Quality & Regulatory Jobs in Pharma & Biotech

Join the engine of Sanofi's mission — where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. As a Senior Manager within our Global specialized Regulatory Science expert unit, you'll play a crucial role in developing innovative regulatory strategies that accelerate drug development through Model-Informed Drug Development (MIDD), Real World Evidence, and novel endpoint approaches. Working directly under Global Head, Regulatory Science — Model-Enabled Development, Real World Evidence & Novel Endpoints, you'll be responsible for hands-on project delivery, regulatory strategy submission, and direct engagement with health authorities on technical...

We are searching for the best talent for Senior Manager, Quality Assurance to join our DePuy Synthes Quality organization located in Palm Beach Gardens, FL. Responsible for the overall management and effectiveness of the key Site Quality Management Systems (Training, CAPA and NR) and risk management processes. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals. Key Responsibilities Implements the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes. Alerts the organization to issues in time to...

We are searching for the best talent for Manager, Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, Florida. The Manager, Quality Engineer is responsible for the overall management and effectiveness of Quality and Compliance execution of NPD Integrations into the Manufacturing environment, QA continuous improvement projects and risk management processes. Key Responsibilities Implements the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes. Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business. Leads...

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

Leads the Branchburg Quality Control Laboratories and serves as integral member of the Quality leadership team. The role is accountable for ensuring compliance with all applicable regulatory and compliance requirements and must ensure the site is anticipating and building capabilities in-line with regulatory expectations and trends. Provides strategic, scientific, and operational leadership for all QC testing activities supporting the commercial manufacturing of tissue products. This role oversees laboratory functions, personnel and budget management, method validation and transfer, regulatory compliance, and continuous improvement initiatives. The Senior Manager will partner cross-functionally to maintain reliable product quality and throughput. Responsibilities Lead a team...

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...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. 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, Global Regulatory Project Management and Strategic Planning - GI² TAU within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory Lead (GRL) on Global...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC...

In this exciting role as a Principal Supplier Quality Engineer in Cardiac Surgery (CS), you will develop supplier quality strategies and lead supplier control activities for new product development programs based in Brooklyn Park, MN and Dexter, MI. Cardiac Surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this operating unit provides an intimate relationship with the Cardiac Surgeon and Cardiac Operating Room by offering an unparalleled depth and breadth of portfolio. Key Technologies Surgical heart valves Cardiac OR solutions (e.g., blood management, cannulae) Extracorporeal life support Coronary artery bypass grafting...

As the Regulatory Affairs Manager, you will be responsible for establishing strategy for worldwide product approval submission activities, directly responsible for execution of submission activities focused on US/EU and for ensuring regulatory compliance for Acute Care and Monitoring products. The Regulatory Affairs manager is expected to accomplish results through hands on and delegation of responsibility to individual contributors. This role will require collaboration with business partners to develop regulatory strategies to support the business goals and translate the strategies into work plans for the Regulatory Affairs teams to implement the newly created ACM OU is committed to excellence in innovation...

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...

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

Validation Technician - Nutrition Manufacturing - Casa Grande, AZ We are seeking a detail‑oriented Validation Technician to support validation and change control activities across equipment, systems, utilities, and processes in a regulated manufacturing environment. This role ensures that all systems meet defined requirements, comply with cGMP standards, and maintain audit‑ready documentation. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on...

Senior Quality Engineer In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We have an opening for a Sr. Quality Engineer at our Minnetonka, MN site within our Electrophysiology division. This position will provide Process/Quality Engineering support to manufacturing for commercially released product, helping to ensure delivery of highest quality product to the customer. What You’ll Work On Reduces and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary...

About This Role As a Senior Associate III in Inspection Management within our Quality Assurance team, you play a pivotal role in maintaining and enhancing quality systems at the RTP facility. Your expertise in GMP activities ensures that our quality systems remain compliant with industry standards. You will lead the charge in managing site inspections, regulatory requests, and overseeing the creation and approval of GMP documents. Your ability to balance departmental workload, mentor team members, and manage key projects will significantly contribute to our team's success. This position not only ensures compliance but also drives continuous improvement, reinforcing our commitment...

ETHICON, Inc., a member of Johnson & Johnson's Family of Companies and located in Cornelia, Georgia, is recruiting current college students for their Engineering Co-op Program. This position is designed for current college students. The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars, energy devices and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy...

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

Ethicon Endo-Surgery is recruiting for a Senior Supplier Quality Engineer (Indirect Materials) , located in either Cincinnati, OH, Juarez, Mexico or Guaynabo, PR. Remote work options may be considered on a case-by-case basis and if approved by the company. 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 of Supplier Quality Engineer is responsible for support and leadership of Quality Engineering activities in New Product Development and ongoing manufacturing...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. The Global Head, Regulatory Science — Model-Enabled Development, Real World Evidence & Novel Endpoints serves as a specialized center of excellence within Sanofi's Regulatory framework, driving innovation in regulatory science through advanced model-informed approaches, real world evidence and novel endpoint development. We accelerate drug development timelines by providing expert guidance on Model-Enabled Drug Development frameworks, regulatory validation of new endpoints, real-world evidence data and cutting-edge regulatory strategies across therapeutic areas. We bridge...

