Quality & Regulatory Jobs in Pharma & Biotech

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

The Sr Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations. Responsibilities Ensure proper integration and support of quality regulations drug, biologics, device and/or combination products. Assist project teams in planning, preparation, review and approval of...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi has been one of the leaders in the vaccine industry for more than 100 years and a globally recognized partner in the prevention of infectious diseases. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is the reference site...

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 Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned...

Use Your Power for Purpose This role provides strategic leadership & operational Quality oversight for development, deployment and enablement of GxP AI capabilities across QSEO and PGS Operations. The AI Compliance Lead is responsible for enabling the deployment of AI initiatives while ensuring all forms of risk are mitigated. This role partners closely with QSEO GPOs and BSOs, as well as with Digital, Legal and other relevant stakeholders to ensure AI capabilities built in Pfizer or through 3rd parties adhere to applicable external regulatory requirements as well as Pfizer specific policy and controls. The AI Compliance Lead plays a key...

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

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...

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we...

Abbott is seeking a Senior Supplier Quality Engineer (SQE) to lead and support supplier quality activities across the product and service lifecycle. This role is responsible for ensuring that suppliers consistently meet Abbott’s quality, regulatory, and business requirements. The Senior SQE will act as a key technical and quality liaison between Abbott and its suppliers, driving continuous improvement, risk mitigation, and compliance with global regulations. This role also supports general QMS processes where applicable, including quality investigations What You'll Work On Lead supplier qualification, selection, and onboarding activities, including supplier risk assessments and quality agreements Develop and maintain supplier quality...

Responsibilities This role is primarily responsible for reviewing data to ensure accuracy, compliance, and completeness within the team or department, while also providing people leadership. Key responsibilities include leading and developing team members, evaluating and interpreting data from various sources, ensuring adherence to regulatory and organizational standards, and identifying trends or discrepancies. The position involves coaching and supporting team members, fostering professional growth, and handling personnel issues as needed. Additionally, this role supports continuous improvement initiatives, prepares technical reports, and collaborates with both internal team members and external stakeholders to resolve data-related issues and maintain high standards of data integrity....

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of R&D and analytical validation studies for complex biomarkers used in the detection, monitoring, and management of cancer. PRIMARY RESPONSIBILITIES Lead Biostatistics efforts designing and executing analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.). Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for validation studies of varying...

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 Overview This position is responsible for developing and carrying out...

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

About This Role As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen’s small molecule portfolio. You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment. What You’ll Do The Associate Director, RegCMC Small Molecule Lead oversees the management and coordination of...

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 Principal Regulatory Compliance - Lead Auditor to be in Danvers, Massachusetts The position of the Principal Regulatory Compliance is responsible for establishing and maintaining robust Compliance Programs at the designated Abiomed sites in order to ensure compliance to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements. The Principal Regulatory Compliance...

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

Technical expert that will independently identify, engineer, and optimize new data, software, or technology solutions that address critical business needs. Works with QA Lab Business Owners and the broader BTS organization to improve existing methods and processes. Read and adapt literature and publicly available information to accomplish assignments. Demonstrate proficiency in a broad range of techniques and methods for information technology engineering, including software development, data warehousing, statistics, machine learning, and/or technology infrastructure. Responsibilities Independently design and develop data, software, or technology solutions to answer scientific or business questions. Demonstrate proficiency across a range of technologies related to programming languages,...

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

This role is responsible for working collaboratively with QA Labs Business Owners, Manufacturing Sites and the broader BTS organization to conceive, design, engineer, and implement data, software, and technology solutions that solve significant scientific or business problems for Quality Labs processes. A successful candidate will develop deep understanding of lab processes to investigate, identify, and implement state-of-the-art technology platforms that drive productivity and efficiency gains in Product Release Testing , Stability Study Operations, and Lab Inventory Management for all AbbVie QC labs. Responsibilities Conceive, design, engineer, and implement data, software, or technology solutions by studying system flows, data usage, and...

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Senior Biostatistician, you will leverage your strong applied statistics background to design and implement statistical analysis and reporting of development and analytical validation studies for complex biomarkers used in the detection, monitoring, and management of cancer. PRIMARY RESPONSIBILITIES With minimal guidance, drive the design and execution of analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic (e.g., IVDR, 510(k), PMA, etc.). Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for studies of varying...

