Quality & Regulatory Jobs in Pharma & Biotech

The Site Analytical Sciences Specialist role is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations, biochemistry, and microbiology. This role requires 2nd shift hours in supporting the West Point Laboratory Operations. Activities Within Role Technical expertise to support New method introduction (Validation /Tech Transfer). New technology introduction. Assessment and implementation of changes for existing methods...

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. M&Q Sr. Director Digital Quality labs, execution and TSMS, Tech at...

Johnson and Johnson is recruiting a Senior Manager, ATSC External Quality located in Gaitherburg, Maryland. Key Responsibilities Provide quality leadership and technical support to ensure effective and compliant execution of quality systems at external manufacturing sites working in the CART space Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners Provide oversight for tech transfer and new product introduction activities in the CART space; lead PAI readiness activities, and support associated health authority filings and approvals Daily management and coordination of the EQ work team supporting the EM as needed Lead...

Job Summary The Quality Engineer II will play a critical role in supporting the Interventional Therapy business by developing, implementing, and maintaining quality standards for both new and existing products. This position requires close collaboration with engineering and manufacturing teams to ensure compliance with regulatory and internal requirements, emphasizing the inspection, testing, and evaluation of product and process quality. The successful candidate will drive continuous improvement initiatives, support root cause analysis, and ensure that corrective actions are effective and thoroughly documented. Key Responsibilities Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished...

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 Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations, and materials management for the internal programs at Vertex Manufacturing Center (VMC), Boston, MA. The position will be a part of the QA operation floor support team. This role will review & support activities related to product disposition, including batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation. The Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs. The position will support multiple production functions (from Quality operations to Quality...

$1500 Sign On Bonus Eligible 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...

We are searching for the best talent for Manager, Supply Chain Quality to join our DePuy Synthes Quality and Compliance organization located in Palm Beach Gardens, FL. About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions...

Quality Project Leader, Packaging Supplier Quality Our location in Columbus, OH, currently has an opportunity for a Quality Project Leader, Packaging Supplier Quality . Primary Function The primary function of Supplier Quality Assurance (SQA) is to assure a high-quality supply of materials through evaluation and development of Abbott Nutrition suppliers worldwide. Packaging SQA is responsible for working and communicating with packaging suppliers as part of an ongoing supplier management process. Packaging SQA supports the following areas (1) Supplier qualification, (2) Supplier development & monitoring, (3) Supplier corrective & preventative actions, (4) Continuous improvement of department & supplier performance, and...

Responsible for various aspects of quality assurance and quality control related to their functional area. Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements. Support troubleshooting and resolution of quality compliance issues. Communicates with Management for Quality Management Review, Quality Initiatives, etc. Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs. $58,656 - $96,500 Bachelor’s Degree OR 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry. Must be familiar with use...

Purpose Support manufacturing operations in the resolution of events and documentation discrepancies. Provide guidance for product/process impact analysis, investigations and risk based evaluations in support to plant events.
Responsible for implementing and maintaining the effectiveness of the Quality System. Responsibilities List up to 10 main responsibilities for the job. Include information about the accountability and scope. Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with AbbVie policies and applicable regulations for the Quality areas under his /her responsibility. Ensures investigations of plant events are evaluated in a timely manner; completed thoroughly...

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...

Senior Director, Quality Assurance What you will do Let’s do this. Let’s change the world! By taking on this leadership role, you will have the opportunity to augment the future and contribution of Quality Operations at Amgen Rhode Island (ARI) through the advancement of Amgen’s pipeline and diversified portfolio from our state-of-the-art Drug Substance manufacturing site located in West Greenwich. In this vital role, you will be responsible for actively driving operational workstreams. You will provide Quality leadership and guidance to site partners as we continue to grow and deliver our mission of "Every patient, Every Time." Your responsibilities also...

Johnson & Johnson is currently recruiting a Senior Quality Manager to join our Aesthetics & Reconstruction (A&R) organization in Irving, Texas. 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 This unique leadership role combines Supplier Quality oversight with Strategy & Deployment responsibilities for the A&R Quality organization. The Senior Quality Manager will ensure the highest standards of quality across our supplier network while driving strategic initiatives that enable operational excellence and compliance....

