Quality & Regulatory Jobs in Pharma & Biotech

Use Your Power for Purpose At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world. What You Will Achieve In this role, you will Lead the completion of assigned complex projects, meet agreed targets and develop plans for work activities on...

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of...

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will Evaluate and review clinical and commercial product batches to ensure compliance with established specifications. Approve investigations and change control activities to maintain compliance with configuration management policies. Contribute to moderately complex projects, managing time effectively and...

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

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Executive Director — Biologics Quality Control (Grade 34) KEY RESPONSIBILITIES The Executive Director, Site Quality Head is responsible for leading all Quality functions at the pharmaceutical manufacturing site, ensuring compliance with global regulatory standards, driving...

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 Quality Systems & Compliance Data Analytics Lead role provides critical...

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. Sr. Principal Infrastructure Architect – Manufacturing & Quality Systems At Lilly,...

We are seeking a Regulatory Affairs Manager to join Abbott’s Heart Failure Division on-site in Pleasanton, CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the...

Purpose 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...

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

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...

Purpose The Associate Director, Global Quality and Compliance Excellence uses advanced subject matter expertise of global quality standards, cGMP, and external agency regulations to lead preparedness for regulatory inspections and audits at AbbVie sites across the global network. Drives the development and maintenance of a quality culture by closely collaborating with AbbVie Manufacturing Site leadership, Quality Lab leadership, global functional groups, and Third Party Manufacturers to conduct mock audits, coach site leadership on opportunities identified, maintain roles and responsibilities, identify potential project gaps, and obtain an in-depth understanding of the quality, compliance, and resource needs at each site. Responsible for...

The Associate Director, Quality provides leadership and direction to the Quality Function they are responsible for within Operations. This Associate Director, Quality is responsible for the effective implementation of AbbVie Quality Systems for which they are responsible for. This could include Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Quality Control, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives. The Sr. Manager of Quality would be expected to manage a budget and leads a team of quality professionals who are responsible for compliance and quality oversight for the...

Purpose The primary responsibility for the Quality Validation Specialis t is the Quality oversight and overall approval of validation and engineering change management activities. The Validation engineering department, will support the implementation of the Validation quality program, and will be expected to independently manage 5+ key projects simultaneously. Responsibilities Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility Executes tasks as required to implement the Validation Master Plan and...

The Strategic Global Labeling Manager in Regulatory Affairs is responsible for developing and delivering patient-centered global product labeling for the safe and effective use of AbbVie products. The key responsibilities include leading cross-functional teams to develop comprehensive label strategies and create accurate labeling for development and marketed products, ensuring compliance with company procedures and applicable regulations. Responsibilities Develop and maintain target labeling and prescribing information, including company core data sheets, and US and EU labeling documents, through the product lifecycle. Make recommendations to proactively optimize labeling language, including effective use of target labeling as applicable, for assigned products. Product portfolio...

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

Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed in alignment with our incredibly high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Line Oversight Program at West Point is an entry level 2 year program with 8 month rotations focused on providing hands-on experience in pharmaceutical quality assurance supporting our Company’s largest and most complex...

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...

Project Leader Quality Assurance – Ingredient Supplier Quality This position works out of our Columbus, OH location in the Nutrition Division . Our Global Supplier Quality Assurance (GSQA) group in Columbus, OH currently has an opportunity for a Project Leader, Ingredient Supplier QA. The primary function of the GSQA group is to ensure a high-quality supply of incoming materials through evaluation, monitoring and development of Abbott Nutrition ingredient and packaging suppliers worldwide. GSQA is responsible for working and communicating with suppliers as part of an ongoing supplier management process. GSQA supports systems such as supplier qualification, supplier development, supplier...

Johnson & Johnson is currently recruiting for a Senior Manager External Quality! This position can be located at any J&J Internal Medicine site in the US, with a preference for New Jersey or Pennsylvania. In this position you will be responsible for providing quality leadership and oversight of external manufacturers in the North America region, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards. Key Responsibilities Ensure effective and compliant execution of quality systems at external manufacturing sites Participate in the selection, qualification, and ongoing monitoring of external partners Provide leadership in the...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at We are searching for the best talent for a Manager, SOX Compliance to join our team in Raritan, NJ . **There is a pre-identified...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi MA BioCampus facilities. QA’s main responsibility is to ensure adherence to cGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities. The QA Process-Centric Unit (PCU) is a team that is...

The Senior Director, Quality Assurance leads the site’s independent Quality Assurance organization, accountable for an effective, risk‑based PQS, final batch disposition, inspection performance, and a culture of continuous improvement and data integrity. Partners with the Site and global Quality leaders to assure supply and compliance. FOCUS AREAS Quality Leadership & Strategy Demonstrate ownership of a site Pharmaceutical Quality System (PQS) aligned to our Quality Manual, including policy/standards oversight, CAPA/change control governance, data integrity, risk-based approaches and periodic management reviews . Able to run an independent QA function , with authority for final batch disposition , QA oversight of manufacturing/testing, and...

The Senior Director, Quality Assurance leads the site’s independent Quality Assurance organization, accountable for an effective, risk‑based PQS, final batch disposition, inspection performance, and a culture of continuous improvement and data integrity. Partners with the Site and global Quality leaders to assure supply and compliance. FOCUS AREAS Quality Leadership & Strategy Demonstrate ownership of a site Pharmaceutical Quality System (PQS) aligned to our Quality Manual, including policy/standards oversight, CAPA/change control governance, data integrity, risk-based approaches and periodic management reviews . Able to run an independent QA function , with authority for final batch disposition , QA oversight of manufacturing/testing, and...

