Quality & Regulatory Jobs in Pharma & Biotech

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

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...

Your skills could be critical in helping our teams accelerate progress. The Manager, Global Regulatory Affairs - CMC has the responsibility of one or several products/valences in the Reg CMC Vaccines group. They will also develop the product(s) CMC submission strategy and is responsible for managing all the regulatory CMC aspects throughout the life cycle of the product(s) they have in charge from development (where necessary) through post licensure. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented...

Provides Regulatory Strategy support for the preparation of and coordination of document packages for regulatory submissions. Conducts review of regulatory documents. Maintains various regulatory databases and document tracking systems. Under direct supervision, may act as Regulatory Strategy department contact for various internal projects or program activities. _ Your Contributions Under direct supervision, assist with preparation of submissions to regulatory authorities (e.g. clinical trial applications, IND/IND supporting documents and maintenance submissions, annual reports, expedited safety reports) Conducts review of clinical regulatory documents. Performs quality checks of submission documentation and publishing output Updates and maintains logs, databases and catalogues of regulatory...

Use Your Power for Purpose The Director, Quality – QMS & Quality Event BPO serves as the owner and key point of contact for the Research, Development and Medical Quality Event process (QMS01) at Pfizer. Additionally, this role supports Pfizer by monitoring the health of the RDM QMS and identifying cross functional areas of opportunity or risk to action and report to quality governance. This colleague also supports other QMS’ / QRCs (e.g. PGS) as applicable. Finally, this role is responsible for QMS oversight activities and including continuous improvement efforts What You Will Achieve QMS Ownership QMS Business Process Ownership...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Eli Lilly and Company seeks a Quality Assurance Associate Director (M2)...

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, manufacturing plants and offices that are designed to inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development. We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of sterile products, making...

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...

We are searching for the best talent for a Manager, Regulatory Affairs (International Regulations) to be located in Irvine, CA. This role will work a Flex/Hybrid schedule with 3 days per week in office . Purpose The Manager, Regulatory Affairs, International Registrations develops and implements regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. You will be responsible for Manages a team of individual contributors and/or supervisors, ensuring the effective identification and preparation of detailed international registration documentation that supports all stages of a medical device's lifecycle, from initial...

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 Operations Compliance Engineer Senior is responsible for the daily activities at the Northborough facility, in partnership with his/her team and peers, to achieve business objectives aligned with site priorities. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives....

The Director, Patient Safety Intake and Regulatory Submissions delivers Global Patient Safety (GPS) Department services according to ICH-GCP guidelines, regulatory requirements and Regeneron standard operating procedures (SOPs) and/or project specific procedures. This position is responsible for the oversight of the processes and systems which enable initial Intake of adverse event data (i.e., via electronic database capture (EDC), phone line, etc.), the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners and internal destinations in compliance with applicable global regulations (ICH-GCP) and contractual obligations, and follow up activities to ensure receipt complete and accurate safety information. This...

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...

As the Americas Regional Quality Head, you are accountable to maintain an effective management oversight on LOC Quality through having in place an effective QMS and a competent LOC Quality team to support GSK Supply Chain and Commercial business. Strong leadership and knowledge are required to develop LOC quality leaders to be highly effective in making quality and business critical decision, including building strong relationships with the external authorities (including FDA, Public Health Agency of Canada, ANVISA), and internal partners GSK commercial organization and GSK regulatory affairs organization. This position is to provide leadership and management support to the America...

ModernaTX, Inc. seeks a Specialist, Quality Assurance (QA) for its Norwood, Massachusetts location. Here’s What You’ll Do Participate in quality focused teams across Moderna’s broad ecosystem of functions. Oversee and review executed electronic and paper batch record documentation and work cross-functionally to drive corrective actions as needed. Execute and review disposition packages to perform Good Manufacturing Practices (GMP) release of drug product for clinical use. Enforce adherence to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and manufacturing documentation. Utilize knowledge to improve operational efficiency and participate in continuous improvement projects. Write, update and revise procedures and work instructions....

As a Medical Director, Senior Patient Safety Physician in Patient Safety BioPharma, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. BioPharma Global R&D drives our innovative pipeline, redefining science into valued new medicines and ensuring patients around the world can access them. Main Duties and Responsibilities In this role, you'll be responsible for the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level. Essentially, the continued safety...

At AstraZeneca, you can be part of crafting the next phase of Operations’ pathway towards the 2025 strategy. Build on our foundations of high performance through agility, responsiveness, reliability and efficiency to deliver our new modalities and complex pipeline to market at speed. Backed by an encouraging team, be part of accelerating our operational excellence with innovations in ground breaking science, Lean ways of working and evolving digital technologies. THIS IS A 3RD SHIFT POSITION M-F 1000PM - 630AM Accountabilities Act as a local process owner/champion for Quality Operations processes External Audit Readiness - handle the preparation activities for internal...

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society. THIS POSITION IS FOR 3rd SHIFT M-F 10pm - 630am. Accountabilities Support specific Quality Operations processes within assigned area External Audit Readiness - support the preparation activities for internal and external inspections, including...

Key Responsibilities Manages and maintains administrative oversight of PD Quality Agreements, facilitating the creation and filing of new quality agreements in the document management system in addition to supporting periodic revision of existing quality agreements. Owns the local execution of the Deviation Monitoring and Deviation Evaluation programs; analyzes deviations across PD sites to identify trends and deficiencies and works with the sites to develop remedial actions as necessary. Authors, reviews and approves documentation. Monitors documentation activities performed in document management system. Supports and coordinates document periodic revisions as required within Product Development Quality. Supports the Document Management program by driving...

