Quality & Regulatory Jobs in Pharma & Biotech

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. Job Summary The Engineer – Facility, Utilities, HVAC, and Equipment (FUME)...

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

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

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

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and...

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

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 Service and Repair Sr. Quality Engineer role to be located at Danvers, MA. Due to significant growth, Abiomed is working to develop and enhance Commercial and Service and Repair (S&R) capabilities globally, including Quality support to these functions. The incumbent will be responsible for supporting multiple workstreams in support of this development activity,...

The Senior Manager, Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. The Senior Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. This role is responsible for primary QA oversight of commercial drug product manufacturing performed at Vertex’s external vendors. The role also provides supporting oversight for commercial drug substance operations. This position ensures robust sterile manufacturing controls, commercial supply continuity, support for global jurisdictional expansion, and high‑level combination product quality alignment. Key Duties and Responsibilities Collaborate with internal...

That’s what makes us Roche. This role is based in Business Strategy & Operations (BSO) which serves as the strategic backbone and operational enabler for Product Development Data Sciences (PDD). The function ensures organizational excellence through robust quality frameworks, optimized resourcing, and aligned strategic execution. BSO brings together cross-functional capabilities across quality and compliance, workforce planning, and strategic operations to empower leaders and teams to deliver with focus, transparency, and accountability. By connecting enterprise priorities with operational realities, BSO drives consistency, clarity, and coordinated progress across PDD and the broader development organization. The Quality & Compliance Lead within Business...

Regulatory, Data Steward & Team Lead (Sr. Manager) Vault RIM process and system is highly dependent on accurate & complete metadata at all levels and there is also an increasing amount of data that Health Authorities are requiring to be tracked and submitted. Master data is crucial for regulatory & Pfizer because it ensures the accuracy, consistency, and reliability of data used in regulatory submissions and compliance processes. Accurate master data directly impacts the quality, safety, and efficacy of products, and any inconsistencies can lead to delayed approvals, product recalls, and regulatory penalties. The Regulatory Data Steward is accountable for...

Vault RIM process and system is highly dependent on accurate & complete metadata at all levels and there is also an increasing amount of data that Health Authorities are requiring to be tracked and submitted. Master data is crucial for regulatory & Pfizer because it ensures the accuracy, consistency, and reliability of data used in regulatory submissions and compliance processes. Accurate master data directly impacts the quality, safety, and efficacy of products, and any inconsistencies can lead to delayed approvals, product recalls, and regulatory penalties. The Regulatory Data Steward is accountable for the creation and maintenance of V-RIM Master Data...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. The Senior Manager, US Ethics & Compliance Advisor, HIV Treatment is a hybrid/office based role located in Foster City, CA. The US Ethics and Compliance Advisor acts as a business partner providing actionable compliance guidance to the US Commercial HIV Treatment business unit and reporting to the US Ethics and Compliance Lead for HIV. Essential Duties and Job Functions Support the execution of the US Healthcare Compliance Program consistent with industry standards. Work with the Senior Director advising HIV Treatment...

As a Quality Inspector II at our Billerica site, you will be essential in making sure our cutting-edge cardiac ablation devices meet the highest quality and safety standards. You will meticulously examine components and assemblies, ensuring they meet precise specifications and function correctly. Leveraging your expertise and the appropriate tools, you will assess whether products conform to our stringent quality criteria or require modifications. By adhering to established protocols and instructions, you'll contribute to operational efficiency and guarantee the safety and reliability of our products for patients. Your sharp attention to detail and unwavering dedication to quality will reinforce our...

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...

This position works out of our Plymouth, 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 vision and FDA/ISO regulations; assures the overall quality of...

Sr Quality Compliance Specialist We are seeking a detail-oriented and proactive Sr. Quality Compliance Specialist to join our Compliance team. This role is critical in maintaining a state of continuous inspection readiness and ensuring compliance with applicable regulatory requirements, including ISO 13485 and MDSAP. The Compliance Specialist will lead and support internal and external audits readiness activities, manage audit-related documentation, and drive quality system improvements. 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 Maintain and continuously improve the inspection...

