Quality & Regulatory Jobs in Pharma & Biotech

Reporting to the Sr. Director of QC Operations, the Associate Director of QC operations is responsible for supporting the operations of the internal ddPCR, qPCR and Cell-based assays. The individual will be responsible for supporting all aspects of the laboratory and facility footprint including safety, compliance, instrumentation and equipment qualification and maintenance. Prior experience with laboratory expansion projects is beneficial. This role is responsible for inventory management, raw material procurement as well as the qualification and bridging of critical reagents needed to support internal and external testing at our CMO/CTL partners. The Associate Director of QC Ops is responsible for...

The Manager of Quality Systems Metrics and Management Review is responsible for overseeing and refining enterprise performance review processes, driving effective metric reporting, and leading the automation and modernization of data review mechanisms and data consumption. This role enables leadership teams to make informed decisions through clear, timely, and actionable insights while advancing digital transformation in operational processes. This position defines, implements, and monitors the performance of systems related to quality assurance across global internal manufacturing sites, third-party manufacturers, suppliers, and/or affiliates. Designs effective quality systems, procedures, and/or processes to ensure compliance as well as efficiency throughout the global network....

Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system. Responsibilities Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods. Performs, coordinates and supports method validations and prepares final reports documenting the validation findings. Receives and interprets the results of bioburden, microbial limits, environmental monitoring, growth promotion testing and sterility testing. Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective action....

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

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

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

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance. Essential Job Duties and Responsibilities This position provides strategic leadership and subject matter expertise within the External Quality (EQ) team as well as to key internal and external partners to ensure the department consistently delivers pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards. The following duties and responsibilities apply, based on the qualification status for each process Manages team providing support in execution of the transactional activities and quality system and process troubleshooting...

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 a Technician, Quality Control to be in San Angelo , TX . Purpose Responsible for conducting complex test and analysis to assure that product comply with established specifications. What you will be responsible for Carries out routine calculations and prepares documentation that shows the results for test performed. Responsible for ensuring personal 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. Organization Overview At Lilly, we serve an extraordinary purpose. We make...

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

Responsible for and manages the full AbbVie global supplier/TPM audit schedule, including supporting procedures, systems and planning. Additionally manages, provides strategy and support to audit planning team, This includes being business system owner of onetrack for supplier/audit (as well as Soltraqs and GTW) IT system and ensuring the accuracy (records) and execution (function) of system vs process. This role owns the external audit process and procedures (including changes, process improvements and updates to procedures, process and systems) and leads the external audit Community of Practice (COP) quarterly updates to ensure alignment of process and potential improvement across the users. Owner...

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...

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...

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 Verve Therapeutics, a wholly owned subsidiary of Eli Lilly...

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

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

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Quality Control Microbiology Supervisor to be located in Athens, GA . The Quality Control Supervisor is responsible for managing and coordinating the activities of the Quality Control associates engaged in receiving,...

Validation Engineer This position works out of our St. Paul, MN location in our Structural Heart Division. In Abbott’s Structural Heart (SH) business, our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. As the Validation Engineer, you'll be responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout business unit. What You’ll Work On Develop and conduct training of company personnel for the divisional software development and validation program. Work with software owners in the...

Career Category Regulatory Let’s do this ! Let’s change the world ! Amgen is seeking a United States Regulatory Lead (USRL) supporting products in the Obesity and Related Conditions Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise , and execution for the development, registration, and lifecycle management of all Amgen molecules. In this product-facing role, you will develop and execute U.S./regional regulatory strategy and tactics under general supervision, represent the region on global teams, and lead U.S. regulatory execution to enable clinical trials and maintain commercial licenses in compliance with local laws, regulations, and Amgen...

Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. 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...

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

As a Senior Post Market Quality Engineer where you'll play a pivotal role in driving quality excellence and continuous improvement. Reporting to the Post-Market Quality Director, you’ll lead trend analysis of complaints and quality data, conduct Product hold, field action activities, and manage quality improvement projects. Based in Colorado, this position offers the opportunity to work in a dynamic, innovative-driven environment where your analytical skills will directly impact product quality and patient safety. Responsibilities may include the following and other duties may be assigned. Monitor Product Performance Collect and analyze data from various sources (complaints, adverse events, clinical follow-up, literature)...

The Senior Radio Regulatory Affairs Specialist is responsible for leading global RF/Wireless regulatory compliance activities for RF‑enabled devices within the Acute Care and Monitoring (ACM) Operating Unit throughout the product lifecycle. The Senior Radio Regulatory Affairs Specialist is dedicated to the Acute Care and Monitoring (ACM) Operating Unit. In this role, the specialist supports New Product Development (NPD) programs and product lifecycle maintenance activities across the RF‑enabled device portfolio. The specialist collaborates closely with Regulatory Affairs colleagues, cross‑functional partners at all levels, external test laboratories and certification bodies, and International Regulatory Affairs teams to ensure ongoing compliance with global RF,...

In this exciting role as an Audit Compliance Manager, you will have responsibility for leading the compliance audit program for the Medtronic Diabetes business. The Audit Compliance Manager is responsible for managing the compliance audit program, for internal, external and supplier audits at the Diabetes sites. This position is an exciting opportunity to work with Medtronic's Diabetes business. This role is instrumental in contributing to defining the direction and plans for process improvement and ensuring the site is audit ready. The individual in this role must be comfortable coaching all employees on audit readiness and working professionally with others to...

Use Your Power for Purpose This position prov ides Quality Assurance oversight for Quality Control (QC) Department . Provide QA (Quality Assurance) review and approval of Quality method validation/ QC equipment qualification, QC protocol, reports, QC process control document, ne w and existing procedures, and Quality Control deviation/investigations . The role required to act independently supports process improvement and facilitates the implementation. How You Will Achieve It Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol, Technical documents, amongst others. Provide final QA approval on change control, compendial assessments, and other documents associated with the...

