Quality & Regulatory Jobs in Pharma & Biotech

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca , we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet...

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Manager, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located High Wycombe, UK; Leiden, Netherlands; Neuss, Germany; Paris,...

The Analyst, Regulatory Policy and Intelligence (RPI) support the US RPI function by conducting research on regulatory intelligence questions and topics within assigned areas and regions. Responsibilities include analyzing and utilizing relevant regulatory approval databases, as well as preparing and delivering regulatory intelligence summaries both orally and in writing. The Analyst should be comfortable working in a dynamic environment and proactively contributing new ideas and process improvements that enhance assigned projects. The Analyst also serves as the office manager for the Rockville MD location and should be comfortable assisting with general office duties. This includes oversight of rental and service...

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

The Executive Director, Regulatory Strategy – Endocrinology is a senior regulatory leader responsible for shaping and driving global regulatory strategy across Neurocrine’s Endocrinology pipeline, spanning early development through commercialization. This leader will oversee regulatory strategy for programs in rare endocrine disorders and obesity and will directly lead a team of three regulatory professionals. This role requires a highly strategic, scientifically grounded, and commercially savvy regulatory executive who can integrate complex development considerations, safety signals, and evolving regulatory requirements into clear, value-maximizing strategies. The Executive Director will serve as a key voice at senior leadership tables, influencing cross-functional decisions to optimize...

What you will do In this vital role the Executive Director, Information Security is a leadership role responsible for the Governance, Risk and Compliance (GRC) across Amgen’s global digital operating environment. This leadership position plays a significant role in developing our comprehensive strategies and frameworks to manage and mitigate risks, strengthen Amgen’s corporate governance, and ensure compliance with applicable laws, regulations, and industry standards (e.g., GxP, SOX, ISO, etc.) The Executive Director will support leadership and peers through the delivery of time-sensitive and tailored information necessary to improve strategic business decision-making. The Executive Director collaborates with stakeholders from Digital,...

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

This position works out of our Pleasanton, CA location in under the Medical Device, Heart Failure Division. As the Senior Supplier Development Quality Engineer you will be responsible for implementing and maintaining an effective Quality System, planning, executing, and documenting audits of external suppliers to ensure compliance with FDA, ISO 13485, and internal quality standards. This role drives supplier performance improvements and collaborates cross-functionally to uphold regulatory and operational excellence. What You’ll Work On Work cross-functionally to lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, product and process planning, quality audits, and...

Senior Quality Engineer This position works out of our Barceloneta location in the Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. The Senior Quality Engineer provides Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. Shift 1st- Monday to Friday What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming material, leads identification of primary root causes...

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

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 Global MQ Labs group is a central group designing,...

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

Join For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world — and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. With almost 70,000 employees operating in more than 120 countries, you will be joining...

Leads the Regulatory Policy function that is responsible for proactively monitoring, analyzing and summarizing developments in regulations, guidance developments impacting pharmaceutical development for Neurocrine Bioscience’s products, pipeline and the patients we serve, primarily for the US. Informs and influences policy matters with external stakeholders, and establishes partnerships with Neurocrine Bioscience’s Government Affairs, Public Policy and Patient Advocacy organizations to support relevant policy matters. Ensures that substantive analysis of US regulatory activities related to prescription drugs are conducted and communicated to relevant stakeholders in Regulatory Affairs, Management and cross-functionally, as needed. Leads the development of regulatory policy positions, written summaries, analyses...

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

Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. The Sr Design Quality Engineer will play a critical role in supporting the Neuromodulation and Pelvic Health business by developing, implementing, and maintaining quality standards for new product development. This position requires close collaboration with R&D engineering and manufacturing teams to ensure compliance with regulatory and internal requirements, emphasizing the inspection, testing, and evaluation of product...

The Associate Business Systems Consultant supports the integration of Business Technology Solutions (BTS), Software Quality Assurance (SQA), Compliance, and Technology Enablement teams in delivering solutions aligned to the Technology Solution Lifecycle (TSL). The role assists in interpreting and translating pharmaceutical regulatory requirements (GxP, CSV, Part 11, Annex 11) and ensuring they are embedded into technology practices and CI/CD pipelines. Supports identification of strategic business opportunities, shaping compliant technology solutions, leading process modernization, and ensuring alignment of digital quality engineering with business and regulatory expectations across multiple business areas. Responsibilities Support liaison activities between SQA, Compliance, and BTS technology enablement teams;...

Leads the strategic integration of Software Quality Assurance (SQA), Compliance, and BTS Technology Enablement teams delivering the Technology Solution Lifecycle (TSL) automation tools. Responsible for ensuring pharmaceutical regulatory requirements (GxP, CSV, Part 11, Annex 11) are accurately interpreted, translated, and embedded into technology practices and CI/CD pipelines. Accountable for identifying strategic business opportunities, shaping compliant technology solutions, leading process modernization, and ensuring alignment of digital quality engineering with business and regulatory expectations across multiple business areas. Responsibilities Lead as the primary liaison between SQA and Compliance leaders and BTS technology enablement teams; broker services, align stakeholders, and resolve interdependencies across...

