Quality & Regulatory Jobs in Pharma & Biotech
145
Open Positions
15
Remote Jobs
129
With Salary Data
Quality and Regulatory professionals ensure compliance with FDA regulations and maintain quality standards in pharmaceutical and biotech operations. These roles require knowledge of GMP, FDA guidelines, and quality management systems.
Key positions include:
- Quality Assurance Manager
- Regulatory Affairs Specialist
- Validation Engineer
- Compliance Officer
- Quality Control Analyst
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Clinical Quality Registered NurseFresh
Remote
Aug 18 $85,000 - $100,000 US Remote Apply →Clinical Quality Registered NurseApply →Fresh
Remote
Aug 18 $85,000 - $100,000
US RemoteHims & 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... | |
Quality Compliance Manager What you will do Let’s do this! Let’s change the world! We are hiring a Quality Compliance Manager, which will operate within the General Medicine & Obesity Quality Therapeutic Area. In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program. (protocol development, database lock, and regulatory submissions/ approvals). Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting... | |
Senior Quality EngineerFresh
Aug 18 Salary N/A Cornelia, Georgia, United States of America Apply →Senior Quality EngineerApply →Fresh
Aug 18 Salary N/A
Cornelia, Georgia, United States of AmericaWe are looking for the best talent for a Senior Quality Engineer to be located in Cornelia, GA with occasional travel to Athens, GA. 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 You will be responsible for Determine quality standards and ensure compliance with industry regulations. Develop and implement quality control processes to ensure flawless production. Collaborate with diverse teams to identify areas for improvement and implement effective solutions. Conduct thorough product... | |
Principal Quality Systems Specialist - Shockwave MedicalFresh
Aug 18 $105,000 - $169,050 Santa Clara, California, United States of America Apply →Principal Quality Systems Specialist - Shockwave MedicalApply →Fresh
Aug 18 $105,000 - $169,050
Santa Clara, California, United States of AmericaJohnson & 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... | |
Senior Manager, Distribution Quality OperationsFresh
Aug 18 $121,520 - $147,200; $121,520 - $147,249 Summit West - NJ - US Apply →Senior Manager, Distribution Quality OperationsApply →Fresh
Aug 18 $121,520 - $147,200; $121,520 - $147,249
Summit West - NJ - USThe Senior Manager Distribution Quality Operations p rovides oversight and support for quality compliance of BMS products at 3PL distribution centers (DCs) and during transportation between facilities. Ensures that BMS quality compliance expectations are met and maintains inspection readiness. Collaborates to develop quality strategies for storage, transportation, and distribution of products. Key Responsibilities Serves as primary DQ USPR contact and provides quality oversight/support for the Manchester, PA USDC and BMS Puerto Rico’s 3PL DC. Reviews and approves change control documents related to storage, transportation, and distribution of products. Supports product launch preparation and activities. Conducts pre-approval assessments and other regulatory... | |
Principal Quality EngFresh
Aug 18 $119,200 - $178,800 Lafayette, Colorado, United States of America Apply →Principal Quality EngApply →Fresh
Aug 18 $119,200 - $178,800
Lafayette, Colorado, United States of AmericaA Day in the Life Medtronic is currently searching for a Principal Quality Engineer to join the New Product Development team at the Lafayette, CO facility. You’ll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities. Key Responsibilities Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services. Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems. Experience with PCBA suppliers and validation of PCBA test... | |
Quality Systems SpecialistFresh
Aug 18 $72,800 - $109,200 Los Angeles, California, United States of America Apply →Quality Systems SpecialistApply →Fresh
Aug 18 $72,800 - $109,200
Los Angeles, California, United States of AmericaMedtronic is a world leader in providing health care products that restore health and extend life. The Medtronic Diabetes R&D team contributes directly to this mission; we deliver software and firmware for Medtronic’s pump and continuous glucose monitoring devices. Our business is growing significantly as the market demands reliable medical devices which look and feel more like consumer devices. We are looking for an Associate Quality Systems Specialist who can help us continue to make devices more robust and reliable for our patients. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention... | |
Quality Technician IIIFresh
Aug 18 $52,800 - $79,200 Grand Rapids, Michigan, United States of America Apply →Quality Technician IIIApply →Fresh
Aug 18 $52,800 - $79,200
Grand Rapids, Michigan, United States of AmericaWe are looking for a skilled and detail-oriented Quality Tech III. This role is a critical part of our operations, responsible for environmental monitoring and testing/labs. Responsibilities may include the following and other duties may be assigned. Reviews sterilization and microbiology test records for accuracy and completion as a part of sterile release process Performs microbiological testing in laboratory and controlled environments Reviews and approves test reports Coordinates shipping of test samples to contract laboratories Maintains inventory of laboratory supplies Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to... | |
R2814855 Regulatory Site Office Manager Location Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Regulatory Site Office Manager, Vaccines will work closely with the Manufacturing and Supply teams, and CMC colleagues on the regulatory assessment of Vaccines site-based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance... | |
Quality Engineering ManagerFresh
Aug 16 $97,300 - $194,700 United States - Minnesota - Minnetonka Apply →Quality Engineering ManagerApply →Fresh
Aug 16 $97,300 - $194,700
United States - Minnesota - MinnetonkaThis position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We are seeking a passionate Manager in Quality Engineering to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products... | |
Sr. Manager Operational Excellence-Transactional Processes (Global Quality)Fresh
Aug 16 $138,400 - $207,600 Minneapolis, Minnesota, United States of America Apply →Sr. Manager Operational Excellence-Transactional Processes (Global Quality)Apply →Fresh
Aug 16 $138,400 - $207,600
Minneapolis, Minnesota, United States of AmericaMedtronic has declared its bold ambition to become the global healthcare technology leader. By doing so, we seek to reach more patients in more meaningful ways, more quickly. Are you looking to create capability and competencies in Operational Excellence (OpEx) for the leader in the Medical Technology industry? As the Operational Excellence Sr. Manager, Transactional Processes, you will be a core member of the team representing Operational Excellence to plan and execute process improvement objectives supporting the Global Quality organization. These objectives include specific operational performance targets as well as the development and training of employees to create a sustainable... | |
Senior Engineer, QualityApply →Fresh
Aug 15 $82,500 - $157,500
North Chicago, IL, United StatesPurpose The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks... | |
Manager, Health Care ComplianceFresh
Aug 15 $100,000 - $173,500 Santa Clara, California, United States of America Apply →Manager, Health Care ComplianceApply →Fresh
Aug 15 $100,000 - $173,500