Medical Devices & Diagnostics Global Services, a member of Johnson & Johnson Family of Companies, is recruiting for a Director, Strategic Capabilities – Packaging Environmental Compliance in Raritan, NJ 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) Zug, Switzerland- Req# R-018482 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as...

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. Associate Quality Control, Environmental and Utilities Monitoring What you will do In this vital role you will be...

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 Bioassay What you will do In this vital role, you will perform testing and assist...

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 Microbiology What you will do In this vital role, you will act as a Subject...

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. We are seeking a dynamic and innovative individual to serve...

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status. POSITION OVERVIEW As a Sr. Director, Early Oncology Global Regulatory Affairs, you will develop and execute Oncology regulatory strategies in...

The Logistics, Compliance and Engineering (LCE) co-op will be a part of a cross functional team that concentrates on deviation management, change control, cold chain management, technology support, and operational efficiency projects in support of the North America Supply Chain Management (NASCM) organization. The LCE co-op will collaborate with Operations, Quality, Automation, and Validation to drive change in a collaborative manner. The candidate will gain some understanding of cGMPs and cGDPs and will be tasked with a problem(s) to solve while contributing to multiple projects and activities across the facility and North America transportation network as required. The individual must...

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities This role reports into the Assoc. Director of Compliance and will report to a cluster lead for the EMEA / AP or US region....

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The senior specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities This role reports into the Assoc. Director of Compliance and will report to a cluster lead for the EMEA / AP or US...

Position Overview - Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing Controls and Device Supplier Management objectives and build QMS capabilities that touch every aspect of our business processes, systems, and data. The Associate Director will collaborate and interact with cross-function teams to identify opportunities for improvement and tackle challenges, balancing effective operations with transformative initiatives. The Associate Director, Quality System & Compliance will support to integrate the Device Supplier Management activities across MDCP programs and product...

The Associate Director, Compliance will possess working knowledge of AbbVie’s business, the current compliance environment, and the broader business impact of compliance issues to develop and provide solution-oriented compliance guidance related to AbbVie’s compliance program for the company’s Market Access Area. The Associate Director will also provide direct oversight for moderate to complex elements of AbbVie’s compliance program at the business unit, functional or corporate level to address compliance needs and training of Market Access leadership across multiple therapeutic-area aligned inhouse and field-based teams and activities, including National and Regional Account Contracting with health plans/PBMs, Group Purchasing Organizations, (GPOs), Supply...

This is a key quality assurance role reporting to the Quality Assurance Manager. This position performs as a Senior Analyst in Quality Assurance oversight of operations, production, process and equipment systems and computer validation at the Bioscience Laboratories Irvine (BLI). This position is responsible for one or more of the following duties or activities Provide QA oversight of operational activities, production, validations, and Technical Services projects. Ensure that QA systems and manufacturing/engineering systems undergo an independent assessment to eliminate any potential conflict of interest between ownership and administration. Review and approve Quality System documents SOPs, validation and technical protocols/reports. Review...

Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist, Ads/Promo Global – Shockwave to join our team located in Santa Clara, CA or Remote . 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....

Position Specialist, Quality Assurance Operations Location Devens, MA ******* 2nd Shift Mon-Fri 1030 am to 700 pm ****** Key Responsibilities Quality floor support for minor and routine manufacturing activities Performs routine manufacturing batch production record review for media/buffer/cryo in support of product release in accordance with specifications and SOPs. Perform walkthroughs of GMP areas documenting observations and areas of concern. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines. May...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Associate II, Shop Floor Quality Assurance team is responsible for 24x7 Quality collaboration and oversight of site operations, including but...

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

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

GSK is currently looking for Materials Operations Compliance Specialist to join our team in Rockville, MD. In this role, you’ll Lead the execution of warehouse operations safety/quality compliance standards by owning on-time closure of notifications, executing root cause investigations, owning/authoring deviations, writing SOPs in compliance with GMP standards and driving overall improvement plan for the department. KEY RESPONSIBILITIES Lead and execute safety and quality investigations including root cause analysis and corrective/preventative (CAPA) actions Lead warehouse improvement plans and execute projects to enhance safety/quality compliance and operational efficiency Establish and maintain warehouse operations inspection readiness state Ensure on-time closure of safety/quality...

Personalized healthcare is the future. 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. Join us and grow your career as you help Abbott shape the future of healthcare. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US on-site at our Alameda, CA location. In this...

Instrument Quality Technician Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Instrument Quality Technician is within our Infectious Disease Developed Markets business unit located in South Portland, ME. In this role you will serve as an advanced technician supporting the Global Instruments Quality organization. If you're looking for a dynamic role where your contributions will drive the development and manufacture of new products, systems, and processes,...

Project Leader (TPM – Third Party Manufacturing) Quality Working at Abbott 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. 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...

Instrument Quality Technician - Lead Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Instrument Quality Technician - Lead is within our Infectious Disease Developed Markets business unit located in South Portland, ME . In this role you will serve as a lead technician supporting the Global Instruments Quality organization. If you're looking for a dynamic role where your contributions will drive the development and manufacture of...

Instrument Quality Technician Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Instrument Quality Technician is within our Infectious Disease Developed Markets business unit located in South Portland, ME. In this role you will serve as an advanced technician supporting the Global Instruments Quality organization. If you're looking for a dynamic role where your contributions will drive the development and manufacture of new products, systems, and processes,...