Beam is seeking a Sr Manager/Manager Regulatory Affairs to progress a broad portfolio of advanced genetic medicines in a fast paced and dynamic biotech environment. The person will be responsible for supporting the development and implementation of the global regulatory strategy for Beam’s programs. Responsibilities In partnership and under guidance from the Regulatory Lead, drive the development of global regulatory strategy for Beam’s portfolio of advanced genetic medicines and ensure integration of regulatory tactics that support the broader corporate strategy. Incorporate evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough...

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 Lilly At Lilly, we unite caring with discovery to make...

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

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...

This position of Senior Associate Clinical Quality, works out of our Lake Forest, IL location in AMD , Abbott Molecular Diagnostics. Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions. What you will do Provide global support to Clinical Development (CD) staff to ensure compliance with company policies, GCP regulations/guidelines, ISO standards, and other applicable requirements. Clinical Study Support Act as a reviewer of protocols, informed consent forms, case report forms and other essential study...

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

Senior Manager, Global Compliance Operations will report to the Senior Director, Head of Global Compliance Operations and is a great opportunity for a highly motivated individual who is interested in independently managing critical components of the Compliance program in a dynamic and fast paced environment. This role requires strong attention to detail, professionalism, sound judgement, and the ability to work cross functionally with multiple stakeholders. The Opportunity to Make a Difference This role is responsible for executing tasks and initiatives that span all three pillars of Sarepta’s Global Compliance Program. The successful candidate will contribute to activities supporting Global Healthcare...

The Regulatory Strategy Manager will be responsible for regulatory support for development programs or marketed products. The Regulatory Strategy Manager will contribute to the development of US regional or global regulatory strategies for development and commercialization of program(s) within the portfolio. This role requires a good understanding of regulatory affairs frameworks, the drug development process, and related concepts. Key Duties and Responsibilities Contributes to the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team Develops proficiency in regional and global regulatory skills Supports global regulatory strategy under guidance of the...

The Document Manager will be part of the Program Quality Team in Vertex’s North America Commercial Patient Support Program Center of Excellence (NAC PSP COE). Reporting to the Senior Document Manager, the Document Manager will play a crucial role within the COE Program Quality Team and contribute to the NAC PSP success through document/knowledge management This role is responsible for supporting disease area Patient Support Programs (PSPs) in the strategy, development, and revision of program documents including standard operating procedures (SOPs) and work instructions (WIs) in collaboration with multiple stakeholders Key Responsibilities Responsible for effectively managing a robust collection of...

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity, and innovation. Abiomed is recruiting for an Entry‑Level Supplier Quality Engineer — Electronics to be located in Danvers, MA. About MedTech...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) Mexico - Requisition Number R-058223 Remember, whether you apply to one or all...

This Associate Director, Regulatory Affairs will work on-site at our Westford, MA location in the Vascular Division. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual will develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management...

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

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This position will support international registrations for the Acute Care & Monitoring Operating Unit products. Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling,...

The Senior Design Quality – Electronic Engineer position, is one of development, improvement and innovation. If you pride yourself on your problem-solving skills and a meticulous attention to detail this may be the role for you. You will be tasked to provide quality engineering support in the design and development of electronic medical device products. Facilitate the application of Design Controls, Risk Management and Change Control processes in the evaluation and implementation of changes to released products. Responsibilities may include the following and other duties may be assigned. Previous experience in Electronic PCB design and development. Preferably with a formal...

Sr. Design Quality Manager - RPE [Released Product Engineering]. Sr. Design Quality Manager for Released Product Engineering [RPE] within ACM OU. With responsibility for the management of all released product engineering changes across the ACM portfolio of products. The role involves the management of a global Design Quality engineering team focused on RPE product changes. Ensuring the ACM portfolio of products remain state-of-the-art and always available to our customers, as we qualify planned and forced product, packaging, labelling and process changes. In this role, you will be tasked with championing the application of industry leading standards in design controls, Risk...

A career at Medtronic is driven by our Mission to alleviate pain, restore health, and extend life for millions globally. As a Quality Engineer I your role, you’ll develop and maintain quality standards, collaborating with engineering and manufacturing teams to ensure products meet rigorous requirements. You will revise and implement inspection and testing protocols, analyze data, and drive corrective actions to uphold reliability and compliance. As a liaison between global R&D and product development groups, you’ll help shape innovative solutions that advance healthcare. Join us to make a meaningful impact and help change lives—together, we’re committed, purposeful, and passionate about...