At Medtronic, our Mission is to alleviate pain, restore health, and extend life for patients worldwide. As a Regulatory Affairs Project Specialist, you will play a crucial role in maintaining ongoing product compliance by assessing changes to existing medical devices and ensuring all necessary regulatory actions are executed. Your responsibilities will include evaluating the impact of product changes, preparing and submitting regulatory filings, and maintaining comprehensive documentation in line with global regulatory requirements. You’ll be part of a collaborative, diverse, and innovative team that values integrity, inclusion, and a commitment to making a meaningful impact in healthcare. This role provides...

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

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Senior Manager, QA for QC is responsible for quality oversight of the Quality Control (QC) Analytical and Quality Control Microbiology laboratory operations at the RayzeBio facility in Indianapolis in accordance with RayzeBio policies, standards, procedures and global...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Senior Specialist, External Manufacturing Quality Assurance is responsible for quality oversight of the Contract Manufacturing Organization (CMO) operations for Radiopharmaceutical products in accordance with business agreements, regulatory standards, and RayzeBio procedures. The scope includes clinical and commercial...

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

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

This role will support the Global Privacy Office in developing, executing, and enhancing AbbVie’s privacy compliance monitoring and analytics program, including the maturity of monitoring initiatives of privacy controls across the enterprise and the execution and adoption of privacy analytics tools and systems to manage and mitigate risk. This role sits in North Chicago with a hybrid in office schedule . Key Responsibilities Responsible for informing, executing and adjusting the annual, Privacy Global and Local monitoring plans leveraging data analytics and performing data analysis to inform our on-going understanding of potential Privacy risks, and providing guidance for monitoring the compliance...

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...

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

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. Must Have Minimum Requirements Bachelors degree required Minimum of 2...

Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Careers That Change Lives In this exciting role as the Senior Quality Systems Program Manager , you will lead strategic initiatives to improve the Neuromodulation and Pelvic Health Quality Management System (QMS), focusing on enhancing customer experience through innovative solutions. Additionally,...

Our Purpose Within the CRDN Design Assurance Laboratory at Medtronic’s Mounds View site, we focus on providing Quality support across all aspects of PDP from pre-market product development to post-market product surveillance. We participate in the design process to ensure the performance and safety of the complex electromechanical devices we develop are assured and maintained throughout the product lifecycle. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment...

The Medtronic Structural Heart & Aortic Operating Unit focuses on developing innovative, minimally invasive therapies for treating structural heart diseases, including conditions affecting the heart’s valves and chambers. We are pioneering technologies such as transcatheter aortic and mitral valve replacement, as well as repair solutions that help restore proper heart function and improve patient outcomes. By combining advanced engineering with deep clinical expertise, the Structural Heart team aims to address unmet clinical needs and enhance quality of life for patients worldwide. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do....

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 Compliance Manager This position works out of our Sylmar, CA location. This is an onsite role . Sets strategy for internal, clinical, and external audits (Regulatory Agencies, Corporate, Certification bodies, and major clients) ensuring sites are audit ready at all times. The incumbent manages a team of auditors across the sites and acts as a change leader, responsible for management of major global improvement activities to improve quality systems, audit readiness, and compliance. Represents the division within Abbott through Corporate based advocacy forums as well as external Regulatory Intelligence Forums such as the Notified Body Audit Coordination...

Quality Compliance Senior Manager What you will do In this vital role you will be responsible for driving Global Quality Compliance Audits and assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks. Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies. Implements risk assessments. Ensure...

Johnson & Johnson is currently recruiting for a Senior Regulatory Compliance Specialist ! This position can be located in Cornelia or Athens, Georgia. Under the supervision of the Regulatory Compliance Manager, the Senior Regulatory Compliance Specialist is responsible for maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements . The Regulatory Compliance Specialist will lead and maintain the internal audit program to help the site sustain a state of readiness to applicable regulatory requirements . Leads and maintains assigned Compliance functions to ensure compliance to applicable regulations...

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

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...

Global Patient Safety, Specialty 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. Global Patient Safety, Specialty 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. As a Global Patient Safety, Specialty Therapeutic Area (TA) Intern at AbbVie, you will spend your summer engaged...

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

Are you eager to expand your expertise in Quality Assurance within a leading pharmaceutical company? We are seeking a motivated early-career Pharmacist with a passion for excellence, meticulous attention to detail, and a strong commitment to high quality standards. In this role, you will help ensure full compliance with Good Distribution Practices in Portugal while collaborating closely with our local team to drive continuous improvement and operational rigor. If you thrive in structured, high‑standards environments and are ready to contribute to a dynamic team, we would be delighted to hear from you. What you will do Bring energy, knowledge and...

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

Johnson & Johnson is recruiting for a Quality Control Analyst- Microbiology Lentiviral Vector (LVV). This position will be located in Raritan, NJ! At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at . ...

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

Johnson & Johnson is recruiting a Director, Regulatory Advertising & Promotion within the Health Care Compliance Organization. The preferred location for this position is Horsham, PA. Secondary locations are Titusville, NJ, Raritan, NJ or New Brunswick, NJ. It is highly beneficial to be co-located with key business partners. Relocation expenses will not be paid/reimbursed. Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 135 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson...

Johnson & Johnson is recruiting for a Supervisor Quality Control- Microbiology! This position will be located in Raritan, NJ! 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 Supervises individual contributors, and...

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. We have an opening for a Sr. Quality Engineer at our Minnetonka, MN site within our Electrophysiology division. This position will provide Process/Quality Engineering support to manufacturing for commercially released product, helping to ensure delivery of highest quality product to the customer. What You’ll Work On Reduces and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing...

Job Title Quality Inspector II This position will work out of our Minnetonka, MN location in our Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION. As the Quality Technician II, you will be responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. What You’ll Work On Perform first article incoming inspection of purchased components and inspection of production operations, including documenting inspection and audit results. Perform final product...