Johnson & Johnson, Vision Jacksonville, FL is recruiting for a Senior Software Validation Quality Engineer, Quality Operations, location in Jacksonville, FL. The Senior Software Quality Engineer is primarily responsible to manage the development & implementation of software validation policies and procedures. They will manage and conduct software validation projects in support of existing computerized systems in the Jacksonville campus. Project responsibilities will be focused on medium to large validation projects. This position may also oversee software qualification activities related to contract repackaging and contract manufacturing projects. Key Responsibilities Facilitates and leads software validation activities/projects with specific focus to manufacturing systems....

Johnson & Johnson is hiring for a Sr Quality Engineer for Shockwave

This global executive role shapes and drives the Corporate Quality vision, delivering strategic leadership and enterprise-wide quality and compliance across Bristol Myers Squibb. As a trusted advisor to senior leadership, the VP ensures alignment with business goals and global regulations, proactively managing quality risks and opportunities. The VP owns the global Quality Management System (QMS), championing its effectiveness and continuous improvement throughout the product lifecycle—from R&D to commercialization. Responsibilities include leading Quality Governance, setting enterprise KPIs , and overseeing SOPs, training, and digital quality systems (including GxP AI governance). With a forward-looking approach, this leader engages regulators and industry peers,...

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...

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

The estimated base salary range for the Design Quality Engineer 2 role based in the United States of America is $73,400 - $110,200. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the...

Quality Engineer I This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer I , you will assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. You will support new...

This Senior Regulatory Affairs Specialist will work out of our Alameda, CA location in the Diabetes Care Division. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment are followed. With limited supervision you will execute tasks and partner across business functions. The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data, and ensuring that the information is reliable and effectively presented to substantiate claims. You may also have opportunities to participate...

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 . IM Transcend is an E2E global business transformation program that will modernize our foundational transactional processes and harmonize them into a standardized platform for growth, agility, and efficiency gains. The program will simplify the SAP ERP landscape, standardizing...

Ethicon (Johnson & Johnson) is currently recruiting for a Quality Engineering Leader . This position will be located in Cincinnati, Ohio. 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 Key Responsibilities Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines The candidate will oversee both Harmonic and Advanced Bipolar divisions within lifecycle and have 3-5 direct reports....

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...

Purpose Statement This role serves to provide leadership in the Quality Operations function to support and drive strategic initiatives, continuous improvement and management of the Quality Center of Excellence in cooperation with the Center of Excellence leads. This position holder will hold responsibility for working closely with regulatory intelligence team and improve AbbVie Global Quality System by ensuring external and internal regulatory and business signals are translated into improvements of the different Quality System elements to consistently deliver compliance and high-quality product. These signals include new or changed external regulations, observations from AbbVie´s regulatory inspections and competitor’s enforcement actions, AbbVie´s...

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...

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

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

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 are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects. Within the Renal Denervation (RDN) Design Assurance (DA) Laboratory at Medtronic’s Mounds View site, we focus on providing Quality support across all...

Quality Assurance Engineer The Quality Assurance Engineer position is within our CMI Unit located in Pomona, California . This role plays a critical part in ensuring product and process quality, compliance, and continuous improvement across operations. Key Responsibilities Lead quality engineering activities related to Product and process changes Product/process quality issues Compliance concerns Partner with operations to drive process improvement and continuous improvement initiatives. Conduct process audits within operational areas to ensure adherence to quality standards. Support the development of new products, including participation in design control activities. WHAT YOU’LL DO Actively partner with operations to perform process audits...

Quality Assurance Specialist I The position of Quality Assurance Specialist I is within our CMI Unit located in Pomona, California. This role will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, complaints, nonconformances, CAPA and/or supplier control. WHAT YOU’LL DO Responsible for implementing and maintaining the effectiveness of the Quality System. Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation. Aid in implementing process improvements with respect to Quality Assurance processes. Maintain Quality...

Senior Director, Global Quality and Operational Excellence, Site Management & Monitoring Location Durham, NC Introduction to role Are you ready to lead the charge in transforming clinical operations? As the Senior Director of Global Quality and Operational Excellence for Site Management & Monitoring (SMM) at AstraZeneca, you'll be at the forefront of shaping our quality, capability, and learning vision. This pivotal role provides strategic direction and global oversight, ensuring our clinical trials are conducted with the highest standards of compliance and innovation. Reporting directly to the VP and Global Head of SMM, BioPharma R&D, you'll develop and execute plans that...