Key Responsibilities Perform independent review and approval of initial Commissioning, Qualification, and Validation (CQV) lifecycle documents and subsequent changes. Review and approval of periodic reviews, re-qualification, decommissioning and retirement and plans, protocols, and summary reports. Review and approval of Standard Operating Procedures, Work Instructions, Deviations, CAPAs and Change Controls related to facilities, utilities, equipment, instruments, and systems. Provide instruction and guidance on CQV quality issues during regulatory agency inspections, deviations, and CAPA discussions. Support the Contract Service Providers program. Provide reports to management related to timely deviation completions, CAPA implementations or other issues related to CQV and CSV activities. Support...

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

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

Position Design Quality Engineering Co-Op Department Design Quality Location Danvers, MA

Johnson & Johnson is recruiting for a Staff New Product Development Quality Engineer for our Joint Reconstruction Platform supporting Shoulder Reconstruction. This position is located in Raynham, MA. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following...

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

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with...

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 are driven by an extraordinary purpose....

Director, Regulatory Affairs Strategy Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio! About AstraZeneca At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing...

Director, Regulatory Affairs Strategy Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio! About AstraZeneca At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing...

Clinical Regulatory Writer, Associate Director Location Gaithesrburg, MD- Hybrid (3 days onsite) Introduction to role Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. Accountabilities As a Clinical Regulatory Writer,...

We are seeking a Principal Regulatory Affairs Specialist to join Abbott’s Vascular Division on-site in Santa Clara, CA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies. What You’ll Work On Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements...

Supplier Quality Engineer II This position works out of our Plymouth, MN location in the Electrophysiology Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. The Supplier Quality Engineer II role will drive improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work...

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...

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

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. " Position will be based out of our brand new plasma donation facility in the Rochester, NY opening October 2025! BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors designated systems and activities,...

The Associate Director, International Regulatory Affairs Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. The Associate Director will design and deliver optimized global regulatory strategies, plans and dossiers that align with AbbVie’s overall business strategy. This individual is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. The Associate Director will interface with International Marketing, Global Legal and Office of Ethics...

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

We are now recruiting a n Associate Director , R&I Clinical Regulatory Writing ( CReW ) . A s part of a clinical delivery or submission team, the Associate Director provide s strategic communications leadership to projects, establish es communication standards and best practice, and continuously advocate s for quality and efficiency. The Associate Director also a uthor s strategic clinical-regulatory documents and provid es critical review to achieve high-quality standards, utilizing best practices for document and accelerated submission delivery . What You will Do The Associate Director, CReW , is expected to Independently manage clinical regulatory writing activities across...

Medtronic has declared its bold ambition to become the global healthcare technology leader. By doing so, we seek to reach more patients in more meaningful ways, more quickly. Are you looking to create capability and competencies in Operational Excellence (OpEx) for the leader in the Medical Technology industry? As the Operational Excellence Sr. Manager, Transactional Processes, you will be a core member of the team representing Operational Excellence, planning and executing process improvement objectives that support the Global Quality organization. These objectives include specific operational performance targets and the development and training of employees to foster a sustainable culture of...

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

Join our dynamic team in Grand Rapids, MI where we are seeking a hands-on Supplier Quality Engineering Manager to drive supplier excellence through continuous improvement and proactive quality with our suppliers. This site manufactures approximately 600 finished products for our Cardiac Surgery (CS) portfolio – most notably Cannulae and Beating Heart products. We are looking for a passionate SQE Manager ready to make an impact, collaborate cross functionally, and grow their career with a global leader in healthcare innovation. This role is 100% onsite at our Grand Rapids, MI manufacturing site. Responsibilities may include the following and other duties may...

Here, your career breakthroughs will change the future of health, in all the best ways. And you’ll change, too. You’ll be inspired, and you’ll inspire people across the world to change how they care for themselves and those they love. Amplify your impact. Join us! Regulatory Affairs Opportunities Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, medical devices and consumer products among others, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure...

Johnson & Johnson is currently seeking a Design Quality Engineering Co-Op to join our Software Design Quality Engineering Team located in Danvers . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at ....

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Global Regulatory Affairs Scholar, located in Spring House, PA, Raritan or Titusville, NJ. Global Regulatory Affairs Scholar Program Overview The Global Regulatory Affairs (GRA) Scholar Program at Johnson & Johnson...

Johnson & Johnson is currently seeking a Supplier Quality Engineer Co-op to join our Supply Chain Quality Team located in Danvers. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at . Requirements Are...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Global Regulatory Affairs Scholar, located in Spring House, PA, Raritan or Titusville, NJ. Global Regulatory Affairs Scholar Program Overview The Global Regulatory Affairs (GRA) Scholar Program at Johnson & Johnson...

Janssen Pharmaceutical, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for Quality Control Analyst- Microbiology Lentiviral Vector (LVV) At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen...