AbbVie’s diversified portfolio provides a unique mix of pharmaceutical products and direct-to-consumer aesthetic products and devices. This allows for distinct opportunities for AbbVie professionals to learn and operate in both spaces, gaining an understanding of the different industries and associated business models. The Global Compliance Audit Associate Director has the primary function to lead/manage global sales and marketing, corporate functions, and other healthcare compliance audits. The role will assist the Director with annual risk assessments and be expected to form relationships with a broad spectrum of stakeholders to understand business risks for US/International locations and recommend a thoughtful audit approach....

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...

About the role The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's mission to provide better health and a brighter future. This role is located in Cambridge, MA and it is Hybrid (not remote). R elocation Benefit is available to support your transition. How will you contribute Ensure compliance to Regulatory Intelligence Procedures by executing the...

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

The Associate Director, Advertising and Promotional Compliance, US, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional material. The Director will also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials. Accountabilities...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Manager, Quality Assurance Investigations at the Cell Therapy Facility (CTF) in Devens, MA will be responsible for providing quality...

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

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

This position works out of our Irvine, CA location on our EP (Electrophysiology) Quality team. Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements. What You’ll Work On Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms. May provide coaching and mentoring for technical team personnel. Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers...

Quality Control Technician II The Quality Control Technician is responsible for bioanalytical quality testing within the Quality Information Management System and SAP system. Provides inputs to facilitate CAPA investigations as required. Owns and approves any testing events. Maintains product and testing inventory and complies with the quality system. Executes daily activities with minimal supervision. Provides input on testing and is an SME (Subject Matter Expert) on their certifications. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the Quality system. Complete Quality testing as appropriate for products per procedures and review all data to determine conformance...

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide. At Medtronic, we must work with a sense of purpose and ownership, knowing there is a human life on the other side of every decision. We bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work....

This is a fully 100% on-site position supporting the Global Operations & Supply Chain unit located at the Boulder, CO Manufacturing site. Responsibilities may include the following and other duties may be assigned. Attend daily tier meetings with other core team members Provide backroom support during internal and external audits Lead and facilitate Quality Walks with Engineering and Manufacturing personnel Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting,...

The Regional Distribution Quality Specialist is responsible for ensuring the quality of distribution operations across the Americas, focusing on warehousing, order fulfillment, product returns, and value-added services such as labeling, boxing and recharging. This role will provide quality support and oversight to ensure compliance with internal and external regulations, standards, and guidelines, specifically ISO 13485, and 21 CFR 820, across multiple 3PL distribution centers in the Americas in support of Medtronic Minimed. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation...

The Opportunity We are seeking a motivated and experienced Quality Assurance Specialist to join the Synthetic Molecule Analytical Chemistry (SMAC) department in Genentech Research and Early Development on the South San Francisco campus. The specialist will be a member of the SMAC Equipment and GMP Operations Group. This role will be responsible for Qualification of GMP equipment and associated compliance documentation, writing qualification protocols, working with QA to obtain protocol approval, and executing validation activities. Manage equipment lifecycle activities and documentation such as system risk assessments, decommissioning, and periodic review; serving as department SME for data migration and archival; initiating,...

Oversight of and participation in the development and execution of Computerized System Validation Life-Cycle documents / protocols, including but not limited to Validation Compliance Assessments, Validation Plans, Qualification Protocols, User Acceptance Tests, Change Controls, Periodic Validation Reviews, Audits, and Corrective Actions for audit findings for automated systems at the Marietta, R&D, Clinical Drug product site. Ensure both technical and procedural content of computerized system validation deliverables reflect current GSK Policy and procedures, government regulations, and industry practices. Coordination of validation activities with internal business partners / key stakeholders in a manner that satisfies procedural and operational requirements. Supervision, management, and...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. The Compliance Engineer organization supports the Engineering and Maintenance (EM) department by performing investigations and supporting the completion of CAPAs and change controls at the Sanofi, Framingham manufacturing facilities. Responsible for managing a compliance EM department supporting and coordinating Compliance efforts for the EM Department consisting of Engineers and specialists. Supports manufacturing facilities and manages staff performance against department’s operational goals. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to...

About the Role This position will provide guidance in validation strategy to the site and global projects. The position will have engineering validation signatory responsibility for approval of cleaning cycle development and cleaning validation protocols and final report documents. This position is responsible for assessing and validating cleaning processes. Primary tasks include development of protocols, coordination of validation activities, execution, preparing final reports and assembly of final validation packages; generation of project plans. Responsibilities will consist of both initial validation efforts as well as revalidation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final...

Vertex is looking to hire a Senior Manager, Program Quality, to join our US Patient Support Center of Excellence (COE). The COE is a group of compassionate and determined individuals who provide operational support to our three commercial Patient Support teams (Cystic Fibrosis, Hematology, and Acute Pain) including support in systems and technology, data and analytics, vendor management and program quality. Additionally, COE team members help design patient support offerings and policies for future Vertex Patient Support Programs (PSP). As the Senior Manager you will be a part of our Program Quality team, where you will play a meaningful role...

JOB SUMMARY Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global development that changes patient lives throughout the product life cycle. The Vice President, Internal Medicine Regulatory Strategy, serves as a senior regulatory leader who has global mindset and expertise of drug development and product lifecycle processes in support of Pfizer’s Internal Medicine portfolio including metabolic disease, cardiovascular risk, diabetes and cachexia. The goal of position is to provide, maintain and direct regulatory resources in the provision of regulatory guidance to projects and products to optimize input to development and commercial decision-making...

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a QC CRS Analyst at the Malvern facility. 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 Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our...

Ethicon LLC is recruiting for a Process Quality Leader position, located in San Lorenzo. 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 Under the direction of the Business Unit Leader, provides technical leadership towards the identification of the causes for non-conformances and process failures, and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Ethicon’s QSR, GMP, and ISO requirements for the entire Business...