Santa Clara, California, United States of AmericaWe are searching for the best talent for a Manager, Health Care Compliance to be based in Santa Clara, CA; New Brunswick, NJ; Raritan, NJ; West Chester, PA; Irvine, CA; or Danvers, MA. Purpose The Healthcare Compliance Manager will support Shockwave Medical, and play a key role in ensuring the Company meets statutory and regulatory requirements relating the health care fraud and abuse; as well as advertising and promotion laws governing commercial and scientific activities. This role will also support Shockwave’s health care compliance integration activities. You will be responsible for Partner with business and functional stakeholders and provide compliance... | |
Senior Investigation Quality LeaderFresh
Aug 15 Salary N/A Athens, Georgia, United States of America Apply →Senior Investigation Quality LeaderApply →Fresh
Aug 15 Salary N/A
Athens, Georgia, United States of AmericaAbout 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 and Johnson is seeking a Senior Investigation Quality Leader, located in Athens, GA. The Senior Investigation Quality Leader is responsible to ensure the generation and completion of robust investigation reports (i.e Nonconformance and Root Cause investigations). This includes,... | |
Senior Manager/Associate Director, Regulatory Medical Writing X-TAFresh
Remote
Aug 15 $137,000 - $235,750 Titusville, New Jersey, United States of America Apply →Senior Manager/Associate Director, Regulatory Medical Writing X-TAApply →Fresh
Remote
Aug 15 $137,000 - $235,750
Titusville, New Jersey, United States of AmericaSenior Manager/Associate Director, Regulatory Medical Writing X-TA At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at... | |
Exp Anlst Quality AssuranceFresh
Aug 15 $77,000 - $124,200 Raritan, New Jersey, United States of America Apply →Exp Anlst Quality AssuranceApply →Fresh
Aug 15 $77,000 - $124,200
Raritan, New Jersey, United States of AmericaJohnson & Johnson is currently recruiting for a CAR-T Specialist 3, Quality Assurance Microbiology. This position will be located in Raritan, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at [CAR-T is... | |
Site Quality DirectorFresh
Aug 15 Salary N/A Anasco, Puerto Rico, United States of America Apply →Site Quality DirectorApply →Fresh
Aug 15 Salary N/A
Anasco, Puerto Rico, United States of AmericaAbout Vision Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.... | |
Regulatory Affairs Specialist IIFresh
Aug 15 $79,500 - $138,700 United States - California - Alameda Apply →Regulatory Affairs Specialist IIApply →Fresh
Aug 15 $79,500 - $138,700
United States - California - AlamedaAs an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions. The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data and ensuring that the information is reliable and effectively presented to substantiate claims. You'll also have opportunities to participate in worldwide regulatory submissions. This is a broad scoped position with strong opportunity for growth and career development based on performance. What You’ll Work... | |
Associate Director, Regulatory AffairsFresh
Aug 15 $178,000 - $194,750 Jersey City, NJ Apply →Associate Director, Regulatory AffairsApply →Fresh
Aug 15 $178,000 - $194,750
Jersey City, NJPosition We are seeking an experienced Senior Manager to Associate Director, Regulatory Affairs, to manage our regulatory clinical trial applications (CTAs) and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to develop ex-US CTAs, and manage the maintenance of applications submitted to Competent Authorities (CAs) in support of study initiation. This role is a member of the program teams within the function of Regulatory Affairs.This role will require a minimum of 3 days a week of onsite presence (or... | |
Senior Validation EngineerFresh
Aug 15 $86,500 - $135,960 USA - CA - Thousand Oaks - Rancho Conejo Apply →Senior Validation EngineerApply →Fresh
Aug 15 $86,500 - $135,960
USA - CA - Thousand Oaks - Rancho ConejoAbout the role As Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. You will report to Head of Engineering Services. This is an on-site position, and you will be required to work all five days from the office. How you will contribute Be a Validation Engineering representative and technical subject matter expert (SME)... | |
Associate Specialist, Quality ControlFresh
Aug 15 $63,900 - $100,500 USA - North Carolina - Wilson Apply →Associate Specialist, Quality ControlApply →Fresh
Aug 15 $63,900 - $100,500
USA - North Carolina - WilsonPrimary responsibilities are routine testing and verification of print and imaging of labels, product inserts, carton materials, foils, etc and their review / release to production. This includes proofs, first prints, and reprints and documentation in a GMP laboratory. Additional responsibilities include entering data into SAP, training to become proficient in drafting investigations, working directly with vendors to correct component deficiencies and improve vendor processes, updating standard operating procedures, trains and learns to coordinate launch activities around print activities around printed material, and approve artwork in our global LIMS system. Testing equipment utilized include but are not limited to Text... | |
Staff Quality EngineerFresh
Aug 15 $111,300 - $222,700 United States - Minnesota - Plymouth Apply →Staff Quality EngineerApply →Fresh
Aug 15 $111,300 - $222,700
United States - Minnesota - PlymouthThis position works out of our Plymouth, MN location in the EP division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As a Staff Quality Engineer, you'll have the chance to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or... | |
Engineer II, Supplier Quality AssuranceFresh
Aug 15 $79,500 - $138,700 United States - California - Pleasanton Apply →Engineer II, Supplier Quality AssuranceApply →Fresh
Aug 15 $79,500 - $138,700
United States - California - PleasantonAt 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... | |
Sr Manager Application Technologies – Quality Learning & Document Management SystemsFresh
Aug 15 $127,300 - $254,700 United States - Illinois - Waukegan Apply →Sr Manager Application Technologies – Quality Learning & Document Management SystemsApply →Fresh
Aug 15 $127,300 - $254,700
United States - Illinois - WaukeganProvides leadership & strategy for a group of IT professionals supporting a major organizational unit responsible for the definition, development, implementation, operation and support of computer-based systems and related processes and tools which provide information for reporting, operations, and decision making for the Quality Non-Complaints, LMS (Learning Management), DMS (Document Management), and Global Engineering Systems (GES) within the Quality-Regulatory-Engineering Services BSS Organization. What You'll Work On Creates and manages Corporate Quality Non-Complaints, LMS, DMS & GES Strategies and Architectural Framework in partnership with Divisional BRM’s Aligns department priorities appropriately, determines critical success factors, evaluates and pursues initiatives, investments and opportunities... | |
Senior Analyst, Data QualityFresh
Aug 15 $101,200 - $146,550 US CA San Diego Apply →Senior Analyst, Data QualityApply →Fresh
Aug 15 $101,200 - $146,550
US CA San DiegoAs Senior Analyst, Data Quality, you will join our Commercial Data Management team and become a key contributor in building scalable quality control processes and partnering closely with cross-functional teams to ensure our data is trusted, accurate, and business-ready. This is an exciting opportunity for a detail-oriented, analytical thinker who enjoys tackling complex data challenges, working collaboratively across teams, and utilizing cloud data technologies to make a significant impact in a pivotal position. Your responsibilities will include the following activities _ Your Contributions (include, but are not limited to) Execute recurring quality control checks on commercial datasets including sources such... | |