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

As a Validation Engineer - Project Leader, working within the Clinical Sterile Operations pilot plant, you will be responsible for the successful delivery of validation life-cycle documents associated with direct impact clinical GMP manufacturing process equipment, clinical manufacturing facility, critical utility systems, and automation systems required for clinical scale, drug product manufacturing. Additional responsibilities include the qualification of microbiology and analytical systems and instrumentation that support clinical GMP drug product manufacturing operations. The Validation Engineer - Project Leader, has the responsibility of ensuring all validation life-cycle activities are performed in compliance with GSK validation life-cycle policy and procedures. This position...

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...

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 Manager of Precursor and Supplier Management leads quality...

The Patient Safety Medical Director will provide medical safety expertise for assigned products, pre- and post-approval. The role will optimize patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of Safety activities through the product life cycle. Key Duties and Responsibilities Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development) Responsible for the safety assessment activities of assigned products under the supervision of a Global Patient Safety (GPS) Disease-area Safety Head Autonomously monitors...

The Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Quality Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. Quality Manager provides quality oversight and sets strategy for process validation, cleaning validation, method validation, and/or product stability activities Demonstrates appropriate quality oversight of root-cause analysis and product impact for product quality investigations, ensuring appropriate CAPA actions are...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers. The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function working in an international and culturally diverse team. The Quality Documents Expert participates to the robustness of the quality system by supporting the Quality...

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

Job Title S enio r Software De velopment Quality Engineer This onsite role is based in Plano, TX , supporting 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. As a Senior Software Development Quality Engineer , you will serve as a quality champion within product development, ensuring that software and system designs meet the highest standards of patient safety, product reliability, regulatory compliance, and clinical effectiveness ....

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at...

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

About GenerateBiomedicines GenerateBiomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform...

The Manager/Senior Manager, Regulatory — Advertising, Labeling, and Promotion (ALP) is responsible for leading U.S. promotional regulatory strategy and supporting ex-U.S. needs across our gene editing portfolio. This role reports to the Director of Regulatory Labeling and serves as a key member of the Promotional Review Committee (PRC/MLR). The position ensures compliant, compelling, and scientifically accurate communications consistent with core labeling and regulatory requirements. Responsibilities Serve as Regulatory lead for PRC/MLR review of promotional, disease awareness, scientific exchange, HCP, and patient-directed materials for certain products, under the supervision of the Director of Regulatory Labelling. Manage the lifecycle of core and...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Supplier Quality Intern to be in Santa Clara, CA. The Intern term is from June to August, 2026. Full time requirement (40 hours per week). Purpose The Quality Engineering Intern will participate and learn about the basics of Supplier Quality processes. Under the guidance of the Hiring Manager and Mentoring Engineer(s), the Intern will...

POSITION SUMMARY The Manufacturing Quality Engineering Co-op will assist in sustaining and improving the quality processes across the manufacturing workflow to ensure quality product is produced and quality procedures are upheld. KEY RESPONSIBILITIES Participate in the investigation of failures and formulation/implementation of action plans for nonconformances, internal corrective actions, and audit findings. Work in cross-functional teams to identify and address non-conformances throughout assembly to final shipment of product. Work with engineering teams to ensure quality procedures are followed in all manufacturing and distributing areas. Use Lean and Six Sigma tools to analyze non-conformance data and identify...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Regulatory Intern to be in Santa Clara, CA . The Intern term is from June to August, 2026. Full time requirement (40 hours per week). Purpose The Regulatory Affairs Intern will participate and learn about the basics of Regulatory processes and procedures in order to assist in Regulatory research, project publishing, organization and benchmarking,...

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

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Reducer Quality Intern to be in New Brighton, MN. The Intern term is from June to August, 2026. Full time requirement (40 hours per week). Purpose The Quality Engineering Intern will gain hands-on experience in the fundamentals of Quality processes and procedures. Under the guidance of the hiring manager and designated mentors, the intern...

WHY JOIN US? Transform billions of patients’ lives through technology, data, and innovative ways of working. You’re disruptive, decisive, and transformative. Someone excited to use technology to improve patients’ health. We’re building a new Health-tech business – Evinova, a fully-owned subsidiary of AstraZeneca Group. Evinova delivers market-leading digital health solutions that are science-based, evidence-led, and human experience-driven. Thoughtful risks and quick decisions come together to accelerate innovation across the life sciences sector. Be part of a diverse team that pushes the boundaries of science by digitally empowering a deeper understanding of the patients we’re helping. Launch pioneering digital solutions that...

Reporting to the AVP of New Modalities Manufacturing Division Quality, this leader is responsible for providing Antibody Drug Conjugate (ADC) expertise and supporting a quality oversight model necessary to facilitate agility and speed-to-market while ensuring sustained, compliant supply of specialty New Modalities pipeline products to global markets, to serve our patients. This leader will leverage ADC experience to support the implementation of a fit-for-purpose quality management system and ensure strategic quality oversight of new modalities products manufactured in our company's network and at external partner sites. The leader will interact with our company's cross-divisional/functional teams from development through commercialization to...