Purpose Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility. Responsibilities Maintains the...

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

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 Regulatory Advocacy Program Manager is responsible for developing and executing strategies to advance Medtronic MiniMed’s interests in regulatory policy and advocacy. This role builds the framework for establishing relationships with regulatory agencies, trade associations, and industry partners, and collaborates across internal teams to ensure MiniMed’s priorities are reflected in regulatory policies and guidance. The Program Manager monitors regulatory developments, analyzes their impact, and leads initiatives to influence relevant regulations affecting medical devices and healthcare technologies. 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...

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

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Quality Assurance Engineer will provide support to various operational teams for a variety of functions. Based on the scope of the assigned area, activities may include process validation, facility validation, test method validation, risk management, change control,...

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

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

TCP Quality Documentation Specialist Our location in Abbott Park ( Lake Bluff), IL currently has an opportunity for Test Control Procedure (TCP) Specialist. This team member will conduct quality-related activities to deliver consistent; high quality documents; services; products and processes. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the quality system. Create, analyze and process electronic Quality testing documents in compliance with QSR, ISO13485 and other applicable standards. Initiate Document Change Requests and associated packages relating to electronic documents and verify for correctness of the submitted Change in alignment with testing site requirements. Participate in...

About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. " Position will be based out of our brand new plasma donation facility in the Rochester, NY opening October 2025! BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors designated systems and activities,...

The Senior Director, Pharmacovigilance Compliance is a critical leadership role within Patient Safety, responsible for the global governance and continuous improvement of compliance controls across the AstraZeneca pharmacovigilance landscape. The role drives both strategic and operational compliance by implementing robust predictive and detective controls, fostering an enterprise-wide safety and compliance culture and s haping policy . Key elements include championing the use of analytics, innovating compliance frameworks, developing compliance policies and standards, and partnering with QPPV to ensure optimal compliance and readiness globally through prediction and early detection. Typical Accountabilities Accountable for the global pharmacovigilance compliance model, encompassing preventive, detective,...

We are looking for Sophomore and Junior students majoring in Chemistry, Bioengineering, Chemical engineering, mechanical engineering, or a related field for a 12-week internship role at our Durham, NC site from May 18 2026 to August 7 2026. Position Support from the Quality perspective to development Project teams and ensure delivery of quality products. Support Quality Systems transformational initiatives through Business Process Management (BPM) with a technical/digital focus. Project management and task execution for Site Improvement projects enabling the implementation digital ways of working. Site, functional and global cross collaboration and interaction (Research and Development, Global Pharmaceutical Quality Systems,...

The audit focus will be primarily medical device software, product cybersecurity, and risk management. We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers. Responsibilities may include the following and other duties may be assigned. Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and product cybersecurity requirements. Remain informed on Regulatory requirements for Software and Product Cybersecurity to identify gaps in medical...

Specialist Manufacturing (Quality Record Owner) - External Supply RMD What you will do In this role, you will own and execute under minor supervision all the processes related to deviations (minor and major), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications, and Supplier Investigations (EN/SICAR), and Change Control quality records. In addition, it is expected to apply process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support quality records originating from manufacturing sites across the Amgen network. This Specialist Manufacturing will also act as the External Supply representative across functional teams 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. At Lilly, we unite caring with discovery to make life better...

Purpose The Associate Director/Director, Quality Risk Management is a strategic leader within AbbVie’s Global Quality Systems team. This role is responsible for driving enterprise-wide excellence and standardization in R&D Quality Risk Management, providing expert oversight, and fostering a culture of proactive risk identification, mitigation, and compliance with global regulatory and industry standards. Additionally, they will lead the QRM Quality System Network, which consists of SMEs and risk practitioners across R&D. Responsibilities The Associate Director/Director, Quality Risk Management is responsible to Serve as the strategic owner and leader of the global R&D Quality Risk Management (QRM) system, driving sustainable excellence and...

