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. Organization Overview Join Lilly’s Global Information Systems Quality (GISQ) team and...

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

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

Shire Human Genetic

Takeda Development Center Americas, Inc. is seeking an Associate Manager, Data Validation Engineer with the following duties provide strategic planning, integrating, execution, build and oversight of clinical trial deliverables. Program study level clinical data validation checks, reconciliation listings and related data cleaning reports adhering to internal processes, approved standards and specifications provided by internal stakeholders. Utilize and contribute to the development of libraries for functions and transformation templates for reuse for study level validation tasks. Lead validation and reconciliation efforts of collected data, both internally and externally, by programming data validation listings, reconciliation checks and reports in a controlled and...

At Medtronic, we’re on a mission to alleviate pain, restore health, and extend life. As a Senior Quality Systems Specialist , you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters. As a Senior Quality Systems Specialist, you will Lead and support Quality System processes , such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control. Serve as a subject...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Senior Manager, Global Regulatory Project Management and Strategic Planning within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs)...

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. Key Duties and Responsibilities Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified. Supports change control assessments, implementation and closure Identifies and facilitates continuous improvement efforts Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed Helps represents Vertex Quality on cross-functional working teams, applying strong communication...

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....

The Associate Director, Clinical Supplies Quality, is a dynamic position that will have responsibility for support of US quality operations and disposition, global distribution planning and management, and requires organizational skills and leadership to work effectively and proactively on global functional teams. Primary Responsibilities Responsible for operational and technical support of Clinical Supply Chain for clinical development programs for the company's portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced Development and execution of Quality and key stakeholder strategies, improvement initiatives in line with business drivers and objectives whilst streamlining processes and...

International Regulatory Affairs Specialist I In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We are currently hiring an International Regulatory Affairs Specialist I to work on-site at our Plymouth, MN location. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry. What...

The Director of Regulatory Information Management (RIM) leads the advancement of business capabilities to enable efficient, consistent, and compliant use, and management, of Regulatory information across AbbVie and with Health Authorities. Provides strategic design, implementation, and ongoing improvements of Regulatory business capabilities. Works closely with Business Process Owners across the enterprise to identify, prioritize, and deliver integrated processes involving Regulatory Information and supporting technologies in support of our broader AbbVie strategies. In addition, the individual has division level influence and is generally considered a key opinion leader and an expert resource both within AbbVie and externally. The individual may influence...

About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. The Sr Specialist Quality Systems within the Product Quality Assurance department is responsible for providing quality assurance support for the biologics...

As part of Pharma Technical Development (PTD) our organization is committed to deliver the Pharma ambitions by bringing game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development. Together with our partners, Global Biologics Bioprocess Development develops robust, efficient, and sustainable bioprocesses including Cell Line & Media Development, Cell Culture & Fermentation, and Purification Development. The Opportunity The Head of Process Validation, Tech Transfer...

This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Quality Engineer I is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to...

At Medtronic Cardiac Ablation Solutions, our vision is to provide cardiac mapping and ablation solutions that will enable clinicians to treat patients more safely and efficiently, with more predictable procedure times and outcomes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. The Senior Regulatory Affairs Specialist develops strategies for...

We are seeking a Quality Engineer II who is passionate about ensuring product quality and regulatory compliance in support of innovative medical devices. In this role, you’ll contribute to cross-functional efforts and continuous improvement in a dynamic, collaborative environment. In this role you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initia tives. This is an onsite role at the Danvers, MA location. As a Quality Engineer II, you will Support product and process...

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...

This position will work M-F business hours, plus weekend on-call support About This Role We are seeking a highly experienced and motivated Senior Microbiology Manager to lead the microbiology function at our state-of-the-art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, and plays a key role in supporting GMP compliance and product quality. What You’ll Do Lead and manage the site microbiology team, including hiring, training, and performance management Oversee environmental monitoring (EM), utility monitoring (WFI, clean steam, compressed gases), and microbiological testing of raw materials, in-process samples,...

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

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

Specialist Quality Assurance This position works out of our Arecibo location in the CRM division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Shift First shift- Monday to Friday As the Associate QA Specialist supports Quality Engineers and Quality Management in implementing and maintaining the effectiveness of the Quality System by maintaining metric dashboards, tracking line support and process monitoring key indicators, identifying and dispositioning manufacturing process defects (scrap, nonconforming material, etc.), assisting in the identification of primary root...

