Quality & Regulatory Jobs in Pharma & Biotech

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

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...

Medtronic Santa Ana is looking for an experienced quality engineer to support our manufacturing in Santa Ana, CA. This position is located in Santa Ana, CA (100% on-site role) and reports into Global Manufacturing and Supply Chain Quality organization. Santa Ana site is part of the OC Campus, consisting of Santa Ana, CA (primarily Cardiac Surgery, Structural Heart portfolio) and Irvine, CA (primarily Neurovascular portfolio). The primary responsibilities for this role includes project management, NPI and day-to-day productions supports with close collaboration with cross-functional supporting teams (engineering, productions, OPEX, microbiology, PMO, facilities, etc.). Responsibilities may include the following and other...

We are searching for the best talent for a Regulatory Affairs Specialist II to support our Spine group. This role will be based in our Raynham, MA office and will work a Flex/Hybrid schedule with 3 days per week in office . There is NO remote option. You will be responsible for Provides regulatory guidance to product development teams in defining regulatory strategies, pre-marketing, and related submissions to support optimal timelines for new/modified product launches in the global market. Execute on the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but...

Biosense Webster a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer located in Irvine, CA! 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 Under general supervision, participate in new and sustaining product/process teams to support design verification tests, process validations, quality processes. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance...

Johnson & Johnson MedTech Research & Development Quality (RDQ) is recruiting for Clinical Supplier Quality Manager. The preferred locations are Raritan, NJ, Titusville, NJ, Bridgewater, NJ, West Chester, PA, Bridgewater, MA, Spring House, PA; Warsaw, IN, Raynham, MA; Jacksonville, FL, or Irvine, CA. However, the role can be performed at any location in the US. Remote work options may be considered on a case-by-case basis and if approved by the company. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help...

Biosense Webster a member of Johnson & Johnson's Family of Companies, is recruiting for an Eng Quality Engineering located in Irvine, CA! 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 Senior Quality Engineer – plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design...

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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing...

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 Deviation Mentor is a key member of the Quality Assurance...

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. Help us advance our purpose to make life-saving medicines that matter...

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

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...

Supplier Development Quality Engineer II This position works out of our St. Paul, MN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Supplier Development Quality Engineer II , you’ll have the chance to develop components and associated quality requirements for new product initiatives. This position is responsible for managing supplier relationships, qualifying components and developing incoming controls that will drive the quality of future components. This will include technical support...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at . We are searching for the best talent for a Quality Technician III. Purpose An individual contributor that executes routine tasks with limited supervision and more complex tasks with support. Executes day-to-day activities such as equipment setup, metrology support, and general housekeeping. Maintains good documentation practices. Performs instrument qualification/validation activities and lab investigations, and data review and metrics reporting. Identifies improvement opportunities...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. The Associate Director, Ethics & Compliance Advisor reports to the US Ethics and Compliance Head and responsibilities include Work with the Senior Director advising Liver Commercial to provide expertise in healthcare compliance, ensuring that activities align with the highest ethical and compliance standards. Partners with leaders across Gilead to build and integrate the compliance program into Gilead’s organization and to embed compliance and integrity into Gilead’s culture. Help drive global consistency in our compliance program and ensure best practices are...

Sr. Quality Engineer will support day to day activities on manufacturing process. Support nonconformance investigations, audit process and CAPA process. Will oversee manufacturing and engineering processes to ensure proper use of tools, materials, and procedures. Developing and implementing quality control to analyze and improve existing systems. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating...

Careers That Change Lives In this exciting role as a Senior Quality Systems Manager, you will have responsibility for QMS Data Analytics, Data Reporting and managing multiple Digital based improvement initiatives within the Quality Transformation organization that will systematically evaluate and transform the capability of the Quality Management System (QMS) to better meet the needs of its stakeholders, both internal and external. Diabetes The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly...

Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer I will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. The Quality Engineer I role is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life of...

The Senior Validation Engineer will be responsible for equipment/facility validation projects in a hands-on role including writing validation protocols, completing data sheets, scheduling and performing validation tests, gathering and analyzing data, and writing final validation reports KEY RESPONSIBILITIES Identify systems requiring validation. Lead the development of required validation procedures and practices with respect to the facility. Develop validation project/assignment detailed schedules to coincide with the milestones on the master plan. Design and implement required validation studies and protocols for the facility and equipment as per required schedules. Coordinate and lead resources required to complete validation studies and tests in a...

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

At 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 Manager – QA will be responsible for quality support for...

Johnson & Johnson is hiring for a Associate Regulatory Operations Specialist – Shockwave Medica l to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the...