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

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. Quality Assurance Floor Support Specialist (Nights) Organization Overview At Lilly,...

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

The Executive Director, Regulatory Operations is responsible for leading the teams of publishing, submission management, regulatory information management, compliance and the regulatory management office. This role will be accountable for creating a high quality organization that utilizes the best in technology, process and project management to deliver global submissions in a highly effective and efficient way. This role will drive the strategic framework for how GRA operates as a group including centralized oversight of functional strategic objectives. Key Duties and Responsibilities Leads the Submissions Management & Publishing groups, and the delivery of quality global dossiers to HAs utilizing effective planning...

Responsible for t he p rin c ip l e s a nd a ppl i ca t i on of qu a l i t y a n d GDP re g ulato r y c omp l ia n ce supporting the global processes for distribution of Vertex materials, intermediates, and finished medicinal products (commercial) across its global distribution network. Stakeholders include GMP QA, Market Quality, Global Logistics, Vendor Management and AIM. This position reports directly to Associate Director/Director, Distribution Quality Key Responsibilities The responsibilities of this position will include, but are not limited to, the following Distribution...

The Associate Director, GMP Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for primary QA oversight of commercial drug substance manufacturing performed at Vertex’s external vendors as well as secondary quality support of commercial drug product manufacturing vendors. This position ensures robust sterile manufacturing controls, commercial supply continuity, support for global jurisdictional expansion, and high‑level combination product quality alignment. The incumbent will mentor team members to provide individual development in addition to efficient and valuable service to project teams. Key Duties and Responsibilities Collaborate with internal and...

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

General/ The Director, Quality Assurance GMP Operations will oversee the GMP QA operations including batch disposition process across CDMOs in the US and Internationally. Responsibilities include day-to day operational quality oversight for internal batch record review operations and QA manufacturing operations from clinical to commercial stage of product globally. The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk mitigation, execution of operational activities participation of governance committees associated with improvements to the disposition process. A key expectation is the ability to closely collaborate and build relationships with internal and external...

General/ The Director, Quality Oversight Lead within Global Clinical Quality (GCQ) is responsible for strategic and operational oversight of key activities such as inspection readiness, the GCQ operational framework, continuous improvement initiatives, and expert guidance on computer systems assurance in a clinical trial setting. Additionally, the Director will be responsible for providing quality oversight to Clinical Development and Biometrics functional areas. We seek an individual with strong leadership skills, expert drug development and GCP knowledge, and advanced understanding of the application of inspection readiness principles in a clinical trial setting. This position reports directly to the Senior Director of Global...

The Director, GDP Operational Quality is r esponsible to partner with Trade Operations to support the distribution of Vertex’s commercial product portfolio. The role is responsible for oversight of team activities, development of personnel and ensuring timely completion and quality of deliverables/goals within their remit. The role supports GDP quality operations for all distribution activities within the US; key stakeholders include Trade Operations, Vendor Quality Management & Quality Compliance. Key Duties and Responsibilities The responsibilities of this position may include, but are not limited to, the following Primary quality partner for Vertex US Trade Operations organization, providing quality input and...

The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST...

The Associate Director, GMP Operational Quality will provide leadership and quality oversight for contract testing laboratories (CTLs) supporting Vertex’s biologics and combination product portfolio across development, PPQ, launch, and commercial lifecycle management. This role ensures that analytical testing, method execution, and data generated by external laboratories meet Vertex, global regulatory, and data integrity standards. Key Duties and Responsibilities Serve as the primary QA lead for CTLs supporting release, stability, characterization, and device-related testing for Vertex’s biologics and combination products. Provide quality oversight for analytical method qualification/validation, method transfer, and lifecycle management activities executed by CTLs. Review and approve analytical protocols,...

General/ Senior Manager, GMP Quality Operations is a technical resource in the principles and application of quality assurance and compliance. The Sr. Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. The role is responsible for maintaining documents reconciliation, labeling control, master batch records and issuance of batch records for production. The quality senior manager is responsible for implementing strict issuance tracking, controlling version updates, and ensuring data integrity (ALCOA+) to prevent unauthorized changes and ensure product safety The role will closely partner with operational stakeholders...

The Compliance Associate Director assists in implementing and further enhancing the anti-corruption/anti-bribery Compliance program. Reporting to the Executive Director Head of Global Compliance Program Strategy, Assurance and Management, the Compliance Associate Director will be responsible for executing compliance-related investigations and supporting the company’s global healthcare fraud and abuse assurance program and activities, including auditing and monitoring, both transactional and live. The Compliance Associate Director will serve as the initial point of contact for business colleagues for these activities, will support department initiatives globally and must have knowledge of the biotechnology/pharmaceutical industry, anti-bribery/anti-corruption laws, and experience executing compliance-related investigations as well...