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

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

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm...

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...

The Sr Quality Engineer is responsible for ensuring the quality and safety of our genomic products and services by implementing and maintaining a quality management system (QMS) that complies with ISO 13485 and ISO 14971. This position is also responsible for conducting risk assessments, developing, and implementing corrective actions, and providing technical support to the R&D team. What You’ll Be Doing Implement and maintain a QMS that complies with ISO 13485 and ISO 14971. Conduct risk assessments to identify and assess potential hazards associated with genomic products and services. Develop and implement corrective actions to address identified hazards and prevent...

At our company's Wilmington Biotech site, we are committed to ‘Using the power of leading-edge science to save and improve lives around the world’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. The Wilmington Biotech site will play a pivotal role in the manufacturing of our company's biologics-based medicines, including in the area of immuno-oncology. This site will establish our company's internal capability to manufacture high potent compounds with full manufacturing and testing operations....

Seeking an experienced leader to serve as Executive Director, Large Molecule Analytical Sciences (LMAS), Biological Critical Reagents (BCR). This position is accountable for building and running an efficient and high-performing organization that ensures reliable BCR supply to support on-time product release and new product introduction, while maintaining compliance with applicable regulations. The candidate will interface extensively with R&D to ensure high technical rigor for introduction of new BCRs during commercialization of pipeline biologics and vaccines. The role also requires extensive engagement with Manufacturing, QA, Regulatory Affairs, and Supply Chain. The ideal candidate should have extensive experience in BCR implementation, qualification...

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

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

The Senior Manager is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply at the Bristol Myers Squibb Cell Therapy Manufacturing Plant in Bothell, WA. The Senior Manager oversees an investigational function of the Compliance and Investigations (C&I) team under the Bothell Manufacturing Sciences and Technology (MSAT) department. The Senior Manager oversees a team of full time BMS employees and contractors performing product and/or process impacting root cause analysis investigation and assessment activities. The Senior Manager develops and enables technical excellence and advanced root cause analysis techniques to ensure thorough investigations...

This is an onsite role located in 1420, Harbor Bay Parkway, Alameda, CA. This is not a remote role/opportunity. The IT Process Architect - Global Quality and Regulatory plays a pivotal role in shaping and optimizing enterprise-wide business processes to support strategic transformation and operational excellence. This role partners with cross-functional teams to design scalable, service-oriented process frameworks that align with business goals, improve efficiency, and enable innovation. The Process Architect ensures that business capabilities, value streams, and workflows are clearly defined, integrated, and continuously improved to drive measurable outcomes across the organization. Core Job Responsibilities Process Architecture & Optimization...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Sr. Software Design Quality Engineer role to be located at Danvers, MA. The Senior Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a key role in product risk management, cybersecurity, change controls, test reviews, and design controls. The engineer should excel in an environment...

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 Experienced Analyst, Quality Control to be located in Malvern, PA. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products?...

The Manager, Quality Systems is responsible for supporting the ownership and oversight of Devens Cell Therapy quality systems, such as CAPA, Investigations per established local and global standards. This position supports the overall compliance and performance of Devens Cell Therapy Quality Systems Management as it applies to the site level, including periodic assessments of process performance and continuous improvement opportunities Duties/Responsibilities Review and approve complex site quality system deliverables and risk assessments associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems. Ensure quality system deliverables are robust and adequately address requirements and risks, by...

If you have experience in regulatory compliance and enjoy working with cutting-edge medical technologies, we’d love to hear from you. Join us as a Senior Regulatory Affairs Specialist. Our products include different technologies (active and non-active, hardware and software) and are sold in more than 30 countries. The Senior Regulatory Affairs Specialist will be part of the US Regulatory team, reporting to Regulatory Affairs Manager, supporting a wide range of activities with frequent interactions with corporate teams in US and globally. Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document...

In this role, you’ll contribute to cross-functional efforts and continuous improvement in a dynamic, collaborative environment, and will provide comprehensive manufacturing quality support throughout the production process. As a Quality Engineer II, you will Support product and process quality for Class II/III medical devices in a regulated manufacturing environment Lead and support nonconformance investigations, CAPA (Corrective and Preventive Actions), and root cause analysis Perform risk assessments and support risk management documentation (FMEA, fault tree analysis) Provide quality engineering support for design changes, process improvements, and product launches Review and approve validations, protocols, and test methods (IQ/OQ/PQ, MSA, etc.) Analyze quality...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned. Contributes to the development and maintenance of Quality programs, systems, processes, and procedures that ensure compliance with global policies, local regulations and practices. Supports monitoring and evaluation of process performance...

We are seeking a dynamic and experienced Associate Director to join the Global Supplier Quality team within External Quality Operations. This leadership role will provide strategic direction and operational oversight for biologics-related material categories (e.g., single-use systems, resins, filters, media, excipients). The Associate Director will serve as a key quality leader, driving supplier performance, risk mitigation, and lifecycle management across a global network. This role requires strong technical expertise, external relationship management, and the ability to influence cross-functional teams and senior stakeholders. Job Responsibilities Provide strategic quality leadership for biologics material suppliers across internal and external manufacturing networks Lead supplier...

Objective / Purpose The Head of Research Quality holds the highest leadership role within the Research Quality organization and serves as a key member of the R&D Quality leadership team. This executive is fully accountable for defining and executing the global strategic vision for Research Quality, overseeing a global team of experienced subject-matter experts dedicated to ensuring integrity, compliance, and ethical excellence in non-clinical research activities, studies, and processes supporting Takeda’s R&D pipeline. Through strategic leadership, impactful stakeholder engagement, and championing an enterprise-wide quality culture, the Head of Research Quality drives organizational success and reinforces Takeda’s commitment to industry-leading standards....