COMPANY BACKGROUND& CULTURE Johnson & Johnson (J&J) is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and professional markets. J&J employs approximately 126,500 people worldwide, deployed in more than 250 operating companies in 60 countries. Products are sold throughout the world and serve a broad segment of medical needs ranging from baby care, first aid, and hospital products to prescription pharmaceuticals, diagnostics, and products relating to family planning, dermatology, and feminine hygiene. Johnson & Johnson and its subsidiaries have built the most comprehensive base...

Johnson & Johnson is hiring for a Sr. Quality Engineer – Shockwave Medica l to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment...

We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in Santa Clara, CA or St. Paul, MN. As an individual contributor, the function of a Regulatory Affairs Specialist I is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide. What You’ll Work On Analyzes the input of cumulative product changes to current product submissions. Shares knowledge...

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...

Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. The Quality Engineer II role is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life of our...

Careers that Change Lives A career Medtronic is currently searching for a Sr. Principal Quality Engineer to join the New Product Development team at the Lafayette, CO facility. You’ll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities. Key Responsibilities Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services. Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems. Experience with PCBA suppliers and validation of PCBA test...

Job Purpose This position is focused on regulatory policy to ensure appropriate and effective regulatory policy development as well as developing and advocating for BMS’s position externally. As part of the team, the Associate Director Regulatory Policy brings an expertise in regulatory affairs and related policy. The Associate Director, Regulatory Policy is responsible for driving regulatory policy mapping, advocacy, clear objectives and actionable outcomes. The incumbent acts as a critical link between global, regional, and local regulatory environments, ensuring the business stays ahead of evolving regulatory policies. A core aspect of the role is driving long term policy goals that...

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect 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 An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Analyst Quality Control to be in San Angelo, TX. Job Summary Responsible for conducting complex test and analysis to assure that product comply with established specifications. Duties & Responsibilities Under general direction and in accordance with all applicable federal,...

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

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, Quality Transformation & Digital Enablement – Transformation Office,...

Job Responsibilities Process Development & Standardization Design and refine the quality processes that support our combination product development lifecycle, with a focus on developing and implementing standardized work and best practices to be applied consistently across all MDCP programs. Champion initiatives to improve the systems governing design controls, change control, and documentation. Interface & Boundary Definition Architect the operational interfaces and delineate clear system boundaries between key internal partner functions (e.g., Drug Product, Packaging, Device Engineering, etc). Establish formal processes for hand-offs and define ownership to ensure seamless integration in the development cycle. Project Leadership & Execution Serve as the...

Principal Software Quality Engineer Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. We focus on providing innovative solutions for ENT conditions, including surgical and therapeutic products designed to improve patient outcomes in ear, nose, and throat health. We are currently offering an excellent opportunity to join the ENT Quality team as a Principal Software Quality Engineer . This position is based onsite in Jacksonville, FL . Role Overview In this role, you will serve as an individual contributor responsible for ensuring the quality of software design and development for medical devices and related software...

Medtronic – Milwaukee, WI manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. In this role, the Quality Engineer I is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Senior Manager, Compliance and Quality Risk Management at RayzeBio serves as the Local Process Owner for Risk Management and Data Integrity, responsible for driving consistent, compliant, and risk-based practices across the site. This leadership role ensures alignment...

Position Senior Specialist, Field Quality Location Devens, MA 12 Hrs. rotational shift 500 am to 530 pm Key Responsibilities Quality floor support of complex manufacturing activities for Large Scale Cell Culture (LSCC) facility. 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...

Join Us in Shaping the Future of Animal Health Our Animal Health division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s largest economic development project to date. As a US Regional Project Quality Lead you will be part of a world-class team at our Center of Excellence in the Animal Health Corridor, contributing directly to the production of veterinary products that improve animal health and welfare globally. Key Responsibilities Acts as the QA/QC lead in establishing the quality assurance, quality control and compliance foundation in future project operations....

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. Additional 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...

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

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

Director- Site Quality Head The Opportunity Abbott Diabetes Care has an opportunity for a Director - Site Quality Head. The Director leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies. What You’ll Work On Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially...

Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Senior Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. The Senior Quality Engineer role is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life of...

As a quality inspector at the Billerica site, you will work as part of a high-performing team in the cleanroom, inspecting catheters used in cardiac ablation procedures. Your attention to detail and commitment to quality will help ensure our products meet the highest standards for patient safety. Schedule Monday - Friday, 10 pm - 630 am (3rd shift / overnight) Environment Cleanroom standards apply. PPE is provided and must be worn in the manufacturing area. Compensation Base hourly rate $24/hr + $3/hr shift differential Quarterly Operations Incentive bonus PTO - 4 weeks / year Paid holidays - 10 / year...