Senior Quality Engineer-Hardware - ENTFresh
Aug 15 $96,800 - $145,200 Lafayette, Colorado, United States of America Apply →Senior Quality Engineer-Hardware - ENTApply →Fresh
Aug 15 $96,800 - $145,200
Lafayette, Colorado, United States of AmericaCareers That Change Lives In this exciting role as a Sr Quality Engineer you will Witness cutting edge surgical navigation and robotic technologies designed to alleviate pain, restore health and extend life. Representative and/or Lead for the New Product Introduction ( NPI ) Quality team on the NPI Core Team on small to medium size project s . Compliance oversight over the medical device NPI activities in accordance with the applicable Standard Operating Procedures (SOP's) and External Standards as part of the NPI process. Contribute and lead activities during the following activities Risk analysis, including product risk a ssessment... | |
Quality Technician II - Boulder, COFresh
Aug 15 $46,000 - $69,000 Boulder, Colorado, United States of America Apply →Quality Technician II - Boulder, COApply →Fresh
Aug 15 $46,000 - $69,000
Boulder, Colorado, United States of AmericaResponsibilities 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 for the chemical or physical property. Performs a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance. Performs required inspections, checks, analysis and documentation of studies. Prepares and monitors quality statistics and reports. Reviews production records for conformance to procedures. Conducts... | |
Senior Quality Engineer-Software -ENTFresh
Aug 15 $102,400 - $153,600 Lafayette, Colorado, United States of America Apply →Senior Quality Engineer-Software -ENTApply →Fresh
Aug 15 $102,400 - $153,600
Lafayette, Colorado, United States of AmericaCareers that Change Lives A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people . Help us engineer the extraordinary! Bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. Learn more about Medtronic benefits and compensation at the bottom of this job description. We... | |
Associate Quality Control- Gels LaboratoryFresh
Aug 15 Salary N/A US - Puerto Rico - Juncos Apply →Associate Quality Control- Gels LaboratoryApply →Fresh
Aug 15 Salary N/A
US - Puerto Rico - JuncosASSOCIATE QUALITY CONTROL- GELS LABORATORY What you will do Let’s do this. Let’s change the world! In this vital role you will be responsible for one or more of the following activities analytical testing, method development, routine sample testing, and data management. This role is a key contributor within the Quality Control department and supports non-standard shift operations, which may include first, second, third, and/or weekend shifts. Specific responsibilities include but are not limited to Conduct routine laboratory testing using techniques such as SDS Page, IEF, Capillary Electrophoresis and Elisa in accordance with SOPs, compendia, and analytical methods. Operate laboratory... | |
The Quality Systems Senior Specialist 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. This role is part of the External Quality Assurance (EQA) team responsible for product quality across a portfolio of topical skincare products that include Natural... | |
This is an exciting opportunity to lead the Biostatistics efforts supporting Natera’s product portfolio of cutting-edge cell-free DNA screening tests. As Lead Biostatistician, you will leverage your medical device/assay development background along with your experience in applied statistics to oversee the design, analysis, and reporting of validation experiments to support our Women’s Health and Organ Health portfolio. The ideal candidate will possess strong communication skills and a deep understanding of biostatistics in analytical validation. PRIMARY RESPONSIBILITIES Study Design and Analysis Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of Women’s Health and Organ Health product... | |
Senior Design Quality Engineer -ElectronicsAug 14 $96,800 - $145,200 Lafayette, Colorado, United States of America Apply →Senior Design Quality Engineer -ElectronicsApply →Aug 14 $96,800 - $145,200
Lafayette, Colorado, United States of AmericaThe Senior Design Quality – Electronic Engineer position, is one of development, improvement and innovation. If you pride yourself on your problem-solving skills and a meticulous attention to detail this may be the role for you. You will be tasked to provide quality engineering support in the design and development of electronic medical device products. Facilitate the application of Design Controls, Risk Management and Change Control processes in the evaluation and implementation of changes to released products. Responsibilities may include the following and other duties may be assigned. Previous experience in Electronic PCB design and development. Preferably with a formal... | |
Senior Design Quality EngAug 14 $96,800 - $145,200 Lafayette, Colorado, United States of America Apply →Senior Design Quality EngApply →Aug 14 $96,800 - $145,200
Lafayette, Colorado, United States of AmericaRole Senior Design Quality Engineer The Design Quality Engineer position is one of development, improvement, and innovation, through cross functional collaboration. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products across the Acute Care and Monitoring [ACM] portfolio of products. Facilitate the application of design controls, Risk Management and Change Control processes in the evaluation and release of product changes. As our Senior Design Quality engineer, your Key Accountabilities... | |
Software Quality Eng II -Aug 14 $80,800 - $121,200 Boston, Massachusetts, United States of America Apply →Software Quality Eng II -Apply →Aug 14 $80,800 - $121,200
Boston, Massachusetts, United States of AmericaResponsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable... | |
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 Regulatory Affairs Director (R7-R8) to... | |
Associate - Quality Assurance - Deviation MentorAug 14 $63,000 - $162,800 US, Concord NC Apply →Associate - Quality Assurance - Deviation MentorApply →Aug 14 $63,000 - $162,800
US, Concord NCAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Deviation Mentor is a key member of the Quality Assurance... | |
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Eli Lilly and Company seeks an Advisor, Global Quality Labs (R5)... | |
This position is responsible for providing investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes. Applicants must comply with Corporate and HR Policies, Security Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function Duties/Responsibilities Perform investigations, using eQMS (Infinity) system, for Supplier Complaints including but not limited to BMS and Supplier’s processes. Create and execute Corrective Actions and Preventive Actions (CAPA) Prepare, submit and discuss finding of the investigation process with key stakeholders. Lead global investigations in collaboration with Global Quality Supplier... | |
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker... | |
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker... | |
Quality & Pharmacy Program Manager, Global Post Market Surveillance (PMS)Remote
Aug 14 $130,000 - $150,000 US Remote Apply →Quality & Pharmacy Program Manager, Global Post Market Surveillance (PMS)Apply →Remote
Aug 14 $130,000 - $150,000
US RemoteHims & 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... | |