OBJECTIVES/PURPOSE Drive the design, implementation, and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures. Lead and develop a global organization, fostering talent, accountability, and high performance to advance quality, ensure regulatory readiness, and drive innovation and operational excellence and execute Takeda’s global Quality strategy for medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, geographies, and therapeutic modalities spanning Takeda’s development pipeline and lifecycle management of marketed products. Drive inspection-ready and escalable, compliant, and...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Oncology Products Policy Research (75%) Conduct research on novel and innovative oncology approaches, including topics such as the contribution of components in PD-L1 combination strategies, validation methods for novel endpoints, and biomarker investigations. Draft science-based articles intended for review, consideration, and presentation to regulatory agencies. Regulatory Intelligence...

Intern - IT Quality Assurance As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Work as a member of the IT Quality Assurance (QA) team, and collaborate with IT engineering functions, to Develop data-driven solutions that enhance IT QA operational efficiency and decision-making. Develop solutions that support the automation of IT QA manual processes using technologies...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following A summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus of Gilead Sciences. The candidate should be enrolled in an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject. The summer...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Create custom innovation solutions using different artificial intelligence, analytics and automation platforms to solve business problems and inefficiencies. Work closely with SMEs and leaders in various functions within Regulatory, Safety and Quality to understand and identify routine, repetitive process steps that could be improved using various technologies....

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following This position provides essential support across all areas of the IT Risk & Compliance program. The internship offers hands-on experience in IT Security, Risk, and Compliance activities, including exposure to governance frameworks, regulatory requirements, and enterprise risk management practices. Interns will gain practical knowledge of industry standards...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following The Office of Ethics and Compliance Intern will assist in a variety of initiatives that strengthen our ethical culture and compliance framework. The intern may be involved in areas such as compliance training development, systems and analytics projects, transparency reporting operations, data privacy activities, and integrated risk...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Assist the Global Inflammation Regulatory Affairs Liaison team with projects to support department goals and objectives. Interns will assist with regulatory submissions and activities, including but not limited to potential submission of clinical study reports, study protocols and protocol amendments, and assist with activities in preparation for...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include but not limited to the following Independently support development and execute GMP method validation. Run experiments according to test methods, specifications, and protocols. Execute laboratory techniques such as Water Content by Karl Fischer, Dissolution and Liquid Chromatography. Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts. Participate in meetings, present and interpret data. Conduct...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Position supports the Analysis of Development and Commercial project actual and forecast data improving overall predictive modeling, reporting and cross-functional collaboration. Position requires skills in analyzing large set of data and willingness to reach out to a large set of stakeholders to advance Projects Analysis work in...

The 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. Responsibilities Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements. Responsible for implementing and maintaining the effectiveness of the Quality...

Purpose 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...

The function of Audit and Compliance Auditor is to performs comprehensive audits for compliance with US and foreign regulation requirements, providing constructive evaluation of quality related systems for AbbVie plants, affiliates, quality service areas and/or suppliers that provide materials, services, and products to AbbVie. Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness, and safety of our products. This position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and...

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...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Supporting activities related to Packaging and Labeling of Phase 1 materials in Foster City Helping develop process flow maps Developing manufacturing instructions for labeling Supporting SOP and WRK instruction updates or creation Showcase your work with a final presentation (PPT) near the conclusion of your internship Required...

Johnson & Johnson is currently seeking a Quality Engineering Team Lead to join our team 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 conclusion of the transaction, you would be an employee of...

We are searching for the best talent for Supplier Quality Indirect Material Lead to join our Supplier Quality team located in Horsham, PA, Spring House, PA, Raritan, NJ, or Gurabo, PR. Please note onsite presence is required. Within the J&J IM segment the Supplier Quality group has responsibilities for supplier lifecycle management of >4500 GmP commercial and clinical suppliers including API, Direct, Indirect Materials and associated services on behalf of our internal network of J&J IM sites globally. Supplier Quality Indirect Material Lead Within the Supplier Quality group the Global Indirect Materials and Services team is tasked with lifecycle management...

Job Title Quality Inspector II This position will work out of our Minnetonka, MN location in our Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION. As the Quality Technician II, you will be responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. What You’ll Work On Perform first article incoming inspection of purchased components and inspection of production operations, including documenting inspection and audit results. Perform final product...

to make a real difference in the lives of many About Lingo Abbott's rich history in developing cutting-edge health technologies is evolving with its new venture into b iowearables . The b iowearables segment is poised to represent the future of the organization, with the potential to generate over $1 billion in revenue within the next five years, supported by Abbott’s robust R&D and financial resources. At Lingo, we are committed to transforming health management with our cutting-edge biowearables that monitor glucose levels and other critical metabolic biomarkers. Our products integrate seamlessly with other health indicators such as sleep, exercise,...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Intern – Global Quality Control Biologics – Lifecycle Management Key Responsibilities will include, but are not limited to the following Research and document the full QC product lifecycle activities, including method validations and transfers, specification establishment, reference standard and critical reagent management, and the responsibilities of a QC product lead. Interview subject matter experts (SMEs) within QC and...

Johnson & Johnson is hiring for a Quality Data Analyst II – Shockwave Medica l to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at...

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position works a Monday to Friday schedule, Day shift. This position will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. In the capacity of Shop Floor QA, the Senior Specialist shall serve as one of the Shop Floor Representatives interacting with Manufacturing, Supply Chaing, Quality Control and other supporting teams. The Senior Specialist, Shop Floor QA, is accountable to monitor...

RPM&SP partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals. Oversees and provides regulatory operational support for programs in the Therapeutic Area Unit (TAU). Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning . The intern will support the Gastrointestinal...