Responsibilities may include the following and other duties may be assigned. Support review of advertising and promotional material to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved to support business needs. Act as SME for Neurovascular Ad Promo process, providing guidance to authors and reviewers on regulatory and internal policy requirements. Support the preparation of US and International promotional labeling material, including the creation of a claims matrix database and claims objects. Lead AI/ML adoption in content and claims management to support...

OBJECTIVES/PURPOSE Provides governance and oversight to all GxP Engineering and associated Equipment validation activities including Facility Engineering standards, Maintenance and Calibration processes, Commissioning, Installation, Operational, and Process Qualifications at Takeda to ensure compliance with GxP regulatory and quality standards while maintaining the integrity of data Oversees Business Processes and partners with Business Process Owners for applicable Validation activities to ensure consistency of approach across the network, including validation site master plans Ensures consistent use of applicable North Star systems to capture engineering and associated validation activities, such as installation and operational qualifications (IQ/OQ), Process qualifications (PQ) and...

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

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

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

Purpose The Sr. Manager, Quality Strategy and Data Analytics will be accountable supporting the creation of the site and/or global Quality Strategy and the successful delivery of assigned programs and projects, and the overall delivery of the Quality Strategy. The role will serve as a key contributor in end-to-end project/program objectives and outcomes, especially driving efficiency and agility with a strong focus on automation and utilization of digital tools (e.g., AI). This role will drive and support projects across the site and/or global quality functions and will identify and communicate opportunities to their respective leadership teams. Additionally, this role will...

We are seeking a Senior Director, GxP Quality to lead and scale quality strategy and operations across our development-stage programs. This is a key leadership role responsible for building and maintaining phase-appropriate quality systems across GCP, GLP, and GMP activities. The Senior Director will partner cross-functionally with Clinical Development, CMC, Regulatory, Technical Operations, and external partners to ensure compliant execution of Generate’s drug development strategy, with their primary focus on clinical quality assurance in the late stage. The ideal candidate brings deep technical expertise, a pragmatic mindset and hands-on approach, and the ability to lead quality initiatives in a lean,...

This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division. 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. We are seeking a high caliber Software Quality Engineer I. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. Work requires the application of theoretical engineering principles, evaluation, ingenuity and creative/analytical techniques typically acquired...

Job Title Electrical Development Quality Engineer II Our location in Sylmar, CA currently has an opportunity for an Electrical Development Quality Engineer II . This is a fully onsite role . A Development Quality/Design Assurance 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. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias,...

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

COMPANY BACKGROUND & CULTURE Johnson & Johnson (J&J) is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and professional markets. J&J employs approximately 126,500 people worldwide, deployed in more than 250 operating companies in 60 countries. Products are sold throughout the world and serve a broad segment of medical needs ranging from baby care, first aid, and hospital products to prescription pharmaceuticals, diagnostics, and products relating to family planning, dermatology, and feminine hygiene. Johnson & Johnson and its subsidiaries have built the most comprehensive...

Johnson & Johnson MedTech Orthopedics (a member of the Johnson & Johnson Family of Companies) is currently seeking a Quality Engineer II to join our outstanding team located in Warsaw, Indiana. 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 Quality Engineer II position will apply leadership, interdependent partnering, and Quality Engineering expertise to ensure efficient and effective quality & compliance and continuous improvement in our end-to-end business with a...

We are searching for the best talent for a Sr. Manager of Enterprise Quality CSV to be located in Raritan, NJ and/or Horsham, PA. Purpose Enterprise Quality (EQ) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. EQ is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections. The...

Johnson & Johnson is currently seeking a Site Based Compliance Manager to join our Regulatory Compliance team located in Raritan, NJ. The Site Based Compliance Manager is highly visible to the Raritan site Leadership team and ensures understanding and alignment of the site to global regulatory compliance initiatives and executes local programs to ensure compliance at the site. Key Responsibilities Lead and complete internal audits (schedule, issue agenda, prepare, conduct audit, issue report, and evaluate responses) at the site, and participate in internal audits at other sites Organize and complete compliance walk-throughs (e.g. GEMBA) of the supported areas and issue...