2026 Summer Intern - Research and Early Clinical Development(ECD) Quality, Compliance & Clinical Capabilities (QC3) Department Summary The Quality, Compliance & Clinical Capabilities (QC3) group is the backbone of quality oversight and management in Genentech Research & Early Development’s (gRED) Early Clinical Development (ECD). Our mission is to be a trusted strategic partner to gRED. We enable a proactive compliance approach, ensuring successful delivery of quality and compliance programs enterprise-wide. We engage, educate, and empower gRED teams to effectively execute risk-based quality and compliance solutions. This internship position is located in South San Francisco, on-site. The Opportunity As an intern...

Johnson & Johnson Neurovascular is recruiting for a Sr Design Quality Engineer, Life Cycle Management in Irvine, California. 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 The position provides quality technical and compliance expertise as part of teams tasked with modifying existing designs, supplier changes, internal manufacturing support, and other lifecycle management activities. The use of engineering and supply chain knowledge to assist in the execution of cross-functional projects in...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Supplier Quality Development Engineering, located in Cincinnati, OH. At Johnson & Johnson Robotics & Digital Solutions, we’re building the future of surgery. Our OTTAVA™ robotic platform unites advanced engineering, digital technologies, and precision manufacturing to deliver next-generation solutions that transform patient care. We are seeking a Supplier Quality Development Engineer to join our rapidly...

About the role The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Regulatory Compliance, Senior Manager ensures that the organization gains regulatory approval for new products and product amendments, and maintains the currency of product licenses and permits. This role involves monitoring regulatory developments, ensuring compliance, and preparing necessary documentation to support Takeda's mission. How you will contribute As a Regulatory Compliance, Senior Manager in our PDT organization, you will ensure the organization is aware of and compliant with legislation and regulations pertaining to the...

About the role As a Deviation Investigator - Quality Control, you will perform deviation investigations, CAPAs, and change controls through knowledge of quality concepts, investigational techniques, and root cause analysis. You will be responsible for routine monitoring, reporting and escalation of quality performance metrics according to established controlled procedures. How you will contribute Operate Brooklyn Park EQMS (e.g., processing of applicable Help Desk Tickets, Administration of user accounts and EQMS user roles). Monitor the EQMS for compliance with procedures, and completion of deliverables according to committed timelines. Track progress against baseline metrics. Lead Global EQMS projects related to EQMS topics...

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...

Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system. Understand Regulations and business processes required to maintain Laboratory Data Integrity. Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements. Adhere to cGMP requirements. Adhere to and supports all EHS & E standards, procedures and policies. Responsible for the timely completion of assigned laboratory testing. Ensure that all test equipment is used and maintained correctly. Able to work independently under minimal supervision. Perform environmental...

At AstraZeneca, we bring people on a journey to drive positive change and action. Are you ready to seize the opportunity to bring the best out of our diverse and hardworking teams by navigating different voices and opinions. We promote positive change by involving our people in the process and shifting their approach – we don’t instruct and implement; we work together so people feel they have participated in the process. We instil a Lean perspective amongst our teams, ensuring a common understanding of the value it brings to each person in the team, the business and our patients. Be...

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 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 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 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 Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Nellcor™ Blood Oxygenation Management Franchise within the Acute Care and Monitoring Operation unit. Activities include participation in change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs or 510ks) and supporting EU MDR implementation. The Sr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory...

As a Senior Regulatory Affairs Program Manager, you will be the strategic linchpin that drives operational excellence across the different arms of the RA function within the Acute Care & Monitoring (ACM) operating unit. Your day will be a dynamic mix of strategic planning and tactical execution. A significant portion of your day will involve facilitating program-level meetings with leadership, where you will use your expertise to guide strategic discussions, manage through risks, and drive critical decisions to ensure the functional commitments are met. You will also dedicate time to analyzing and interpreting complex performance data, balancing resource demand across...

The Opportunity The Healthcare Compliance Office (HCO) Sr. Compliance Manager Auditing position leads internal compliance audits across Genentech This individual is responsible for conducting complex, in-depth healthcare compliance audits and facilitating corrective action plans within areas of the Genentech organization. This individual designs and effectively executes HCO audits by working closely with other members of the HCO Auditing team or by leading a team comprised of consultants and legal counsel. In the role, this individual Uses knowledge of compliance risks and understanding of database reporting capabilities to develop audit strategies and audit plans Executes routine and ad hoc healthcare compliance...

The Opportunity The Pharma Technical Regulatory - Devices and Combination Products (PTR-DCP) team is seeking a highly motivated regulatory professional with relevant industry experience to join the team. The successful candidate will be responsible for developing and executing regulatory strategies for combination products and standalone physical devices in accordance with domestic and international regulations and guidance. In addition to portfolio-related responsibilities, the individual will play a role to build regulatory capabilities, shape regulatory policy, and establish the necessary device regulatory infrastructures/processes to support our portfolio. What You’ll Do At the Regulatory Program Director level, the individual (a) has in-depth specialist...

Key Responsibilities Subject Matter Expert (SME) and / or Local Process Owner (LPO) for Vendor Qualification and Management. Manage lifecycle activities of qualification and routine oversight of GMP and GDP vendors. This includes assessing new vendors, developing and revising Quality Agreements, providing input to the vendor risk assessment and audit program, and maintaining accurate data within the Approved Vendor List in the electronic Supplier Quality Management system. Subject Matter Expert and / or Local Process Owner for Material Qualification and Management. Manage the lifecycle activities of materials used for the manufacture of drug substance, which involves material qualification, maintenance /...