We are seeking a Senior Manager, Full Stack engineer, to serve as a technical leader in an AI first, agile product environment supporting Global Regulatory Sciences (GRS) technologies. This role is accountable for the end-to-end build and run of AI-native technology assets supporting Global Regulatory Sciences, ensuring solutions are reliable, accessible, secure, compliant, and cost-effective. The Senior Manager designs, builds, and operates AI native products where large language models, agentic workflows, and data-driven intelligence are the default paradigm—not an addon. The role blends hands-on full-stack engineering, AI product thinking, and operational ownership, with responsibility for both delivery and long-term‑ sustainability...

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...

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 together. ...

The New Product Introduction (NPI) Engineer – Equipment Validation is responsible for supporting and executing equipment validation activities to support the successful introduction of new products into manufacturing. This role ensures that production and test equipment are properly specified, installed, qualified, and validated in compliance with internal procedures, quality system requirements, and applicable regulatory standards. The NPI Engineer partners cross-functionally with R&D, Manufacturing, Quality, and Suppliers to drive robust validation strategies, mitigate risk, and ensure equipment readiness for launch, scale-up, and sustained production. Key Responsibilities Work closely with internal Manufacturing, Quality Control, and Equipment Validation teams, as well as external...

Senior Manager, Computer Systems Validation (CSV) – Cell Therapy Location Summit, NJ Department Equipment Commissioning and Qualification Organization The Senior Manager, Computer Systems Validation (CSV), Equipment Commissioning & Qualification supports design, development, delivery, validation, maintenance, and support of GMP computerized systems at multi-use sites. This individual interacts with internal team members, peer-level customers, and external service providers, supporting multiple projects and ongoing activities to ensure regulatory compliance. The Senior Manager supervises contract and/or full-time staff to facilitate departmental deliverables and directly supports CTDO Summit. Key Responsibilities Management Lead a team of up to 9 people. Interview and hire internal/external...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. As GRA CMC Lead within our GRA CMC & GRA Device Organization, you’ll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide. Ready to get started? Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on...

Supplier Quality Engineer This position works out of our Pomona, CA location in the Toxicology Business Unite , 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 Supplier Quality Engineer is part of the product development core team responsible for quality engineering deliverables including specification development, risk management, process and test method characterization and control plan development. What You’ll Work On Plans and perform...

Senior Quality Professional Validation At Molecular Diagnostics, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. Position Senior Quality Professional – Validation Location Molecular Diagnostics Business Unit, Des Plaines, Illinois The Senior Quality Professional – Validation is responsible for ensuring compliance with applicable Corporate and Divisional policies and procedures. This role manages all validation activities, including protocol development, document review, controlled document storage, and resolution of problem reports....

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

In this exciting role as a Quality Engineer I, you will help support manufacturing validation, quality systems, product quality, and manufacturing site transfer at the Rice Creek Pharma Operations Manufacturing site in Fridley, MN. The product portfolio includes new technologies and next-generation products in the combination drug/device product space. 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 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration...

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

Sr Supplier Quality Engineer Pre-Market for Cranial & Spinal Technologies Remote We are seeking a committed professional to join our team. This position is remote within the U.S., with a strong preference for candidates located in the Midwest (ideally Indiana) to support collaboration with regional suppliers. The role requires approximately 50% travel throughout the Midwest to engage directly with suppliers and support quality initiatives. Must have a valid driver's license. We value what makes you unique. Together, we can change healthcare worldwide. In this exciting role as a Senior Supplier Quality Engineer, you will have responsibility for leading a...

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 About Oncology 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. Our Oncology team is focused...

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 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 Regulatory...

Johnson & Johnson is currently recruiting for an Innovative Medicine Transformation IT Compliance Senior Manager (Transcend Program) and the role will be based in Titusville, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn...

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 Process Validation Engineer II to join our Team! This is an onsite/hybrid role. The Process Validation Engineer II will support and drive the initiative to establish a robust and...

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

We are searching for the best talent for a Senior Design Quality Engineer I to be based in Danvers, MA. 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 Purpose This person will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products! Activities will include risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support statistical...

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 Compliance Lead to be located in Athens, GA. This position will be accountable for the site internal quality program and external GMP audit and inspection management programs, lead and/or coordinate team...

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

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

This position works out of our Atlanta,GA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. As a Senior Quality Manager, the individual will play a crucial role within Abbott’s Heart Failure organization with primary focus to maintain overall Quality Management System compliance to internal policies, applicable standards and external regulatory requirements. What You’ll Work On The incumbent defines and develops strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications etc) to...

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...

About the Role We are seeking a highly skilled Senior Manager to join our dynamic team supporting biologics regulatory submissions. In this role, you will serve as the lead author for key Module 3 Common Technical Document (CTD) sections. You will apply your analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory submissions. You will be an integral member of cross-functional teams, collaborating closely with Quality Control, Quality Assurance, Regulatory, Analytical Research and Development, and Chemistry, Manufacturing and Controls (CMC) colleagues to deliver submissions to support commercial approval. The ideal candidate will have extensive analytical...