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...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a highly motivated Senior Manager to join the Global Supplier Quality team within External Quality Operations. This position will support Biologics (e.g., single-use systems, resins, filters, media, excipients) material categories. The role is designed to provide hands-on operational execution and external relationship management for the material categories. The individuals will manage global changes, investigations, and onboarding activities, while also growing into broader leadership roles over time. The role is highly visible, offers tremendous growth potential, and requires...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a highly motivated Senior Manager to join the Global Supplier Quality team within External Quality Operations. This position will support Parenteral Packaging (e.g., vials, syringes, stoppers) and Device categories . The role is designed to provide hands-on operational execution and external relationship management support for the material categories. The individuals will manage global changes, investigations, and onboarding activities, while also growing into broader leadership roles over time. The role is highly visible, offers tremendous growth potential, and...

The Sr. Principal Analyst, Quality Systems plays a key role within the QARA (Quality and Regulatory) Technology function. The role will be a key technical resource overseeing the Quality Batch Disposition system. Primary responsibilities include gathering and refining requirements, determining options for solution design, supporting integrations, maintaining system operations, and delivering enhancements. Key Duties and Responsibilities Serve as the platform owner for an integrated quality batch disposition system. Implement and manage data and technology solutions across Vertex Quality, with focus on integrated quality batch disposition system. Lead installation, configuration and troubleshooting processes for integrated batch disposition Conduct data quality assessments,...

Vertex is in an exciting time of growth and innovation, and technology and data are valued as strategic assets. The Data & Software Engineering team in the Data, Technology and Engineering (DTE) organization is seeking an experienced technology lead to help create, maintain, and implement the technology strategy, platforms and applications that enable data quality (DQ) across the enterprise. As the Associate Director, Data Quality, you will report to the Director, Data Governance and be responsible for building and managing data quality platforms, processes and strategy. You will work across the organization with data engineers, analysts, data stewards and product...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In your role, you may work from one the following Medtronic sites Mounds View, Minnesota Boston, Massachusetts Fridley, Minnesota (OHQ) Lafayette, Colorado Rice Creek, Minnesota Jacksonville, Florida Irvine, California (UCI) In this critical role, you will serve...

Responsibilities may include the following and other duties may be assigned. Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems. May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products. Oversees the investigation and evaluation of existing technologies. Guides the conceptualization of new methodologies, materials, machines, processes or products. Directs the development of new concepts from initial design to market release. Manages feasibility studies of the design to determine if capable of functioning as intended....

GSK is currently looking for a Quality System & Data Associate Director to join our team in Rockville, MD. The Quality System & Data Associate Director provides leadership to a team of Quality professionals and is critical in overseeing data integrity and governance, document control, training compliance, Quality Management System (QMS) deployment, as well as defining and driving the site Quality Improvement Plan. The role also includes responsibility for driving GPS for Quality, Quality Culture and embedding Digital Strategy into the Quality organization. The Quality System & Data Associate Director reports to the Site Quality Director and is part of...

EM and S Vaccines and Large Molecules GenMed Head of Transversal Quality Location Cambridge, MA, Framingham, MA, Morristown, NJ About the Job 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. External Manufacturing & Supply Vaccines and Large Molecule GenMed is responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in...

About the role The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's mission to provide better health and a brighter future. This role can be located in Cambridge, MA or Zurich, Switzerland and is Hybrid (not remote). R elocation Benefit is available to support your transition. How will you contribute Ensure compliance to Regulatory Intelligence Procedures...

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. Overview The Senior Director, Global Quality – Supplier and Materials Management,...

The role primarily supports M-F day shift. Candidates must be willing to support rotational weekend work (likely every other weekend) as required to meet project timelines and operational priorities. About This Role The QC Bioassay & Virology group in RTP, NC has an opportunity for an Associate III within the release and stability testing team. The group supports Quality Control testing of GMP samples using a broad range of biological analytical methods, including bioassays, cell-based assays, PCR, ELISAs, potency and binding assays. The team also provides reagent qualification testing, validation and transfer of analytical methods, and technical support of QC...

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients. What You Will Achieve This position is part of the PSSM (PharmSci Small Molecule) API Operations Quality team in Groton, CT. The candidates time will be split between support of the Quality Operations of GMP Clinical API Manufacturing role and support of documentation management activities. The Quality...

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. Quality & Compliance Internship Program Overview The Quality and Compliance organization within the Enterprise organization for the Med Tech and Innovative Medicine sectors are seeking highly motivated...

The Associate Regulatory Affairs Director (RAD) , Regulatory Science & Execution will be accountable for the develop ment, implement ation and maintenance of regulatory strategies for assigned project(s)/ product (s) and regulatory jurisdiction ( s ) , with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide tactical and strategic input to and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working...

Do you have expertise in, and passion for Patient Safety? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Working with one of the broadest and deepest OnDo cology pipelines in the industry offers the...