Purpose Describe the primary goals, objectives or functions or outputs of this position. The Senior Validation Engineer/Analyst functions as the lead for maintenance, engineering, and validation activities within the assigned site/area of responsibility. Equipment, facility, utilities and cleaning are within the scope of responsibility. The incumbent is the primary liaison with the Operations, engineering services, and third party vendors for executing activities within area of responsibility. All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations. Responsibilities List up to 10 main responsibilities for...

Purpose The Associate Director/Director, Quality Risk Management is a strategic leader within AbbVie’s Global Quality Systems team. This role is responsible for driving enterprise-wide excellence and standardization in R&D Quality Risk Management, providing expert oversight, and fostering a culture of proactive risk identification, mitigation, and compliance with global regulatory and industry standards. Additionally, they will lead the QRM Quality System Network, which consists of SMEs and risk practitioners across R&D. Responsibilities The Associate Director/Director, Quality Risk Management is responsible to Serve as the strategic owner and leader of the global R&D Quality Risk Management (QRM) system, driving sustainable excellence and...

MANAGER QUALITY CONTROL - BIOCHEMISTRY LABS (3rd Shift) What you will do In this vital role you will lead all Biochemistry laboratories during the night shift (including Wet Chemistry and HPLC Labs) —ensuring compliant, accurate testing and fostering an impactful team that safeguards product quality and patient safety. Specific responsibilities include but are not limited to Lead and develop a successful QC team, fostering a culture of safety, compliance, and continuous improvement. Oversee daily QC operations to ensure timely, accurate, and reliable testing aligned with production schedules. Serve as the QC subject matter expert during audits and inspections, ensuring...

MANAGER QUALITY CONTROL - HPLC LABS (2nd Shift) What you will do In this vital role you will lead the HPLC Labs during the 2nd shift —ensuring compliant, accurate testing and fostering an impactful team that safeguards product quality and patient safety. Specific responsibilities include but are not limited to Lead and develop a successful QC team, fostering a culture of safety, compliance, and continuous improvement. Oversee daily QC operations to ensure timely, accurate, and reliable testing aligned with production schedules. Serve as the QC subject matter expert during audits and inspections, ensuring inspection readiness. Provide technical guidance and...

This position is a M-F business hours schedule (8A-5P) and is full time on-site at our RTP facility About This Role As an Associate III, QC Raw Materials, you will play an integral role in the Quality Control Raw Materials team at the Biogen RTP Pharma site. This critical position supports functional, tactical, and operational objectives by sampling, inspecting, and testing raw materials while maintaining strict adherence to cGMP documentation standards. Your expertise in Gas Chromatography (GC) and wet chemistry will be essential as you perform compendial testing and manage data entry into electronic laboratory information management and inventory systems....

We are seeking a strategic, experienced, and proactive Ethics and Compliance Program Manager to help design and build the global compliance program for Medtronic Diabetes – a $2.8 billion medical device business that has recently announced that it will be spinning out into a standalone public company. Reporting to the company’s Chief Compliance Officer, the Compliance Program Manager will play a pivotal role in helping the company prepare for and operate successfully as a publicly traded company, aligning compliance programs with public company standards and shareholder expectations. In this role, you will support the execution of key operational initiatives that...

In partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be accountable for the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach....

This position works out of our Lake Forest IL facility. What You’ll Work On Abbott’s Office of Ethics & Compliance has an exciting opportunity for a Sr. Compliance Analyst located in Lake Forest, IL. The Sr. Compliance Analyst will be responsible for providing support for developing, updating and maintaining elements of Abbott’s compliance program at the franchise, business unit, regional, divisional or corporate level. The Sr. Compliance Analyst will assist in the development and administration of the OEC training and education program as well as the implementation of the divisional monitoring plan. Additional Main Responsibilities The Sr. Compliance Analyst performs...

At Astrazeneca, we get our pipeline out to patients sustainably, reliably and safely. We certify every batch and ensure manufacturing supplies move without challenges. Backed by a science-led approach, we follow evidence to reach outcomes that benefit patients and AstraZeneca. Working on an immensely rich pipeline we adapt to get new medicines out quicker. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk. Accompanied by our digital and Lean evolution in Operations, we have a sharp focus on patient-centricity, constantly asking what more we can do to deliver to patients safely. This...