The Associate Director is recognized as an expert in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with regulatory requirements. This role is responsible for oversight and coordination of GMP activities in support of Commercial Release and serves as primary QA contact on cross-functional teams. The Associate Director manages and develops personnel and support department and functional activities. KEY DUTIES AND RESPONSIBILITIES The responsibilities of this role may include, but are not limited to, the following Responsible for oversight of analytical activities...

At Vertex, quality is at the heart of everything we do, especially as we pioneer transformative advancements in Cell and Gene Therapy (CGT). The CGT Quality Lead is a critical member of our Data, Technology, and Engineering (DTE) team, ensuring that the Vertex Connects Portal for CGT systems and integrated applications meet the highest quality standards and regulatory compliance. This role is pivotal in safeguarding the integrity of our CGT applications by managing quality deviation life cycle processes, collaborating with Quality partners, and ensuring timely resolution of quality events. The CGT Quality Lead will play a key role in driving...

The Associate Director, GMP Operational Quality is responsible for quality oversight of QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. The role will also oversee team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates...

Role Summary Supervise medical reviews for ICSRs during both clinical development and post-marketing, managing workflows and oversight to ensure evaluations are timely, accurate, and compliant. Serve as the main contact between operations and global patient safety medical teams. This position will contribute to setting standards, enhancing quality and inspection preparedness, executing vendor management, and working with both internal and external stakeholders to share medical expertise with operations teams and communicate operational regulatory requirements to the medical and PV Science groups. Key Responsibilities Lead the operational strategy and standards for ICSR medical review across all case types. Conduct thorough clinical evaluations,...

The Associate Director, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics, including but not limited to vendor key performance indicators, vendor quality metrics, and a vendor risk scorecard, to QA and to key business partners at the enterprise and program levels. The role also drives continuous improvement in Vertex vendor quality processes and governance to assure Vertex remains adherent to regulatory expectations and supports QA operational quality oversight and management...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. 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. This critical role Influences the development of external regulations, guidance, policy, and other initiatives that are external and relevant to Sanofi. Obtains Quality Intelligence through regulatory surveillance, benchmarking and participating in Trade and Industry Associations. Serves to clarify the existing regulatory framework to inform our internal compliance...

Sr Associate Quality Control What you will do In this vital role you will complete and review analytical testing in our cGMP laboratory. The role will be on-site based out of Amgen Rhode Island and will work under the mentorship of the front-line manager. The Bioanalytics team provides analytical expertise in testing the following in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing. Responsibilities include Follow safety guidelines, cGMPs...

Sr. Supplier Quality Engineer Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Temecula, CA , currently has an opportunity for a Senior Quality Engineer . This role will serve as liaison between internal Abbott third party manufacturers and Abbott Vascular. Ensures effective implementation of quality and compliance requirements between multiple quality systems and sites. THIS IS AN ON-SITE DAILY ROLE. WHAT YOU'LL DO Position Responsibilities Work...

The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. The role will also have responsibilities associated with QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. This role requires collaborative interaction with cross-functional partners such as analytical and process development, clinical and commercial QC, and manufacturing operations to ensure the on-time closure 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. Associate Vice President – Head of Digital Strategy and Innovation...

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

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

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

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We are seeking an experienced and highly motivated Senior Manager, QA to support site manufacturing operations as they pertain to the development and commercialization of new combination products. This role offers an exciting opportunity that will be key to Gilead's success as we...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Director, Global Compliance Systems and AI Enablement will lead the strategy, development, and execution of advanced technology solutions, particularly AI-driven tools,...

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

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

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

Senior Associate Quality Control Lead - Nights What you will do In this vital role you will play a key role in the Quality Control team as the lead for night shift support. Reporting directly to the Director of Quality Control, the Senior Associate, Quality Control I (Night Shift Lead) is an experienced QC professional who provides independent technical execution and shift-level leadership within a GMP-regulated laboratory environment. This role is accountable for leading night shift QC operations, ensuring accurate sample management, timely analytical testing, and sustained compliance with GMP, data integrity, and safety requirements. Provide operational leadership for...

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

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

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 has been one of the leaders in the vaccine industry for more than 100 years and a globally recognized partner in the prevention of infectious diseases. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is the reference site...

Use Your Power for Purpose This role provides strategic leadership & operational Quality oversight for development, deployment and enablement of GxP AI capabilities across QSEO and PGS Operations. The AI Compliance Lead is responsible for enabling the deployment of AI initiatives while ensuring all forms of risk are mitigated. This role partners closely with QSEO GPOs and BSOs, as well as with Digital, Legal and other relevant stakeholders to ensure AI capabilities built in Pfizer or through 3rd parties adhere to applicable external regulatory requirements as well as Pfizer specific policy and controls. The AI Compliance Lead plays a key...

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

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

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

Ready to redefine what's possible in molecular diagnostics? Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At BillionToOne, we've built something extraordinary—a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today.Our people are our greatest asset talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer...