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

The Associate Director of QC Raw Materials manages and directs the Vertex cell and gene therapy raw materials team. This position will provide leadership and technical expertise in Quality Control Raw Materials Program Management. The role is responsible for leading other QC personnel, optimizing Department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values Key Responsibilities Develop and execute the QC Raw Materials program strategy for in-house manufacturing of Vertex Cell and Genetic Therapies. This position requires strong partnerships with process development(PD), Supply Chain...

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of three key businesses Cardiac Pacing Therapies, Defibrillation Solutions, and Cardiac Diagnostic Services. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward...

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is composed o f four key businesses Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. 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...

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. 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...

As a Sterile Operations, Validation Leader, you will provide guidance and direction to a team of Validation Professionals supporting the construction, start up, commissioning, and qualification of an R&D, clinical manufacturing, Drug Product filling facility. The new DP facility as well as this position will be located in Marietta, Pennsylvania. After the facility is released for GMP manufacturing, the role will include routine validation support of the facility including, but not limited to validation maintenance, Change Control management, new equipment / system introduction, decommissioning, and other validation life-cycle requirements. This role requires consistent and continuous on-site presence. Although the role...

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. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was...

Job Tite Summer 2026 Intern - Validation Team Location Swiftwater, PA About the Job 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. Our team is looking for a summer intern to assist in lab experiments, development and validation studies for cleaning and shipping validation with different vaccine products. In addition, the intern will also support collecting and analyzing...

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. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was...

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 selected candidate will join Sanofi's Manufacturing and Supply – Vaccines division as a Quality Control Virology intern at the Swiftwater facility, gaining valuable hands-on experience in vaccine testing processes while contributing to our mission of protecting global health. As a QC Virology Intern, the candidate will support our team...

Position Global Quality Large Molecule Analytical Sciences (GQLMAS) , Our Company's Manufacturing Division is responsible for the commercialization of vaccine analytical techniques from Phase III through launch including transfer to commercial manufacturing sites as well as in-line analytical support to enable world-wide robust vaccine availability. This team is highly motivated, fast-paced and focused on the rapid advancement of our Company's vaccines pipeline, plus growth of existing products. This position will influence all stages of late stage development, validation, transfers and assay life-cycle management and methods supporting our Company’s vaccines pipeline and inline products. Specific job responsibilities will include Timely...

This Regulatory Affairs Project Manager position is an onsite opportunity working out of our St. Paul, MN location in the Abbott Vascular Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. In collaboration with the Regulatory leadership, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets. Additionally,...

This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment to innovation and excellence. But we’re more than just a...

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

This position is responsible for providing investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes. Applicants must comply with Corporate and HR Policies, Security Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function Duties/Responsibilities Perform investigations, using eQMS (Infinity) system, for Supplier Complaints including but not limited to BMS and Supplier’s processes. Create and execute Corrective Actions and Preventive Actions (CAPA) Prepare, submit and discuss finding of the investigation process with key stakeholders. Lead global investigations in collaboration with Global Quality Supplier...

We are seeking a Principal Regulatory Affairs Specialist to join Abbott’s Vascular Division on-site in St. Paul, MN. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position 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. Supports necessary regulatory activities required for product market entry. The individual may...

This position works out of our Plano, TX location in the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. This role performs inspection and testing of purchased materials, components and products in accordance with policy and procedures. What You’ll Work On Performs visual, dimensional and functional inspection and testing according to documented policies and procedures. Records inspection and test data as prescribed by written instructions and procedures. Recommends changes...

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will Perform validation testing, system administrator management, laboratory support and laboratory troubleshooting on laboratory instruments and computer systems. Plan, develop, and execute Installation Qualifications (IQ), Operation Qualifications (OQ), Performance Qualifications (PQ). Develop and execute validation and verification...

About the role This position holds ultimate responsibility for the overall Quality Assurance of Site Teardown and Fractionation Operations at Takeda’s Los Angeles Manufacturing Facility. The role is essential in ensuring that all quality-related activities meet regulatory standards and uphold Takeda’s commitment to excellence. The incumbent will work in close partnership with Manufacturing and Engineering Business Unit Leaders to ensure the timely implementation and ongoing maintenance of prevention-based Quality Systems. These systems include exception management, CAPA, Change Control, and Quality on the Shop Floor, all of which are critical to maintaining compliance and driving operational efficiency. Beyond quality oversight, the...