Careers that Change Lives We anticipate the application window for this opening will close on - 9 December 2025 Careers that Change Lives In this exciting role as a Manufacturing Quality Engineer II, you will be a part of the Americas Service & Repair team with a focus on spare part/accessory manufacturing and some device manufacturing. Service of medical devices is crucial to ensuring their safe and effective operation, which ultimately allows healthcare professionals to deliver reliable and high-quality care to their patients. You will be an integral part of the team that supports the company’s quality policy to Put...

As a CAPA Quality Systems Specialist , you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters. As a CAPA Quality Systems Specialist, you will Lead and support Quality System processes , such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control. Serve as a subject matter expert (SME) for one or more Quality System elements in compliance with FDA...

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

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

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

Onsite- 100% 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 onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Supplier Quality Engineer II , you will be responsible for ensuring the quality and compliance of materials we procure at our Medtronic Tempe Campus (MTC) . This specific role will support the procurement of electronic components,...

Onsite- 100% 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 onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Senior Supplier Quality Engineer, you will be responsible for ensuring the quality and compliance of materials we procure at our Medtronic Tempe Campus (MTC) . This specific role will support the procurement of electronic components, indirect...

· Strategic Leadership & Vision Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations. Champion regulatory innovation and novel approaches to accelerate development and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices. · Global Regulatory Excellence Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with evolving health authority requirements and internal governance. · Enterprise Collaboration & Influence Cultivate strong, collaborative relationships across Gilead’s global...

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. Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing...

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...

About Vision 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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime....

About the role Join us as our Global Regulatory Intelligence Lead and play a pivotal role in the governance, quality oversight, and optimization of Takeda's global processes for Regulatory Intelligence. You will ensure alignment with regulatory expectations and industry best practices, fostering strategic partnerships to enable effective implementation and scalability of these processes. We are seeking an experienced visionary leader to shape and execute our Regulatory Intelligence Roadmap , driving innovation and operational excellence across global regulatory functions. How You Will Contribute Reporting to the Head of Market Surveillance, you will Drive compliance, operational sustainability, and continuous improvement across Takeda’s...

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

Employer Shockwave Medical, Inc. Senior Quality Engineer Job Code A011.10370 Job Location Santa Clara, CA Job Type Full-Time Rate of Pay $126,000 - $138,000/year Job Duties Support manufacturing and work cross-functionally to resolve technical problems. Participate in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Support and provide solutions to broad problems, accomplish assignments of various complexity, develop protocols for design and/or process activities (including those related to verifications or validations), determine criteria, and subsequently generate summary (or final) reports. Process, investigate, and complete customer complaints. Requirements Employer will...

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

POSITION SUMMARY Robotics and Digital Surgery, a division of Johnson & Johnson Medtech Surgery Group, seeks a Head of Quality and Compliance for the Monarch platform. The role oversees Design & Development, Manufacturing/Operations, Quality & Compliance, and Post Market Surveillance, reporting to the Global VP of Q&C Robotics and Digital Surgery at the Santa Clara campus in California. This role is responsible for overseeing Quality and Compliance, with a focus on product design, manufacturability, and reliability throughout Product Development, Operations, Distribution, and Commercial processes. The position involves collaboration with teams including quality associates, engineers, and managers, who carry out product...

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...

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...

Purpose The Quality Associate supports the Quality Function that they are responsible for within Operations. This could include Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency. Responsibilities Responsible for various aspects of quality assurance and quality control related to their functional area. Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements. Support troubleshooting and resolution of...

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do...

Quality Control Supervisor 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 Quality Control Supervisor is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will perform work required to ensure Company product quality is maintained at standards set forth by Company Quality System and mandated by regulatory agencies such as the FDA, ISO, and USDA. The focus areas for...

Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional digital transformation initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes. dCMC intends to deliver Increased productivity and speed to clinic/market Accelerated timelines for site, filing, and launch readiness Improved access to product and process data Streamlined transfer of process and product knowledge with reduced error rates A key enabler of these outcomes is implementation of digital solutions that will install the foundational capabilities needed to realize dCMC’s vision of frictionless flow of data from development to commercialization...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Manager, Shop Floor Quality Assurance, Cell Therapy ,...

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

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 An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. J&J Innovative Medicine is recruiting for a Sr. Project Manager - Innovative Medicine Quality & Compliance, t his is a duration based role of 18 months, reporting...

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 professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. In this exciting role as a Senior Supplier Quality Engineer you will have responsibility for management of suppliers within the Plymouth, MN SQE team. You will be accountable for changes to existing supplied products and processes, as well as oversight of performance and improvement activities. You will also lead the oversight of supplied products, ensuring conformance to purchased materials or finished...

The Regulatory Compliance Senior Analyst supports Illumina’s global compliance framework through the execution and continuous improvement of compliance auditing and monitoring activities. This role ensures that Illumina’s operations, quality systems, and regulatory programs meet applicable global requirements and uphold the company’s high standards of ethical and compliant conduct. The position focuses on performing compliance reviews, supporting audit preparation and execution, maintaining documentation, and tracking corrective actions. Operating in a highly matrixed, global environment, the incumbent partners with Legal, Compliance, Quality, Regulatory Affairs, and other business functions to monitor adherence to regulatory requirements and contribute to inspection readiness. *This is a...

Regulatory Affairs Associate - One PDR The Position This is a temporary, 2-year contract position. Embark on a transformative two-year journey with the One Product Development Regulatory (PDR) Early Talent (ET) Program, meticulously crafted to impart comprehensive foundational knowledge in regulatory affairs. This dynamic initiative blends hands-on assignments with tailored learning solutions, making it an ideal entry-point for aspiring regulatory professionals. Participants gain invaluable insights into the complete lifecycle of pharmaceutical products, from initial clinical trials to market exit, by engaging in diverse activities across various therapeutic areas and stages of development. The latter part of the program offers the...

Johnson & Johnson is currently recruiting for a Staff Quality Engineer! This position will be located in Cincinnati, Ohio. This position will support New Product Development or Lifecycle Engineering within the Energy Quality organization, based in Cincinnati, OH This position will support the Energy franchise that may include Harmonic, Advanced Bipolar, Capital and Megadyne. Defines, leads and implements state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations. Influences the company's business, tactical directions, and financial results through a sharing of technical expertise. Performs complex design analysis...

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

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

Envision working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie’s Co-Ops. The Quality Assurance Validation department is responsible for plant validation including validated system (Equipment/Process), risk/design and change control compliance. Our team ensures alignment with Global Quality Systems for validation and related functions, e.g. engineering, risk management. Key Responsibilities Include The Validation Engineering position will support the planning and execution of tasks reporting into the QA Validation department. This role will support various areas of manufacturing and/or Quality Control (QC)...

Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Join us for a career in IT that changes lives. Careers that Change Lives A Day in the Life POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY...

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

About the role As Director, Global Quality Systems (DMS & LMS), you will serve as the enterprise Business System Owner for Takeda’s Document Management System (DMS) and Learning Management System (LMS). You you will drive the design, implementation, and deployment of the DMS & LMS electronic systems. You will be expected to navigate highly complex, cross-functional challenges—balancing compliance, business needs, and technological innovation—while remaining sufficiently hands-on to understand system configurations, investigate issues, and support end users when needed. As the business owner of these critical quality systems, you will play an essential part in advancing Takeda’s digital quality landscape. Takeda...