This individual will be part of the Operations legal team and must possess deep substantive expertise in global trade areas core to the Medtronic Diabetes business. This role will work across geographies resulting in unique ability to 1) advise on complex legal regulatory questions, 2) identify common and conflicting legal issues and positions across the company, and 3) contribute to high-level policy decision-making. This individual will provide import and customs compliance advice to help mitigate risks and provide support to Global Trade Operations, global regional and business unit lawyers, and other relevant functions. Specific global trade areas of legal and...

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

This position works out of our Austin TX facility. What You’ll Work On Abbott is currently seeking an experienced professional to provide Support for developing, updating and maintaining basic and routine elements of Abbott’s compliance program at the franchise, business unit, divisional or corporate level. Assists with the revision and administration of OEC education and training (including supporting materials) and assists with the implementation and administration of division monitoring plan. Core Job Responsibilities The Analyst performs the following with moderate supervision from the OEC Manager/Director Supports and communicates with the business to provide OEC and divisional policy interpretation and requirements,...

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...

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...

Purpose The Quality Assurance Supervisor II is responsible for the organization, administration, and supervision of Quality Assurance employees within the manufacturing operations. Responsible for properly overseeing the day-to-day operations by prioritizing shop floor presence. This includes delivering high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team. Ensures that appropriate controls are developed and maintained for new, intermediate and finished products. Responsible for GMP compliance, manufacturing quality, product control and release, system execution and quality planning for...

Employer Vertex Pharmaceuticals Incorporated JOB TITLE Quality Control Senior Specialist LOCATION 1 Harbor Street, Boston, Massachusetts, 02210 OPENINGS 1 DUTIES Provide a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in-process, release and stability samples. Ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values. Serve as RSL representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs. Coordinate and facilitate laboratory activities to meet commitments on-time. Maintain accurate laboratory records and adhere to cGMP/GDP expectations....

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...

Johnson and Johnson Innovative Medicine is recruiting for a Quality Assurance Specialist to be located in Athens, Georgia . 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 This position is responsible for ensuring compliance in all cGMP API Manufacturing Facilities at the J&J Innovative Medicine, Athens Georgia...

The Senior Quality Engineer will play a critical role in driving quality systems improvements and ensuring compliance with regulatory requirements. This position is responsible for leading CAPAs, managing quality improvement projects and collaborating across departments to enhance product quality and process effectiveness. The ideal candidate will possess strong leadership skills, technical expertise, and a passion for delivering exceptional results. This role is 100% onsite at our Rice Creek, MN site. Responsibilities may include the following and other duties may be assigned Manage CAPA lifecycle, including root cause analysis, corrective action implementation, and preventive measures and ensure timely completion. Plan, execute...

Specialist Supply Chain Compliance What you will do In this vital role you will require a strong ability to collaborate cross-functionally with other Amgen business units. Operational Responsibilities Own and manage deviations, trend investigations records, CAPA and CAPA EV records. Lead root cause analysis sessions. Own and manage the trend trigger and periodic evaluation report for temperature excursions and distribution complaints. Provides training sessions related to SC Compliance. Act as Subject Matter Expert (SME) for the Quality Systems Deviation, CAPA, CAPA EV, Temperature excursion, Distribution Complaint and Periodic monitoring. Participate in and support inspection readiness activities, audits and inspections....

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As an Associate Director, Global Regulatory Affairs, you will act as the Regional Regulatory Lead on more complex or multiple products, compounds,...

Our Company has constructed a new manufacturing facility to significantly expand its production capacity. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding dedication to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA)...

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...

To ensure Design Control activities are robust in ensuring the highest quality and reliability of products from concept through manufacturing. Ensures that development products have the appropriate characterization and validation data to demonstrate that business objectives have been met, prior to formal transfer to manufacturing. What You’ll Work On Recruits, coaches and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI regulations, etc.). Recommends and implements changes to the Quality System as the...

Quality Systems Analyst II The Quality Systems Analyst II will be responsible for supporting trend escalations, ensuring that potential product or process issues are thoroughly assessed and effectively managed. This includes applying structured root cause analysis (RCA) methodologies such as 5 Whys, Fishbone diagrams, and 6M frameworks to identify underlying drivers, validate findings, and reach well-supported conclusions for investigations. 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 Support complaint investigation activities related to glucose meters, ensuring compliance with procedures...