The Patient Safety Medical Director will provide medical safety expertise for assigned products, pre- and post-approval. The role will optimize patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of Safety activities through the product life cycle. Key Duties and Responsibilities Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development) Responsible for the safety assessment activities of assigned products under the supervision of a Global Patient Safety (GPS) Disease-area Safety Head Autonomously monitors...

Introduction to role Are you ready to lead the charge in strategic communication excellence? As part of the Clinical Regulatory Writing team, you'll be at the forefront of crafting pivotal clinical-regulatory documents that align with project strategies and regulatory requirements. Our mission is to support core therapeutic areas throughout all phases of clinical development, ensuring successful submissions and approvals. Join us in driving communication leadership and making a tangible impact on drug projects! Accountabilities Independently manage clinical regulatory writing activities across a portfolio of work. Author clinical-regulatory documents within a program, ensuring adherence to regulatory, technical, and quality standards. Provide...

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide. Medtronic's Endoscopy Operating Unit (OU) is seeking a strategic and accomplished Sr. Director of Quality Assurance and Regulatory Affairs (QA/RA) to lead and evolve the global quality and regulatory function. This individual will be responsible for overseeing all aspects of quality compliance, regulatory strategy, product approvals, and post-market surveillance...

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...

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. The Cardiac Surgery Business is one of the fastest growing businesses, helping valve replacement patients across the globe. This role reports to the Sr Quality Manager . We are learning about culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our...

Careers That Change Lives In this exciting role as the Senior Principal Clinical Quality Specialist in the Cardiac Surgery O perating U nit , you will be responsible for providing experienced, comprehensive, and advanced expertise as the Operating Unit Quality Specialist . The Senior Principal Clinical Quality Specialist plays a critical role in ensuring the integrity, accuracy, and compliance of scientific data submitted to regulatory authorities. This position leads and conducts comprehensive audits, investigations, and quality reviews to assess adherence to regulatory requirements and internal standards. The specialist documents findings, recommends and tracks corrective and preventive actions, and may oversee...

Prin . Software Design Quality Engineer Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. The unit focuses 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 Prin. Software Quality Engineer. This position is based onsite in Jacksonville, FL. In this role, you will serve as an individual contributor with responsibilities in our technical functions to advance existing technology or introduce new technologies and therapies. You...

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

About the role The GMS Global Customs & Trade Compliance Excellence Management role delivers a unique customer experience through the development and management of a self-driving, compliant, and regionally unique distribution network, with our commitment to the patient, people, and planet. As the Global Clinical Trial Compliance (CTC) operational excellence subject matter expert, you will support continuous improvement efforts across Global Manufacturing and Supply (GMS) sites, ensuring alignment between site-level practices and network-wide projects. Additionally, you will monitor regulatory intelligence for GMS Global Quality (GMSGQ) by researching, analyzing, and tracking evolving regulations, while supporting CTC Regional Leads and Local CTC...

About the role As the Head of Quality Assurance you will lead quality oversight to ensure that all products meet applicable regulatory and Takeda quality standards across global markets. You will oversee critical quality systems including batch record review, product release, change control, deviation management, and annual product reviews, while driving compliance with cGMP and regulatory requirements. You will contribute in global and site-level strategic initiatives, supports regulatory inspections, and provides direction during quality-impacting incidents. Additionally, this position is accountable for resource and budget management, talent development, and succession planning to support long-term organizational success. You will report into the...

We anticipate the application window for this opening will close on - 12 Aug 2025 Position Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Irvine, CA. Provide quality engineering support for the successful development of Neurovascular products. Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Work with vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and guide wires to ensure quality products. Utilize Statistical analysis tools including DOE (Design of Experiments), SPC (Statistical Process Control), ANOVA (Analysis of Variance),...

We anticipate the application window for this opening will close on - 12 Aug 2025 Position Senior Quality Engineer for Covidien, LP, (a Medtronic company) located in Irvine, CA. Responsible for ensuring the quality and compliance of the manufacturing processes for a variety of vascular devices such as embolic coils, stents, catheters, balloons, aspiration devices, coatings, and guide wires. Leverage Good Manufacturing Practices (GMP) standards and navigate the complexity of government and medical device industry regulations including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and ISO 9001 standards to ensure products are consistently produced per the quality...

Purpose Establish, Implement, lead, and manage an effective Global GxP Data Integrity Program supporting Global Operations. Lead business ownership for Quality Operations global enterprise IT systems ensuring system applications support and manage the business effectively. Build an effective strategic business process improvement plan to ensure business processes associated with each respective enterprise system is managed to reflect a best-in-class quality operating system. The role is responsible for ensuring Quality Centers of Excellence associated with global enterprise systems and associated quality system processes are effectively operating to optimize business processes. Responsibilities Lead the Data Integrity program for AbbVie Operations Engage with...

We are seeking an experienced, high caliber Sr. Quality Inspector to perform quality control inspection activities. 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. Operates all associated test and measurement equipment as instructed and as documented in procedures. Recommends changes to policies and procedures. Documents non-conformances in Non-Conforming Material Review system. Participates in GR&R studies as directed by engineers or technicians. Collects data for First Article inspections. Performs testing and inspection in accordance with special test requests. May...