About the role Takeda’s Los Angeles Quality Control team is seeking a QC Specialist III who will serve as the primary LIMS subject matter expert (SME) for the site. In this role, you will design, configure, and optimize LIMS and related digital solutions—driving compliant, paperless, and highly efficient QC laboratory operations. You will lead end-to-end implementation of system changes and support complex QC projects, leveraging deep LabWare expertise, data analytics, and digital tools to enhance data integrity and operational excellence. This role is ideal for someone passionate about digital transformation in the lab environment, with strong hands-on LIMS experience and...

Step into a pivotal role where you’ll be at the heart of our advanced manufacturing environment, safeguarding both product quality and patient safety. As a leader in the Environment and Microbial disciplines, you’ll ensure our operations not only meet—but exceed—regulatory standards. You’ll have the opportunity to perform specialized microbial testing and orchestrate the dynamic activities of the microbial laboratory. This is your chance to make a direct impact, driving excellence and innovation across our manufacturing processes, while collaborating with a passionate team dedicated to improving lives. Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting...

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. Our diagnostics division is looking for a Senior Quality Operations II at our North Chicago/Abbott Park site. This is an individual contributor role requiring comprehensive knowledge in the specific area. The position involves executing highly complex or specialized projects, adapting precedent, and making significant departures from traditional approaches to develop solutions. The role also includes conducting complex and critical...

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

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Associate Director of Validation is responsible for leading the validation function to ensure that manufacturing facilities, utilities, equipment, processes, and computerized systems comply with regulatory and company standards for pharmaceutical/radiopharmaceutical production. This role oversees validation activities from...

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

Associate Quality Control What you will do Let’s do this! Let’s change the world! The Associate Quality Control will provide analytical testing support for the Quality Control Microbiology laboratory at Amgen, Thousand Oaks. The QC Microbiology lab supports testing from the beginning to the end of a product’s lifecycle, from Process Development to final Drug Product. Some of the tests that the Associate may perform on a routine basis include Total Aerobic Count, Sterility, Biological Indicators, and Polymerase Chain Reaction, among other tests. Responsibilities include Execution of QC Microbiology assays following assigned procedures Analysis of analytical test results and reporting...

This opportunity is an exciting and challenging role that will be key to Gilead's success as we work towards bringing new combination products, such as pre-filled syringes and autoinjectors, to market. As a Sr Quality Engineer I , you will be a key Quality person who ensures compliant processes are in place to support the successful implementation and execution of Gilead’s combination product lifecycle management. Key Responsibilities Develop key relationships and interface extensively with internal stakeholders to address and resolve quality and compliance issues related to drug-device combination products. Identify gaps in existing processes and lead cross-functional teams to develop...

About Vision 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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime....

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

About the Role As Head of Global Quality Device Compliance for the US and Rest of World region, you will provide strategic direction and oversight for GxP medical devices, including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements are established, effective, and maintained in compliance with all applicable regulatory requirements. This role partners closely with regional Device Compliance leads and cross-functional stakeholders to drive alignment and uphold Takeda’s global device quality standards. You will play a key role in enabling innovation while protecting patient safety across the product lifecycle. How...

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

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

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

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

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

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 QA Specialist- Quality Assurance Validation & Tech Support – Facilities & Utilities Focus What you will...

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products. Position Responsibilities Potency test raw materials, experimental samples, in-process lot material, and final product animal vaccines by ELISA, fill volume, or other methodologies for USDA release and subsequent sale in accordance with regulatory and internal requirements. Assist testing investigations, Change management, periodic reviews, MPS tools implementation Assist the...

Facilities Compliance Specialist 1 - US1 The Facilities Compliance Specialist works within the Facilities Compliance team and is supported with leveling up our quality maturity within the AMR facilities organization with primary focus in San Diego. Provide Compliance support for assigned Facilities Operations, Validation, and Engineering in the AMR region. Provide direct support and guidance for all Facilities compliance activities conducted within Manufacturing and related Operations. Support in process improvement and global/regional alignment Facilities compliance projects. Responsibilities Demonstrate strong competency and expertise in Facilities-related Compliance requirements and a proven ability to provide value-added support to fulfill business objectives Support...