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. The Quality Engineer will analyze quality standards for components, materials and services. This role work closely with operations and engineer to ensure GMP and product support. It will apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met to customers. What You’ll Work On...

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

About 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,...

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...

As a Quality Engineer I at Medtronic, you will champion our commitment to continuous improvement and operational excellence by proactively identifying opportunities for innovation across our processes and systems. Embedded within the Airways DC Quality support team, you’ll deliver dedicated support to daily logistics operations, driving best-in-class results through standardization, simplification, and a relentless pursuit of quality. In this role, you’ll focus on detecting gaps and issues, providing actionable solutions, and ensuring full compliance with Medtronic’s rigorous Quality procedures and governing regulations—all while embodying our Mission to alleviate pain, restore health, and extend life. This role is 100% onsite in...

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

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

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

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

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 Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. We are seeking a highly motivated and technically skilled student majoring in the life sciences, medicine, pharmacology/pharmacy, or related discipline for a Co-op role. The goal of this position is for the individual to gain broad insight into the drug development process and knowledge of regulatory affairs. The student should...

We are seeking junior and senior undergraduate or PharmD students majoring in Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering, or a related field for three full time 12-Week Student Intern roles in Gaithersburg, MD for a May 18th - August 7th contract period. Position Duties This posting has three openings for the below teams Regulatory Oncology TA Center of Excellence Help with gathering of data for IVDR (in-vitro diagnostics regulation)/GMO (genetically modified organisms) metrics . Support an update of GMO regulatory country requirements incl uding research of publicly available information . Support EUDAMED (European database on Medical...

The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. 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...

We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN or Plano, TX. This position performs three 1-year rotations that include specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. Additionally, during certain rotational periods the position may be responsible for regulatory operations activities such as logistics management of global product release, and maintaining tools needed for managing global regulatory...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Senio r Quality A uditor is responsible for planning, executing, and reporting on internal and external audits to ensure compliance with applicable GxP regulations (GMP, GLP, GCP), internal procedures, and industry standards. This role supports the continuous improvement...

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...

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...

Company Overview Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies...

Company Overview Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies...

MANAGER QUALITY CONTROL - MICROBIOLOGY LABS (3rd Shift) What you will do In this vital role you will lead all microbiology laboratories during the night shift—ensuring compliant, accurate testing and fostering an impactful team that safeguards product quality and patient safety around the clock. Specific responsibilities include but are not limited to Lead and develop a successful QC team, fostering a culture of safety, compliance, and continuous improvement. Oversee daily QC operations to ensure timely, accurate, and reliable testing aligned with production schedules. Serve as the QC subject matter expert during audits and inspections, ensuring inspection readiness. Provide technical...

Global Regulatory Policy team engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important policy issues within the U.S. aligned with Amgen’s goals and priorities. In this vital role you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business and will serve as a U.S. Policy Lead for Global Regulatory Policy and Intelligence. Key Responsibilities include Masters a range of regulatory policy topics and provides strategic U.S> regulatory policy advice and guidance related to Amgen’s product portfolio , including a focus on artificial intelligence...

SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Saving lives is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for a passionate Senior Regulatory Affairs Specialist who has direct experience submitting regulatory submissions for both the Americas and the EU....

The Site Analytical Sciences Specialist role is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations, biochemistry, and microbiology. Activities Within Role Technical expertise to support New method introduction (Validation /Tech Transfer). New technology introduction. Assessment and implementation of changes for existing methods and equipment Change in technical element of method e.g. Parameter change Change in...

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. Principal Engineer TSMS Validation - Eli Lilly and Company Job Summary...

Job Title Quality Assurance Manager Our location in Temecula, CA, currently has an opportunity for a Manager, Quality Assurance THIS IS AN ONSITE ROLE. As the Manager, Quality Assurance, you will lead the team of Quality supervisors and Quality Control personnel to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. You will directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements. What You'll Work On Implement a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the...