The position will be heavily involved in close partnership with Active Pharmaceutical Ingredient (API) manufacturing contractors and technical personnel and interacting with their functional equivalents in Quality Disposition and Pharmaceutical Research and Development and, Procurement on strategic objectives utilizing external contractors including Good Manufacturing Practice (GMP) qualification as well as site/project selection. Additionally, the incumbent would serve as the bridge between research and development, and Commercialization activities and develop strong working relationships with external quality management personnel. The incumbent would be the key quality representative attending and contributing to oversight and business review meetings with our company and contractor personnel...

AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of people, where the burden of disease is greatest. During the COVID-19 pandemic, we played an important role as part of a truly global effort to respond to a new and unprecedented challenge. We will continue to advance science in vaccines and immune therapies and work with partners to drive improvements in public health and ensure our science reaches millions more people. Role The Senior Regulatory Affairs Director (SRAD) leads the global regulatory strategy for complex...

The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. Key Duties and Responsibilities Provides quality assurance support in the design and development of combination medical device products, facilitating the application of design controls and risk management. Supports Design History File establishment, creation, approval, and maintenance Supports Design History File audits at Phase Gates to ensure product development projects comply with applicable design control regulations (21 CFR 820)...

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. Moderna is solidifying its footprint in Madrid, a city that thrives on creativity and innovation. As a crucial...

Associate Director, US Advertising & Promotion Regulatory (A&P Excellence) Takeda Pharmaceutical USA-MA-Virtual About the role Join Takeda as an Associate Director, US Advertising & Promotion Regulatory (A&P Excellence) where you will be working on the US Medical team. In this role, you will be empowered to serve as an internal expert on A&P Excellence standards, FDA regulations, guidance's, and enforcement trends governing the promotion of prescription drug and biologic products. In addition, you will contribute to Takeda's mission by providing regulatory review support to help ensure regulatory compliance of promotional materials generated for assigned product(s), as well as other responsibilities...

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...

We deliver 4.3 billon 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 Quality Control Raw Materials Department is responsible for the testing of Raw Materials and Components for use at Sanofi Massachusetts manufacturing sites. The department is responsible for the management and continuous improvement for control, testing, and inspection of raw materials. A Quality Control Analyst will be expected to successfully...

The Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs. They independently perform routine audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution of audit findings, and notify relevant management of unresolved...

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

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. R esponsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product R esponsible for Design Assurance activities supporting changes to commercial products. Mentor team members through technical problem solving including CAPA investigations and triaging issues. Provide technical...

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...

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

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 . Free medical coverage for employees* via the Health Investment Plan (HIP) PPO 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 bachelor’s degree. A company recognized as a great...

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

As the Quality Assurance Specialist III - Global Product Distribution & Affiliates , your key responsibilities will be Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as part of a QA team supporting Gilead’s global logistics operations. Serves as a project lead within the function or QA representative on cross functional projects. Maintains routine programs and processes to ensure high quality products and compliance with EU & FDA current Good Distribution Practice (GDP) and National Association of Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements. Supports Global and Regional QA teams as well as...

As the Associate Director, Quality Assurance - Global Product Distribution & Affiliates, your key responsibilities will be Serve as a key member of the QA Global Supply Chain team who are collectively responsible for implementation of cohesive & effective QA processes across the Gilead distribution network as well as developing medium and long-term strategic plans with our Global Logistics (Commercial & Clinical), and Supply Planning business partners, which support the overall strategic plans for the Supply Chain & Quality organizations. Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as part of a QA team supporting...

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...

The Director, Quality Risk Management will drive consistent Global Leadership on Quality Risk Management (QRM), the Risk Management Framework, Risk Posture considerations and provide support for key QRM processes within the GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP) across the Product Lifecycle. Accountable to drive QRM process optimization, integration, adoption and continuous improvement through capability building, key stakeholder engagement, digital enhancement, trend analysis of QRM data and guidance on authoring QRM procedures. Works cross-functionally to develop performance improvement initiatives throughout the organization by interacting and working with many great teams and leaders across the BMS network....