At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our capital products line (Automated Impella Controller). In this role, you will have the unique opportunity to contribute to manufacturing life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts. This position will be located in Danvers, MA. Responsibilities and Duties Provide quality engineering support in the development and manufacturing of...

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...

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

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...

The Director, Quality Assurance will be responsible for team leadership and technical subject matter expertise in Sterile Drug Product Quality Operations at our Company's Rahway, New Jersey site. This position will serve a critical role in supporting the expansion of clinical development activities at the site with responsibilities including, but limited to the following Execute GMP quality assurance activities directly related to sterile drug product production and release for clinical trial material supply. Support the start-up of a new, state-of-the-art sterile filling line. Support the design and operational readiness of multiple other significant capital projects that are aligned with the...

The Specialist in the Vaccine Biological Critical Reagents (BCR) group will be responsible for supporting the vaccines BCR programs. This position will perform hands-on work in warehousing, distribution and inventory management for biological critical reagents, such as reference standards, positive controls, and other critical materials. Under limited guidance, the incumbent will independently support the entire lifecycle of BCRs, from generation and testing to inventory and shipping. All work will be conducted to the highest quality and conform to GMP and regulatory expectations. Primary Responsibilities include, but are not limited to The Specialist in the Vaccine BCR group will be responsible...

The Quality Control Planner is responsible for the oversight of the QC Laboratory Planning and Scheduling within the QC Team. It is also responsible for the procurement of consumables, reagents, and laboratory supplies. Additional responsibilities include short- and long-term forecasting to enable efficient and effective laboratory scheduling, including testing, equipment, and facilities maintenance, as well as other laboratory services coordination. It is responsible for defining laboratory scheduling system as well as identifying continuous improvement opportunities within the planning, procurement, and lab services process. Responsibilities Perform short- and long-term forecast of laboratory demand, including commercial product testing, as well as non-commercial...

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

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

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

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

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. RayzeBio, a Bristol Myers Squibb company, is looking for a Senior Associate II, Analytical Development at their Indianapolis manufacturing site. The person will be responsible for method development and implementation, method validation, verifications, or transfer, as well as stability...

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...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Quality Control- Clinical Release & Stability (CRS) Analyst to be in Malvern, PA, Purpose The QC CRS Analyst is responsible for conducting biochemical and testing of drug substance, final product release...

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

We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to define and implement innovative regulatory strategies toexpeditethe development and approval of our transformative pipeline. You will serve as theglobalregulatoryleadon relevant project teams to formulate and execute development strategies for developmental programs. You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDAand MAA submissions. Your Role You will work side by side withyour regulatoryand research and development colleagues to develop...

SECTION 1 JOB SUMMARY* The Regulatory Compliance Engineer, under the supervision of the Regulatory Compliance Manager, is responsible for maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements. SECTION 2 DUTIES & RESPONSIBILITIES* In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position 1. External audit/inspection readiness and management. Support external audit/inspection readiness activities to ensure site readiness at all times including audit logistics, from room/back room arrangements, identifying/preparing SME’s, etc. Support external audits/inspections of the site e.g....

We are searching for the best talent for Director, Quality Strategy & Deployment, Abiomed to join our MedTech Heart Recovery organization located in Danvers, MA. Abiomed, part of Johnson & Johnson MedTech Heart Recovery, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a...

Summary The Senior Engineer, IT Computer System Validation, Cell Therapy Devens role will provide support to the Digital Plant team at the Devens Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change controls related to computerized systems. This position work closely with the Digital Plant (IT/Automation) subject matter experts and other key stakeholders, such as Manufacturing Science and Technology (MS&T), Quality Engineering (QE), and Manufacturing Operations. Major Duties & Job Responsibilities Gain a thorough understanding of computer systems deployed at Devens CTF. Act as CSV Subject Matter Expert (SME)...

Responsible for leading QC deviation, laboratory investigations, CAPAs and change control. May provide support during health agency inspection Shift Available Tuesday- Saturday, Hybrid Evening Shift 300 p.m. to 1130 p.m. Duties/Responsibilities Lead and author QC deviation, laboratory investigations, CAPAs and change control. Work with QC SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls. Perform document revision, project, CAPA and deviation/ investigation, change mgmt. actions, related tasks and/ or continuous improvement efforts. Train and mentor others on deviation, investigation, CAPA and change control process/ procedures. May support health agency inspection as...

In this exciting role as a Supplier Quality Engineer at our North Haven Facility, you will collaborate with a diverse network of suppliers to resolve quality challenges affecting production. This role involves working closely with the production team to promptly address issues and drive improvements in component quality. The engineer will play a key role in establishing quality standards for suppliers, enhancing quality system programs, and partnering with cross-functional teams to execute qualification projects. The main responsibilities in this role are; D2D quality support to lines, NCMR & CAPA work, QMS and Compliance area specifics, Supplier Change Requests, and Approved...

In Coronary and Renal Denervation, we love what we do. That's because we're passionate about the patients we serve around the globe and the "second life" and improved health we can give to those with Coronary Artery Disease, High Blood Pressure, and other conditions. We're also driven by the promise of Renal Denervation and its potential to change the way patients around the world manage their uncontrolled hypertension. 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...

In Coronary and Renal Denervation, we love what we do. That's because we're passionate about the patients we serve around the globe and the "second life" and improved health we can give to those with Coronary Artery Disease, High Blood Pressure, and other conditions. We're also driven by the promise of Renal Denervation and its potential to change the way patients around the world manage their uncontrolled hypertension. 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...