Director, CMC Regulatory Affairs – BiologicsAug 14 $210,375 - $272,250 United States - California - Foster City Apply →Director, CMC Regulatory Affairs – BiologicsApply →Aug 14 $210,375 - $272,250
United States - California - Foster CityGilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. KEY RESPONSIBILITIES The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position will ensure “right first time” global approvals of CMC regulatory (Biologics) submissions,... | |
Assoc Director, ValidationAug 14 $165,495 - $214,170 United States - California - La Verne Apply →Assoc Director, ValidationApply →Aug 14 $165,495 - $214,170
United States - California - La VerneKey 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... | |
GCP Quality Compliance Manager What you will do Let’s do this! Let’s change the world! In this vital role you will provide critical support to the Process Quality function by assisting in the implementation, monitoring, and continuous improvement of Amgen’s R&D Quality Management System (QMS) and Regional Quality Oversight. Accountabilities Assist in maintaining and improving the QMS by helping to track, document, and implement quality initiatives, ensuring that procedures and processes meet regulatory requirements. Contribute to the collection, analysis, and reporting of quality metrics (KPIs, KQIs), helping to identify trends, risks, and areas for continuous improvement. Provide hands-on support to... | |
Sr. Supplier Quality EngineerAug 14 $121,400 - $145,200 Minneapolis, Minnesota, United States of America Apply →Sr. Supplier Quality EngineerApply →Aug 14 $121,400 - $145,200
Minneapolis, Minnesota, United States of AmericaWe anticipate the application window for this opening will close on - 20 Oct 2025 Position Sr. Supplier Quality Engineer for Medtronic, Inc. located in Minneapolis, MN. Responsible for communicating technical objectives between Medtronic and suppliers. Coordinate with cross-functional groups in supplier selection process. Developing and maintaining incoming inspection procedures, ensuring inspector trainings and qualifying parts for SOQ program. Responsible for Supplier Change process between Medtronic and Suppliers to evaluate and implement changes at Supplier. Responsible for Supplier and Medtronic CAPA (Corrective and Preventive Action) Supplier related Product and Process NCMR (Nonconforming Material Report) by working with the supplier... | |
Quality Engineer I- JRuizAug 14 Salary N/A Ponce, Puerto Rico, United States of America Apply →Quality Engineer I- JRuizApply →Aug 14 Salary N/A
Ponce, Puerto Rico, United States of AmericaAligned with our mission to alleviate pain, restore health, and extend life, we are seeking a dedicated Quality Engineer I to join our Ponce manufacturing business unit. This role offers an incredible opportunity to contribute to technical excellence in manufacturing quality operations while ensuring the delivery of medical devices that meet the highest standards of safety and quality for our patients and customers. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to... | |
Senior CAPA & Quality Systems SpecialistAug 14 $89,600 - $134,400 North Haven, Connecticut, United States of America Apply →Senior CAPA & Quality Systems SpecialistApply →Aug 14 $89,600 - $134,400
North Haven, Connecticut, United States of AmericaAt 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... | |
Data Steward, Quality SystemsAug 14 $100,000 - $173,500 Raritan, New Jersey, United States of America Apply →Data Steward, Quality SystemsApply →Aug 14 $100,000 - $173,500
Raritan, New Jersey, United States of AmericaWe are seeking an individual with a strong track record of work behaviors and extensive experience to join our team at Johnson & Johnson as a Data Steward, Quality Systems! This position can be located in Raritan, NJ, Titusville, NJ or Horsham, PA . This is a unique opportunity to contribute significantly to the development and implementation of world-class quality systems in the pharmaceutical industry. As a global leader in healthcare, Johnson & Johnson offers a dynamic and ambitious work environment where you can excel and demonstrate your capabilities. For more than 130 years, diversity, equity & inclusion (DEI) has...
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Senior Manager, Health Care Compliance OfficerAug 14 Salary N/A Horsham, Pennsylvania, United States of America Apply →Senior Manager, Health Care Compliance OfficerApply →Aug 14 Salary N/A
Horsham, Pennsylvania, United States of AmericaWe are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be based in Horsham, PA. 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 Purpose The Senior Manager, Health Care Compliance Officer will be responsible for collaborating with Commercial and Medical Affairs on activities and... | |
Head of Quality & Compliance, Monarch PlatformAug 14 Salary N/A Santa Clara, California, United States of America Apply →Head of Quality & Compliance, Monarch PlatformApply →Aug 14 Salary N/A
Santa Clara, California, United States of AmericaJob Summary Auris Health, a member of Johnson & Johnson's Family of Companies, is recruiting for Head of Quality and Compliance (Q&C) Leader for our Monarch platform. This role will directly report to Global VP of Q&C Robotics and Digital Surgery and will be in Santa Clara, California. This role is an end-to-end role with responsibilities including Design & Development, Manufacturing/Operations, Quality & Compliance and Post Market Surveillance. As a leader, you will drive exceptional Quality and Compliance including focus on customer safety and product design, and manufacturability and reliability throughout the Product Development, Operations, Distribution, and Commercial processes. The... | |
Director, Quality Assurance, Digital SolutionsAug 14 $169,300 - $338,700 United States - California - Sylmar Apply →Director, Quality Assurance, Digital SolutionsApply →Aug 14 $169,300 - $338,700
United States - California - SylmarThe Opportunity Abbott’s Digital Solutions organization, part of the Medical Devices group, partners with our Diabetes, Cardiovascular, and Neuromodulation businesses to develop and commercialize digital technologies that expand access to care, optimize medical procedures, and improve chronic disease management. Together with Abbott’s life-changing medical devices, Digital Solutions leverages technologies such as AI and data interoperability to enable people to live life to the fullest. We are seeking a Director, Quality Assurance to join our team and establish the QA function within Digital Solutions for a diverse and growing portfolio of digital health products, including software as a medical device (SaMD),... | |
Engineering Manager - Supplier QualityAug 14 $140,800 - $211,200 Tempe, Arizona, United States of America Apply →Engineering Manager - Supplier QualityApply →Aug 14 $140,800 - $211,200
Tempe, Arizona, United States of AmericaOnsite- 100% At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Supplier Quality Engineering (SQE) Manager , you will be responsible for ensuring the quality and compliance of electronic components, indirect materials, and services procured at our Medtronic Tempe Campus (MTC) for the design and manufacture of... | |
Senior Auditor, Global Compliance AuditAug 14 $75,300 - $150,700 United States - Illinois - Chicago Apply →Senior Auditor, Global Compliance AuditApply →Aug 14 $75,300 - $150,700