We are seeking an experienced Senior Quality Engineer who will play a pivotal role in maturing Element’s Quality Management System (QMS) towards ISO 13485 compliance and provide quality engineering expertise on Element’s on-market products. This is an incredible opportunity for someone who is passionate about being a leader that can work with significant autonomy and independent judgement to achieve our Quality goals and lead continuous improvement projects with cross-functional teams. We are looking for candidates with a solid background in medical devices (Class I-II). Experience with developing strong working relationships with both internal and external customers to influence and enable...

This role supports the administration, oversight, and continuous improvement of the electronic Quality Management System (eQMS), including Deviation, CAPA, and Change Management processes. The position ensures quality records are compliant, complete, and closed within established timelines while maintaining alignment with regulatory and business requirements.In addition to process support, this role provides QMS system administration, testing, reporting, and end-user guidance to ensure the quality system operates effectively and supports inspection readiness. Primary Responsibilities Provides support for the implementation and maintenance of the quality systems program. Assists with the oversight of the Corrective and Preventive Action (CAPA) process to...

Quality Compliance External Affairs, Senior Specialist Quality What you will do Pharmacopeial Program Management Lead project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP), ensuring structured review and implementation of periodic updates. Coordinate cross-functional teams and site points of contact at global manufacturing sites to execute required changes in alignment with compliance timelines. Ensure all pharmacopeial changes are appropriately assessed, documented, tracked, and maintained in a current state within Amgen systems. Author compendial assessments within Amgen’s documentation management systems for audit readiness purposes. Regulatory Intelligence & Industry Engagement Proactively monitor early signals, emerging trends, and evolving regulatory...

The Director, Quality Assurance will be responsible for team leadership and subject matter expertise in Quality Operations, Facilities and Validation at the 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 not limited to the following Execute GMP quality assurance activities directly related to facilities, equipment, and automation for clinical trial material supply capabilities. Support the design phases and operational readiness of multiple significant cross-modality capital projects that are aligned with the expanding site mission. Drive quality from design through qualification,...

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 Senior Compliance Program Auditor will play a critical role in ensuring the accuracy, integrity, and compliance of the organization’s billing practices. This individual will execute audit projects, assess risks associated with billing, regulatory, and operational risk, and...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for 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...

Position Senior Manager, Quality Assurance Shop Floor 2nd Shift Location Devens, MA The Senior Manager, Quality Assurance Shop Floor (QASF) 2nd Shift is a key people leader. The incumbent manages front line managers, and their teams, and will play a pivotal role in ensuring the highest quality standards in our cGMP Cell Therapy processes. The QASF organization is responsible for quality oversight of shop-floor activities at the Devens Cell Therapy Facility (CTF) including the manufacturing, release testing, and packaging of autologous drug product. The incumbent will be at the forefront of our night shift operations, fostering a culture...

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...

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...

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...

Join a talented global team that's powering AstraZeneca to better serve patients, every day. As a Reasonable Accommodation & Employment Compliance Specialist, you will administer the full lifecycle process associated with medical and religious accommodations. This includes reviewing ADA requests for accommodation, engaging with employees in the interactive process, and providing an organizational decision on the accommodation to the leave and disability vendor and employee. You will manage complex ADA requests and maintain compliance with federal, state, and local laws related to job protection and accommodating employees with disabilities. This role will also lead US employment compliance programs and serve...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will provide Quality Assurance leadership and oversight for Gilead’s Global Logistics operations supporting...

The Cardiac Surgery Operating Unit is a highly specialized, multidisciplinary environment dedicated to the surgical treatment of complex heart and great vessel conditions. The unit brings together cardiac surgeons, anesthesiologists, perfusionists, nurses, and technologists who work in close coordination to deliver procedures such as coronary artery bypass grafting, valve repair and replacement, and advanced structural heart interventions. Equipped with state-of-the-art technology and supported by rigorous safety and quality protocols, the unit operates with a strong focus on precision, efficiency, and optimal patient outcomes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything...

Manufacturing Line 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 Manufacturing Line Quality Engineer is within our Infectious Disease business unit located at a ll sites under Abbott Diagnostics Scarborough QMS . In this role you will provide support for product quality assurance, process improvements, and all quality system programs. RESPONSIBILITIES Support production with resolution of quality issues in accordance with established procedures. Support production...

Job Title Sr. Supplier Development Quality Engineer We currently have an opening for a Sr. Supplier Development Quality Engineer for the CRM division. This role can be located at our Sylmar, CA location. As a global leader in Cardiac Rhythm Management, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. What you’ll do Assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and...

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...

Quality Assurance Senior Associate, Drug Substance Plant What you will do Let’s do this! Let’s change the world! In this role as Senior Associate QA, you will be responsible for providing quality oversight to Drug Substance manufacturing facilities at Amgen Thousand Oaks, working within a shift system. Under general supervision, you will support and ensure compliance for Manufacturing, Facilities, and Engineering staff in their processes, procedures, and use of quality systems. You will engage directly with a diverse range of partners, establishing effective working relationships with production operators, line leads, shift supervisors, warehouse staff, facilities, maintenance, and engineering teams. This...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Global Support Function Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Company’s Legal Regulatory Group is seeking one intern for 8 weeks (June-July 2026) in our Upper Gwynedd site. The intern should expect to be working on-site at least three days per week and will have the option to work remotely up to two days per week. The Company's Legal Regulatory Group...