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

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 Quality Engineer II and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and...

Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner. _ Your Contributions (include, but are not limited to) Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects Develops CMC regulatory strategies to ensure optimal product development...

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 within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. The Quality System Supervisor will have quality oversight of the manufacturing processes to...

The Quality Systems and Compliance (QSC) group provides compliance oversight for Development Sciences (DevSci)) in gRED. In addition, QSC is accountable for the implementation, realization and maintenance of Quality systems that support the Quality Management System (QMS) in DevSci, including business and quality process ownership of Change Control, Corrective / Preventive Actions (CAPAs), Deviations, Document management, Good Laboratory Practices (GLP) Archival, Records Management, Risk Management, Knowledge Management, Training Management and the Service Provider/Vendor oversight program. This position participates in and provides quality and compliance leadership in the design, establishment and maintenance of programs and processes that ensure quality products and...

The Quality Systems and Compliance (QSC) group provides compliance oversight for Development Sciences (DevSci)) in gRED. In addition, QSC is accountable for the implementation, realization and maintenance of Quality systems that support the Quality Management System (QMS) in DevSci, including business and quality process ownership of Change Control, Corrective / Preventive Actions (CAPAs), Deviations, Document management, Good Laboratory Practices (GLP) Archival, Records Management, Risk Management, Knowledge Management, Training Management and the Service Provider/Vendor oversight program. This position participates in and provides quality and compliance leadership in the design, establishment and maintenance of programs and processes that ensure quality products and...

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease...

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 is based...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at The Sr. Manager Proactive Compliance and Continuous improvement has responsibility for supporting the development and management of Small Molecule (SM) Platform sites compliance improvement...

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. In this exciting role as a Quality Technician III supporting the Cardiac Ablation Solutions organization, you will have responsibility for the inspection and testing of returned products as part of the complaint handling process. The Technician will be capable of supporting...

Senior Specialist Quality Assurance The position of Senior Specialist Quality Assurance is within our Infectious Disease Developed Markets business unit located in South Portland, ME . In this role you will be responsible for administrative and non-product software activities that support the efficient functioning of Quality Assurance and the Quality System. What You’ll Work On Responsible for reviewing and approving non-product software lifecycle deliverables. Participate in Quality System processes, which may include training, corrective action and preventive action (CAPA) activities, quality audits, and non-software product validation. Apply established software quality and engineering methods to the investigation and solution of...

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

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

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

The Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and AbbVie policy compliance for the manufacturing plant. Responsible for implementing and maintaining the effectiveness of the Quality System. Support the ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her...

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...

The Vice President, Compliance is a strategic leader responsible for designing, implementing, and continuously improving the company’s Corporate Compliance Program to oversee promotional materials, field training, and HCP/patient programs. As an objective advisor, the Vice President, Compliance ensures the organization operates with integrity and in compliance with all applicable laws, regulations, and internal policies. Reporting to the Chief Legal Officer, the Vice President, Compliance partners with executive leadership, the legal and compliance function, the Audit Committee of the Board of Directors, and employees at all levels to foster a culture of ethical conduct and accountability. Beam is transitioning to a...

About the Role This application is for a 6-month student role from July - December 2026. Resume review begins in January 2026. The Co-op, Bio Quality Assurance position at Biogen's Research Triangle Park (RTP) facility is a unique opportunity to immerse yourself in the world of Quality Assurance within a biopharmaceutical setting. Joining the Quality Assurance team, you will engage in key tactical and operational activities to ensure the highest standards of quality are upheld. Your main focus will be on Quality Risk Management and Inspection Readiness, where you will learn the intricacies of quality operations. Working from 800 am...

About the Role This application is for a 6-month student role from July - December 2026. Resume review begins in January 2026. As an intern, you will be an integral part of our Quality Assurance team. Working a standard 800 am to 430 pm shift from Monday to Friday, you will contribute to key tactical and operational activities that support our quality standards. Your primary focus will be on creating Power BI dashboards that enhance the visibility and efficiency of investigation and batch record workflows. By developing standard work plans and reporting on key metrics, you will play a pivotal...

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

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shift NIGHT shift available, Panama schedule ( 12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays) 6 pm to 6am Duties/Responsibilities Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations. Able to interpret problems and effectively prepare surrounding...

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Supply Chain Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shift NIGHT shift available, Panama schedule ( 12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays) 6pm to 6am Duties/Responsibilities Provide Quality on-the-floor oversight to Manufacturing/ QC/ Supply Chain Operations & responding to minor issues or escalating to senior members. Perform and document operational verification...

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

Purpose The Senior Specialist, Employee and Workplace Relations will support HR compliance related matters, to include the creation and management of employee separation agreements, affirmative action responsibilities, departmental analytics and other HR compliance-related matters that support our business needs. Key Responsibilities Responsible for the creation and management of separation agreements Support for affirmative action and related compliance activities and audits Support compliance-related initiatives to include restructurings and other projects as needed Liaison and vendor management with internal and external partners Identify opportunities and enhancements, conduct research and analysis, and consult across organizational levels in a timely, professional and accurate manner...

Purpose The Compliance Manager is responsible for the management and coordination of 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 participates in quality system management review. Oversees Global Product Surveillance CAPA program and is responsible for the site’s internal audits. Oversees internal, supplier and regulatory audits and preparation activities....

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...

SUMMARY The Specialist, Validation Engineer I supports the successful implementation of manufacturing, and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. T he incumbent is tasked with qualifying new equipment, facilities, utilities and maintaining equipment systems in a qualified / validated state a cco r ding t o established policies and pr o cedures. The i ndividual participates in proj e cts an d ongoing wor k activities of l ow to moderat e complexity. With minimum supervision and given general instructions, this individual carries out routine tasks and functions,...