United States - Illinois - ChicagoThe Senior Auditor, Global Compliance Audit, has the primary responsibility of conducting global sales and marketing compliance audits for all of Abbott’s global operating divisions and Affiliates. Compliance audits provide assurance on the effectiveness of the key elements of Abbott’s Ethics & Compliance Program. The audit scope areas covered include, but are not limited to, the following activities undertaken by the Commercial businesses within the Corporation Meals, Travel and Entertainment Expenses Professional Service Arrangements Training & Education Support Charitable Contributions Commercial Transactions Research Funding and Scientific Activities /Publications No-Charge Products Promotional Practices Ethics & Compliance Program Third-party Activities Transparency Reporting... | |
Director Software QualityAug 14 $147,300 - $294,700 United States - Illinois - Abbott Park Apply →Director Software QualityApply →Aug 14 $147,300 - $294,700
United States - Illinois - Abbott ParkThe Opportunity The Director, Software Quality is responsible for Abbott’s corporate quality policies and strategic programs associated with both product and non-product related software inclusive of design and development, validation and cybersecurity. Products include PC application software, mobile applications, embedded firmware and hardware products for medical monitoring systems, all digital and cloud products across Abbott’s portfolio. This role leads and directs activities associated with quality, regulatory, and compliance areas of Abbott. Responsible for developing a standard interpretation of regulations for Abbott, facilitating policy development and deployment to the divisions. Actively influence regulations through industry groups and other channels. Provide oversight... | |
Sr Quality Compliance ManagerAug 14 $146,700 - $293,300 United States - California - Pleasanton Apply →Sr Quality Compliance ManagerApply →Aug 14 $146,700 - $293,300
United States - California - PleasantonThis position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. As a Senior Quality Compliance Manager, the individual will play a crucial role within Abbott’s Heart Failure organization with primary focus to maintain overall Quality Management System compliance to internal policies, applicable standards and external regulatory requirements. What You’ll Work On The incumbent defines and develops strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications... | |
Job Title Quality Manager Our location in Sylmar, CA currently has an opportunity for a Quality Manager . This is a fully onsite role . The Quality Manager is responsible for implementing and maintaining an effective Quality System. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. WHAT YOU’LL DO Responsible for implementing and maintaining an effective Quality System as it relates to Post Market and Management Responsibility Independently lead groups and projects to resolve complex issues. analyze complex problems... | |
Quality Systems Specialist II(Hybrid)Aug 13 $78,408 - $104,544 Gaithersburg, Maryland, United States Apply →Quality Systems Specialist II(Hybrid)Apply →Aug 13 $78,408 - $104,544
Gaithersburg, Maryland, United StatesGeneDx (Nasdaq WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com . Summary The Quality Systems Specialist II is responsible for supporting, maintaining, and improving the Quality Management System (QMS) at GeneDx. This role... | |
Engineering Validation AssociateAug 13 $66,500 - $110,900 United States - North Carolina - Sanford Apply →Engineering Validation AssociateApply →Aug 13 $66,500 - $110,900
United States - North Carolina - SanfordUse Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of... | |
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. Will monitor and approve cleanings for the manufacturing rooms and equipment... | |
Principal Automation Quality EngineerAug 13 $119,200 - $178,800 Tempe, Arizona, United States of America Apply →Principal Automation Quality EngineerApply →Aug 13 $119,200 - $178,800
Tempe, Arizona, United States of AmericaOur Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting the patient first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. Your dedication to quality is important to our customers and, most importantly, to their patients. We are seeking an Automation Quality Assurance Engineer who will be a team leader in the Quality Optimization team for system related quality processes responsible for ensuring the quality and integrity of software and hardware processes related to process automation. The ideal candidate will focus on... | |
Regulatory Law ParalegalAug 13 $69,500 - $102,350 Titusville, New Jersey, United States of America Apply →Regulatory Law ParalegalApply →Aug 13 $69,500 - $102,350
Titusville, New Jersey, United States of AmericaWe are searching for the best talent for a Regulatory Law Paralegal to be based in Titusville, NJ. Purpose The Regulatory Law Paralegal contributes to the achievement of key Johnson & Johnson Law Department priorities by providing proactive and professional support to the Regulatory Legal team 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 review of advertising and promotional materials and activities, social media, and regulatory compliance. Assist with advertising and/or regulatory challenges, develop... | |
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Company Overview At Lilly, we serve an extraordinary purpose. We make... | |
Quality Assurance Senior Manager What you will do Let’s do this! Let’s change the world! In the rapidly evolving landscape of clinical trials, ensuring the quality and compliance of innovative technologies is paramount. This role reports to the Executive Director, Precision Medicine/Diagnostics and R&D Supplier Quality, and is dedicated to supporting the implementation of a comprehensive and proactive Quality Assurance (QA) strategy for diagnostic or health technology products used in Clinical Trials, including third-party collaborations and oversight. The individual in this role is crucial in managing and overseeing programs and projects related to R&D supplier/service provider quality, diagnostics, imaging, digital... | |
Senior Quality EngineerAug 13 $96,800 - $145,200 Billerica, Massachusetts, United States of America Apply →Senior Quality EngineerApply →Aug 13 $96,800 - $145,200
Billerica, Massachusetts, United States of AmericaWe value what makes you unique. Together, we can change healthcare worldwide. We are seeking a Senior Quality Engineer to join our team in Billerica, MA. This role is integral to ensuring the highest standards of quality and compliance in our medical device manufacturing processes. As a key member of our Quality team, you will collaborate cross-functionally to enhance product reliability, optimize processes, and uphold regulatory compliance. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with... | |
Principal eDiscovery Compliance Specialist, Mounds View, MNAug 13 $109,600 - $164,400 Mounds View, Minnesota, United States of America Apply →Principal eDiscovery Compliance Specialist, Mounds View, MNApply →Aug 13 $109,600 - $164,400
Mounds View, Minnesota, United States of AmericaAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You will lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Medtronic’s eDiscovery program is a key program in the broader strategy of Global Information Lifecycle Management, Discovery Management, and overall good data stewardship. This position offers the opportunity to manage eDiscovery for a wide variety of litigation and legal matters. The eDiscovery Specialist reports to the Sr Program Manager of Global Information and Discovery Management. This is an individual contributor role. This role... | |
Associate Director, Global Regulatory Affairs, Advertising and PromotionRemote
Aug 13 $153,600 - $241,340 Massachusetts - Virtual Apply →Associate Director, Global Regulatory Affairs, Advertising and PromotionApply →Remote