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

Global Development Compliance ensures quality and compliance in Clinical Development in partnership with R&D Quality and GCP Functions. We champion continuous improvement, foster innovation, and maintain an efficient, inspection-ready clinical development model. Embracing technology and automation, we aim to enhance efficiency, streamline processes, and accelerate the delivery of medicines to patients. As GDC Intern, you will have the opportunity to contribute to focused projects for Takeda’s R&D and GCP Functions that help drive efficiency, streamline processes, and accelerate the ways we work. Key responsibilities may include GCP Continuous Improvement Projects Support overall development of new or revised Good Clinical Practice...

At Takeda’s Brooklyn Park, MN, Facility, we manufacture Entyvio and Adcetris — monoclonal antibody therapies that help patients live healthier, brighter lives. The Engineering Validation team plays a key role in ensuring our systems and processes meet strict regulatory standards. As part of the Engineering Department, we collaborate with multiple departments and functions to safeguard product quality and patient safety. Validation is essential to earning regulatory approval and delivering trusted therapies. Interns will gain hands-on experience in a purpose-driven environment where science and teamwork come together to make a real-world impact. As an Engineering Validation Intern, you will contribute to...

Quality Control (QC) Microbiology ensures the safety and integrity of pharmaceutical products by performing critical testing & sampling such as bioburden, endotoxin, sterility, and environmental monitoring. The team supports manufacturing operations by managing the site’s contamination control strategy, monitoring cleanroom conditions, critical utility sampling/ testing and product in-process and final container testing and ensuring compliance with regulatory standards. Through robust microbial testing and data analysis, QC Microbiology plays a vital role in maintaining product quality and patient safety. How You Will Contribute As a QC Microbiology Intern, you will have the opportunity to… Assist with microbiological testing such as environmental...

Your skills could be critical in helping our teams accelerate progress. The Director, Global Regulatory Affairs – Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists. The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Background RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative...

This position works out of our Tbilisi, Georgia location in the Established Pharmaceuticals business. As the Administrative and regulatory affairs assistant, you’ll have the chance to provide assistance and support to the country manager and other members of the company by handling day to day administrative tasks and contributing to the department projects and regulatory affairs projects. What You’ll Do Provide administrative services for all members of the company. Sending correspondence Preparing orders Office support (stationery, paper, water, tea, coffee, milk, organization of equipment repair , refilling cartridges, organization of office cleaning , minor repairs) ...

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

The Associate Director, 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...

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Senior Compliance Engineer located in Santa Clara, CA. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics and Digital Solutions was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Senior Software Quality Engineer and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and...

Staff Quality Auditor This role for the Staff Quality Auditor will serve as experts for the compliance team with respect to observation tracking, auditing, regulations and standards and the Division quality system. This role will conduct internal quality audits to assess compliance to the requirements of the quality system, as well as FDA, ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You'll Work On Plan, perform, support and document...

Compliance Quality Software Lead As a Compliance Quality Software Lead , your role will include responsibilities such as ensuring that SWQA computerized systems used in the support of the Quality System and development of ADC customer facing products, are developed, validated and maintained in compliance with regulatory and corporate requirements. You will provide quality engineering expertise to investigate, audit, analyze, propose improvements, and manage processes in the Quality Management Systems and development of ADC consumer products and mobile applications. Identify and implement initiatives for continuous improvement. Author, change and update software QA procedures as applicable. Ensure compliance with all...

We have an immediate opportunity for a Analyst, US Trade Compliance, in our Lake County, Abbott Park, IL location. As the Analyst, your primary role is to conduct audits of Abbott’s U.S. import/export operations to ensure compliance with the applicable U.S. customs regulations. What You'll Work On Perform transactional testing/audits as a member of the US trade compliance audit team. Perform periodic spot checks to assess the timeliness and effectiveness of the site/division post-entry/post-export review processes. Conduct quarterly risk-targeting analysis. Provide analytical support for disclosures and other reporting requirements. Monitor site/division compliance improvement plans to ensure timely implementation and close-out....

The intern will be joining the Lab Excellence Team, a group focused on advancing quality, efficiency, and compliance within the QC laboratories. The team partners across both chemistry and microbiology operations to deliver high-impact projects such as equipment onboarding, data trending and analysis, investigation support, and continuous improvement initiatives. By collaborating with QC, validation, project management, and quality assurance functions, the Lab Excellence Team plays a key role in strengthening laboratory operations and driving sustainable improvements that support both day-to-day testing and long-term strategic goals. The Quality Control Continuous Improvement Intern will support a dynamic special projects team within the...

At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more

Global Quality Systems Management & Improvement is responsible for overseeing critical business processes that ensure quality measures for the entire enterprise. Takeda is in the middle of a major process transformation of critical business processes, with a heavy emphasis on digitalization and new ways of working. You will have the opportunity to learn about important business processes used across the industry, but think creatively as a fresh set of eyes to help is challenge the status quo and embrace a digital and AI-powered ways of working. How You Will Contribute As a Quality Systems Improvement Intern, you will have the...

The US Medical Advertising & Promotion Regulatory (Ad/Promo) team ensures that all promotional communications for Takeda’s marketed pharmaceutical products meet FDA regulations and industry standards. The department provides strategic regulatory guidance to cross-functional partners to support compliant and effective commercial activities. In addition to reviewing promotional materials, the Ad/Promo team conducts regulatory research, tracks FDA enforcement trends, and drives process improvements. The Ad/Promo Regulatory Intern will gain practical experience applying FDA regulations and guidance to pharmaceutical advertising and promotional activities. This role includes conducting regulatory research, supporting evaluation of promotional strategies, and assisting with key projects that impact marketed products....