We are searching for the best talent for Manager, Regulatory Affairs to support the Power Tools team within our Orthopaedics group. The preferred location for this role is Palm Beach Gardens, FL but candidates in Zuchwil or Oberdorf, CH will also be considered . This role will work a Flex/Hybrid schedule with 3 days per week on-site There is NO remote option . 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...

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. This critical role Covers all Lifecycle phases of pre-authorization to regulatory submission, submission to pre-approval inspection (PAI), PAI...

The primary responsibility for the Validation Specialist is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists This role serves to provide Quality Assurance oversight of site validation documents/ practices and reports up through the site Quality organization Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all...

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. Manager Quality Control Support - Digital Laboratory Systems What you will do In this vital role you will...

People-centered, data-driven, connected. We're solving the world's biggest health challenges with healthcare technology. We fuse technology and research for groundbreaking solutions. From less-invasive surgery that minimizes a patient's downtime to the world’s smallest pacemaker, our technology transforms lives. At Medtronic, at our Warsaw production facility, also known as Warsaw Orthopedics, manufactures Spinal Implants and Brain/ENT components. Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications...

This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. We are seeking a highly knowledgeable individual to combine expertise in scientific, regulatory, and business issues...

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

We are searching for the best talent for our Manager, MISE Vendor and Quality Management position to be located in Titusville, New Jersey. 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 The role Manager, MISE Vendor and Quality Management is responsible for developing and managing the quality...

Biosense Webster a member of Johnson & Johnson's Family of Companies, is recruiting for an Eng Quality Engineering located in Irvine, CA! Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Senior Quality Engineer – plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design...

Purpose This individual will be responsible for leading and supporting Quality Risk Management (QRM) activities for AbbVie products such as Combination, Pharmaceutical and medical devices. Support the strategic direction to ensure business objectives are met to support and sustain the Quality System in compliance to Quality Risk Management regulations, guidance’s and standards. Responsibilities Drive Quality Assurance activities to develop, implement and sustain required QRM regulations and standards to comply to global requirements. Assure proper integration for AbbVie products such as device, combination, drug and biologics regulations. Areas of direct responsibility include development and maintenance of QA procedures for risk management...

Position As the Director, IT Computer System Validation & Quality Assurance, you will play a pivotal role in ensuring the compliance, reliability, and quality of our computer systems within the biotechnology domain. This position offers a unique opportunity for an experienced professional to lead and make a significant impact on our company's success. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Millbrae, CA office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration....

For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development—we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day. Click here to learn more about Medtronic Neurovascular brain treatments and therapies. #Neuroscience Join...

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. This position will support the lifecycle management of instrumentation within the Quality Control department at the Swiftwater, PA location while strictly adhering to Sanofi procedures, Health Authority Regulations, and cGMP's. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives....

This position works out of our Liberty, SC location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. We are seeking a high caliber Sr. Quality Engineering Technician who will work under general supervision, builds routines for non-contact inspection equipment to support incoming inspection activities. Interprets drawing & blueprint requirements and applies test or inspection methods to verify requirements. Performs tests according to written protocols; adjusts incoming inspection plans to support supplier quality engineering; maintains accurate...

Manager of Customs & Trade Compliance Our location in Lake Forest, IL , currently has an opportunity for a Manager of Customs & Trade Compliance . This role will provide leadership and direction to ensure site compliance with all relevant customs regulations and trade laws and other US regulatory agency requirements. It will be the responsibility of this position to develop a staff of experts in the import/export compliance field that will serve the current and future demands of the supply chain operation. What You’ll Work On Manage import/export process and develop effective internal controls to ensure site compliance...

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

Are you looking for a high-profile supply chain leadership role that allows you to accelerate efficiency and global product delivery? If so, this Cross Border Compliance Portfolio Manager ole could be an ideal opportunity to explore. As a Cross Border Compliance Portfolio Manager, you will play a key role in the Global Supply Planning Hub by contributing to everything related to attaining the right level of inventory of finished products, Active Pharmaceutical Ingredients (API) and Bulk in the network. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the...

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

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...

Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi’s diversified portfolio in order to meet corporate and business objectives. This GRL would be in the Neurology Therapeutic Area. Decisions are made in alignment with the TA, GBU Head and up to the GRA LT as needed. The GRL is the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT). We...