The Senior Director, GCP & GPV will lead clinical quality and pharmacovigilance strategy across development-stage programs. This role ensures global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPV) compliance, provides guidance on clinical trial operations and safety reporting, and fosters a culture of quality, compliance, and patient safety. The Senior Director drives proactive risk identification and mitigation across the clinical development and pharmacovigilance lifecycle, ensuring inspection readiness and effective regulatory engagement. This leader will partner cross-functionally to embed quality and safety considerations in clinical planning and will oversee a small, high-performing team of quality and pharmacovigilance professionals. Here's how...

Responsibilities may include the following and other duties may be assigned. Develops, implements, administers and certifies compliance policies, procedures, and practices. Ensures alignment with legal and ethical standards of the organization. Provides compliance advice, investigates complaints and verifies deficiencies are corrected. Develops employee communication and training programs that focus on the elements of a companywide compliance program. Enforces anti-bribery and anti-competition laws. Analyzes metrics and audits functional compliance program. Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program. SPECIALIST CAREER STREAM Typically an individual contributor with responsibility in...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Cardiac Ablation Solutions (CAS) is one of the Operating Units within the Cardiac portfolio at Medtronic. At CAS, we are developing next generation medical technologies that treat patients with abnormal heart rhythms. Our technologies save lives and improve the quality of living for millions of patients across the world by advancing innovation for the diagnosis and ablation of cardiac arrhythmias and enabling clinicians to...

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

Job Title Sr. Quality Engineer This position works out of our Saint Paul, Minnesota location in the Vascular Division. This is a fully onsite role. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. The Senior Quality Engineer will be responsible for providing quality engineering support and leadership within product manufacturing, design transfer, and process/system/services in the...

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

This position works every day on site out of our Carlsbad, CA location in the Cardiometabolic Division in Abbott Rapid Diagnostics. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. What You’ll Work On This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. In addition...

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. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned...

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of R&D and analytical validation studies for complex biomarkers used in the detection, monitoring, and management of cancer. PRIMARY RESPONSIBILITIES Lead Biostatistics efforts designing and executing analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.). Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for validation studies of varying...

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 This position is responsible for developing and carrying out...

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

About This Role As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen’s small molecule portfolio. You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment. What You’ll Do The Associate Director, RegCMC Small Molecule Lead oversees the management and coordination of...

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

Technical expert that will independently identify, engineer, and optimize new data, software, or technology solutions that address critical business needs. Works with QA Lab Business Owners and the broader BTS organization to improve existing methods and processes. Read and adapt literature and publicly available information to accomplish assignments. Demonstrate proficiency in a broad range of techniques and methods for information technology engineering, including software development, data warehousing, statistics, machine learning, and/or technology infrastructure. Responsibilities Independently design and develop data, software, or technology solutions to answer scientific or business questions. Demonstrate proficiency across a range of technologies related to programming languages,...

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

This role is responsible for working collaboratively with QA Labs Business Owners, Manufacturing Sites and the broader BTS organization to conceive, design, engineer, and implement data, software, and technology solutions that solve significant scientific or business problems for Quality Labs processes. A successful candidate will develop deep understanding of lab processes to investigate, identify, and implement state-of-the-art technology platforms that drive productivity and efficiency gains in Product Release Testing , Stability Study Operations, and Lab Inventory Management for all AbbVie QC labs. Responsibilities Conceive, design, engineer, and implement data, software, or technology solutions by studying system flows, data usage, and...

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Senior Biostatistician, you will leverage your strong applied statistics background to design and implement statistical analysis and reporting of development and analytical validation studies for complex biomarkers used in the detection, monitoring, and management of cancer. PRIMARY RESPONSIBILITIES With minimal guidance, drive the design and execution of analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic (e.g., IVDR, 510(k), PMA, etc.). Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for studies of varying...

Introduction to role Are you ready to set the global agenda for cyber governance and regulatory adherence within a firm where trusted, protected technology accelerates life-changing medicines to patients? Can you translate complexity into crucial action that protects trust while enabling ambitious innovation and speed? As Executive Director for Global Cyber GRC, you will lead the enterprise approach to information security. You will coordinate technological risk and ensure our most critical data, platforms, and partners operate with resilience, regulatory confidence, and clear accountability. You will connect cyber risk to strategic decisions, equipping the company’s leadership team and Board with sharp,...

2026 Summer Intern - PTQ Quality Processes Department Summary Global Quality and Compliance (PTQ) ensures we deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is a competitive advantage for Roche. You will report to the US Internship Program Manager in the PTQ Quality Process Function. The ideal candidate is a self-starter deeply curious and energized by learning. You should be comfortable with working through ambiguity and are able to prioritize and manage multiple demands and commitments. Your role will be to help Quality Processes fulfill...

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. urpose The purpose of the Senior Director – GPS Safety Data...