The Senior Manager, GxP Strategic Document Partner supports the Associate Director of GxP Quality Document and Records Management by managing, assessing, and delivering high-impact, compliant documents and records management solutions in alignment with quality objectives, regulatory standards, and business priorities. The Senior Manager serves as a strategic document partner for assigned area(s) and/or quality system(s), leading document impact and needs analyses and partners with the business to lead Global document initiatives, supporting a functional document hierarchy which integrates the development, maintenance, and distribution of critical documents that support the organization’s strategic goals and initiatives. This role requires expertise in consulting,...

The Director, Quality Analytics is accountable for advancing the Quality Analytics Center of Excellence by delivering trusted, decision‑grade insights across Quality and GxP domains. This role leads a team that designs and scales metrics, dashboards, and advanced analytics to strengthen quality governance, operational oversight, and continuous improvement across modalities and product lifecycle stages. This role is a people manager, responsible for building and developing a high‑performing team, establishing clear priorities and operating rhythms, and ensuring analytics and AI solutions are implemented in a controlled, compliant manner suitable for regulated environments. The role partners cross‑functionally to improve data quality and reliability,...

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

JOB SUMMARY The Senior Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology’s regulatory strategic and operational deliverables. The Senior Manager, RPMSS is responsible for ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule and with quality that meets or exceeds business needs. The Senior Manager, RPMSS is viewed as a key member of the GRST (Global Regulatory Strategy Team). The Senior Manager, RPMSS’ responsibilities encompass regulatory strategic and scenario planning, execution of regulatory and submission deliverables, team effectiveness, resource management, risk management, and information and communication...

Onsite 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. Careers that Change Lives LOCATION This position will support the Advanced Surgical Instruments Manufacturing business 5 days onsite within Medtronic’s Surgical Innovations group located in Boulder, CO. This is an on-site role supporting the Global Operations & Supply Chain organization at the...

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

We are searching for the best talent for a Senior Supervisor, Quality Control to be based in Jacksonville, FL. 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....

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...

J&J MedTech is recruiting for a Senior Quality Engineer, New Product Development , located in Cincinnati, OH! 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 In this role you will be responsible...

Ethicon, a member of the Johnson & Johnson family of companies is currently hiring a Senior Manager, Quality/Regulatory Value Stream Lead, MedTech, to join its dynamic team. Remote work options may be considered on a case-by-case basis and if approved by the Company for US based candidates. About Medtech 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...

As a Regulatory Affairs Specialist II, you will have the opportunity to contribute to a variety of regulatory activities supporting new and on-market IVD products as part of a dynamic and collaborative team. Responsibilities Support RA team in coordinating, compiling and preparing document packages for submission to regulatory agencies Write and/or edit submission documents using regulatory templates Review project documentation for regulatory submission soundness Independently contribute to multiple projects/teams within the department. Assist with design and process change assessments for regulatory reporting impact and compliance Monitor new and revised regulatory requirements; disseminate information as directed by management Assist in the...

Quality Engineer I This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer I , you will be responsible for supporting and maintaining quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency regulations. Uses problem solving, technical writing, and communication skills to gather cross functional buy in for improvements...

We have an immediate opportunity for a Controls & Compliance Supervisor - CFS Americas Hub in our Lake County, Abbott Park, IL location. Abbott Park is the global corporate headquarters of Abbott Laboratories and the base in which the US Finance Shared Services center maintains operations. From this location, Finance Shared Services provides processing and expertise to Abbott divisions and affiliate companies across the Americas. The core services are in Record to Report, Order to Cash, Source to Pay and Master Data Management. The Financial Shared Services hub is part of Corporate Finance and has regional counterparts in EMEA and...

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 Jr. Customs Trade Compliance role reports to the Customs & Trade Compliance Manager and is accountable for engaging Abbott CoreDx and Transfusion's Trade compliance operations with an emphasis on Import/Export compliance and department operations while ensuring the utmost compliance with U.S. Import and regulatory requirements related to 19 CFR and 15 CFR and established internal policies and procedures....

Senior Associate Quality Assurance What you will do Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements. Duties include but are not limited to Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments,...

Quality Engineer 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 through the design and provision of device and management solutions for the treatment of structural heart disease. As the Quality Engineer I, you’ll have the chance to provide process/quality engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Also provide process/quality engineering support to product development teams, helping to ensure development of highest quality new products....

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 Opportunity The position of Quality Control Technician 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 CMDR What You'll Work On Perform testing...

Job Title Sr. Engineer Supplier Quality This position works out of our Temecula, CA location in the AVD Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. We are seeking a high caliber Senior Engineer Supplier Quality d rives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers for technical, quality and manufacturing...

We anticipate the application window for this opening will close on - 7 May 2026 Position Sr. Regulatory Affairs Specialist for Medtronic, Inc. located in Mounds View, MN. Responsible for developing regulatory strategies, preparing U.S. regulatory submissions, and obtaining and maintaining approval for products and therapies to markets worldwide. Assess the regulatory impact of changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy. Prepare document packages for regulatory submissions from all areas of company and inspections for Food and Drug Administration Quality Systems Regulation (QSR). Compile all materials required in submissions,...