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...

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 all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System,...

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...

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

Senior Specialist Quality Assurance What you will do In this vital role, you will serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Supplier Quality Management (SQM) activities, with primary responsibility for Inspection Readiness and QMS Assessment & Improvement (A&I) programs. You will drive quality excellence across Amgen’s global external network and play a central role in ensuring successful regulatory outcomes. Key responsibilities include Own and lead the SQM/GSQ inspection readiness processes , ensuring best-in-class inspection execution and outcomes across global and virtual sites. Provide strategic and tactical leadership for inspection and audit preparation, inspection and...

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...

Join AstraZeneca as a Lead Quality Advisor, Site Quality (Development Quality). At AstraZeneca, quality is how we deliver on our mission to transform patients’ lives. We’re seeking a Lead Quality Advisor to provide GMP leadership across our development value chain—from internal Drug Substance and Drug Product to Pack & Label and clinical trial supply. In this high‑influence role, you will Build and translate robust, risk‑based cGMP standards into practice across Development Provide QA oversight of manufacturing documentation, deviations, risk assessments, and SOPs Release internal Drug Substance, Drug Product, and IMP for clinical trials (DevQ release) Lead/host regulatory inspections and contribute...

SENIOR REGULATORY OPERATIONS SPECIALIST – (Lafayette, CO, or Mounds View, MN) Join a diverse team of innovators who bring their world view, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. The Senior Regulatory Operations Specialist position is part of the Acute Care & Monitoring (ACM) Regulatory Affairs Team supporting regulatory compliance processes. Primary responsibilities include leading process improvement and...

Use Your Power for Purpose The Senior Validation Specialist 1 will support a diverse variety of qualification activities for manufacturing processes and equipment within a biopharmaceutical manufacturing facility, including shipping validation, equipment qualification, steaming and depyrogenation qualification. What You Will Achieve This role will also provide technical support for continuous improvement projects, driving the projects to completion to support the ongoing activities within a manufacturing environment. As a Senior Validation Specialist 1, you will act as a subject matter expert / program owner within the team, ensuring that the program remains compliant with corporate, regulatory, and industry standards and regulations....

Quality Technician (Process Monitoring) I This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. This position provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions. Assists engineers in developing methods and procedures to control or improve manufacturing processes. What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Assists engineering in...

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide. The Senior Software Engineering Program Manager drives the evolution of Medtronic’s product development processes to set new industry-leading standards serving as a domain expert in Software Design Control. Lead our team by coaching internal customers across our diverse product portfolio, to elevate Software Design Control capabilities throughout the organization....

Associate, Quality Control Analytical, Cell Therapy Role Overview The Associate, QC Analytical, supports cGMP lot release and stability testing for cell therapy products by preparing samples and reagents, completing test methods, operating instruments per SOPs, and maintaining accurate documentation. The role focuses on learning and performing routine activities with high quality and data integrity, assisting with lab maintenance and inventory, and supporting QC operations to meet timelines. Role Responsibilities Routine analytical testing Complete assays under supervision (e.g., automated cell counting, viability, ELISA, PCR, flow cytometry, basic cell culture handling) following approved methods and cGMP/GDP expectations. Sample and reagent preparation Prepare...

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 Lexington, MA POSITION Senior Manager, Device Quality Engineering POSITION DESCRIPTION Takeda Development Center

Reporting to the Director, Material Compliance Operations- Material Review, the Associate Director of Global Material Review Compliance is accountable for implementation of processes, standards and compliance monitoring and supplemental medical compliance training supporting the scientific development and review of medical content of pharmaceutical promotional and non-promotional materials for marketed and investigational products/devices. This position plays a crucial role in ensuring presentations of medical, scientific information, and documentation meet various standards for pharmaceutical promotion and scientific exchange. This role is responsible for fostering positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups from Global Headquarters, Affiliates 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. This is an opportunity you don’t want to miss! Lilly is...

The Executive Director, Privacy Law and Compliance is responsible for leading the organization’s global privacy strategy, governance, and compliance programs under the NextGen Privacy Program framework in partnership with Business Insights and Technology (BI&T). This role sits in the newly formed AI, Data and Privacy Law and Compliance department and ensures adherence to international data protection laws and internal standards while enabling responsible data use across all business units. The position requires strategic vision, operational excellence, and strong leadership to manage privacy risks, foster a culture of compliance and trust, and drive technology-enabled solutions for scalability. Key Responsibilities Strategic Leadership...

The Senior Director, AI Governance, Law, and Compliance is responsible for defining, implementing, and leading the organization’s global AI governance strategy in partnership with Business Insights and Technology (BI&T). This role sits in the newly formed AI, Data and Privacy Law and Compliance department and ensures that AI technologies—including generative AI and high-risk systems—are developed and deployed in compliance with evolving international laws, ethical standards, and technical safeguards. The position drives enterprise-wide accountability for responsible AI, harmonizing regulatory requirements (EU AI Act, U.S. OMB M-24-10, OECD Principles, ISO/IEC 42001) and fostering innovation while minimizing legal, operational, and reputational risks. Key...

About This Role As a Senior Manager, Regulatory CMC Lead, you will provide regulatory CMC expertise to support assigned projects and products, contribute to global CMC regulatory strategy, and where appropriate, lead regulatory submissions and related strategic activities. You will be part of a dynamic team, collaborating closely with the CMC Global Regulatory Lead and key stakeholders to compile and prepare submissions/documentation for biologics projects. Your role will involve managing routine and non-routine regional Health Authority interactions, serving as the primary global contact for regulatory CMC activities. In late-stage development programs, you will be the contact for assigned regions, ensuring...