Global Development Compliance (GDC) ensures quality and compliance in Clinical Development in partnership with R&D Quality and GCP Functions. We champion continuous improvement, foster innovation, and maintain an efficient, inspection-ready clinical development model. Embracing technology and automation, we aim to enhance efficiency, streamline processes, and accelerate the delivery of medicines to patients. As a GDC Intern, you will have the opportunity to contribute to focused projects for Takeda’s R&D and GCP Functions that help drive efficiency, streamline processes, and accelerate the ways we work. Key responsibilities may include Support overall development of new or revised Good Clinical Practice (GCP) and...

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. 2026 Quality & Compliance Intern- Patient Service (Pharm D) reports to the Associate Director of Quality & Compliance for US Patient Services. This role is responsible for assisting in the development of quality and compliance strategies, methodologies, and roadmaps to enhance process improvements. The objective is to ensure a superior experience for both internal and external stakeholders involved in patient services across all brands. Key responsibilities...

This is an ONSITE opportunity at Medtronic Neurovascular located in Irvine, California. In the Neurovascular Operating Unit, we are committed to delivering meaningful innovation to advance stroke treatment. You can view more about the business and our products at Our goal as an operating unit is to ensure that we utilize the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career. Join a diverse team 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. Organization Overview Lilly is currently constructing an advanced manufacturing facility for...

About This Role The Sr Associate I will support and lead team initiatives regarding compliance, documentation, writing deviations, lab exceptions, Actions, and environmental excursions. The Sr Associate I must have practical knowledge of current regulations and cGMPs to ensure all work is performed in a cGMP manner, with adherence to regulatory regulations. What You'll Do Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions Author technically sound moderately complex reports with minimal guidance Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels...

Purpose Manages Quality Engineers and Quality Trainer engaged in activities to support Product Surveillance for Medical Devices and Combination products. The Global Compliance Manager is responsible for the management and coordination of a team of Quality Engineers and Quality Trainer. Manages project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates in maintaining quality system documentation including but not limited to Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and...

The “Automation Validation Lead” will be responsible for oversight and hands-on execution of the automation system lifecycle for all GxP-Regulated Automation Computerized Systems, ensuring compliance with regulatory requirements, Automation Computer Systems Validation (ACSV) and Lifecycle procedures with Data Integrity requirements. Primary Responsibilities Oversight and Execution of Automation CSV Activities Provide comprehensive oversight and execution of all automation CSV activities across both Beam NC and Cambridge sites,ensuring compliance with regulatory requirements and internal SOPs. Plan, organize and lead the development, execution, and approval of all validation documentation,including Validation Plans Requirements Specifications System Impact Assessment Installation/Operational/User Acceptance Testing (IQ/OQ/UAT) Traceability Matrices Validation...

Quality Technician II This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer Technician II, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership...

Associate Director, Risk Based Quality Management (RBQM) Global Development | Clinical Operations Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products. Residing within Clinical Operations, Risk Based Quality Management (RBQM) Strategy & Operations is responsible for implementing RBQM in support of the Gilead portfolio. The Associate Director, RBQM...

The QC Microbiology Director is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides strategic leadership and oversee daily microbiological operations. Responsibilities include leading the microbiology QC team supporting both clinical and commercial programs for biologics and small molecule sectors. This individual is committed to personnel interactions (approachable) and mentoring of staff for timely project completion and regulatory compliance. The leader collaborates with cross-functional teams, works with CTLs, and fosters a culture of continuous improvement. Job Responsibilities Lead the development and implementation of end-to-end Quality Control (QC) microbiological strategies for Gilead’s...

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

Electrical Engineering experience preferred, PCBA manufacturing/testing/designing experience preferred, supplier quality engineering experience preferred, position may be located at North Haven, CT or Lafayette, CO Careers that Change Lives A career Medtronic is currently searching for a Senior Quality Engineer to join the New Product Development team at the North Haven, CT facility or the Lafayette, CO facility. You’ll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities. Key Responsibilities Supplier selection and qualification while ensuring suppliers...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. This role is responsible for developing and maintaining quality systems and/or key process(es) pertaining to Risk Management while providing quality engineering support within new product development, manufacturing, system/services support and/or post market support. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element. Interprets regulations and requirements to...

This Principal Regulatory Affairs Specialist – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market. What You’ll Work...

This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products...

About the role As a Quality Control Analyst II, you will build and review routine in-process, drug substance, and stability test methods promptly. You will use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower). You will report to Team Lead Quality Control. This position is for the 2nd shift, with working hours from 200 pm to 1030 pm, Monday through Friday. How you will contribute Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal). Conduct test methods including samples generated for...

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...

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

Purpose Serves as the lead for the evaluation, implementation, and continuous improvement of laboratory technologies, workflows, and systems supporting New Product Introductions (NPIs), existing product enhancements, and lab transformation initiatives. Serves as the key liaison between QC laboratories, IT, and global functional stakeholders to drive high-impact projects. Provides subject matter expert guidance on test method validation and transfer, lab efficiency, safety, and compliance strategies while mentoring peers and championing innovation across laboratory operations. Responsibilities Leads planning and execution of New Product Introductions (NPIs) within the QC laboratories including evaluation of test methods, instrumentation, lab readiness, and training strategies. Primary point...

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...

Position Senior Manager Cleaning Validation Location Devens, MA Key Responsibilities Provide strategic oversight and management of the cleaning validation program, ensuring alignment with regulatory requirements and industry best practices. Develop, write, and execute cleaning validation protocols, reports, and risk assessments. Establish acceptance criteria and sampling plans for cleaning verification and validation. Delegate tasks and coordinate the execution of cleaning studies, ensuring timely and effective completion. Optimize and update cleaning validation strategies and procedures to reflect current industry standards and regulatory expectations. Perform swab and rinse sampling, cleanability, degradation and sampling recovery studies reviewing analytical results against acceptance limits. Support...