General/ The Director, Quality Assurance GMP Operations will oversee the GMP QA operations including batch disposition process across CDMOs in the US and Internationally. Responsibilities include day-to day operational quality oversight for internal batch record review operations and QA manufacturing operations from clinical to commercial stage of product globally. The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk mitigation, execution of operational activities participation of governance committees associated with improvements to the disposition process. A key expectation is the ability to closely collaborate and build relationships with internal and external...

Introduction to role Are you ready to lead strategic communications in clinical drug programs? As an Associate Director in Clinical Regulatory Writing, you'll provide leadership and expertise in authoring high-quality clinical-regulatory documents. Your role will be pivotal in ensuring these documents align with project strategies and regulatory requirements, representing the skill on both drug and non-drug projects. Accountabilities The Clinical Regulatory Writing team is at the forefront of providing expert communications leadership to drug projects. As an Associate Director, you will manage clinical regulatory writing activities across a portfolio, ensuring that documents meet regulatory, technical, and quality standards. You'll lead...

Introduction to role Are you ready to set the global agenda for cyber governance and regulatory adherence within a firm where trusted, protected technology accelerates life-changing medicines to patients? Can you translate complexity into crucial action that protects trust while enabling ambitious innovation and speed? As Executive Director for Global Cyber GRC, you will lead the enterprise approach to information security. You will coordinate technological risk and ensure our most critical data, platforms, and partners operate with resilience, regulatory confidence, and clear accountability. You will connect cyber risk to strategic decisions, equipping the company’s leadership team and Board with sharp,...

QC Chemistry performs testing in support of Framingham Manufacturing. The new Framingham Manufacturing facility is one of the first of its kind worldwide and puts Sanofi at the forefront of bio-manufacturing. The whole industrial process is digitalized, paperless, and is 80 times more productive than a traditional factory. Our Framingham facility leads the way in delivering the next generation of biologics manufacturing. The Team is a diverse group and will be able to offer their own experiences and knowledge that others don’t possess. They communicate openly with each other, sharing their thoughts, opinions, and ideas. They offer each other support...

Specialist Quality Control What you will do In this vital role you will complete and review analytical testing in our cGMP laboratory. The role will be on-site based out of Amgen Rhode Island and will work under the mentorship of the front-line manager. The QC Bioanalytics team provides analytical expertise in testing the following in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing. Responsibilities Follow safety guidelines, cGMPs (Good...

ASSOCIATE QUALITY CONTROL What you will do Let’s do this. Let’s change the world! In this vital role you will perform and document laboratory testing in support of product quality, ensuring compliance with Good Manufacturing Practices and contributing to the delivery of safe and effective therapies to patients. Specific responsibilities include but are not limited to Perform routine and non-routine laboratory testing and approval for compendial methods May prepare solutions May perform general troubleshooting to laboratory equipment following standard operating procedures May review analytical data following GMP guidelines and ALCOA principles Perform laboratory documentation and data entry, review, analysis, and...

Quality Associate Director What you will do Let’s do this! Let’s change the world! In this vital role, you will serve as Amgen’s operations enterprise leader for the Supplier Quality Management (SQM) Quality Management System (QMS) processes. Reporting to the Business Performance & Quality Management System Leader, you will drive the global SQM strategy, lead digital transformation through DQMS and AI-enabled capabilities, and ensure consistent, compliant, and inspection-ready SQM execution across Amgen’s global operations and affiliate network. You will also shape and govern end-to-end SQM processes ensuring Amgen remains aligned with regulatory expectations and positioned for Quality 2032 ambitions. As...

Associate Quality Control What you will do In this vital role you will be responsible for activities including microbiology & analytical testing, sample and data management, as well as equipment and instrumentation operation and maintenance in a highly dynamic, team environment. Responsibilities Perform on site sample collection and sample handling to support GMP operations and Environmental/Water monitoring within Manufacturing clean room and Utility areas. Perform testing and data review for compendia, non-compendia methods, and routine laboratory procedures. Daily review and authorization of environmental and in process batches. Use of testing and data review within automated sampling systems, such as...

2026 Summer Intern - PTQ Quality Processes Department Summary Global Quality and Compliance (PTQ) ensures we deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is a competitive advantage for Roche. You will report to the US Internship Program Manager in the PTQ Quality Process Function. The ideal candidate is a self-starter deeply curious and energized by learning. You should be comfortable with working through ambiguity and are able to prioritize and manage multiple demands and commitments. Your role will be to help Quality Processes fulfill...

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. urpose The purpose of the Senior Director – GPS Safety Data...