Your skills could be critical in helping our teams accelerate progress. The Lead, Regulatory Data is a strong project leader and expert business analyst who can combine consulting, information quality excellence and digital expertise with pharmaceutical and biotechnology regulatory knowledge to drive strategic projects. This position will prioritize acquisition projects and be part of the acquistion data migration core team acting as the Migration Lead representing the business. The Migration Lead role is the business owner for the regulatory data migration at an operational level and ensures the migration goal is planned and executed effectively and in line with Sanofi...

SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Saving lives for us is not just a cliché but is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for passionate engineers who are excited about working in the software field and...

The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio. The Sr Specialist has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining regulatory responsibilities include reviewing changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, submitting product changes and annual reports, and ensuring that our product technical documentation is current and accurate. SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR In the Neurovascular Operating Unit, we are committed to delivering meaningful innovation to advance...

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

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 Engineer II role to be located in Raynham, MA . At Johnson & Johnson, we pride ourselves on our world-class products and our commitment to making a difference in the lives of people around the globe. As a Quality Engineer, you will play a vital role in ensuring the quality of our...

We are searching for the best talent for a Director, Regulatory Advertising & Promotion to be based in Horsham, PA. The primary location will be Horsham, PA with the option to work from a secondary location (Titusville, NJ; Raritan, NJ; or New Brunswick, NJ) once a week. 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...

Managing a team of up to 14 Regulatory Project Managers, the Regulatory Project Management Lead will build, develop, and oversee a high-performing regulatory project management team. This individual will manage team members, provide strategic guidance, and ensure regulatory projects are executed efficiently and in compliance with global standards. In addition to hands-on project oversight, this role will enhance the project management framework, developing processes and best practices that support regulatory excellence and continuous improvement. Here's What You’ll Do Build and Develop Regulatory Project Management Capability Establish a robust regulatory project management framework, incorporating industry best practices, tools, and processes. Design...

Purpose As the Suppliers and Incoming Section Manager, this role is responsible for ensuring that AbbVie Biologics maintains an Approved Suppliers Program aligned to AbbVie's policies and Regulatory Requirements, and that all incoming materials received at the site are inspected, sampled, tested and disposition according to established policies and procedures. Responsibilities Comply with AbbVie policies, plant procedures, Food and Drug Administration (FDA), EMA, and other applicable regulatory agencies cGMP regulations and requirements. Implement and maintain the effectiveness of the Quality Systems. Develops and strives to achieve impact goals for the department aimed to help meet business objectives. Perform quality assurance...

Purpose The Manager, Medical Device External Quality is part of AbbVie’s External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties. In this capacity, the Manager, Medical Device External Quality, champions best practices related to sustaining product quality, equipment qualification, and manufacturing process validations. As such, the Manager, Medical Device External Quality works closely with AbbVie’s Contract Manufacturing Organizations (CMOs), relevant third-party suppliers (e.g.,...

Job Summary The associate CQV Engineer supports the commissioning, qualification, and validation (CQV) of laboratory instruments and systems, ensuring compliance with regulatory requirements and internal standards. This entry-level role provides hands-on experience in validation processes while working closely with senior engineers. Key Responsibilities -Assist in the development and execution of IQ, OQ, and PQ protocols for laboratory equipment and automated systems. -Conduct periodic calibrations, system verifications, and validation activities to support compliance with industry standards. - Collaborate with cross-functional teams (e.g., R&D, QA, lab staff) to gather system requirements and maintain validation documentation. - Draft, review, and update validation documentation,...

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 In this role, you will Manage GMP or GDP external vendors and contracted services in support of clinical supply and new product development through the lifecycle of the vendor. Responsible for new vendor qualification including Partner with business lines on selection process,...

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...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 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...

In this dynamic role, as a Senior Customer Quality Technology Manager, you will lead a team of Quality Technologists to drive the Global Customer Quality Technology Strategy and Transformation. Your efforts will focus on managing, strategizing, and implementing innovative solutions to enhance quality, ensure compliance, and reduce costs within Complaint Handling, Field Corrective Actions, and Product Hold Order processes. The Customer Quality Technology team is dedicated to developing robust, intelligent technologies through strong collaboration with Customer Quality, Core Quality Services, GOSC, IT, and external vendors. Together, you will advance Customer Quality's vision of fostering positive patient outcomes, ensuring confident compliance,...

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. Senior Associate Quality Control, Environmental and Utilities Monitoring What you will do In this vital role you will...

Quality Control Associate - Bio analytics What you will do Let’s do this! Let’s change the world! In this vital role the Associate in Quality Control at Amgen contributes to maintaining the quality of products and manufacturing processes. They perform QC testing, analyze results, document findings, and work with the production team to address any quality issues. Responsibilities include the following Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks Operate and maintain specialized laboratory equipment and instrumentation Participate in laboratory investigations and audits as necessary At all times, follow safety guidelines, cGMPs and other applicable...

Johnson & Johnson is hiring for a Sr. Regulatory Affairs Specialist (Remote) – Shockwave Medical to join our team located in Santa Clara, CA and Remote US . 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...

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

Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist (Ad/Promo) – Shockwave Medical to join our team located in New Brighton, MN or Remote US . 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...

Employer Medical Device Business Services, Inc. Senior Quality Systems Engineer Job Code A011.5112 Job Location Palm Beach Gardens, FL Job Type Full-Time Job Duties Perform quality systems duties, including maintenance of corrective action and preventative action (CAPA) and supplier systems. Provide leadership and project management to special quality projects. Ensure compliance with the CAPA system and support the Nonconformance (NC) system, including trending, analysis, and reporting of quality metrics. Facilitate Quality Progress Report (QPR) and Quality System Management Review (QSMR) meetings. Serve as site trainer for CAPA and NC systems. Make proposals and assist in the development of CAPA...