JOB SUMMARY Global Regulatory Sciences (GRS) serves as a strategic leader and catalyst, enabling high‑quality, efficient, and innovative, label‑focused global development that changes patient lives throughout the product lifecycle. This position reports to a Sr. Vice President, GRS. Member of the GRS Leadership Team and RU Leadership Teams Partners with other Global Regulatory Leaders and RU Heads to assure consistent professional and appropriate regulatory support and cross TA portfolio oversight Works with all relevant GRS contacts and other internal contacts Works with external contacts including Regulatory authorities (FDA, EU, MHLW, etc.), professional scientific and regulatory groups, trade associations, and consultants....

Executive Director, Global Regulatory Strategy, Policy and Intelligence Location Gaithersburg, MD (US) Overview AstraZeneca is seeking an Executive Director to lead enterprise regulatory strategy on intelligence and external policy across all therapeutic areas. This leader will accelerate patient access, enable innovative development pathways, and elevate regulatory excellence globally by advancing data-driven, AI-enabled regulatory intelligence, shaping emerging frameworks for novel modalities and evidence, and partnering across R&D to deliver differentiated outcomes for patients and the business. What you’ll do Leadership and Strategy Set a clear vision for Global Regulatory Strategy, Policy and Intelligence, leveraging digital, data, and AI...

The Clinical Quality Associate Director helps set strategic direction across R&D. They provide comprehensive Quality Management support services. They embed quality and compliance “Right From Me” and ensure ongoing proactive inspection readiness. The Associate Director, Clinical Quality is accountable for developing and delivering digital solutions that reduce manual quality efforts. They also maintain these solutions and deploy innovative tools to track inspection readiness and clinical quality across the organization. The role develops and enhances best practices for quality and compliance; contributes to vendor oversight to uphold quality agreements and performance across R&D; maintains strong internal and vendor networks to promote...

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...

Company AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. Our impact spans immunology, oncology, neuroscience, eye care, and the Allergan Aesthetics portfolio. Locations Irvine, CA; Lake County, IL; Ludwigshafen, Germany preferred Job Purpose The Quality Toxins Office (QTO) provides compliance strategy, design, implementation, and continuous improvement to support global toxin quality strategy across Therapeutics and Aesthetics. The QTO assures robust global compliance programs to assure quality oversight, controls, compliance, and defining quality standards across AbbVie’s toxin enterprise. The Associate Director, Quality Toxins Office...

Purpose The primary responsibility for the Validation Specialist I is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists Responsibilities Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility Executes...

Performs quality laboratory testing required for the manufacturing process, utilities, raw materials, in process samples and final product following specifications in both the microbiological and analytical laboratories. Performs microbiological and analytical testing such as bio burden, endotoxin, TOC, pH and conductivity to water samples used in the product manufacturing process and to the final product. Performs in process product testing such as bio burden, and endotoxin and analytical testing (HPLC, Gel Electrophoresis, DNA), among others. Performs other microbiological lab testing such as growth promotion and identification of microorganisms. Provides support in method transfer, equipment/instrument qualification and process validation. Understand Regulations...

Responsibilities In this role, an individual supports site manufacturing operations and quality by managing the approved supplier list including supplier qualification, performance, and maintenance. They help maintain and implement the company's Quality System, ensuring all activities and procedures align with company standards and regulatory requirements. The person also assists Incoming and Manufacturing QA in investigating plant events, performing product impact analyses, and managing product/material holds when needed. They collaborate effectively with other local and global QA and Technical departments, participate as the Supplier QA in Global Supplier Center of Excellence (CoE) meetings, and approve standard operating procedures and change management...

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

Purpose As a Senior Analyst on the Compliance HR Operations team, you will are operating globally within HR Shared Services. The position partners across the HR Operations landscape, works closely with cross-functional stakeholders enterprise-wide, and engages externally with auditors to help ensure consistent and timely execution of HR processes, data governance, and internal controls. This is a hands-on, execution-focused role with emphasis on HR and Payroll associated audits, compliance initiatives, internal controls, and operational improvements. This role will serve as a key contributor to this team. They will be a professional who brings a strong foundation in HR Compliance, Shared...

Purpose The Quality Control Planner is responsible for the oversight of QC Laboratory Planning and Scheduling within the Plant QC Group. Additional responsibilities may include short-term forecasting for enablement of efficient and effective laboratory scheduling, maintenance of laboratory planning and scheduling applications, evaluation and presentation of laboratory KPI's, and cross site harmonization of planning/scheduling processes. Responsibilities Maintains/manages laboratory planning/scheduling application, ensuring accurate configuration for laboratory workflows and timely prioritization of laboratory samples. Monitors, maintains, evaluates, and reports out laboratory KPI's. Collaborates with Laboratory Management to identify and implement process changes that enable continuous improvement. Participates in cross-site harmonization of laboratory...

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

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

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...

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

Manager, Rare Disease Compliance What you will do In this vital role you will will serve as a strategic partner to the Rare Disease Business Unit (RDBU), working closely with RDBU leadership to uphold Amgen’s reputation and advance ethical, patient-centric compliance solutions. As part of Amgen’s Worldwide Compliance & Business Ethics (WC&BE) organization, this role supports a strong culture of compliance, integrity, and ethical decision-making through data-driven insights and proactive engagement. Reporting to the Senior Director, Rare Disease Compliance, the Compliance Manager will leverage advanced analytical capabilities (including statistical analysis, data mining, and predictive modeling) to assess compliance, translate...

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...

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate...

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 Contract Compliance Analyst III will facilitate contract implementation and revenue pull-through activities, both proactive and reactive, with internal and external parties. This position will ensure the public and private payer reimbursement. The role is also fundamental in...