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

As a Principal Regulatory Affairs Specialist at Medtronic, you will play a critical role in shaping the global regulatory strategy for innovative medical technologies. You will provide strategic input and technical guidance to ensure our products meet evolving domestic and international regulatory requirements. This high-impact role involves leading regulatory submissions, maintaining compliance, and driving collaboration across teams to support product development and lifecycle management. Your expertise will directly influence patient access to life-changing therapies worldwide. Key Responsibilities Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering global regulations. Lead or perform coordination and...

About the role Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management and serious breach process. This role focuses on defining activities, processes, and standards to meet quality requirements relevant to deviation management and serious breach. This position supports Takeda's mission by maintaining high standards of quality and compliance in clinical trials. This role is located in Cambridge, MA and is Hybrid (not remote). R elocation Benefit is available to support your transition. How will you contribute Drive the implementation of clinical deviation management and Serious Breach process across Clinical Program Quality. Acts as...

Shire Human Genetic Therapies, Inc. is seeking a Quality Control Analyst II with the following duties test biochemistry analytical methods for release and stability samples using qPCR (Quantitative Polymerase chain reaction), Kinetic Activity, Osmolality, Specific activity, Enzyme Activity, A280-320 protein concentration, pH, visual inspection and Reconstitution methodology. Provide subject matter expertise to junior level analyst in the lab. Proficiently use pH Meter, UV Spectrophotometer and solo VPE (Visual path extension), M5 and 384 Plate readers, 7500 fast Real-time PCR (Polymerase chain reaction) system and Osmometer. Provide support on maintenance of lab instruments in support of GMP (Good manufacturing Practices) testing....

Use Your Power for Purpose At Pfizer, we are committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer vaccines. By maintaining high standards and adapting to regulatory changes, you will play a key role in ensuring that our life-saving treatments reach those in need promptly and safely. What You Will Achieve ROLE SUMMARY This Director, Global...

Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate...

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

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...

Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of QC leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QC Head. Responsibilities Lead the biologics site Raw Materials and Incoming Materials laboratory processes and programs for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, FDA Guidalines, EMA, ANSI, among others. Ensure robustness and approves investigations Raw Materials & Incoming, quality and process excursions...

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...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. R ESPONSIBILITIES Serve as a Lead Subject Matter Expert and Process Owner for assigned areas, processes, and technologies. Lead collaborations with CRO partners to ensure continuous improvement and alignment with Gilead’s RBQM framework, including representing RBQM in governance committees. Provide oversight of vendors performing RBQM activities, ensuring effective, high quality, and timely delivery of portfolio requirements. Support inspection-readiness and participate in audits and regulatory inspections, serving as a point of contact for RBQM. Study Risk Assessment and Mitigations Provide expert...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. At Medtronic Cardiac Ablation Solutions, our vision is to provide cardiac mapping and ablation solutions that will enable clinicians to treat patients more safely and efficiently, with more predictable procedure times and outcomes. 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...

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). USA (Raritan, Titusville, New Brunswick, Horsham) Req # R-029355 Belgium (Beerse) Req # R-029498 Switzerland (Schaffhausen) Req # R-029484 Ireland (Cork) Req # R-029498 The Vice President Quality Systems is responsible for providing high-level strategic oversight and direction for quality initiatives across the organization, including QMS, process ownership, capa/escalation and...

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

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...

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...

This position works out of our Atlanta , Georgia location in the Heart Failure Division . In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Supervisor, Quality is responsible for the performance of his or her team and meeting any assigned project timelines and objectives. Keys to success include proper management of product support while ensuring quality and compliance of employees/equipment, promotion of a safe and positive work environment, constant pursuit of business excellence initiatives, successful management and development of...

This position works out of our Sylmar CA or Austin TX facily. What You’ll Work On Abbott is currently seeking an experienced professional to provide Provides direct oversight for moderately complex elements of Abbott’s compliance program at the franchise, business unit, regional, divisional, or corporate level. Responsible for directing the development and administration of OEC education and training, and development and implementation of divisional monitoring plan. Identifies compliance risk areas and recommends action plans to ECO or direct management. Responsible for direct compliance support of key business activities for the applicable business unit. Responsible for direct compliance support to e.g....

That’s what makes us Roche. The Opportunity As the site Data Integrity & Quality Governance Lead, you will be responsible for supporting the data integrity related programs governing compliance to all applicable regulations and guidances, both external and internal (e.g., 21 CFR 211, 21 CFR Part 11, EudraLex Volume 4 Part I, II and Annex 11, ICH Quality Guidelines, Industry Standards, GSP005, GSP006, Network and Local SOPs). You will be responsible for helping to provide oversight of the site data integrity program, and supporting initiatives with respect to data management, governance, integrity, issue resolution and quality. You will be responsible...