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 #Li-Hybrid We are searching for the best talent for Quality Engineer 1 NPD to be in Irvine, California . The NPD Quality Engineer 1 executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of a product. Involved in NPD teams and other activities to develop products, design verification tests, process validations and...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at #Li-Hybrid We are searching for the best talent for Quality Engineer 1 NPD to be in Irvine, California . The NPD Quality Engineer 1 executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of a product. Involved in NPD teams and other activities to develop products, design verification tests, process validations and...

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

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

About 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 Quality Technician NPD to be in Irvine, California . Responsibilities Supports engineering activities focused on developing of testing to challenge catheter design or manufacturing. In a laboratory or manufacturing environment, test catheters based on engineering designs following standard test methods and protocols to support NPD prototype testing, verification and validation, and characterization testing. Follow...

Personalized healthcare is the future. Bio-wearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Diabetes is a growing problem worldwide, and at Abbott Diabetes Care (ADC) we are helping people with diabetes lead healthier, happier lives. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, and we‘re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. ADC is responsible for the development and launch of new digital products based on the FreeStyle Libre platform, the world’s #1 continuous glucose monitoring (CGM)...

GSK is currently looking for a QA Compliance Lead to join our team in Rockville, MD. In this role you’ll lead the site to ensure all relevant Quality Systems are in place, in use and effective to ensure an environment whereby the site is inspection ready and able to support successful regulatory, third party and central inspections. Key Responsibilities Manage end to end third-party, central and regulatory inspections Participate in regulatory agency audits and act as an SME on Quality topics. Manage Quality Risk Model Manage various QA databases Manage Management Review by Quality Council preparations and output Write and...

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...

The Associate Director, Regulatory Affairs Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC 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 CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters....

Regulatory Affairs Global 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 Global 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...

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 Associate Director of Chemistry, Manufacturing & Controls (CMC) - Quality Assurance develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in Development (radiopharmaceuticals). The emphasis of...

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Sr. Quality Engineer, you'll p rovide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. What You’ll Work On Reduces and controls manufacturing process defects (scrap, nonconforming material, customer complaints)...

Senior Quality Manager This position works out of our San Diego, CA location in the Rapid and Molecular Diagnostics, Infections Diseases business . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As the Senior Quality Manager , you’ll be responsible for managing the Design Quality group supporting development of diagnostic products such as instrument, software, reagents and commodities...

We are searching for the best talent for Senior Regulatory Affairs Program Lead to support our Electrophysiology business. This role will be based in Irvine, CA and work a Flex/Hybrid schedule with 3 days per week in office. Purpose Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. You will be responsible for Ensures compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management. Instills and drive a regulatory culture. Establish and support...

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

Purpose Responsible for quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include on-body delivery systems, pre-filled syringes, auto-injectors, infusion pumps, enteral and sub-cutaneous tubing, pump carrying accessories, and other drug administration system accessories. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Develops the appropriate Regulatory, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs,...

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

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

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

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

Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise. In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our...

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide. At Medtronic, we must work with a sense of purpose and ownership, knowing there is a human life on the other side of every decision. This position will be on-site 4+ day/week, based at one of the following Medtronic North America sites Mounds View, MN Irvine, CA Tempe, AZ...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. This is a people leader role within the QA Packaging and Labeling team in Gilead's External Quality Operations department. The ideal candidate will have established people leader experience and some packaging/labeling experience. This is an onsite position based at our headquarters in Foster City, CA. Knowledge D emonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards. Demonstrates excellent verbal, written and interpersonal communication skills. Experience as an effective people leader,...

OBJECTIVES Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ Partner with teams across CPMQ to proactively assess the needs for functional processes and system enhancements Lead the development of internal functional processes and training and ensure alignment with global processes and regulatory requirements and expectations. Drive the implementation and change management of processes and systems across CPMQ Create mechanism to monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans Engage with CPMQ teams to foster a culture of learning and continuous improvement Lead CPMQ...

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Manager, Global Trade Compliance based in Cambridge/Lexington, MA reporting to the Senior Director – Global Clinical Supply Chain Import Export Operations and Global Trade Compliance . At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an...

The Director will provide strategic support and compliance oversight for business initiatives within the US Allergan Aesthetics business with a focus on Plastics and Regenerative Medicine (PRM), Body Contouring and digital/social media. Responsibilities Partners with US AA Leadership for PRM, Body Contouring and digital marketing to provide moderate to complex OEC and functional policy interpretation and provide guidance on the requirements. Active contributing member of the PRM Leadership Team, bringing compliance insights, governance and strategic solutions to support business goals and improve compliance. Conducts compliance risk assessments, trend analysis and provides recommendations for novel, creative and compliant business activities to...

Purpose The Senior Quality Engineer is responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc. Responsibilities Perform QA activities related to Combination Product and Medical Device Design Transfer and Change Management Ensure compliance with company policies and procedures. Perform design control and risk management activities according...

Purpose Primarily responsible for quality assignments related to batch records, quality approvals, exception reports, metrics, and other documentation. Responsibilities Review/approve/release batch record packets and associated documentation Provide quality approvals of materials in the materials management system as defined by procedures Write/review/approve exception documents and corrective actions/preventive actions (CAPA) and ensure they meet timeliness requirements Review/approve clinical documentation and specifications, as applicable Write/review/approve policies/processes/procedures and related documents Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, R&D GxP Compliance Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Director, MSAT Validation & Digital that can be in either Raritan, NJ, Ghent, Belgium, or Sassenheim, Netherlands. Please note that this role is available across multiple countries and may be...