Aug 13 $153,600 - $241,340
Massachusetts - VirtualAbout 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... | |
Director, Process Optimization Lead (Unified Regulatory Platform)Aug 12 $160,000 - $276,000 Raritan, New Jersey, United States of America Apply →Director, Process Optimization Lead (Unified Regulatory Platform)Apply →Aug 12 $160,000 - $276,000
Raritan, New Jersey, United States of AmericaAbout 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, Process Optimization Lead (Unified Regulatory Platform) to be located in Raritan, NJ or Cambridge, MA. Purpose The Director, Process Optimization Lead (Unified Regulatory Platform) is responsible for driving an... | |
Senior Auditor, Compliance Internal AuditAug 12 $82,500 - $157,500 North Chicago, IL, United States Apply →Senior Auditor, Compliance Internal AuditApply →Aug 12 $82,500 - $157,500
North Chicago, IL, United StatesAbbVie’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... | |
Senior Manager, Quality Engineering in Devens, MAAug 12 $130,700 - $158,400 Devens - MA - US Apply →Senior Manager, Quality Engineering in Devens, MAApply →Aug 12 $130,700 - $158,400
Devens - MA - USAt 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 Manager, Quality Engineer is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility... | |
Manager Computer System ValidationAug 12 $90,440 - $109,600 Summit West - NJ - US Apply →Manager Computer System ValidationApply →Aug 12 $90,440 - $109,600
Summit West - NJ - USAbout the Role This position will drive computer system validation activities for the Summit site Manufacturing Execution Systems (MES) supporting the Summit, NJ Cell Therapy manufacturing site. This role is ideal for someone with a strong IT/Computer Science foundation and 5 years or more of hands-on experience in the pharma/biotech industry. You’ll partner with other cross-functional teams such as QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions and support. Key Responsibilities Lead end-to-end validation activities including test preparation, authoring of IQ/System/UAT scripts, Dry Run, test data setup, environment readiness, test execution facilitation,... | |
Associate II, Shop Floor Quality Assurance Cell Therapy in Devens, MAAug 12 $75,360 - $91,300 Devens - MA - US Apply →Associate II, Shop Floor Quality Assurance Cell Therapy in Devens, MAApply →Aug 12 $75,360 - $91,300
Devens - MA - USAt 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... | |
Manager, Health Care ComplianceAug 12 $100,000 - $173,500 West Chester, Pennsylvania, United States of America Apply →Manager, Health Care ComplianceApply →Aug 12 $100,000 - $173,500
West Chester, Pennsylvania, United States of AmericaWe are searching for the best talent for a Manager, Health Care Compliance to be based out of the Orthopedics' offices (e.g. West Chester, PA; Raynham, MA; Raritan, NJ; New Brunswick, NJ; Warsaw, IN; or Palm Beach Gardens, FL.) Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose Under the direction of the HCCO Orthopedics, the HCC Manager is primarily responsible for the implementation and support of programs designed to ensure the... | |
Associate Director, Clinical Regulatory Writing Location Boston, MA Introduction to role Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. Accountabilities As a Clinical Regulatory Writing Associate Director, you will... | |
Quality Processes Lead (Change Control Lead)Aug 12 $96,525 - $160,875 USA - Maryland - Rockville Apply →Quality Processes Lead (Change Control Lead)Apply →Aug 12 $96,525 - $160,875
USA - Maryland - RockvilleAre you a quality professional looking for a challenging opportunity to develop and oversee quality systems, review and approve GMP documentation, serve as QA representative on project teams, and manage QA projects? If so, this could be a great position to explore. Join GSK as a Quality Processes Lead where you will generate, support, coach and approve change controls. You will also provide guidance to QA and other departments on Quality issues. You will help ensure the site is always Inspection Ready. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include... | |
Sr. Supplier Quality EngineerAug 12 $75,300 - $150,700 United States - California - Temecula Apply →Sr. Supplier Quality EngineerApply →Aug 12 $75,300 - $150,700
United States - California - TemeculaSr. Supplier Quality Engineer Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Temecula, CA , currently has an opportunity for a Senior Quality Engineer . This role will serve as liaison between internal Abbott third party manufacturers and Abbott Vascular. Ensures effective implementation of quality and compliance requirements between multiple quality systems and sites. THIS IS AN ON-SITE DAILY ROLE. WHAT YOU'LL DO Position Responsibilities Work... | |
Specialist Quality AssuranceAug 12 $79,500 - $138,700 United States - California - Alameda Apply →Specialist Quality AssuranceApply →Aug 12 $79,500 - $138,700
United States - California - AlamedaSpecialist Quality Assurance The primary function of the Quality Specialist is to assist in maintaining the quality system. The role can have responsibility for one or more of the following processes Batch release Complaint Coordination Metric maintenance Surveillance Program Testing Program Document Control Exception Report and CAPA System Batch and Sample Retention and Maintenance 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 Assist with administration and ensuring compliance to Quality Management... | |
Senior Audit & Compliance Program Manager - CRMAug 12 $140,000 - $210,000 Mounds View, Minnesota, United States of America Apply →Senior Audit & Compliance Program Manager - CRMApply →Aug 12 $140,000 - $210,000
Mounds View, Minnesota, United States of AmericaBring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. Our expanding portfolio delivers measurable clinical and economic value – and opens doors. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Responsibilities may include the following and other duties may be assigned. Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory... | |
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and... | |
Supervisor, Quality Control- Night ShiftAug 12 $86,500 - $135,960 USA - GA - Social Circle - Hwy 278 Apply →Supervisor, Quality Control- Night ShiftApply →Aug 12 $86,500 - $135,960
USA - GA - Social Circle - Hwy 278About the role As a Supervisor, Quality Control, you will have a staff performing many biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental monitoring programs. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations. You will be responsible for results regarding product quality and conformance to regulations and quality policies. In some instances, you will be responsible for a functional area and may not have team members. This position works 600pm- 230am Monday-Friday.... | |
Global Head of Quality and Regulatory Affairs, LingoAug 12 $193,300 - $386,700 United States - California - Alameda Apply →Global Head of Quality and Regulatory Affairs, LingoApply →Aug 12 $193,300 - $386,700
United States - California - Alamedato make a real difference in the lives of many About Lingo Abbott's rich history in developing cutting-edge health technologies is evolving with its new venture into b iowearables . The b iowearables segment is poised to represent the future of the organization, with the potential to generate over $1 billion in revenue within the next five years, supported by Abbott’s robust R&D and financial resources. At Lingo, we are committed to transforming health management with our cutting-edge biowearables that monitor glucose levels and other critical metabolic biomarkers. Our products integrate seamlessly with other health indicators such as sleep, exercise,... | |