As a Quality Technical and Validation Manager, you will be responsible for overseeing the technical quality assurance and validation activities to ensure compliance with regulatory requirements, industry standards, and GSK policies. You will play a critical role in maintaining the highest levels of product quality and safety. This role leads a team that has responsibility and accountability for ensuring the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within GSK's manufacturing and analytical environments. This includes overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless introduction of products from...

The Compliance Program Manager plays a critical role in ensuring the effective execution of Field Corrective Actions (FCA) across the organization. The role is responsible for overseeing the enterprise FCA planning process, ensuring compliance with quality system requirements, and driving continuous improvement in the FCA process. Additionally, the Compliance Program Manager will help to foster a culture of accountability and excellence while managing the end-to-end FCA process. This position demands a proactive approach to problem-solving, exceptional organizational skills, and a strong commitment to maintaining the highest standards of regulatory compliance and patient safety. Responsibilities may include the following and other...

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. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of...

Are you ready to help advance healthcare innovation? J&J is recruiting for a Global Design Lead (data design and process design), reporting into QC Operations in Raritan, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for...

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. As a Supervisor Quality Assurance, main responsibility will include ensuring the quality standards and procedures are upheld in all site and operational processes. Role expectations will include leading a team in monitoring, evaluating, and improving operational efficiency and effectiveness while maintaining compliance with regulatory requirements and company standards. What You’ll...

This position works out of our Alameda, CA office in the Lingo Division. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. This position is responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. What You’ll Work...

What you will do In this role the Senior Engineer position reports to the Sr, Manager of Validation. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the Amgen Ohio facility. Functions The Senior Engineering will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the Amgen Ohio manufacturing site. The position is a key role in the Process Development team where the candidate must manage and/or apply...

Job Responsibilities Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions Lead new quality focused initiatives focused on new learnings, findings, and observations to continuously improve CDS quality practices and methods Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions...

J&J MedTech Surgery, a global leader in surgery with products and solutions found in almost every operating room around the world, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues so that people may live longer, healthier lives. Through our surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats, we deliver innovation to make a life-changing...

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 and...

Quality Control Inspector II Structural Heart Business Mission Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. The Quality Control Inspector II provides an independent, unbiased evaluation of materials or the work of others. The results of the Inspector's evaluation is documented and communicated to organizational stakeholders with an interest in the evaluation's outcome - typically, this is supplier development and/ or manufacturing. The Inspector's approval certifies the work or material meets Abbott's quality system requirements. What You’ll Work On...

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

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

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 Johnson & Johnson is recruiting for a Staff Software Quality Engineer , located in Santa Clara, CA. Our team advances the MONARCH™ surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products. We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes and advance medical professionals’...

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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing...

Quality Assurance Senior Manager What you will do This QA Sr. Manager role will be responsible for the quality oversight of primary component suppliers. This person is an integral member of the Amgen cross-functional supplier team(s) that includes, but is not limited to, business operations, process development, supply chain and combination product quality. Key Responsibilities include Ensure appropriate quality oversight of suppliers in line with global regulations, define quality requirements for suppliers and monitor performance Quality liaison between Amgen and the supplier Negotiator and owner of quality agreements Prepare external site for inspections including development of inspection playbooks....

Lead global regulatory strategy and execution for our innovative biologics/combination product portfolio. As Sr. Director of Regulatory Strategy, you will shape and drive regulatory pathways from preclinical through commercialization and lifecycle management. This key leadership role combines strategic oversight of registration requirements, regulatory submissions, and health authority interactions across markets. The ideal candidate brings deep expertise in global biologics regulations, with demonstrated success in navigating complex regulatory landscapes for combination products. Join our dynamic team to advance breakthrough therapies while ensuring regulatory excellence and compliance across all stages of drug development. The ideal candidate will live in the San Diego...

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 is currently seeking a Facilities Management Compliance Lead to join our team. The role will be located in Wilson , North Carolina . As the FM Compliance Lead you will be responsible for the compliance and...

Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory guidance to cross-functional partners in support of various programs. What You’ll Work On Prepares robust regulatory applications to achieve departmental and organizational objectives. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise on complex worldwide strategies with the help of international regulatory affiliates. Compile,...

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

Senior Development Quality Manager This position works out of our Menlo Park, CA 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. We are seeking a passionate Senior Development Quality Manager to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring...

We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in Sylmar, CA or Scottsdale, AZ . As an individual contributor, the function of a Regulatory Affairs Specialist I is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for US and international registration assessments. What You’ll Work On Annual Reports – FDA APRs, ARCs (support), Custom Devices, Ics (support)...