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. Eli Lilly RTP is a new state of the art Parenteral,...

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 This position will be part of the Regulatory Legal...

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...

MAIN PURPOSE OF THE ROLE Provide Process/Quality Engineering and Quality Systems support to distribution activities, helping to ensure delivery of highest quality product to the customer. MAIN RESPONSIBILITIES Support QMS Implementation and maintenance of applicable distribution sites. Activities include documentation updates, new releases of documents, QMS reviews for audit preparation, participation in internal and external agency audits Reduces and controls distribution process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. Execute qualification/validation activities to support distribution projects and internal process implementation driven by the business units....

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

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

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

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

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...

A Senior Laboratory Technician, Quality Control/Senior QC Lab Tech is responsible for performing advanced laboratory procedures independently for the testing of veterinary biologicals according to strict government and company-imposed guidelines. Technicians may work with a variety of technical equipment while completing Quality Testing. At all times technicians must follow Good Manufacturing Practices and Standard Operating Procedures (SOPs) and adhere to all safety and company policies, perform duties assigned by department management. A Senior QC Lab Tech must possess thorough knowledge of the underlying principles used in testing procedures and understand the material being evaluated, i.e. virus, bacteria, cell line, etc....

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 Night Shift Sr. Manager, Quality Assurance, will support the...

Key Responsibilities Contributes directly to the completion of projects through the development of validation schedules, project plans, master plans, validation protocols and reports for systems that may be complex in nature to support clinical and commercial manufacturing. Works independently to resolve moderately complex to complex validation issues with very limited direct supervision. Conducts and serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations related to distribution and validation activities. Provides technical assessment and approval for engineering and process changes. Forecast external support requirements for continuous validation support, including implementation of new projects. Coordinates the activities of...

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. 2026 Quality & Compliance Intern- Patient Service (Pharm D) reports to the Associate Director of Quality & Compliance for US Patient Services. This role is responsible for assisting in the development of quality and compliance strategies, methodologies, and roadmaps to enhance process improvements. The objective is to ensure a superior experience for both internal and external stakeholders involved in patient services across all brands. Key responsibilities...

As an RDQA GQC Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical industry. You will support the RDQA GQC organization, working collaboratively and strategically with colleagues across R&D. The role of RDQA is to ensure the highest standards of quality and compliance in all we do. We are committed to safeguarding patient safety and upholding ethical conduct, serving as a cornerstone for trust and integrity. By continuously improving, and collaborating with partners, we promote a quality-focused culture that supports innovation...

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 Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. This individual will support the Eyecare Therapeutic Area. Additional Responsibilities Include Prepares device regulatory product strategies....

As a QA & Compliance Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical and medical device industry. You will support the R&D Quality Assurance & Compliance team, which develops, implements, and continually improves the AbbVie Quality System in R&D. The team ensures that clinical research and operations consistently meet regulatory requirements, internal standards, and ethical guidelines, thereby protecting patient safety, upholding data integrity, and supporting the reliable development and approval of products. Key Responsibilities Independently review complex clinical trial and...

The Sr. Director, Clinical Quality Assurance will act as a leader in the Quality organization and will be responsible for the quality oversight for Beam’s clinical trials and overall GCP (Good Clinical Practice). The position will be critical to the overall strategy and growth of the Quality organization for Beam as the company grows and evolves from Development to a Commercial organization in preparation for licensure. Reporting to the VP, Compliance, the position will be a key liaison with the Clinical Operations team, Clinical Development, Medical and Safety teams, programs teams, regulatory, and others back to the Quality organization. The...

In this cross-functional quality role, you will actively participate in design control activities, including research and diagnostic applications. You will ensure product and process conformance to applicable safety and quality system regulations and standards (e.g. FDA (820), ISO 13485, ISO 14971, IVDR). You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure the company's products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional project teams. Position Responsibilities - Provide Quality oversight to ensure Illumina’s products...

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...

