addition, Abbott’s Eterna spinal cord stimulator (SCS) - which is the smallest implantable, rechargeable SCS device on the market designed to treat chronic pain - received the Accenture Corporate Innovator Award from Chicago Innovation. The Director, Quality Engineering will direct and guide the management team in the...

This position works out of our Abbott Park, IL location for our AQR Abbott Quality and Regulatory division. The function of the Quality Program Manager is to provide leadership, oversight, and project management covering Abbott’s Quality System. This includes division / business support and quality expertise and consulting activities. The Quality Program Manager will support Divisions across all Abbott Quality Systems in activities associated with quality, regulatory compliance areas. The candidate will provide strategic, technical, and business support across all Quality Systems by interacting directly with Divisions and providing quality and technical expertise and strategic consulting activities for the Divisions....

General/ The Associate Director, Quality Assurance is responsible for supporting the day-to-day Quality Operations of Contract Manufacturing Organizations (CMOs) for Cell & Genetic Programs through the management of quality management system (QMS) events. The role will assure Quality oversight for technical and operational CDMO activities from clinical throughout product commercialization activities, post-approval process monitoring, and deviation management. The role is also responsible for the development and maintenance of relationships with the internal and external partners, to drive compliance, monitor performance, and support continuous improvement activities. The role will closely partner with operational stakeholders and participate in associated governance for the...

General/ The Senior Manager Manufacturing Technical Sciences QA is accountable for end-to-end technical quality oversight of Cell and Genetic Programs throughout clinical development, commercialization, product launch and post approval lifecycle management activities. This includes establishing relevant product quality standards for current or novel technologies, ensuring internal and cross-functional alignment with industry and regulatory expectations, and identifying product quality risks and mitigations throughout development for the assigned programs. The role will closely partner with operational stakeholders to participate in Cell & Genetic therapies projects and associated governance to meet business, regulatory, and operational requirements. . Key Duties & Responsibilities Participate in...

Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Provides regulatory leadership for an assigned therapeutic area with multiple products in various stages of development and works on assigned products to ensure compliance with applicable global regulatory requirements. Facilitates identification and resolution of scientific and regulatory issues with the regulatory agencies. Directs the preparation and submission of INDs, NDAs, BLAs. Management of regulatory personnel with oversight and responsibility across the organization. May manage contractual and budgetary responsibilities with best business practices. Champions to stakeholders at all levels within the organization the development of company goals...