Quality Compliance Manager What you will do Let’s do this! Let’s change the world! We are hiring a Quality Compliance Manager, which will operate within the General Medicine & Obesity Quality Therapeutic Area. In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program. (protocol development, database lock, and regulatory submissions/ approvals). Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting...

A Day in the Life Medtronic is currently searching for a Principal Quality Engineer to join the New Product Development team at the Lafayette, CO facility. You’ll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities. Key Responsibilities Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services. Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems. Experience with PCBA suppliers and validation of PCBA test...

About Synchron Synchron is a neurotechnology company with a mission to deliver the first commercially scalable brain-computer interface (BCI) for millions of people with paralysis to reconnect with the world. Our minimally invasive BCI system is designed to enable users to control digital devices directly through thought, restoring access and control over the digital world. Our team is working at the intersection of healthcare and technology to translate breakthrough research into real-world care. Join us in shaping a more connected and accessible future. As a Quality Assurance Engineer in our newly formed division in San Diego, CA, you will...

Job Title Software Quality Engineer II Our location in Sylmar, CA currently has an opportunity for an Software Quality Engineer . This is a fully onsite role . This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for non-product software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. 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 DO Provide guidance and training to the...

This position works out of our Alameda, CA office and is responsible for ensuring that Abbott and Lingo product software and computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. This is an individual contributor position which may have responsibilities to monitor and direct the work of contractors/temporaries. What You’ll Work On Participates as a member of the project team for Lingo products that incorporate software/firmware into their system. Completes SWQA tasks in accordance with current Quality System Requirements. Works independently with objectives given by SWQA Manager....

This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We are seeking a passionate Manager in Quality Engineering to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products...

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

Senior Manager/Associate Director, Regulatory Medical Writing X-TA At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. 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...

As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions. The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data and ensuring that the information is reliable and effectively presented to substantiate claims. You'll also have opportunities to participate in worldwide regulatory submissions. This is a broad scoped position with strong opportunity for growth and career development based on performance. What You’ll Work...

Position We are seeking an experienced Senior Manager to Associate Director, Regulatory Affairs, to manage our regulatory clinical trial applications (CTAs) and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to develop ex-US CTAs, and manage the maintenance of applications submitted to Competent Authorities (CAs) in support of study initiation. This role is a member of the program teams within the function of Regulatory Affairs.This role will require a minimum of 3 days a week of onsite presence (or...

About the role As Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. You will report to Head of Engineering Services. This is an on-site position, and you will be required to work all five days from the office. How you will contribute Be a Validation Engineering representative and technical subject matter expert (SME)...

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to Career development with an international company where you can grow the career you 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 a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s...

Provides leadership & strategy for a group of IT professionals supporting a major organizational unit responsible for the definition, development, implementation, operation and support of computer-based systems and related processes and tools which provide information for reporting, operations, and decision making for the Quality Non-Complaints, LMS (Learning Management), DMS (Document Management), and Global Engineering Systems (GES) within the Quality-Regulatory-Engineering Services BSS Organization. What You'll Work On Creates and manages Corporate Quality Non-Complaints, LMS, DMS & GES Strategies and Architectural Framework in partnership with Divisional BRM’s Aligns department priorities appropriately, determines critical success factors, evaluates and pursues initiatives, investments and opportunities...

As Senior Analyst, Data Quality, you will join our Commercial Data Management team and become a key contributor in building scalable quality control processes and partnering closely with cross-functional teams to ensure our data is trusted, accurate, and business-ready. This is an exciting opportunity for a detail-oriented, analytical thinker who enjoys tackling complex data challenges, working collaboratively across teams, and utilizing cloud data technologies to make a significant impact in a pivotal position. Your responsibilities will include the following activities _ Your Contributions (include, but are not limited to) Execute recurring quality control checks on commercial datasets including sources such...

Careers That Change Lives In this exciting role as a Sr Quality Engineer you will Witness cutting edge surgical navigation and robotic technologies designed to alleviate pain, restore health and extend life. Representative and/or Lead for the New Product Introduction ( NPI ) Quality team on the NPI Core Team on small to medium size project s . Compliance oversight over the medical device NPI activities in accordance with the applicable Standard Operating Procedures (SOP's) and External Standards as part of the NPI process. Contribute and lead activities during the following activities Risk analysis, including product risk a ssessment...

Careers that Change Lives A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people . Help us engineer the extraordinary! Bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. Learn more about Medtronic benefits and compensation at the bottom of this job description. We...