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 Lead Quality Assurance Engineer, Supplier Quality will provide supplier related QA technical and compliance support for commercial, clinical, and future products. This role ensures all suppliers and the materials provided are in compliance with product specifications and...

Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Senior Director, Regulatory Affairs-Biosurgery to be in Raritan, NJ with a minimum of 25% domestic and international travel! About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare...

Sr. Technician Quality Microbiology Our location in Lake County, IL, currently has an opportunity for a Senior Quality Technician. The role involves coordinating and performing Microbiology testing and Good Manufacturing Practices (GMP) to support efficient production testing. This position is essential for maintaining high-quality standards and supporting continuous improvement within the organization. What You’ll Work On Perform product testing including Bioburden, Sterility, and Enumeration testing. Ensure that Microbiology testing is scheduled for department according to production due dates. Manage electronic quality information management system and media growth promotion testing. Provide support during audits by providing data and represent the...

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...

We are presently hiring for a Regulatory Affairs Specialist to work on-site at our Santa Clara, CA location. This new team member performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry. What You’ll Work On Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Acts as core team member providing review and analysis of applicable regulatory...

AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board. Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture. The scope of compliance audits may include, but is not limited to, the following...

Responsible for quality of assigned New Product Introduction (NPI) 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 infusion pumps, enteral and sub-cutaneous tubing, pump carrying accessories, and other drug administration system accessories. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Develops the appropriate Regulatory, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs, marketing, Product Development and other cross-functional stakeholders....

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...

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...

About the role The Head of Regulatory Legal is responsible for developing and leading the global legal strategy supporting Global Quality (GSQ), Research & Development (R&D), Regulatory Affairs, and Plasma Derived Therapies (PDT) across the enterprise. This role provides high-level legal counsel on regulatory matters (FDA, EMA, and other global agencies), manufacturing, supply chain, and the product development lifecycle from research through clinical trials. As a trusted advisor to senior leadership, the Head of Regulatory Legal leads a team of legal professionals, ensures compliance with all relevant laws and regulations, mitigates legal and regulatory risks, and collaborates across business units....

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

About the Role This application is for a 6-month student role from July - December 2026. Resume review begins in January 2026. The Global Trade Compliance team’s mission is to enable Biogen’s purpose and commitment to patients, shareholders and communities by managing risks, creating values, driving excellence in execution and critical capabilities. We do this by ensuring that all our products (finished drugs, drug substances, clinical samples, etc.) move across multiple countries in compliance with international trade regulations and without delays. Global Trade Compliance also pays a key role across Biogen’s end to end business planning by completing due diligence...

We are hiring for a Regulatory Affairs Specialist to work on-site at our Santa Clara, CA location. As an individual contributor, this new team member will combine knowledge of scientific, regulatory and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. The individual may share knowledge and expertise with others in support of team activities as well as identify data needed, obtain this data and ensure that they are effectively presented for the registration of products worldwide. What You’ll Work On Prepares robust regulatory applications (either for FDA or for international...

We are presently hiring for a Regulatory Affairs Specialist II to work on-site at our Cardiac Rhythm Management (CRM) location in Sylmar, CA. This new team member performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry. What You’ll Work On Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Acts as core team member providing review...

Professional Quality - CAPA This position works out of our Abbott Park, IL. location in the Transfusion Medicine , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Professional Quality will conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes, which adds value to the business. This position is part of the Lake County Transfusion Medicine CAPA team. What You’ll Work...

Position Overview We are seeking a strategic leader to establish and lead our new Regulatory Intelligence organization. The Sr. Director, Head of Regulatory Intelligence will set the strategic direction for the team, oversee the integration of regulatory insights into organizational decision-making, and represent the organization at the highest levels. This role is pivotal in shaping our regulatory intelligence strategy, setting key initiatives, and delivering actionable insights on emerging regulatory guidance and health authority enforcement trends. Key Responsibilities Set strategic direction and priorities for the Regulatory Intelligence team to ensure alignment with organizational goals. Represent the organization at the executive level,...

Director, Global Customs & Trade Compliance Location New Brunswick, NJ We are seeking a Director of Global Customs & Trade Compliance to lead our customs strategy and ensure adherence to international trade regulations. This leadership position is responsible for driving global alignment, optimizing duty savings, and managing compliance across all our operations. You'll work closely with regional teams to develop and implement effective trade strategies that support our global supply chain. Responsibilities Strategic Leadership Influence and execute the strategic direction for global customs compliance. Process Optimization Partner with Regional Compliance Leads to standardize and optimize global trade activities, policies, and...

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

Are you a highly skilled professional, interested in Quality Excellence, driven by a passion for innovation and a desire to make a tangible impact? We have a thrilling opportunity for a Senior Quality Excellence Lead to join our Global Quality team. At Roche, our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. The Opportunity As a Senior Quality Excellence Lead, you will play a pivotal role in driving excellence, efficiency and effectiveness across our global quality landscape, from managing the...

At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. At For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world — and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a...

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 Senior Director, Patient Safety & Quality is the accountable affiliate...

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...

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

About the Role Takeda is seeking an experienced Associate Director, Head of IMP Quality to lead quality operations for investigational medicinal products (IMPs) from clinical development through to commercialization. This role provides strategic, industry-leading oversight of Takeda’s quality processes, ensuring compliance with global regulations, cGMP standards, and corporate policies. As the head of a highly skilled team, you will define quality standards, oversee audits, manage deviations, and lead process improvement initiatives. You will play a key role in supporting Takeda’s mission to deliver high-quality, safe, and effective therapies to patients worldwide. How You Will Contribute Provide strategic leadership and oversight...