At Johnson & Johnson Innovative Medicine, we use heart, science and ingenuity to create transformational medicines to improve the health of humanity. Every day, we work to advance scientific research and commercial innovation, to deliver solutions that provide value to patients, physicians and healthcare systems around the world. With a diverse company culture, we celebrate the uniqueness of our employees and are committed to inclusion. We collaborate with the world for the health of everyone in it. Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter intern for its 2026 program. We offer an exciting immersive summer...

We are searching for the best talent for a Senior Manager, Technology Quality – Orthopedics Separation, to be based in Raritan, NJ; New Brunswick, NJ; Horsham, PA; or West Chester, PA. This is an 18-24 month duration-based role. Purpose The Senior Manager, Technology Quality - Orthopedics Separation is responsible for successful execution and implementation of Separated GxP Computerized Systems in accordance with the defined business vision/strategy. Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both...

Quality Engineer This position works out of our Sturgis, MI 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 our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. For over 70 years, Abbott’s Sturgis, Mich. , has been impacting its community while producing products that provide essential nutrition to millions of families around...

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

Instrument Quality Technician 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. Instrument Quality Technician Location South Portland, ME Business Unit Infectious Disease Developed Markets About the Role Join our team as an Instrument Quality Technician and play a key role in serving as an advanced technician supporting the Global Instruments Quality organization. If you're looking for a dynamic role where your contributions will drive the development and manufacture of...

The position of Program Manager is within our Infectious Diseases business unit located On Site in Westbrook, Maine . 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. In this role, you will manage all aspects of a large scale and complex project, from start to finish, so that it is completed on time and within budget. This role reports into the Program Management Office, and has 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, Regulatory Policy Research and Operations. This position is a hybrid role and can be located in Raritan, NJ or Washington, D.C. The Director, Regulatory Policy Research and Operations...

Specialist Quality Complaints What you will do and what we expect of you In this vital role you will Duties Ensure product complaint records are processed according to FDA guidelines, SOPs and other regulatory agencies’ guidelines; Evaluate subject matter expert assessments; Provide guidance and technical advice to conduct complex complaint investigations, determine corrective actions, and determine steps necessary to ensure the proper level of control for product in distribution; Ensure quality of complaint records and applies analytical abilities to evaluate complex situations using multiple sources of information; Execute against prioritized work plans to ensure timely investigation and closure of...

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

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

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

Senior Quality Assurance Specialist will be responsible for approving key quality records including deviations, change controls and corrective/preventative actions (CAPA) at the La Verne site. This role will involve close collaboration with cross functional teams and subject matter experts (SMEs) to review and support impact assessments and risk evaluations. The Specialist will provide guidance to ensure that investigations, changes, and improvements are properly assessed for regulatory and operational impact, supporting a culture of continuous improvement and adherence to GMP requirements. Responsibilities Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Participates in writing...

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

Global Patient Safety, Oncology TA Intern Overview Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. The Global Patient Safety, Oncology Therapeutic Area (TA) Intern will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical industry. The intern will support the enhancement of clinical safety insights by leveraging reverse translatability to improve non-clinical capabilities (e.g. complex in vitro models (CIVM) or...

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

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. Intern will be joining the Regulatory Affairs U.S. Advertising and Promotion (USAP) Standards Team. The Standards Team leads USAP through department-wide initiatives, influences process improvements and fosters the review of compliant promotional and R&D communications. Key responsibilities may include Learning the FDA Regulations on Drug Advertising & Promotion Understanding the detailed USAP activities Creating reports, including metrics, department highlights and communications Attending meetings Creating presentation materials...

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

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...

The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Bispectral Index™ (BIS™) monitoring product portfolio within the Acute Care and Monitoring operation unit. This role is fit for an established, productive individual contributor who works independently on projects or programs with general supervision. In the position, you will work with your manager to set objectives for your own work in alignment with broader project goals and actively contribute to key milestones. You will also participate in cross-functional activities, requiring awareness of wider organizational issues. You will recommend and support improvements...

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. This This position has the responsibility and authority to support the development and implementation of the overall objectives and long-range regulatory strategies that impact both the introduction of new products and the market status of existing products. The Principal Regulatory Affairs Specialist will exercise a leadership role and serve as a mentor to help develop regulatory depth...

The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Nellcor™ pulse oximetry monitoring and digital solutions HealthCast™ VitalSync™ remote patient monitoring product portfolios within the Acute Care and Monitoring operation unit. This role is fit for an established, productive individual contributor and leader who works independently on moderately to highly complex projects or programs with limited general supervision. In the position, you will set objectives for your own work to align with broader project goals and actively contribute to key milestones. You will also participate in cross-functional activities, requiring awareness...