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

The IT Regulatory Quality Manager, is a key member of the Software Quality Assurance (SQA) team, responsible for ensuring that AbbVie’s IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role requires strategic leadership in defining, implementing, and optimizing quality systems, and involves direct collaboration with cross-functional teams, Business stakeholders, and the Business Technology Services (BTS) Quality organization. The IT Regulatory Quality Manager will provide oversight of quality activities, especially across Mergers & Acquisitions (M&A), drive improvement initiatives, troubleshoot IT quality issues, and support all phases of the IT solution lifecycle. The incumbent acts...

The Program Compliance Senior Analyst (PCSA) is responsible for monitoring and reconciliation to ensure data is accurate and compliant with 60+ individual country policies; and Abbvie’s OPPFs, procedures, and CFMs for all activity including top tier Congress activity . The PCSA is also responsible for the successful close-out of activities, ensuring financial, transparency and compliance accuracy of all costs and activity associated with events planned within AbbVie’s Business Service Group or by Third Party Vendors, as required by country specific, federal and state government reporting and regulations. The PCSA role includes the continued enhancement of Cross Border Transparency requirements by...

Responsible for assisting with the internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards. Responsibilities Assists with planning and conducting internal compliance audits of all operations within the facility. Helps the team to become more proactive in preparing for audits. Provides support with company and regulatory agency (i.e. DEA, FDA) inspections. Follow up on audits to assure that action plans are developed and completed in a timely fashion. Assist with management review and associated metrics for the plant. Creates compliance performance metrics. Provides support...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. The purpose of this position is to provide quality oversight of Sanofi sponsored GMP manufacturing and testing of Biologics drug products and genomic medicines at the clinical injectables manufacturing (CIM) operation, third parties (Contract Manufacturing Organizations (CMOs), and oversight of BioAnalytics or clinical laboratory operations (CLOs). The primary responsibility of this position is to perform lot disposition activities for United States and follow-on clinical markets. The responsibility is significant for ensuring...

Our Coronary & Renal Denervation group is looking for their next Senior Principal Quality Systems Specialist. In CRDN, 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....

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...

Job Summary Vertex is seeking a highly motivated and experienced Associate Director, Quality Control to join our External Manufacturing, Cell and Genetic Therapies (CGT) team. This role is pivotal in driving quality excellence and operational efficiency across our commercial CGT manufacturing sites and testing facilities. The successful candidate will lead key quality initiatives, develop and execute lifecycle management (LCM) strategies, and champion digital transformation within the Quality Control (QC) function. This is a hybrid role, offering a dynamic and collaborative work environment. Key Responsibilities Develop and execute Lifecycle Management (LCM) strategies to ensure continuous improvement, scalability and compliance across QC...

Associate Director, Patient Safety Technical Solutions Location Wilmington, DE The Patient Safety Technical Solutions Team is accountable for managing the information assets and systems owned by the Chief Medical Office (CMO), ensuring they are effectively supported and governed across the enterprise as well as for deploying system analytics and informatics expertise to meet Global Patient Safety’s (GPS) scientific, business and compliance needs. Reporting to the ‘Director; PS Technical Solutions’, the ‘ Associate Director; PS Technical Solutions ’ provides Information reporting and technical expertise across AstraZeneca’s enterprise business-critical Patient Safety Pharmacovigilance (PV) reporting systems. The role holder works within a team...

Johnson and Johnson is recruiting for a(n) Manager Facilities Management (FM) Compliance . Remote work options may be considered on a case-by-case basis and if approved by the company. 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 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...

The Senior Source Quality Development Engineer (Sr. SQE) leads source quality for Direct Material suppliers that make Johnson and Johnson Electrophysiology (EP) components, putting supplier quality strategies, standards, and processes into practice. Key responsibilities Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management. Support supplier selection, qualification, ongoing monitoring, and orderly disengagement when needed. Support component qualification for NPI projects at EP with cross-functional teams and suppliers Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision. Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the...

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 Senior Analyst, Compliance in Malvern, PA or Spring House, PA. The role of Sr. Compliance Analyst will support compliance activities across R&D Therapeutic Development & Supply (TDS) organization. A...

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 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 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....

Johnson and Johnson Vision Care is recruiting for a Quality Systems Analyst , located in Jacksonville, Florida. 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 This position will support the site administration and execution of the Quality Management System (QMS) Processes and support delivery of Quality System projects. In conjunction with Quality Systems management, this person will drive the flawless and compliant execution of the assigned processes to meet customer...

General Information Position Manager Quality Control Department Name Quality Operations Physical Location of Role Malvern, PA or Spring House, PA Manages all aspects of Quality Control (QC), in support of designated Innovative Medicine Supply Chain (IMSC) sites and supports Malvern Clinical Operations in full compliance with established cGMP and IMSC requirements. Activities include managing in-process testing, raw material testing, environmental monitoring sample testing, utility sample testing, validation sample testing, stability sample testing, method transfer and method validation sample testing, testing of reagents, media, and buffers, and other samples as appropriate. Other non-testing activities include sample management, equipment lifecycle...

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...

Our nutrition business develops science-based nutritional products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna®– to help get the nutrients they need to live their healthiest lives. At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to Career development with an international company where you can grow the career you...