About the Role We are seeking a highly experienced and driven Principal Validation Engineer to lead process validation initiatives for complex electro-mechanical medical devices. This senior-level role is critical to ensuring product quality and regulatory compliance through robust validation strategies across both manual and automated assembly processes. As a key technical leader, you will define, develop, and execute validation strategies in a fast-paced environment, working cross-functionally with Manufacturing, Quality, R&D, and Regulatory teams. Your deep expertise will help guide strategic decision-making and ensure validation excellence throughout the product lifecycle. Key Responsibilities Develop and Lead Validation Strategies for complex electro-mechanical systems,...

Conducts independent quality control reviews of regulatory, scientific, and clinical documents with applicable checklists by checking against sources to ensure that the results presented are accurate and delivers documented quality control review comments to the author through resolution. Ensures quality control review documentation is completed from all areas and provided/uploaded to the applicable master file(s) per the established business processes and procedures. Interacts daily with ClinPharm writers and/or ClinPharm writing managers and interfaces/communicates with applicable cross-functional areas. Communicates and provides deliverables to ClinPharm writers, ClinPharm writing managers, and others as applicable. Accountable for receiving and meeting the main objectives/deliverables of...

Purpose Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market. Responsible for assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetics Devices, etc. Responsibilities Primary driver for the quality and compliance aspects of Design transfer and on-market change management. Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and...

Our Company is expanding its global vaccine production by adding an end to end laboratory capability located in the Durham, NC campus. The facility will be used to produce the bulk active ingredient, finished product. The Associate Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing. The position will focus on microbiology and sterility testing for commercial production. The successful candidate will work on assay development, assay validation, equipment validation, and GMP laboratory readiness. The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples, including bulk vaccine, filled vaccine,...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL), Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The PQL is a strategic matrixed leadership position responsible for end-to-end product quality strategy. The PQL will serve as an individual contributor and as the primary Quality representative on the PDM Product Strategy Team(s), and lead of the Product Quality Team. The candidate should have a scientific and technical understanding of drug development and...

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer II , you’ll have the chance to assure products, processes, and quality records conform to quality standards and establish compliance within Abbott's quality system. We need you to be responsible for maintaining a strong collaborative partnership with multi-functional teams. Help facilitate success by protecting patient safety and meeting business needs. You will...

of a Post-Market Risk, Quality Engineering Manager – reporting to Director of Post-Market Risk, Surgical Operating Unit. Responsibilities may include the following and other duties may be assigned. Plans, manages and implements aspects of the Surgical Operating Unit’s (SOU) Post-Market Risk Management of 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 in support of Post-Market Risk Leads the investigation and evaluation of risk of production and field issues. Manages the Post-Market Risk Quality Engineers...

In this exciting role as a Quality Systems Specialist – CAPA Specialist supporting the Tempe Campus - you will have responsibility for compliance to the Corrective and Preventive Action (CAPA) processes and Medical Device regulations and requirements, serve as a CAPA subject matter expert; provide guidance to CAPA owners and CAPA Board members to develop CAPA activities and conduct assessment of CAPA documentation. The Quality System CAPA Specialist will ensure compliance with Medtronic policies, FDA regulations, ISO 13485, and other requirements by rigorously assessing CAPA activities and documentation. They will participate in CAPA Board activities, provide guidance and mentorship on...

Johnson & Johnson is hiring for a Sr. Director, Quality Operations and Supplier Quality for Shockwave

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 a Quality Inspector II to be in Danvers, MA. Job Summary The Quality Inspector II will perform basic inspections and sorting of incoming materials, parts/components. Provide support as needed to the Operations group. Duties and Responsibilities Perform inspections of...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Sr Manager, Supply Chain Quality EndoMech and Energy to be in Guaynabo, Puerto Rico. The Sr Manager, Supply Chain Quality EndoMech and Energy will support the Ethicon-Endo Surgery LLC (EES) Supply Chain Quality organization to transform the way we serve customers and patients with high-quality and compliant products each and every day into the...

About the Role The Quality Associate 1 – Document Control is in the Quality Systems organization supporting the Takeda Round Lake aseptic pharmaceutical manufacturing facility. This employee’s primary responsibility will be to serve as an administrator for the electronic document control system and for the document control process. This employee’s secondary responsibility will be to serve as the Records and Information Management steward at the site. This employee will be expected to support projects aimed at improving documentation and record management processes at the Round Lake facility, including launches of and changes to electronic systems. This support may include computer...

EMPLOYER AstraZeneca Pharmaceuticals LP Associate Regulatory Affairs Director LOCATION Gaithersburg, Maryland HOURS Full-Time; Mon-Fri (40 hours/week) DUTIES Provide strategic regulatory input to the development, commercialization and life cycle management of the assigned product(s). Serve as the regional regulatory leader. Provide ad hoc project input to support regional RAD or GRLs for specific project tasks. Play a key role influencing Regulatory authorities through regular contacts to improve Regulatory outcomes. Undertake leadership of cross- functional teams in major Regulatory Submissions (NDA, IND/CTA), Health Authority Interactions, Label discussions, and securing NDA/BLA Approvals. Act as a member of the Global Regulatory Strategy Team...