At our Company, we are committed to fostering an inspiring workplace that empowers our employees to innovate and excel. Our Global Workplace and Enterprise Services (GWES) team provides essential solutions that ensure a safe and productive environment, while prioritizing the well-being of our colleagues, communities and the environment, making a positive impact beyond our organization. The Associate Director, Compliance is a leadership role responsible for driving Environmental, Health, and Safety (EHS) compliance and governance across the GWES operating areas in the SE Pennsylvania region. This role ensures reliable, compliant, and cost-effective operations by integrating regulatory requirements into GWES processes, enabling...

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

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...

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 believe in the talent of our workforce. One...

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. Gilead Sciences PDM External Quality is currently seeking a leader at the Associate Director/Director level to lead a team of Quality Professionals...

Job Title Quality Manager Our location in Temecula, CA, currently has an opportunity for a Quality Manager (Development) in our Vascular Division. This is an onsite role. This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. WHAT YOU’LL DO...

Senior Supplier Quality Engineer 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 a Senior Supplier Quality Engineer, you'll have the chance to be part of a team of Engineers responsible for activities related to supplier selection, evaluation, re-evaluation, material qualification, supplier performance and receiving inspection. This position contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices...

Undergrad Intern - Operations - Quality - Remote (Summer 2026) What You Will Do This internship will be approximately 13 weeks that includes both project-based and experiential learning. In conjunction with the project work, you will have the opportunity for professional development through training sessions, one-on-one mentoring, and various networking events. Operations is one of three foundational functions at Amgen with a mission to manufacture and deliver safe and effective medicine to patients around the world. Operations is divided into the following five sub- functions Supply Chain, Process Development, Quality, Manufacturing, and Facilities & Engineering. We are currently seeking...

Strategic Planning & Operations Sr Mgr - General Medicine, Biosimilars & Regulatory Policy What you will do In this vital role you will partner with other Global Regulatory Affairs and Strategy (GRAAS) Strategic Planning and Operations (SPO) Sr Managers to provide flexible, high-impact support across Amgen’s Regulatory Affairs organization, driving and implementing department goals and initiatives, supporting senior GRAAS leaders in strategic planning and execution of department needs, and collaborating cross-functionally. The primary focus of this role is to support the Biosimilars and General Medicine therapeutic area VP and teams, and the Global Regulatory Policy & Intelligence (GRPI) AVP...

Job Title Quality Engineer Our location in Temecula, CA, currently has an opportunity for a Quality Engineer in our Vascular Division. This is a fully onsite role. The Quality Engineer 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 meeting business needs. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters...

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...

Quality Engineer II 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 the Quality Engineer II , you'll be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Lead the investigation, resolution, and prevention of product and process non‑conformances by applying systematic problem‑solving methodologies, driving effective...

The Patient Safety Science Therapeutic Area Lead will be responsible for leading and managing a team of scientists within a therapeutic area in the Worldwide Patient Safety organization. This critical role involves ensuring the safety of our medicines through effective pharmacovigilance, pharmaco-epidemiology, and risk management strategies. The role will oversee both pre-marketing and post-marketing product support, ensuring compliance with global regulatory requirements, and driving strategic initiatives to enhance safety science processes. Duties & Responsibilities General Product Scientific Support Partner with fellow Therapeutic Area (TA) Leads and the Head of Patient Safety Sciences to plan, lead, and advance programs and...

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly...

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

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...

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...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited...

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...

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 recalls....

At Medtronic Neuromodulation (NM) and Pelvic Health (PH), our therapies use advanced stimulation, sensing, software, and digital technologies to restore function and relieve suffering for people living with movement disorders, epilepsy, chronic pain, and pelvic health disorders. Our newest generation of systems can listen directly to neural signals and intelligently adjust therapy in real time — representing a breakthrough era of personalized neuromodulation. In this highly dynamic and rapidly evolving R&D environment, every design decision matters, and the quality of our designs directly influences clinician confidence, patient outcomes, and global healthcare impact. The Design Quality Engineering Director for the Neuromodulation...

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 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...

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 Quality Engineer to be in Raritan, New Jersey The Quality Engineer shares a passion for ensuring the highest quality experiences for our patients and customers. This position will be responsible for the leadership and support of Quality Engineering activities pertaining to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure...