Sr. Hardware Design Quality Engineer Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Senior Design Quality Engineer is within our Infectious Disease Developed Markets business unit located at San Diego, CA In this role you will actively participate in product development and transfer activities, ensuring product and process conformance to FDA and ISO 13485 standards. This position will review validation methods and protocols, test methods, statistical...

Specialist Quality Complaints What you will do and what we expect of you In this vital role you will Duties Ensure product complaint records are processed according to FDA guidelines, SOPs and other regulatory agencies’ guidelines; Evaluate subject matter expert assessments; Provide guidance and technical advice to conduct complex complaint investigations, determine corrective actions, and determine steps necessary to ensure the proper level of control for product in distribution; Ensure quality of complaint records and applies analytical abilities to evaluate complex situations using multiple sources of information; Execute against prioritized work plans to ensure timely investigation and closure 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. At Lilly, we unite caring with discovery to make life better...

Global Patient Safety, Oncology TA Intern Overview Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. The Global Patient Safety, Oncology Therapeutic Area (TA) Intern will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical industry. The intern will support the enhancement of clinical safety insights by leveraging reverse translatability to improve non-clinical capabilities (e.g. complex in vitro models (CIVM) or...

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. Intern will be joining the Regulatory Affairs U.S. Advertising and Promotion (USAP) Standards Team. The Standards Team leads USAP through department-wide initiatives, influences process improvements and fosters the review of compliant promotional and R&D communications. Key responsibilities may include Learning the FDA Regulations on Drug Advertising & Promotion Understanding the detailed USAP activities Creating reports, including metrics, department highlights and communications Attending meetings Creating presentation materials...

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

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

At our Company, we are committed to fostering an inspiring workplace that empowers our employees to innovate and excel. Our Global Workplace and Enterprise Services (GWES) team provides essential solutions that ensure a safe and productive environment, while prioritizing the well-being of our colleagues, communities and the environment, making a positive impact beyond our organization. The Associate Director, Compliance is a leadership role responsible for driving Environmental, Health, and Safety (EHS) compliance and governance across the GWES operating areas in the SE Pennsylvania region. This role ensures reliable, compliant, and cost-effective operations by integrating regulatory requirements into GWES processes, enabling...

Job Title Quality Manager Our location in Temecula, CA, currently has an opportunity for a Quality Manager (Development) in our Vascular Division. This is an onsite role. This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. WHAT YOU’LL DO...

Undergrad Intern - Operations - Quality - Remote (Summer 2026) What You Will Do This internship will be approximately 13 weeks that includes both project-based and experiential learning. In conjunction with the project work, you will have the opportunity for professional development through training sessions, one-on-one mentoring, and various networking events. Operations is one of three foundational functions at Amgen with a mission to manufacture and deliver safe and effective medicine to patients around the world. Operations is divided into the following five sub- functions Supply Chain, Process Development, Quality, Manufacturing, and Facilities & Engineering. We are currently seeking...

Strategic Planning & Operations Sr Mgr - General Medicine, Biosimilars & Regulatory Policy What you will do In this vital role you will partner with other Global Regulatory Affairs and Strategy (GRAAS) Strategic Planning and Operations (SPO) Sr Managers to provide flexible, high-impact support across Amgen’s Regulatory Affairs organization, driving and implementing department goals and initiatives, supporting senior GRAAS leaders in strategic planning and execution of department needs, and collaborating cross-functionally. The primary focus of this role is to support the Biosimilars and General Medicine therapeutic area VP and teams, and the Global Regulatory Policy & Intelligence (GRPI) AVP...

Job Title Quality Engineer Our location in Temecula, CA, currently has an opportunity for a Quality Engineer in our Vascular Division. This is a fully onsite role. The Quality Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. 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...

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

The Patient Safety Science Therapeutic Area Lead will be responsible for leading and managing a team of scientists within a therapeutic area in the Worldwide Patient Safety organization. This critical role involves ensuring the safety of our medicines through effective pharmacovigilance, pharmaco-epidemiology, and risk management strategies. The role will oversee both pre-marketing and post-marketing product support, ensuring compliance with global regulatory requirements, and driving strategic initiatives to enhance safety science processes. Duties & Responsibilities General Product Scientific Support Partner with fellow Therapeutic Area (TA) Leads and the Head of Patient Safety Sciences to plan, lead, and advance programs and...

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

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly...

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

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

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

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited...

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

At Medtronic Neuromodulation (NM) and Pelvic Health (PH), our therapies use advanced stimulation, sensing, software, and digital technologies to restore function and relieve suffering for people living with movement disorders, epilepsy, chronic pain, and pelvic health disorders. Our newest generation of systems can listen directly to neural signals and intelligently adjust therapy in real time — representing a breakthrough era of personalized neuromodulation. In this highly dynamic and rapidly evolving R&D environment, every design decision matters, and the quality of our designs directly influences clinician confidence, patient outcomes, and global healthcare impact. The Design Quality Engineering Director for the Neuromodulation...