Principal Supplier Quality Engineer Join us at Medtronic’s Boulder, Colorado facility - a dynamic hub for surgical innovations within our Medical Surgical portfolio. As a Principal Supplier Quality Engineer, you’ll play a pivotal role in advancing Medtronic’s mission to alleviate pain, restore health, and extend life for patients around the world. If you’re driven by challenge, energized by innovation, and passionate about making a real difference, this is your opportunity to be part of the next generation of life-changing medical technology. At Medtronic Boulder, your work will help shape the future of healthcare and positively impact patients’ lives every...

Gilead Sciences PDM External Quality is currently seeking a leader at the Associate Director/Director level to lead a team of Quality Professionals to drive strategy development and implementation of standardized communication, training and rollout of Gilead’s Quality standards, requirements, systems and tools to the Gilead’s contract organization global network. The successful candidate must possess expertise in leading cross-functional business and quality process mapping, identifying improvements to existing business and quality processes and leading Operational Excellence (OpEx) initiatives that span multiple PDM External Quality teams. Being able to utilize the tools & training associated with business process management in a strategic...

Associate Director, Regulatory Submissions Archive Operations Location Rahway, NJ (Hybrid role - onsite 3 days per week required) Functional Area Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) The Associate Director of Regulatory Submissions Archive Operations serves as the Business System Owner (BSO) for the Veeva RIM Submissions Archive and is also responsible for managing the physical paper archives for GRACS. This dual role ensures seamless integration and governance of both digital and physical regulatory records, supporting audits, inspections, litigation, and business transactions. Specific responsibilities of this position include Digital Archive Ownership (Veeva RIM...

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

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

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...

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 Quality Engineer is within our Cardiometabolic unit located at San Diego, CA. Responsibilities Analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. Apply quality principles, analyzes quality records, prepares reports and recommends improvements. Conduct inspection, verification and validation of components or materials used in...

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

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

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

POSITION OVERVIEW You will typically act as the Regional Regulatory Lead on the assigned products, compounds, indications or projects in Virology. With guidance, you will define the regulatory strategy, plans and objectives for the assigned products or projects. You will typically lead the Regulatory Submissions Teams associated with assigned products or projects and represent Global TA Regulatory to cross-functional sub-teams. You may serve as a Gilead contact to / for regulatory authorities. You will oversee and manage the work of less experienced colleagues supporting your work. You will coach and advise less experienced colleagues in completing their work and developing...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Director, Quality Control to be located in Gurabo, PR. The Director of Quality Control is a key member of the site leadership team, responsible for leading all aspects of all...

In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. To lead GRTs within Amgen’s GRAAS organization To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions To provide Regulatory leadership to cross-functional teams for high complexity...

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

Summary In this cross functional quality role, you will actively participate in design control activities, including research and diagnostic applications. You will ensure product and process conformance to applicable safety and quality system regulations and standards (e.g. FDA (820), ISO 13485, ISO 14971, IVDR). You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure the company's products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional project teams. Key Responsibilities - Provides Quality oversight to ensure...

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and...

We are seeking a highly skilled Risk Management Expert with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety, regulatory compliance, and effective risk mitigation throughout the product lifecycle. Develop and maintain comprehensive strategies for risk management activities, including Creating and managing risk management plans and reports, as well as conducting regular risk reviews. Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures. Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential...

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and...

About Vision 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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime....

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 professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products. Position Responsibilities Potency test raw materials, experimental samples, in-process lot material, and final product animal vaccines by bacterial titrations, bacterial proof of inactivation or bacterial identification or other methodologies for USDA release and subsequent sale in accordance with regulatory and internal requirements. Assist testing investigations Assist the area...

Quality Professional The Specialist Quality Assurance within Abbott Diagnostics Division will analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. What You’ll Work On Design/Change Control - Responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity. Risk Management – Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc. Design Verification/Validation – Understands and applies basic Design Verification/Validation methods...