Senior Quality Assurance Specialist – NEW Altavista Warehouse (DC) This position works out of our New Distribution Center in Altavista, VA within 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 our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Altavista, Va. , is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited...

About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their...

Performs lab support activities and participates in basic routine and non-routine testing and general QC Microbiology laboratory work for the in-process support, release and of commercial products and/or clinical development in a GMP testing environment. Monday - Friday shift. Must be able to work weekends, off-shifts, and overtime as required. Must be willing and able to work reliably on a flexible schedule. How You Will Achieve It · Applying the principles of good manufacturing practices (GMP) on a daily basis · Performing maintenance of QC lab equipment, procedures and systems · Performing QC sample testing · Creating and revising standard...

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

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to all collaborators and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives globally. Accountabilities Lead and/or contribute to the planning, preparation, and delivery of both simple and complex submissions...

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 QC Analytical Support Intern will assist the Quality Control department with laboratory-based and data-focused projects supporting vaccine development and manufacturing. This hands-on internship offers exposure to analytical testing, method development, and quality systems within a regulated pharmaceutical environment. The intern will collaborate with QC analysts and cross-functional teams to...

The Sr. Specialist, Quality Assurance is an individual contributor role within the QA Investigations (QAI) team providing quality oversight of Deviation related processes for clinical and commercial Cell Therapy manufacturing at BMS Bothell. This role Collaborates cross-functionally on deviations to ensure accurate root cause analysis (RCA) and corrective and preventive actions (CAPA) have been identified. Ensures the deviation and associated records contains technical merit and completeness according to regulatory expectations. Coaches customers and team members on the deviation process and navigation within the electronic management system. Acts as a Subject Matter Expert in cGMP, GDocP, Data Integrity (DI)/ALCOA+ principles, risk...

The Analyst, Regulatory Policy and Intelligence (RPI) support the US RPI function by conducting research on regulatory intelligence questions and topics within assigned areas and regions. Responsibilities include analyzing and utilizing relevant regulatory approval databases, as well as preparing and delivering regulatory intelligence summaries both orally and in writing. The Analyst should be comfortable working in a dynamic environment and proactively contributing new ideas and process improvements that enhance assigned projects. The Analyst also serves as the office manager for the Rockville MD location and should be comfortable assisting with general office duties. This includes oversight of rental and service...

The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

Responsibilities may include the following and other duties may be assigned. Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families Accountable for and owns the Risk Management Files for assigned product families within the Robotic Surgical Technologies business. Maintains Risk Management Files for assigned product families Conducts product Risk Analysis (PHA, RAC, SSRCI/System & Use FMEAs) in compliance with ISO14971 Evaluates product Risk Management Files against field data to ensure accuracy and correctness of predicted risks; validating pre-market Benefit Risk Analysis and updating the Risk Management Files...

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...

JOB SUMMARY The Design Quality Engineer Co-Op shares a passion for ensuring the highest quality experiences for our patients and customers. This position will be responsible for the support of Quality Engineering activities pertaining to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH) Platform. WCH is a market leader in surgical tissue healing with a broad portfolio including Antibacterial sutures, Knotless Tissue Control Devices, Topical Skin Adhesives, Skin Closure Systems, and traditional absorbable and non-absorbable surgical sutures with innovative needle technologies. DUTIES & RESPONSIBILITIES In accordance with all applicable federal,...

Auris health Inc a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Regulatory Compliance Specialist ! This position will be located in San Jose, California. Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, endoluminal intervention and general surgery. This includes the MONARCH®, OTTAVA and Polyphonic platform, a first-of-its-kind robotic technology and digital solutions. Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years...

Johnson & Johnson is recruiting for a Sr. Manager, Clinical Quality Risk Management Lead at a MedTech site in one of the following locations Raritan, NJ ; New Brunswick, NJ; Jacksonville, FL; Miami, FL; Cincinnati, OH; Raynham, MA; Santa Clara, CA or Irvine, CA. 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 Sr. Manager, Clinical Quality Risk Management Lead for Surgery advances the Clinical Quality Risk Management (CQRM) objective,...

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, Regulatory Policy - North America. This position is a hybrid role and can be located in Raritan, NJ or Washington, D.C. The Director, Regulatory Policy - North America,...

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

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...

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

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

About the Role This application is for a 12-week internship role from June - August 2026. Resume review begins in February 2026. The QA Ops intern will partner with MFG on a logbook project for Parenteral Filling (PF) which will include review of the KNEAT logbooks to update the flow and documentation to make them more user friendly and ensure all information is easily captured for review. Additionally this intern will work with Training on QA Shop Floor OJTs to revise and update them to be more user friendly within Veeva. The intern will also look for opportunities to streamline...