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

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

We are searching for the best talent for a Regulatory Law Paralegal to primarily support the Global Regulatory Legal Team (GRLT) in the Global Legal Organization (GLO), to be based in New Brunswick, NJ. Purpose The Regulatory Law Paralegal contributes to the achievement of key Johnson & Johnson GLO priorities by providing proactive and professional support to the GRLT and its business partners. You will be responsible for Work closely with regulatory lawyers and business partners to assist in the support and review of commercial and compliance programs and materials, which could include advertising and promotional copy review, social media,...

The Associate Director of Regulatory Affairs – Soft Tissue Fillers supports regulatory objectives for the company’s soft tissue fillers devices for new products introduction (NPI) including coordination, management of global submissions to support new registrations. As Global regulatory lead (GRL), directs and supports development of the regulatory strategy related to NPI activities for device regulatory activities in a variety of countries including but not limited to US, EU, Japan and China. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact new products introduction. Supports Aesthetics business at Regulatory Authority/Notified Body meetings...

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

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

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. What You’ll Work On Preparation of regulatory submissions for Electrophysiology Mapping and Imaging devices to achieve departmental and organizational objectives. Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining...

Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will manage the commercial regulatory strategy and execution of such for one or more high-volume and/or otherwise...

Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Compliance Operations and Project Manager is responsible for managing day-to-day operational activities and leading key compliance-related projects from initiation through completion within the Ethics & Business Integrity function. This role requires a strategic thinker with strong project management skills, attention to detail, and the ability to work collaboratively across departments. We are an innovative global healthcare company with...

This role is critical to day-to-day quality engineering (QE) support within our Advanced Surgical Instruments (ASI) Focus Factory. The ideal candidate will be supporting various product s including Robotic s Instrumentation and Advanced Stapling. This role is critical for the Validation of new production lines and day to day support of the manufacturing of medical devices for clinical use. Also, Investigation of critical defects an d CAPA implementation will be c rucial for success. As a Senior Quality Engineer, you will Provide hands-on, proactive quality engineering support within a dynamic manufacturing environment. Support and lead validation activities for new products...

Careers that Change Lives We are currently seeking a Quality Engineer II to join our growing team supporting the Cranial and Spinal Technologies (CST) portfolio. The CST operating unit provides a comprehensive portfolio of proven powerful technologies setting the highest standards of integrity and reliability in Cranial and Spinal care. This position will require you to be onsite in Memphis, Tennessee at least four days a week with one day a week working remotely. In this role, you will be instrumental in developing and maintaining quality standards for our medical products. You will work closely with engineering and manufacturing teams...

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...

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

This Regulatory Affairs Manager will work on-site in Alameda, CA for our Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As the Regulatory Affairs Manager, you will combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by Abbott Diabetes Care, meet the required legislation in Canada and Latin America. Additionally, the Manager will have department/group/site level influence and is generally recognized...

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

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

Director of Validation, Cell Therapy Technical Operations reports to the Senior Director, Cell Therapy Technical Operations within the Cell Therapy Development and Operations (CTDO) organization. This Technical Leadership role will provide Technical oversight to drug product and vector sites, covering process validation for commercial cell therapy products manufactured globally via internal and external manufacturing sites. This role will serve as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy the standards to site MS&T at internal and external sites. The validation lead is accountable for developing...

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

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

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

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. Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, Innovation, Expertise. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A2 Shift (6pm to...

Purpose Execute Compliance area activities related to compliance projects, inspections (external, internal, customers), and regulatory submission documentation. Responsibilities Responsible for conducting a comprehensive internal audit program and ensures that the Internal Audit system is effectively implemented. The incumbent must work closely with the QA Director in the handling of external regulatory inspections and on the resolution of regulatory compliance issues. Assists in the development, implementation and continuous improvement of the Internal Audit System and utilizes audits and consultations as a training vehicle to increase awareness of Compliance expectations. Monitors and maintains plant compliance with Operations and regulatory/applicable standards requirements. Participates...

The Sr. Director, HRBP for Global Regulatory Strategy and Worldwide Patient Safety in Drug Development, plays a pivotal role in providing strategic partnerships to senior leaders for these functions. This role is at the forefront of driving transformative people strategies, workforce planning, and architecting cutting-edge organizational designs. You will be the catalyst for talent innovation, fostering team synergy, and spearheading dynamic change management initiatives. Given the global presence of the client group across multiple BMS locations and geographies, close alignment with the People Org and function leadership is essential to ensure the seamless execution of a forward-thinking workforce and talent...

Key Responsibilities Lead strategy and execution of complex sterile product qualification activities. Expertise in contamination control, cleaning validation and isolator systems. Adopt best practices for continuous qualification of sterile production facilities. Provides relevant CMC support for sterile products pre- and post-approval filings. Interface with Senior Leadership Team to provide a unified set of goals and objectives for the Validation team. Assist with onboarding of new technologies and provide oversight for new qualification programs. Work with Quality to adopt an effective quality management system and achieve the quality objectives. Provide leadership for Validation team and ensure growth and development of staff...

At Medtronic's Pyramid site in Memphis, TN, we are seeking a dedicated Quality Engineer II to join our team. In this role, you will be instrumental in developing and maintaining quality standards for our medical products. You will work closely with engineering and manufacturing teams to ensure that our products meet stringent quality standards. Your responsibilities will include designing inspection methods, conducting quality assurance tests, and performing statistical analyses to uphold product reliability and compliance. If you're ready to leverage your skills in quality engineering to enhance healthcare solutions, we encourage you to apply and become part of our mission...