This position works out of our corporate Abbott Park, Illinois location or other applicable Abbott location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbotts Manufacturing sites. Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring executive management is aware of compliance business risks and regulatory...

Job Title Sr. Process Quality Engineer This position works out of our St. Paul, MN (New Brighton) location in the Abbott Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. What You’ll Do Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Support the investigation, resolution and prevention of product and process...

Job Title Process Quality Engineer This position works out of our St. Paul, MN (New Brighton) location in the Abbott Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. What You’ll Do Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Support the investigation, resolution and prevention of product and process nonconformances...

This role is responsible for overseeing and improving upon established compliance and quality system processes associated with patient support programs (area of focus will be patient engagement & contact centers). This person should be familiar with quality management system processes (CAPA, Training, Audits, Metrics and Monitoring) as well as change management, process mapping and continuous improvement tools. This role will support the implementation of Patient Services Q&C Roadmap. This role is also responsible to maintain a culture of excellence to ensure a superior experience for partners and patients that will deliver desired outcomes and enable timely, informed decisions. RESPONSIBILITES Assist...

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. Organization Overview At Lilly, we serve an extraordinary purpose. We make...

About This Role As the Senior Director, Global Regulatory CMC - Drug-Device Combination Products, you will serve as the enterprise regulatory leader for our global device and combination product portfolio. Operating within the Product Delivery Solutions team, you will have end-to-end accountability for defining and executing CMC regulatory strategy across development, licensure, commercialization, and lifecycle management. Your role is crucial in shaping the long-term regulatory posture for device-enabled therapies, ensuring patient supply continuity, and influencing global regulatory policy. Reporting to the VP, Head of Product Delivery Solutions, you will be a core member of both the Product Delivery Solutions Leadership...

Career Category Regulatory Let’s do this! Let’s change the world! Amgen is seeking a Global Regulatory leader with expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. The Global Regulatory Leader (GRL) is a product facing role that leads the Global Regulatory Team in the Regulatory Affairs organization. The purpose of this role is To lead one or more Global Regulatory Teams within Amgen’s Global Regulatory Affairs department To develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of...

KEY RESPONSIBILITIES The Senior Director Quality Control is vital for the success of Clinical Biologics QC, providing strategic leadership and overseeing daily operations. Responsibilities include leading the cGMP QC team that manages the release testing and stability program supporting Gilead’s Clinical biologics drug substances and drug products. The role is accountable for refining clinical QC processes across Gilead’s biologics internal and external manufacturing and testing network, ensuring compliance with global cGMP and Gilead’s Quality Management System. This individual collaborates with cross-functional teams, fosters a culture of continuous improvement, and offers mentorship to the QC team for timely project completion and...

About the role This position supports the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. How you will contribute Lead the execution of CD/PQ/CV/PV/RV activities. Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts. Supervise and manage contractors or consultants as needed. Participate in change control review board. Track and trend...

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

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...

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, GCP Compliance in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to...

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

Job Title Manager, Design Quality Assurance This position works out of our St. Paul, MN (New Brighton) location in the Abbott Vascular division. The Design Quality Assurance Manager has the broad objective of assuring the quality of design from development through manufacture and distribution for assigned products of the division. The successful incumbent will assure product designs provide necessary safety, efficacy, regulatory compliance and customer satisfaction while balancing the need for speed to market for new innovations as well as cost effectiveness. The ability to appropriately identify, assess and mitigate risks in the design of products can result in...

We have an immediate opportunity for a Senior Analyst, Global Trade Compliance in our Chicago, IL Willis Tower or Abbott Park, IL location. As the Senior Analyst, you will Review products and provide guidance on Export Control Classification Number (ECCN) classifications. Responsible for conducting monitoring of transactions in certain countries that Abbott operates in to ensure compliance with trade controls. Responsible for trainings and ensuring compliance in the area of restricted party screening, in addition to conducting monitoring in the same area. Manage and coordinate the controlled technology plans globally. What You'll Work On - Responsible for ensuring compliance with...

Director, Payor Relations & Regulatory Affairs The Opportunity Acelis Connected Health’s (ACH) DME & IDTF businesses operate across all states in the US with several hundred payor plans to serve it’s 80,000+ patients on service. This Director, Payor Relations and Regulatory Affairs will be accountable to develop strategies and drive ongoing activities that maintain and expand payor coverage while ensuring ACH remains compliant standards required by The Joint Commission, state agencies, and CMS (Medicare/Medicaid). These activities include leading the development, implementation, and monitoring of processes related to commercial payor contracting, state licensing, and CMS enrollments. These processes span across all...

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

Staff Quality Engineer This position works out of our Plymouth, MN location in the EP 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 a Staff Quality Engineer , you'll have the chance to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing...

We are presently hiring for a Regulatory Affairs Specialist II to work on-site at our Pleasanton, CA location. This new team member performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry. What You’ll Work On Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Acts as core team member providing review and analysis of applicable regulatory...

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform 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. What You’ll Work On Preparation of regulatory submissions for Electrophysiology devices to achieve departmental and organizational objectives. Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities. Acts as...

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

Principal Objective of the Position Provide Quality oversight during Clinical Supply Operations drug product and packaging and labeling manufacturing activities, and other GMP support areas. Provide Quality on the floor in-Process support during manufacturing operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines. Performs QA manufacturing floor support activities within the Clinical Supply Operations areas to ensure compliance with all principle of current Good Manufacturing Practices (cGMP). Support material and component release for clinical drug product manufacturing. Key Responsibilities and Major Duties Performs QA Manufacturing Support Program activities and upholds the program’s principles and initiatives....