The Cardiac Surgery Business is one of the fastest growing businesses, helping ECMO patients across the globe. We are 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 vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and access to healthcare. The Quality Engineer II role reports to the Senior Quality Manager. This individual will be part of the Operational Quality team at our Dexter, MI Site. This role supports...

We are seeking a dedicated and detail-oriented Environmental Compliance Specialist to join our North Haven, CT, facility. This role is an exciting opportunity to contribute to Medtronic’s mission to reduce environmental impacts, maintain the safety of our employees, and ensure compliance with environmental and safety regulations. The Environmental Compliance Specialist will help foster a culture of safety, environmental stewardship, and regulatory compliance across the site. Key Responsibilities Ensure environmental compliance for a manufacturing site. Evaluate new construction projects, new processes, process changes, etc. and determines the regulatory impact including the need for permit changes. Implements the applicable regulations / company...

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 Senior Specialist, QC Compliance, Cell Therapy is responsible for leading QC deviation, laboratory investigations, CAPAs and change control. May provide...

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....

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

The Director, Regulatory Affairs - CMC (CGT) is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of AstraZeneca's C ell and Gene T herapies (CGT). This position may be based in Santa Monica, CA or Gaithersburg, M D and reports to the Senior Director, CMC Regulatory Affairs (CGT) . Essential Functions and Responsibilities Provide strategic guidance during all stages of product development and l ead the development and implementation of global CMC regulatory strategies for the pipeline of AZ cell and gene products . Interpret global regulations and guidance to identify...

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

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

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...

This Computer Systems Validation engineer position can work remotely within the U.S . What You’ll Work On Develop, implement and maintain secure, resilient enterprise-grade cloud processes for multiple software and systems in tandem with architects and system engineers. Lead/support validation efforts and deliverables for projects requiring validation. Work together with development operations and development teams to develop and implement monitoring and security solutions in stand-alone and embedded product software and supporting applications. Create and execute validation test scripts and document test results in accordance with standards. Actively monitor, assess, recommend, and lead tactical and strategic initiatives based on new and...

This Computer Systems Validation engineer position can work remotely within the U.S . What You’ll Work On Develop, implement and maintain secure, resilient enterprise-grade cloud processes for multiple software and systems in tandem with architects and system engineers. Lead/support validation efforts and deliverables for projects requiring validation. Work together with development operations and development teams to develop and implement monitoring and security solutions in stand-alone and embedded product software and supporting applications. Create and execute validation test scripts and document test results in accordance with standards. Actively monitor, assess, recommend, and lead tactical and strategic initiatives based on new and...

This Computer Systems Validation engineer position can work remotely within the U.S . What You’ll Work On Develop, implement and maintain secure, resilient enterprise-grade cloud processes for multiple software and systems in tandem with architects and system engineers. Lead/support validation efforts and deliverables for projects requiring validation. Work together with development operations and development teams to develop and implement monitoring and security solutions in stand-alone and embedded product software and supporting applications. Create and execute validation test scripts and document test results in accordance with standards. Actively monitor, assess, recommend, and lead tactical and strategic initiatives based on new and...

About the role Join Takeda as the Head, Digital Ethics & Compliance for Takeda's U.S. Business Unit (USBU) at the senior director level. You will lead the strategic alignment and integration of global digital risk and control frameworks within the USBU. Your leadership will ensure the implementation and adoption of Digital Ethics & Compliance (DE&C) initiatives to promote responsible innovation and regulatory compliance across Takeda's U.S. operations. Acting as a trusted DE&C authority and collaborator, you will focus on enhancing Takeda's ethical culture, risk management, and compliance standards while leveraging advanced technologies to drive innovation and growth in a compliant...

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

We anticipate the application window for this opening will close on - 9 Sep 2025 Position Sr. Quality Engineer for Covidien, LP, (a Medtronic company) located in Plymouth, MN. Responsible for ensuring the quality and compliance of the manufacturing processes for a variety of vascular devices including 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, EU-MDR and BSI standards to ensure products are consistently produced per the quality standards. Coordinate risk...

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

The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP’s. This role is crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications. What You’ll Be Doing ●Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. ●Collaborate with cross-functional teams to obtain necessary product composition data and hazard information for accurate SDS generation. ●Manage the review, approval, and distribution of SDS to internal and external stakeholders....