Regulatory Affairs Specialist II The position of Regulatory Specialist II is within our Toxicology business based in Lake Forest, IL or Pomona, CA . In this role, you will work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for domestic and/ or international product registrations for new and modified products, regulatory assessment of product changes, review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files. What You’ll Work On Provides extended regulatory support for diagnostic product and commercial diagnostic products Assists in...

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Prior experience working with software development teams, diabetes management devices (e.g. insulin dosing algorithms), and artificial intelligence/machine learning technologies is preferred. This role will also be...

Senior Quality Manager, Design Transfer The Senior Quality Manager, Design Transfer position will have responsibility for the design transfer of all Diabetes Care Blood Glucose Monitoring Systems (strips, meters & accessories), FreeStyle Libre portfolio of products, medical device combination products, new medical sensors, Lingo which will deliver products to over 15MM customers globally over the next 5 years with a revenue of over $10Bn. In addition, this position will also be accountable of transfer of all designs (new product introductions, product changes to on market products, test method validations, complaint investigation techniques) into all manufacturing sites, including contract manufacturers....

Your skills could be critical in helping our teams accelerate progress. Sanofi is 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 possible. Ready to get started? Main Responsibilities Advice and guidance based on integrated safety review Provide expertise on translational safety science for early development projects to ensure translation of non-clinical and emerging preclinical data into potential clinical risk Support...

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...

The Regulatory Affairs Manager will work on-site at our Plymouth, MN location for our Electrophysiology division. As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. This new team member will develop and supervise regulatory professionals as well as share knowledge and expertise with others in support of team activities. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. This Regulatory Affairs Manager may analyze broad scope implications...

As the Associate Director, Cleaning Validation and Contamination Control Expert, you will be the primary accountable for setting up technical expectation for the site contamination control and cleaning validation strategies that are agile and adequate. You will be accountable for establishing improved cleaning validation and contamination control strategy, maintain them and provide support to site investigations through complex issues and challenges related to microbial contamination. You will work in a highly cross-functional matrix environment and will work closely with cleaning validation and contamination control counterparts in quality and engineering organizations. This role will provide YOU the opportunity to lead key...

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. Preference for software-based regulatory experience or familiarity with software regulations and requirements. The Principal Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostics products and External Pacemaker to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval....

We are currently looking for a Principal Quality Engineer to join our growing team supporting the Cranial and Spinal Technologies (CST) portfolio. The CST operating unit provides a comprehensive portfolio of proven powerful technologies setting the highest standards of integrity and reliability in Cranial and Spinal care. This position will work a hybrid schedule with 3 days onsite at our Memphis, Tennessee location. Travel expectation less than 20% Careers That Change Lives In this exciting role, you will have primary responsibility for leading quality assurance strategies and execution for new and commercialized devices. This is a dynamic opportunity where you...

Engineering Director - Supplier Quality | Diabetes This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. This position will be located on-site...

Takeda Development Center Americas, Inc. is seeking an Associate Director, Regulatory Data Governance Lead with the following duties Oversee the establishment of Regulatory Information Management data governance policies; Lead efforts in defining appropriate metrics to measure the quality of the metadata relative to usability and compliance with internal and regulatory policies; Establish the data management practice and process Own, lead and manage all aspects of RIM/eDMS metadata management practice including capture and maintenance, lineage, sensitive data tagging and management, metadata standards and data discoverability; Maintain the Regulatory Data Catalog Document Data classification and quality rules; Identify and assign data governance...

Use Your Power for Purpose The Principal Validation Engineer under Andover Site Technical Services (STS) is the principal owner of the Pfizer (PGS) Andover site validation program and master plan. The incumbent is responsible for delivering overall site validation program effectiveness and compliance in partnership with validation program owners across Andover site functions and the Pfizer network. What You Will Achieve In this role, you will Principal owner of overall Andover site validation philosophy and master plan in partnership with local owners of validation programs, associated technical disciplines, and relevant Pfizer global/network/site quality system principals applicable to biologics drug substance/drug...

This position will involve much interaction with Internal J&J customers (Operating Companies and Business Units) and external Transportation providers at all levels of their respective organizations. Key Responsibilities Support major RTO projects through data analysis (i.e. Operating Company initiatives, reports, databases, etc.). Provide recommendations to project teams based on analysis Maintain databases used by RTO and RTO suppliers for various transactions. Updates to metrics while working to improve and enhance processes with all available data. Lead cost and service improvement initiatives as related to transportation and logistics processes. Complete all assigned training on time. Qualifications Education Candidate must be currently...

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 JP Morgan 2024, Dave Ricks announced Lilly Catalyze360, our external...

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 Quality Assurance Associate for Materials Management is responsible for the...

Drives development and execution of plans that build and manage an infrastructure to effectively support the company's needs in logistics, distribution, import/export, and trade compliance across a complex supply chain spanning multiple continents, which includes contract manufacturers, distribution centers, and warehouses for pharmaceutical products. Supports effort to ensures that Commercial and Clinical shipments of raw materials, intermediates, drug substance, drug products, and clinical trial materials are delivered securely, reliably and cost-effectively while meeting relevant compliance requirements. _ Your Contributions Leads, plans and controls the flow of materials, products, services and related systems information from point of origin to point of...

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 Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable for management of all assigned programs/products as the internal expert on US and international Codes, guidance, and industry standards pertaining to prescription medicine promotion. How you will contribute As our Associate Director, Global Regulatory Affairs...