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

Responsibilities The responsibilities of the Senior QA Specialist is to maintain commercial product specifications current in all GMP systems, as well as the management of SAP workflow to ensure compliance to product dossiers and enable timely release of products. Lifecycle management of specification include revisions based on feedback from health authorities during post approval changes and submission of a commercial products to additional countries, or from continuous process verification where a change to approved specification is warranted. The Senior QA Specialist needs to manage change control record in GVault pertaining to specification revision, and must be well verse in using...

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

This position will work NIGHTS from 6 PM to 6 AM on a 2-2-3 rotation schedule About This Role The Senior Quality Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral Facility. Specifically, this role will have primary quality oversight of the following activities (1) Shop floor support ensuring critical steps are executed according to batch record and procedural requirements, (2) Exceptions review and approval and (3) Respond to operational needs that require QA approval. What You’ll Do Ensures Product documentation and other...

About This Role As the Director of Quality Control , you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in our Parenteral Filling, Antisense Oligonucleotide, and Oral Solid Dose (OSD) operations at RTP Pharma. You will develop and manage QC budget plans and lead the management of laboratory quality systems, including analytical instruments & equipment , testing...

The Information Security Governance, Risk & Compliance (GRC) Director is responsible for leading and maturing the company’s global security governance framework, enterprise cyber risk management program, and compliance activities across IT, OT, cloud, and regulated medical device environments. This leader ensures alignment with cybersecurity expectations, Quality System requirements, and industry best practices. The Director partners closely with IT, R&D, Operations, Legal/Privacy, Quality & Regulatory (QARA), and Internal Audit to strengthen the company’s security posture, reduce enterprise risk, and ensure readiness for audits, inspections, and regulatory submissions. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has...

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

SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Saving lives is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for a passionate Senior Regulatory Affairs Specialist who has direct experience submitting regulatory submissions for both the Americas and the EU....

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). Belgium (Beerse) Req # R-047878 USA (New Brunswick, Raritan, Titusville, Horsham) Req # R-048279 Switzerland (Schaffhausen) Req # R-048282 Ireland (Cork) Req # R-047878 J&J Innovative Medicine Supply Chain (IMSC) safely and efficiently manufactures high quality (bio) medicines for global markets. We serve the pharmaceutical companies Johnson & Johnson as a center...

The Logistics, Compliance and Engineering (LCE) co-op will be a part of a cross functional team that concentrates on deviation management, change control, cold chain management, technology support, and operational efficiency projects in support of the North America Supply Chain Management (NASCM) organization. The LCE co-op will collaborate with Operations, Quality, Automation, and Validation to drive change in a collaborative manner. The candidate will gain some understanding of cGMPs and cGDPs and will be tasked with a problem(s) to solve while contributing to multiple projects and activities across the facility and North America transportation network as required. The individual must...

We are seeking a strategic, experienced, and proactive Compliance Director to help design and build the global compliance program for Medtronic Diabetes – a $2.8 billion medical device business that has recently announced that it will be spinning out into a standalone public company. Reporting to the company’s Chief Compliance Officer, the Compliance Director will play a pivotal role in helping the company prepare for and operate successfully as a publicly traded company, aligning compliance programs with public company standards and shareholder expectations. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention...

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...

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...

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

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 Senior Associate/Principal, GMQO is to support the...

About the role As the Head Global Quality Digital Health and Artificial Intelligence Compliance (Open), you will provide enterprise-wide leadership, governance, and oversight for digital health, Artificial Intelligence (AI), and Machine Learning (ML) across Takeda’s Quality organization. You will ensure regulatory compliance, data integrity, and the sustainable integration of AI-driven technologies across GxP and non-GxP environments. Working cross-functionally, you will drive consistency, continuous improvement, and harmonization of digital health and AI practices across the global network. You will also establish governance structures, performance indicators, and communities of practice to enhance quality decision-making and sustain compliance excellence. How you contribute ...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline...

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...

Responsible for applying expertise to directly contribute to supporting the development, implementation, administration and continuous improvement of all aspects of the company"s Compliance and Ethics program. _ Your Contributions (include, but are not limited to) Provide sound compliance guidance consistent with applicable laws, regulations and Neurocrine policies Develop and deliver training on compliance policies and procedures Provide services in a timely and efficient manner Conduct (or assist with) internal investigations on compliance matters Draft investigation and audit reports Other duties as assigned Requirements Bachelors degree or equivalent AND 6+ years experience in the biotech/pharmaceutical or medical device industry, including experienced...

Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO,...

Senior Manager, Quality Engineering -- Minnetonka MN This position works out of our Minnetonka , MN location in the Electrophysiology business. 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 Senior Manager Quality Engineering , you’ll provide leadership and guidance for the quality engineering department supporting commercial products and new product development. This role is responsible for developing goals, objectives, procedures, policies, and systems that are in line with company goals and objectives, mission and...

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 Quality Assurance Intern will play an integral role in supporting QA Operations across multiple areas, including internal manufacturing (shop floor activities), external manufacturing oversight, and incoming material release. This position provides hands-on experience in ensuring compliance with...

We are looking for sophomore and junior students majoring in the biosciences, chemistry, engineering, or a related field for a 12-week internship role in Gaithersburg, MD from May 18 2026 to August 7 2026. Position Develop a risk-based approach to reduce or eliminate the need for routine revalidation of bioreactors Build Smartsheets automations to link multiple schedules into a single, synchronized view, enabling seamless real-time scheduling and project demand visibility. Perform revalidation of Bioreactor steam sterilization process per regulatory standards Position Requirements Sophomore and junior students majoring in the biosciences, chemistry, engineering, or a related field. Candidates must have...

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

2026 Summer Internship - External Quality Department Summary External Quality is responsible for the Quality and Compliance of externally sourced raw materials, supply from CDMOs, and distribution quality from Roche sites to Affiliates, including the certification for the EU market. We serve our patients through external partnerships because access to quality products is every patient’s right. We leverage external partners to offer flexibility to our internal capacity at the correct cost and quality. We enable our external partners to reliably deliver compliant, quality products to our supply chain customers so that we can deliver to patients worldwide. We do this...

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Specialist II! This position will be located in Raritan, NJ! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.Janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is...

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity JOB LOCATION Cambridge, MA POSITION Clinical Program Quality Manager POSITION DESCRIPTION Takeda Development Center Americas, Inc. is seeking a Clinical Program Quality Manager with the following duties Support GCP compliance activities for oncology clinical trials through the development and implementation of program-specific, risk-based audit and compliance strategies; conduct audits of investigator sites, clinical documentation, vendors, and internal systems to ensure adherence to GCP, regulatory requirements, and internal policies; assess...

Senior Director, External Q uality Testing Operations This role can be based in Foster City, CA or Parsippany, NJ Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters , and everyone has a chance...

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...

Senior Director, Global Supplier Quality Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. Director, Ethics and Compliance Investigations About the Role The Director, Ethics & Compliance Investigations, plays a key role in promoting Gilead’s culture of integrity, transparency, and accountability. We are seeking a dedicated and experienced investigator to join Gilead’s Ethics & Compliance Investigations team. This position will lead and manage internal investigations into potential violations of law, regulation, or company policy, ensuring that each investigation is handled promptly, confidentially, and in accordance with company policies and regulatory requirements. The successful candidate...

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

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

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

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

Job Title Quality Engineer This position works out of our Temecula, CA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts,...

The Sr. Compliance Counsel is responsible for broad compliance consultation and for recommending continuous solutions while executing and leading a team of compliance professionals who execute the Neurocrine Compliance and Ethics program to ensure compliance with all applicable laws and regulations. _ Your Contributions (include, but are not limited to) Provide clear and sound compliance advice to key stakeholders, executive management and employees at Neurocrine, consistent with applicable laws, regulations and Neurocrine policies Leads team of compliance professionals and ensures team executes on predetermined goals, provides coaching and mentoring, fosters Neurocrine’s culture and uses company programs and policies to attract...

OBJECTIVES Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business units and affiliates. Contributes to and implements the engagement strategy among R&D, Business Units and affiliates and Quality to ensure a global framework and robust quality systems are in place for the transition of R&D pipeline to the commercial space. Drives a fit-for-use global Quality framework that elevates the capabilities in the business units and the affiliate and enables them to deliver their clinical research and pharmacovigilance-related regulated activities with high compliance and agility. Establish and maintain relationships with key stakeholders outside...