Position Senior Manager Validation Engineering Location Devens, MA Key Responsibilities Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility and processing equipment systems. Leads functions responsible for installation, operational and performance qualification (I/O/PQ) of systems arising from projects and change controls. Leads the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance. Ensures execution of program to predefined schedule. Establish validation project plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination...

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 role is part of National Contract Operations and Supply Chain (NCOSC), which delivers end-to-end services that enable affordable patient access, deliver insightful customer experiences, and support enriching employee experiences across IAM Contract Management, Service Agreement, Account Management, and Channel Strategy lifecycles. The Integrated Account Management (IAM) team holds direct account and contract responsibility across the U.S. health care system — including pharmacy benefit managers (PBMs), health plans, state Medicaid agencies, pharmacies/wholesalers, and infusion companies — for our Company's commercial and government business. Our success depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. We...

Provides leadership & strategy for a group of IT professionals supporting a major organizational unit responsible for the definition, development, implementation, operation and support of computer-based systems and related processes and tools which provide information for reporting, operations, and decision making for the Quality Non-Complaints, LMS (Learning Management), DMS (Document Management), and Global Engineering Systems (GES) within the Quality-Regulatory-Engineering Services BSS Organization. What You'll Work On Creates and manages Corporate Quality Non-Complaints, LMS, DMS & GES Strategies and Architectural Framework in partnership with Divisional BRM’s Aligns department priorities appropriately, determines critical success factors, evaluates and pursues initiatives, investments and opportunities...

Senior Quality Technician 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 Senior Quality Technician is responsible for inspection and for ensuring all product specifications are met to comply with regulatory IDEV standards. What You’ll Work On Perform routine and First Article mechanical and visual inspections of procured materials, manufactured product, tooling and/or processes per IDEV documentation (drawings, specifications, procedures, workmanship standards and...

Director - Global Quality Auditing and Supplier Management The Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program Responsibilities Perform comprehensive and detailed GMP compliance audits of animal health sites, contractors, business partners, and suppliers, requiring approximately 50% worldwide travel. Develop and maintain Technical Quality Agreements. Design and build Business Continuity Process and Quality Risk Assessment Module in Reliance. Implement standard Supplier Qualification process across sites. Implement efficiency and productivity improvements in the Supplier Audit Program,...

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

At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. The Wilmington Biotech Campus will play a pivotal role in the manufacture of our company's biologics-based medicines, including in the area of immuno-oncology. This site will establish our company's internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029. This facility will be a significant supplier of Antibody Drug Conjugates and High Potent Compounds and will also be critical...

Clinical Regulatory Writing Manager (Associate Director) Location Boston, MA - Hybrid 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 Writing Manager...

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

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Software Reliability Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to...

Quality Assurance Senior Manager What you will do In our mission to serve patients, speed is absolutely critical. We’re rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team – working toward our mission of advancing high potential programs for cancer patients around the world. The position serves as the Quality Alliance Lead and the primary Amgen Quality point of contact for coordination interactions with Amgen business partners. This position will also support Portfolio Strategy Quality responsibilities. Responsibilities include Responsible for leadership and coordination of...

At Reporting to the Associate Vice President, Clinical and Development Digital Solutions (CDDS IT), the Executive Director, Digital Regulatory and Safety, will lead our efforts in transforming regulatory submissions and pharmacovigilance through modern platforms and responsible generative AI. Primary Responsibilities Develop and promote a multiyear product strategy for Digital Regulatory & Safety, aligning with IT and Research and Development (R&D) priorities, including prioritized roadmaps and investment cases to deliver enterprise value, focusing on innovation, risk, regulatory compliance, and scalability. Act as a senior technology business partner to various stakeholders, translating strategic needs into product investments. Define and drive adoption...

This is an onsite position, Monday through Friday, with occasional weekend and off-shift support required About This Role We are seeking a highly experienced and motivated QC EM/UM and Contamination Control Specialist to oversee the Environmental and Utilities Monitoring and Contamination Control Strategy programs at our state-of-the-art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, supporting regulatory compliance, and driving improvement in contamination control strategies. What You’ll Do Lead cross functional initiatives across low bioburden drug substance manufacturing areas, including cleanroom qualification, environmental and utilities monitoring, and personnel...

Do you have expertise in, and passion for, Regulatory Affairs ? Would you like to apply your expertise and channel the scientific capabilities in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person....

Senior Corporate Counsel, Quality Law Position summary The Senior Corporate Counsel role will have the opportunity to join the dynamic Global Manufacturing, Supply and Corporate Transactions Law team at BMS. In part, the team provides critical support and partnership to the Company’s Global Product Supply & Development organization, helping to deliver on our mission to serve patients in need. The team provides comprehensive legal support for the Company’s manufacturing operations, supply chain, import/export, customs and trade, facilities and engineering, product development, EHS and Occupational Health matters, and Quality. The Senior Corporate Counsel will support the Global Quality organization. Primary...

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...

As a Validation Lead/Validation Engineer at Recursion, you will be at the forefront of ensuring the overall quality performance and compliance throughout the organization by defining, implementing, and maintaining a risk-based computer system validation and assurance program (CSV/CSA). Your role will directly support Recursion's mission to decode biology by enabling cutting-edge research and innovation through reliable IT services. From ensuring operational excellence in systems performance to driving proactive solutions for security and compliance, you’ll play a key role in empowering teams across the company to achieve their goals. Please note This is a 6-month contract role. In this role, you...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. This is a people leader role within the QA Packaging and Labeling team in Gilead's External Quality Operations department. The ideal candidate will have established people leader experience and some packaging/labeling experience. This is an onsite position based at our headquarters in Foster City, CA. Knowledge D emonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards. Demonstrates excellent verbal, written and interpersonal communication skills. Experience as an effective people leader,...