This position works out of our Abbott Park, IL location within the Abbott Quality and Regulatory Corporate Headquarters and/or any Abbott location for the right candidate. The function of the Quality Program Manager is to provide leadership, oversight, and project management covering external inspections as related to Abbott's Quality System. This includes division / business support, quality/regulation expertise and consulting activities. As the Manager of Quality Assurance, you’ll have the chance to provide leadership for pre-inspection, during inspection, and post inspection support. This support encompasses FDA inspections for the Nutrition, Medical Device, Diagnostics, and Pharmaceutical sectors within Abbott. What You’ll...

This role offers an exciting and challenging opportunity that will be key to Gilead's success as we advance new combination products, such as vial kits and pre-filled syringes, to market. You will be a key Quality leader responsible for managing compliance for combination products compliance at Gilead La Verne site. We are looking for an experienced Quality professional to ensure that our QMS provides comprehensive support of these combination products. Roles/Responsibilities Monitor medical device standards for quality management system (QMS) updates to ensure adherence to global regulations Monitor device/combination product enforcement trends in the industry and develop recommendations and action...

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

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

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. Join Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high level 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. Join Takeda as an Associate Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff....

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...

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

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...

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...

Janssen Biotech, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Lead at the Spring House, PA campus! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part...

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 Principal Quality Systems 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...

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance (QA) Associate II at the Spring House, PA campus! 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....

FUNCTION Regulatory Affairs (RA) Global Labeling POSITION OVERVIEW 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...

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...

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. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing...

Sr Engineer I, Validation Duties/Responsibilities The Sr. Engineer I, Validation will play a critical role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility. This position requires a hands-on validation engineer with experience in GMP, an understanding of lab/manufacturing equipment, and a proven track record in validation processes. Establish validation protocols, risk assessments, and qualification plans to support GMP operations. Acts as a validation Subject Matter Expert (SME) providing support to multi-function teams, advises operations on validation matters, and potentially serves as the point of contact...

Position The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories (Research & Development) by Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines. Contributing to the continuous improvement of the operating model for regulatory activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy. Providing quality advice to stakeholders creating optimal development, commercialization, and drug/delivery device supply strategies Building our leadership...

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....

Position Description Perform procedures required for testing samples in compliance with current good manufacturing procedures (cGMP), safety and environmental guidelines, including clean room entry and aseptic procedures. Meet testing schedules, which may include working longer hours to complete testing and cleanup. Maintain accurate and compliant documentation. Assist in reviewing and updating current procedures for equipment and processes. Assist in planning, development and implementation of new procedures or special projects, resolution of testing issues by recommending solutions to issue or routes of investigation. Assist in cleaning and sterilization of equipment used in the department as well as cleaning work areas (including...

Use Your Power for Purpose At Pfizer, the impact you will have on improving patients' lives is profound. You will play a crucial role in navigating and interpreting the growing regulatory demands to ensure optimal patient care. Your expertise and commitment are crucial in adapting to these changes and maintaining the highest standards of patient care. Join us in our mission to make a global impact on patient care. Role Summary You will support the administration of the Vaccines Quality Records and Training Compliance team in accordance with Records Management policies and procedures and the Enterprise Records Retention schedule. You...

Purpose Primarily responsible for conducting audits of investigative clinical sites in R&D to assess and assure compliance with regulations, guidelines, policies, procedures and sponsor requirements Responsibilities Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures. Lead investigation site audits to ensure compliance to global regulatory requirements as well as AbbVie requirements. Effectively communicate audit results, both orally and in writing. Review corrective action plans/audit responses for adequacy and approve if adequate Lead Global System Audits to evaluate internal Abbvie areas for compliance to applicable SOPs and local regulations Review clinical research documents, such as research...

Join us as the Quality Center of Excellence Lead at our Wilmington Biotech site, where you'll shape the future of breakthrough medicines by ensuring top-tier quality and compliance with global regulations. Lead a high-performance team, drive commissioning and validation excellence, and collaborate globally to deliver life-changing therapies right first time to patients worldwide. If you have 10+ years in Quality Assurance and a passion for innovation and leadership, this is your opportunity to make a global impact. & SPECIFIC OBJECTIVES The Quality Center of Excellence (COE) Lead role will involve establishing the Quality COE structure at the Wilmington Biotech...