Manager Design Transfer Quality EngineeringAug 12 $97,300 - $194,700 United States - Texas - Austin Apply →Manager Design Transfer Quality EngineeringApply →Aug 12 $97,300 - $194,700
United States - Texas - AustinManager, Design Transfer Quality Engineering This 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. This position will be based... | |
Sr. Quality EngineerAug 11 $110,400 - $145,200 Minneapolis, Minnesota, United States of America Apply →Sr. Quality EngineerApply →Aug 11 $110,400 - $145,200
Minneapolis, Minnesota, United States of AmericaWe anticipate the application window for this opening will close on - 14 Oct 2025 Position Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Fridley, MN. Responsible for New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Ensure the development and maintenance of high-quality, reliable, and safe medical devices that meet or exceed regulatory standards and customer expectations. Coordinate complaint investigations for Medtronic’s returned implantable devices. Accept and handle returned implantable devices, cleaning and sterilization process. Coordinate test results, clinical data, DHR (Device History Records) and product performance data.... | |
Senior Manager, Global Regulatory Project Management and Strategic PlanningAug 11 $137,000 - $215,270 Massachusetts - Virtual Apply →Senior Manager, Global Regulatory Project Management and Strategic PlanningApply →Aug 11 $137,000 - $215,270
Massachusetts - VirtualAbout 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)... | |
Senior Quality Systems Manager, Quality Data Analytics - Minneapolis, MNAug 11 $149,600 - $224,400 Mounds View, Minnesota, United States of America Apply →Senior Quality Systems Manager, Quality Data Analytics - Minneapolis, MNApply →Aug 11 $149,600 - $224,400
Mounds View, Minnesota, United States of AmericaWe’re hiring for a Sr Quality Systems Manager- Quality Data Analytics. This role is a unique blend of Quality and Data Analytics skills. This manager leads the Quality Data Analytics team, enabling entity success and leadership insights, and accelerating transformation. The team provides quality data insights for OU’s, Regions, and Enterprise Functions. This leader will own the quality data insights strategy, data visualization, automation, continuous improvement, and overall quality data metrics and reporting. Responsibilities may include the following and other duties may be assigned. A Day in the Life Facilitate the strategy, formulation, and prioritization of initiatives that span areas... | |
Associate Director, Global Regulatory Affairs Advertising and PromotionAug 11 $147,000 - $212,333 Morristown, NJ Apply →Associate Director, Global Regulatory Affairs Advertising and PromotionApply →Aug 11 $147,000 - $212,333
Morristown, NJYour skills could be critical in helping our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and disease-related materials for assigned products. As the product expert, this individual helps to develop and implement regulatory strategies related to promotional and advertising campaigns for marketed products and development projects. Provides input into labeling strategies for investigational and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global healthcare company with one... | |
Sr. Manager, Clinical Quality Therapeutic AreaRemote
Aug 11 $147,004 - $174,757 United States - Remote Apply →Sr. Manager, Clinical Quality Therapeutic AreaApply →Remote
Aug 11 $147,004 - $174,757
United States - RemoteSenior Manager, Clinical Quality Therapeutic Area What you will do Let’s do this! Let’s change the world! In this vital role you will be a team member on one of the Therapeutic Area (TA) Quality teams, which include Oncology, General Medicine, Rare Disease, and Inflammation/ Biosimilars, and you will report to one of the TA Quality Leads within Clinical & Research Quality (CRQ). As a Senior Manager you will provide proactive, end to end quality oversight through various methods of risk-based quality management activities, including quality by design and real-time analysis of quality data/metrics. In this important role, you will... | |
Senior Director, BWI Quality & ComplianceAug 11 Salary N/A Irvine, California, United States of America Apply →Senior Director, BWI Quality & ComplianceApply →Aug 11 Salary N/A
Irvine, California, United States of AmericaJohnson & Johnson is recruiting for a Senior Director, BWI Quality & Compliance to support our Cardiac Electrophysiology business. The role is based in Irvine, CA. POSITION SUMMARY Head of Quality, responsible for ensuring effective implementation of BWI Quality Management System. RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position Leads BWI Worldwide Quality functions, setting the strategies and goals in accordance with applicable regulatory requirements. Johnson and Johnson Enterprise, Medical Device and CSS policies and goals. Product Quality – Oversees directly and indirectly organization of Quality professionals,... | |
Senior Quality Engineer - ENTAug 11 $96,800 - $145,200 Jacksonville, Florida, United States of America Apply →Senior Quality Engineer - ENTApply →Aug 11 $96,800 - $145,200
Jacksonville, Florida, United States of AmericaCareers that Change Lives Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. Agility and responsiveness are critical to our success with remote monitoring, wearables, robotics, AR/VR, telemedicine, and more. Experience what it’s like to work at a company with an exciting product pipeline of patented inventions driving innovation in the healthcare space. The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and... | |
Sr. Associate/Principal Associate - Supplier Quality Management - QA – Manufacturing LogisticsAug 11 $63,000 - $162,800 US, Indianapolis IN Apply →Sr. Associate/Principal Associate - Supplier Quality Management - QA – Manufacturing LogisticsApply →Aug 11 $63,000 - $162,800
US, Indianapolis INAt 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 an experienced quality associate to manage the Supplier... | |
Associate Director - Trade Import Export ComplianceAug 11 $122,250 - $179,300 US, Indianapolis IN Apply →Associate Director - Trade Import Export ComplianceApply →Aug 11 $122,250 - $179,300
US, Indianapolis INAt 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. Associate Director - Import Trade Compliance Responsibility Statement Lead the operations... | |
Senior Director, Regulatory CMCRemote
Aug 11 $241,768 - $293,000 Remote - United States - US Apply →Senior Director, Regulatory CMCApply →Remote
Aug 11 $241,768 - $293,000
Remote - United States - USRayzeBio, 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 We are seeking an experienced and motivated Sr. Director in Regulatory Affairs - CMC. This position will report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions and direct report(s) within RayzeBio. Responsibility expectations... | |
Manager, Quality Assurance Technical Operations - InvestigationsAug 11 Salary N/A Devens - MA - US Apply →Manager, Quality Assurance Technical Operations - InvestigationsApply →Aug 11 Salary N/A
Devens - MA - USPosition Manager, Quality Assurance Technical Operations - Investigations Location Devens, MA Key Responsibilities Provides quality support to Devens Site through quality review and approval of investigations. Reviews and approves discrepancy reporting, investigations and corrections and actions associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems. Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports. Provide guidance and decision making on deviation decisions within the manufacturing site and support areas. Perform routine GMP walkthroughs of processing and support areas within the Devens site.... | |