This is a full time on-site position with M-F business hours About This Role The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. This individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate II provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and Corporate policies, cGMP, safety,...

The Manager Labeling Regulatory Affairs Strategic Labeling, develops and maintains US/EU package inserts and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. The Manager leads discussions to ensure global consistency of labeling and educates team members concerning global consistency of labeling. Responsibilities Leads teams on labeling decisions based on knowledge of processes and regulations. Educates others as to new labeling regulations regarding Company core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), Structured Product Labeling (SPL) , or Instructions for Use ( IFUs) Reviews and assesses data to...

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

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

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 Global Regulatory Policy & Strategy strives to enable Lilly to...

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

Join Medtronic as a Sr. 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 support design and development of cardiac surgery products. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare. 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...

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

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

Senior Supplier Quality Engineer This position works out of our Plymouth, MN location in our Structural Heart Division. In Abbott’s Structural Heart (SH) business, our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. As a Senior Supplier Quality Engineer, you'll have the chance to be part of a team of Engineers responsible for activities related to supplier quality management, qualifying purchased materials, investigating supplier performance issues, evaluating opportunities with incoming material, and managing supplier change notifications. This position contributes to the development, establishment...

The Opportunity We are seeking an experienced Quality Systems Auditor with expertise in medical device and software auditing to support internal audit program required for compliance with global regulatory standards and collaborating with Abbott Medical Device Business Units for external inspection preparation and support. This role will s upport M edical D evice Products . What You’ll Work On I nternal 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 to provide inspection readiness...

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

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 is based...

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. The Privacy & Compliance Intern supports the...

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. The CSV and Data Compliance Intern supports...

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. The Quality intern will join the Quality...

Position We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strategy across our clinical-stage development programs. In this role, you will play a key role in both shaping regulatory strategy and driving hands-on execution across assigned programs. You will provide regulatory guidance throughout the development lifecycle, ensure alignment with FDA and international regulatory requirements, and partner closely with cross-functional teams to advance programs in a compliant, efficient, and high-quality manner.This role will report directly to the SVP, Regulatory Affairs and requires a minimum of 3 days per week onsite (or more as business needs require) in...

Leads and manages Risk Based Quality Management (RBQM) activities for assigned clinical studies across all phases and various clinical development therapeutic areas. Activities include but are not limited to development and oversight of study risk management plans, collaboration with cross functional study team members and relevant stakeholders to apply RBQM principles in support of study oversight, issue resolution, and central monitoring activities. _ Your Contributions (include, but are not limited to) Acts as the Risk Management Lead at the study level and is responsible for leading the cross functional study team through the development, execution and oversight of study level...

Senior Director, Global Regulatory Strategy - Early Development & Business Development Location Boston, MA 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 is purposely designed with collaboration in mind, providing...

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 Software Design Quality Engineer II role to be located at Danvers, MA. The ideal candidate for the Software Design Quality Engineer II 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. The engineer should have the ability...

Johnson & Johnson is currently recruiting a Staff Regulatory Compliance Specialist! This position can be located in Santa Clara or San Jose, California. The Staff Compliance Engineer (Senior Analyst, Enterprise Compliance) will support, maintain, and lead when necessary, the Internal Audit Program to help the site sustain a state of readiness to applicable regulatory requirements. Leads and maintains the assigned Compliance functions to ensure compliance to applicable regulations and directives such as 21 CFR 820, 21 CFR 4, ISO 13485/EN ISO 13485, ISO 14971/EN ISO 14971, European Medical Device Directive and European Medical Device Regulation, Canadian Medical Devices Regulations...

About This Role The Director of SABR Submissions Sciences is responsible for leading Global Delivery Management (GDM) function This role is globally accountable for the operational leadership of GDM function. GDM function delivers timely and quality submissions to global regulatory authorities for both major submissions and Lifecycle management. This role provides strategic leadership, optimizes resource allocation, develops initiatives, and drives operational excellence for entire GDM function. Cross functional collaboration and building trusted relationships (with Regulatory, Reg CMC, Portfolio Management etc) Leads the planning, preparation, and submission of regulatory documents (e.g., eCTD, IND, NDA) to health authorities, ensuring compliance and strategic...

Key Responsibilities Global Quality Project & Portfolio Management Own and maintain Global Quality project portfolios , ensuring visibility, alignment, and execution across the network. Monitor project progress, proactively manage risks and dependencies, and ensure initiatives are delivered on time and within scope . Drive end‑to‑end planning and execution of global quality initiatives, including detailed project plans, timelines, milestones, and resource management. Collaborate closely with Project Leads and Quality Leadership to track progress, manage risks, and communicate outcomes across the organization. Quality Systems Enablement & Integration Capture, prioritize, and manage Quality Systems enhancements and platform integrations , ensuring timely and effective...

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

We are seeking an Associate/Director, Regulatory Operations and Intelligence who will play a critical role in supporting global regulatory submissions, overseeing submission processes, managing regulatory documentation and gathering regulatory intel to keep programs and organization updated with latest regulatory trends. Additionally, this role involves managing regulatory submission and publishing systems used in Regulatory Affairs. Collaborate with Regulatory Leads to support the development of submission/content plans (planning, reviewing, publishing, and timelines - e.g., pre-submissions, INDs/CTAs) to global regions (e.g., US, UK, EU). May contribute to the authoring of administrative submission documents. Perform critical reviews of documents for consistency and quality, identifying...