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

We have an immediate opportunity for a Manager Quality Assurance in our Abbott Park , IL location. What You'll Work On Primary Job Function The function of the Manager, Quality Business Support – Technical Design Quality is to provide corporate-wide support of Abbott’s Quality System and product submissions. The candidate must possess a working knowledge of Quality System requirements, design controls and risk management, as well as an understanding of the US IVD regulatory submissions process and required contents. The candidate must have experience in product design quality and technical (R&D, Technical Support, or manufacturing) roles. The primary activities and...

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

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...

The Opportunity At Roche, our commitment to quality in Pharma Development is unwavering. We aim to deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. As a Quality Excellence Lead , you will play a pivotal role in driving excellence across our global quality landscape, from Good Clinical Practice (GCP) and Pharmacovigilance (GVP) to Medical Device Regulations (MDR) and beyond. Different roles are available to successful candidates, one of which includes Global Process Ownership for managing unplanned Quality Events. This is your chance to shape quality strategies and deliver impactful...

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...

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...

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

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. This Quality Control Analyst II is responsible for performing routine and complex testing of in-process samples, stability samples and final products in accordance with SOPs for product release and validation. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives....

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...

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Our location in Sylmar, CA , currently has an opportunity for a Software Quality Engineer II . This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for...

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

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

This position Medical Director, Patient Safety and Compliance, works out of our Lake Forest, IL location in the Infectious Disease Business Unit in Abbott Rapid Diagnostics. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. What You’ll Work On This position will manage Patient safety to provide medical risk and sexual transmitted diseases (STD) guidance for the business group, including support to maintain focus on product performance and safety, product/program development and customer education. The director hired will work cross functionally to support lateral flow technology (LFT) in sexual transmitted diseases (STD), and provide input...

Nourish the world and your career as part of the Nutrition team at Abbott. Abbott’s Nutrition Division 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 get the nutrients they need to live their healthiest life.. WHAT WE OFFER AT ABBOTT At Abbott, you can have a good job that can grow into a great career. We offer Career development with an international company where...

About This Role The Senior QA Associate II in the Quality Systems organization is responsible for understanding quality systems, contributing to oversight of quality systems, and maintaining GMP and laboratory activities at the Biogen RTP facility. They should be proficient in their understanding of the quality systems and apply that knowledge in coaching and continuous improvement. The primary responsibilities of the Senior QA Associate II in the Quality Systems team include quality compliance for managing Drug Substance (Bio) Quality Systems, responsible as the Business Process Owner for the document issuance process, authoring Site Reports (Site Management Review Report), change control...

The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Nellcor™ Blood Oxygenation Management Franchise within the Acute Care and Monitoring Operation unit. Activities include participation in change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs or 510ks) and supporting EU MDR implementation. The Sr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory...

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. Learning Center of Excellence (CoE) The CoE is the powerhouse of...

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

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...

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

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 Eli Lilly, we create medicines that give people new hope...

Summary/Scope Bristol Myers Squibb (BMS) is a global biopharmaceutical company engaged primarily in the discovery, development, and commercialization of novel therapies for the treatment of human diseases. The Lab Planning and Execution group is part of the Translational Science (TS) team within Translational Medicine (TM). TS leads internal and external diagnostic research & development activities to support multiple disease areas of interest including hematological malignancies, inflammatory disease programs, neuroscience, cardiovascular, fibrosis, and solid tumor indications. The TS team integrates scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients...

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...

Staff Quality Auditor This role for the Staff Quality Auditor will serve as experts for the compliance team with respect to observation tracking, auditing, regulations and standards and the Division quality system. This role will conduct internal quality audits to assess compliance to the requirements of the quality system, as well as FDA, ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You'll Work On Plan, perform, support and document...

This is a full time, on-site position About This Role This position will support our drug substance (Bio) site at our Research Triangle Park NC facility. The primary responsibilities of the Senior Associate III include quality compliance for managing site inspections, completing regulatory requests for partner and Biogen products, authoring Site Reports (Site Management Review Report and Site Master File), change control support, and the review and approval of site-specific GMP documents (Work Instructions, Master Production Records, and Solution Records) for compliance to applicable regulatory and corporate guidance documents, and consistency with business source documentation. What You’ll Do Management of...