Director, Technology-Global Regulatory Operations What you will do In this vital role you will lead the end-to-end digital strategy, delivery, and operational excellence of Global Regulatory Affairs and Safety (GRAAS) systems. This role will provide strategic oversight of the capabilities provided by platforms such as Veeva Vault RIM, Lorenz DocuBridge, and TrialScope, while driving transformational initiatives that improve regulatory operations, data quality, and compliance across all regions and product lifecycles. The successful candidate will operate at the intersection of technology, compliance, and business process—partnering with senior regulatory leaders, technology partners and external vendors to ensure global systems deliver business...

ABOUT THE ROLE The Associate Director, GCP Audit & Compliance provides strategic quality oversight to clinical, medical, and pharmacovigilance suppliers across Takeda’s global network. You will lead the risk-based supplier audit program, drive compliance insights, and partner closely with stakeholders to ensure adherence to GCP, GCLP, and GVP standards. This role combines audit leadership, supplier oversight, and strategic risk management to enhance end-to-end clinical quality. HOW YOU CONTRIBUTE Lead strategic quality oversight activities for clinical, laboratory, medical, and PV suppliers. Develop, execute, and continuously improve the global risk-based supplier audit program. Conduct supplier audits end-to-end, including planning, execution, reporting, and...

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

Purpose This position leads and maintains compliant Documentation Quality Systems (QS) according to AbbVie policies, procedures, and applicable government regulations by managing the documentation review board to process and update complaint plant procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation. It also provides leadership to a team for the creation and/or update of material codes in the SAP inventory system and the electronic batch record recipes in POMs system. The Quality Systems and Third-Party Contractor (TPC) role also is the main QA point of contact with TPC to manage regulatory compliance and business continuity requests in a...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Senior Validation Engineer will lead validation efforts to support the Radiopharmaceutical facility and GMP operations in Indianapolis. This role is responsible for the development, execution, and management of commissioning, qualification, and validation (CQV) documents and protocols for...

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

Careers That Change Lives In this exciting role as a Senior Quality Systems Manager, you will have responsibility for QMS Data Analytics, Data Reporting and managing multiple Digital based improvement initiatives within the Quality Transformation organization that will systematically evaluate and transform the capability of the Quality Management System (QMS) to better meet the needs of its stakeholders, both internal and external. Quality Data steward, supporting Data analysis and reporting methodologies Leading a team of Data analysts to support specific analysis where needed to perform advanced data analysis, dashboarding, and reporting in support of quality improvement goals ...

Vertex is seeking an experienced Regulatory Affairs Advertising & Promotion Director to provide strategic and tactical regulatory direction for the review and approval of product, pipeline, and disease state communications for its pain assets in the US. This role is critical in ensuring that all promotional and nonpromotional communications meet regulatory requirements and support Vertex’s business objectives. The Director will collaborate cross-functionally to develop viable communications and implement processes that drive compliance and business success. Key Duties and Responsibilities Serve as a regulatory expert on US statute, regulations, and relevant guidance governing product promotion and related communications, including pipeline and...

The CQAD is the first point of contact on quality and compliance matters for the Oncology Site Management and Monitoring (SMM) function. They are responsible for developing, tracking and analyzing quality metrics at country level. They provide direction and advice on how to apply GCP principles to SMM Oncology personnel so that their work can be conducted while meeting high quality standards. The CQAD utilizes regulatory guidance, globais standards and SOPs to provide compliance advice to SMM Oncology. When appropriate, the CQAD recommends and communicates improvement opportunities to the Business Process & System Owners (BPOs). CQADs supports SMM Oncology management...

About the Role You will provide guidance in validation strategy to the site and global projects. You will have engineering validation signatory responsibility for approval of cleaning cycle development and cleaning validation protocols and final report documents. You will assess and validate cleaning processes. Primary tasks include development of protocols, coordination of validation activities, execution, preparing final reports and assembly of final validation packages; generation of project plans. Responsibilities will consist of both initial validation efforts and revalidation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final documents are archived and may be included...