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

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

JOB SUMMARY Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and...

Organizational context Within our company's Manufacturing Division, the Micro Analytical Sciences (MAS) section within the Global Quality Large Molecule Analytical Sciences (GQLMAS) organization, located in Wilmington, Dunboyne and Oss, scientifically support the microbiological laboratories in the commercial production sites for vaccines, biologics and small molecules. The MAS team plays a crucial role in supporting the transfer, troubleshooting and life cycle management of the microbiological test methods (including equipment) for all modalities. This includes compendial test methods, non-compendial test methods, and alternative microbiological methods. Furthermore, MAS is seen as the owner for global microbiological methods and equipment packages to ensure a...

As an individual contributor, this position performs 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. This new team member will support necessary regulatory activities required for product market entry. What You’ll Work On Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. Reviews and evaluates communications to ensure communications convey all necessary...

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

The Senior Director, Regulatory Submission Management champions functional and cross-functional project and submission management excellence. The incumbent is expected to apply deep subject matter expertise in project and submission management to lead and identify opportunities, shape objectives and drive execution of key functional and corporate objectives. This role will be responsible for driving timeline risk mitigation and contingency planning. Key Duties and Responsibilities Provide strategic and operational project, submission and program leadership activities at all stages of the lifecycle (initiation through closeout). Drive communication cross-functionally and with senior leaders on project, submission and program planning topics including timelines, status, risks...

Site Quality Head (Associate Director level) #LI-Onsite Location Winter Park, Florida At Novartis, we are redefining the future of cancer care through Radioligand Therapy (RLT) - a powerful convergence of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are building a team of passionate, purpose driven quality leaders who are inspired to make a meaningful impact. This is a unique opportunity to play a critical role in the start-up and ongoing quality operations of a new RLT manufacturing site, helping ensure the delivery of life changing therapies to patients around the world. As the...

Site Quality Head (Associate Director level) #LI-Onsite Location Denton, Texas At Novartis, we are redefining the future of cancer care through Radioligand Therapy (RLT) - a powerful convergence of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are building a team of passionate, purpose driven quality leaders who are inspired to make a meaningful impact. This is a unique opportunity to play a critical role in the start up and ongoing quality operations of a new RLT manufacturing site, helping ensure the delivery of life changing therapies to patients around the world. As the...

Quality Technician This position of Quality Technician works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine Division. The Quality Technician is responsible for bioanalytical and/or platform quality testing within the WWLIMS or QIMS system and SAP system. Provides inputs to facilitate CAPA investigations as required. Maintains product and testing inventory and complies with the quality system. Undertakes the role of a Quality Technician with minimal supervision. Redline documents and reviews operating procedures when needed. Execution of daily activities with minimal supervision. Accountability/Scope Individuals execute daily testing in a high-paced laboratory environment. Identify and...

Senior Associate Quality Assurance What you will do Live What you will do Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements. Duties include but are not limited to Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL...

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 Director, CMC Regulatory Affairs. This hybrid work position will be located in Beerse, Belgium, Warsaw, Poland, Allschwil, Switzerland, or our East Coast USA location (Horsham, PA, Spring House, PA, Titusville, NJ...

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...

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. Reporting to the Senior Vice President, Global Regulatory Affairs, this position is responsible for … Key Responsibilities Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure global CMC regulatory requirements and strategy are understood by project teams. Play a hands-on role in planning, preparing, and coordinating CMC documents for...

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

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...

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

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 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 is currently seeking a Quality Systems Manager to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina. This role will support the construction, operational start-up and end state of the DS site operations...

The Reliability Engineer is responsible for ensuring medical devices meet lifetime, safety, and performance expectations through rigorous testing, data analysis, and cross-functional collaboration. This role focuses on identifying early-life failures, improving product robustness, and supporting design and manufacturing teams with data-driven reliability insights. Responsibilities Execute reliability engineering activities across the product lifecycle, including Design for Reliability (DfR) in R&D and post‑market support. Perform early‑life testing using engineering methodologies to identify components at risk of premature failure. Conduct reliability tests such as environmental, thermal, shock, vibration, and lifecycle testing; develop test methods as needed to evaluate component and system durability. Apply...

About Cardiovascular 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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at Weare searching for the best talent for a...

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...

Do you have knowledge in Regulatory Affairs Strategy and Policy, underpinned with experience transforming Digital processes with AI and automation ? If you want to work on innovative projects of high importance for our Respiratory and Immunology (R&I) portfolio, then AstraZeneca is the place for you. Our aspiration is to be pioneers in science, leading in our disease areas to truly transform patient outcomes. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has significant impact on science, medicines, and patients. The Global Regulatory...

This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed About This Role We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. What You’ll Do Act as the primary team lead and represent the team in absence of Manager Conduct...

Schedule This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours. About This Role We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this...

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

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...

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 Avid group’s mission is to discover, develop, and deliver diagnostic...

Vertex

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

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Senior Quality Program Manager – Quality Core Team Member (QCTM) and be at the forefront of transforming lives through advanced medical technology. In this highly visible role, you will serve as the Quality Core Team Member for...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. The candidate will audit/inspect/release all incoming company Animal Health pharmaceuticals, third party pharmaceuticals, medical devices, third party biologic and diluents...