Supplier Quality Engineer II This position works out of our St. Paul, MN location in our Structural Heart Division. In Abbott’s Structural Heart (SH) business, our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. As a Supplier Quality Engineer II you will l ead efforts to enhance and correct the quality of components from external suppliers. Establishes acceptance criteria for materials. Tracks supplier performance to enforce corrective actions, address manufacturing yield issues, and resolve field failures. Coordinates supplier-initiated changes with cross-functional teams What...

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

Job Title Quality Engineer This position works out of our Liberty, SC location. This is an onsite role . The Quality Engineer is involved in all aspects of the manufacturing operation from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes. The Quality Engineer is also expected to assist in the identification and resolution of quality related issues. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. What You’ll Work On Implements Process Monitoring Systems by...

Schedule 5am-5pm (2-2-3 rotation) Major Duties and Responsibilities Quality floor support of complex manufacturing activities Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs. Perform walkthroughs of GMP areas documenting observations and areas of concern. Perform training on routine facility Quality tasks for new team members. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines. May support review of quality master data. Authors...

Please note This role does not include direct reports or formal people management responsibilities. Director, Global Customs & Trade Compliance Location New Brunswick, NJ We are seeking a Director of Global Customs & Trade Compliance to lead our customs strategy and ensure adherence to international trade regulations. This leadership position is responsible for driving global alignment, optimizing duty savings, and managing compliance across all our operations. You'll work closely with regional teams to develop and implement effective trade strategies that support our global supply chain. Responsibilities Strategic Leadership Influence and execute the strategic direction for global customs compliance. Process...

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

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

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

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

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

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

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

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

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

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

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

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...

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

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

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

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

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

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

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

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

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

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

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

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

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

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

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...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

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

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

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

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

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

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...

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

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

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

In Coronary and Renal Denervation, we love what we do. That's because we're passionate about the patients we serve around the globe and the "second life" and improved health we can give to those with Coronary Artery Disease, High Blood Pressure, and other conditions. We're also driven by the promise of Renal Denervation and its potential to change the way patients around the world manage their uncontrolled hypertension. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4...

In Coronary and Renal Denervation, we love what we do. That's because we're passionate about the patients we serve around the globe and the "second life" and improved health we can give to those with Coronary Artery Disease, High Blood Pressure, and other conditions. We're also driven by the promise of Renal Denervation and its potential to change the way patients around the world manage their uncontrolled hypertension. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4...

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

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

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

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

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

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

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...

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

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

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

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

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

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

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

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

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

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

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

Purpose The Compliance Manager is responsible for the management and coordination of project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates in maintaining quality system documentation including but not limited to Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and participates in quality system management review. Oversees Global Product Surveillance CAPA program and is responsible for the site’s internal audits. Oversees internal, supplier and regulatory audits and preparation activities....

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

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

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

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

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

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

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity JOB LOCATION Lexington, MA POSITION Senior Manager, Device Quality Engineering POSITION DESCRIPTION Takeda Development Center

Reporting to the Director, Material Compliance Operations- Material Review, the Associate Director of Global Material Review Compliance is accountable for implementation of processes, standards and compliance monitoring and supplemental medical compliance training supporting the scientific development and review of medical content of pharmaceutical promotional and non-promotional materials for marketed and investigational products/devices. This position plays a crucial role in ensuring presentations of medical, scientific information, and documentation meet various standards for pharmaceutical promotion and scientific exchange. This role is responsible for fostering positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups from Global Headquarters, Affiliates and...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Senior Manager, Quality Engineering - Minnetonka MN This position works out of our Minnetonka , MN location in the Electrophysiology business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Senior Manager Quality Engineering , you’ll provide leadership and guidance for the quality engineering department supporting commercial products and new product development. This role is responsible for developing goals, objectives, procedures, policies, and systems that are in line with company goals and objectives, mission and...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Contract Compliance Analyst III will facilitate contract implementation and revenue pull-through activities, both proactive and reactive, with internal and external parties. This position will ensure the public and private payer reimbursement. The role is also fundamental in...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Lead Quality Assurance Engineer, Supplier Quality will provide supplier related QA technical and compliance support for commercial, clinical, and future products. This role ensures all suppliers and the materials provided are in compliance with product specifications and...

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

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

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

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