The Patient Safety Associate Medical Director will provide medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development). This role will optimizes patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe, through the effective and timely completion of Safety activities through the product life cycle. Key Duties and Responsibilities Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development) Responsible for the safety assessment activities of assigned products under the supervision...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. The Associate Director RA serves as the regulatory lead on relative Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune 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. Purpose The purpose of the Senior Director, Global Regulatory Affairs, 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. Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company,...

The Senior Manager, Senior Process Validation Engineer, provides process validation support to the Devens Cell Therapy Facility (CTF). The Senior Manager leads and participates in facility and process validation activities, including process tech transfers and lifecycle management changes. Responsible for leading Process Validation activities including, but not limited to Product Lifecycle Management changes, Process Performance Qualifications (PPQ), microbial hold studies, and comparability studies. Technical subject matter expert for facility start up, technology transfer, and process validation. Performs data analysis, including the use of statistics, and prepares written protocols/reports/summaries supporting validation studies. Supports equipment and facility commissioning, qualification and validation. Leads/Owns...

Job Title Sr. Compliance Analyst This role Sr. Compliance Analyst works out of our Lake Forest, IL location in the Cardiometabolic business unit in Abbott Rapid Diagnostics. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. As the Sr. Compliance Analyst , you’ll have the chance to assist with meeting the division’s strategic direction and tactical implementation of internal and external audits, error remediation and other tactical objectives to ensure that...

About the role As a Quality Control Technician II, your primary responsibility is to ensure compliance with procedures and regulatory requirements in the manufacturing facility. You will be responsible for quality support and oversight of manufacturing operations, which includes presence on the floor and for performing Acceptable Quality Limit (AQL) sampling of finished product. Additional responsibilities include triage for potential issues on the floor, raw material investigations, Quality on the Shop Floor (QOTSF), online batch documentation review, sample management, kitting of batches, and raw materials release. This role is a night shift, 600pm – 630am on a 2-2-3 work schedule....

Purpose Describe the primary goals, objectives or functions or outputs of this position. 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...

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...

Responsible for planning, writing, implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems. Evaluate, propose and implement technology solutions that improve digitization, compliance and productivity. Serve as the CSV subject matter expert and provide guidance on and interpretation of global GxP guidance and regulations of computerized systems, electronic records, electronic signatures, and data integrity requirements. Collaborate with peers across Acadia on procedures relating to quality, data integrity and computer system validation. Primary Responsibilities Responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. At Our Quality Assurance team ensures every single material inside of our products is manufactured, processed, tested, packaged, stored...

At Medtronic, we A career at Medtronic is purposeful, mission-driven, and unlike any other. We are committed to alleviating pain, restoring health, and extending life for millions worldwide. As a Quality Technician on 3rd shift, you will be part of a dedicated, experienced, and high‑performing team at our Grand Rapids site. You will support manufacturing operations by reviewing potential nonconformances, executing product and material containment activities, and supporting material disposition decisions. Working closely with cross‑functional partners, you will help ensure compliance with regulatory and company requirements while delivering results the right way—supporting the production of life‑changing medical devices that...

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

The Senior Quality Manager will be part of the Program Quality Team in Vertex’s North America Commercial Patient Support Program Center of Excellence (NAC PSP COE). The COE is a group of compassionate and determined individuals who provide operational support to our commercial Patient Support Programs (Cystic Fibrosis, Hematology, Diabetes and Kidney) in areas such as systems and technology, data and analytics, vendor management and program quality. Additionally, COE team members help design patient support offerings and policies for future Vertex Patient Support Programs (PSP). The Senior Quality Manager will play a meaningful role within the COE and contribute to...

Senior Associate Quality Control What you will do In this vital role you will support the QC Immunoassay and General Testing team by performing testing and data review/approval for ELISA methodology assays, qPCR, Karl Fisher Moisture, BLE (Break loose and Extrusion) and UV Spectroscopy. Staff member may also perform additional testing such as Viscosity, Osmolality and Reconstitution Time. Responsibilities Report, evaluate, trend and approve analytical data. Troubleshoot, solve problems and communicate with partners. Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook. Participate in audits, initiatives, and projects that may be departmental or organizational in scope....

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 currently seeking a Quality Director to join the Quality Team in Wilson, North Carolina. While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both...

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans....

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The intern candidate will be a member of Manufacturing Sciences, Analytics & Technology (MSAT), who's role is the technical guardian of manufacturing processes and technologies from product launch through their commercial manufacturing lifecycle. MSAT is known for its advanced expertise in Biotechnology, Chemistry, Pharmaceutical and Analytical Sciences, Process Design &...

Quality Assurance Supervisor - Abbott Nutrition Plant - Casa Grande, AZ Main Purpose of Role Lead the supervision of manufacturing inspection and testing activities across all stages of production. Ensure product integrity and compliance with quality standards by identifying and addressing defects and failures. Your work directly contributes to delivering safe, high-quality products that improve lives. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people...

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. 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 Opportunity The Quality Assurance Specialist supports the US Workplace Services team within RMDx Toxicology by ensuring operational processes, documentation, and...