Field Quality, QA Operations Senior SpecialistAug 11 Salary N/A Devens - MA - US Apply →Field Quality, QA Operations Senior SpecialistApply →Aug 11 Salary N/A
Devens - MA - USPosition Field Quality, QA Operations Senior Specialist Location Devens, MA Shift 700 am to 330 pm Monday to Friday Key Responsibilities Quality floor support of complex manufacturing activities Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs. Perform walkthroughs of GMP areas documenting observations and areas of concern. Perform training on routine facility Quality tasks for new team members. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed. Assures all electronic and paper documentation, which requires QA review is... | |
Quality Assurance Senior AssociateAug 11 $80,300 - $133,900 United States - North Carolina - Sanford Apply →Quality Assurance Senior AssociateApply →Aug 11 $80,300 - $133,900
United States - North Carolina - SanfordUse Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will Perform batch record review and final batch disposition for clinical and commercial materials to ensure high quality products are released in a timely manner Effectively review/approve GMP documents to ensure quality attributes are met. Participate in... | |
Senior Supplier Development Quality EngineerAug 11 $86,700 - $173,300 United States - California - Pleasanton Apply →Senior Supplier Development Quality EngineerApply →Aug 11 $86,700 - $173,300
United States - California - PleasantonThis position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. We are seeking an experienced, high caliber Senior Supplier Development Quality Engineer to be responsible to act as the site interface to suppliers. What You’ll Work On Drives the development, maintenance and improvement of quality of components sourced from outside suppliers. Reviews new design specifications and proposes changes to existing specifications to support component quality and manufacturability. Develops... | |
Software Data Validation Engineer IIAug 11 $79,500 - $138,700 United States > Milpitas : 1820 McCarthy Blvd Apply →Software Data Validation Engineer IIApply →Aug 11 $79,500 - $138,700
United States > Milpitas : 1820 McCarthy BlvdAt Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, 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. Our Diabetes division currently has an opportunity for a Software Data Validation Engineer II. What You'll Do Investigate and report unexpected events, issues or software bugs through the data output from production telemetry. Investigation may include marco quality issues spanning multiple months of data... | |
Senior Cleaning Validation EngineerAug 8 $123,930 - $160,380 United States - California - La Verne Apply →Senior Cleaning Validation EngineerApply →Aug 8 $123,930 - $160,380
United States - California - La VerneSr. Cleaning Validation Engineer Job Responsibilities · Serve as the Cleaning Validation lead of cross functional team and able to provide guidance during planning, designing and development of projects. · Write and review technical documentation (cleaning cycle development reports, SOPs, system lifecycle documentation, protocols & reports for engineering and validation testing, cleaning validation master plans) · Creation, execution of Cleaning Validation Protocols, including identification and resolution of non-conformances/deviations. · Assist in preparation of regulatory submissions and presents validation in respective SME areas to regulatory authorities during regulatory inspections. · Manage contractors performing system qualifications, ensure the quality of completed deliverables.... | |
Quality Engineer II (2nd Shift)Aug 8 $60,000 - $120,000 United States - Indiana - Westfield Apply →Quality Engineer II (2nd Shift)Apply →Aug 8 $60,000 - $120,000
United States - Indiana - WestfieldQuality Engineer II (2nd Shift) This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Quality Engineer II, you’ll have the chance to provide process/quality engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Also provide process/quality engineering support to product development teams, helping to ensure development of highest quality... | |
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was... | |
SalesForce Quality Management Technical Specialist - RemoteRemote
Aug 7 $94,000 - $178,500 North Chicago, IL, United States Apply →SalesForce Quality Management Technical Specialist - RemoteApply →Remote
Aug 7 $94,000 - $178,500
North Chicago, IL, United StatesAs System Owner responsible for overall delivery inclusive of technical direction, adherence to SLC deliverables, in the development and support of applications and systems by assisting in the preparation of system specifications, testing, and implementation of efficient, cost-effective solutions with different tech stack and architectures spanning N-Tier Architectures and, SaaS space inclusive of Salesforce. Responsibilities Work with PMs for management of projects, budget accountability and project deliverables. Post completion audit of projects and assist in continuous improvement efforts. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Serve as technical lead for projects/programs and technical teams to develop,... | |
Director of AI Model Evaluation & Quality Validation - LLMs & Generative AIAug 7 $230 - $260 Seattle, WA Apply →Director of AI Model Evaluation & Quality Validation - LLMs & Generative AIApply →Aug 7 $230 - $260
Seattle, WADirector of AI Model Evaluation & Quality Validation - LLMs & Generative AI This Opportunity We are seeking a highly skilled and experienced Machine Learning Expert to join our team and evaluate the effectiveness of our AI models utilizing Large Language Models (LLMs). The ideal candidate will have a strong background in machine learning, natural language processing (NLP), and a proven track record of working with LLMs. You will be responsible for assessing the performance, accuracy, and efficiency of our AI models, identifying areas for improvement, and providing actionable insights to enhance their effectiveness. You will work... | |
Exec Director, Regulatory Affairs-Combination Products & DevicesAug 7 $274,550 - $355,300; $302,005 - $390,830 United States - District of Columbia - Washington Apply →Exec Director, Regulatory Affairs-Combination Products & DevicesApply →Aug 7 $274,550 - $355,300; $302,005 - $390,830
United States - District of Columbia - Washington· Strategic Leadership & Vision Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations. Champion regulatory innovation and novel approaches to accelerate development and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices. · Global Regulatory Excellence Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with evolving health authority requirements and internal governance. · Enterprise Collaboration & Influence Cultivate strong, collaborative relationships across Gilead’s global... | |
Senior Associate Quality Control (Monday - Friday 7:00am - 3:30pm EST)Aug 7 $81,082 - $98,151 US - Rhode Island - West Greenwich Apply →Senior Associate Quality Control (Monday - Friday 7:00am - 3:30pm EST)Apply →Aug 7 $81,082 - $98,151
US - Rhode Island - West GreenwichSenior Associate Quality Control What you will do Under minimal supervision, the Sr. Associate Quality Control staff member will be responsible for the following Performing testing and data review per various microbiology methods, assisting with sample point and method validation, document writing and review, equipment operation and maintenance, and troubleshooting testing and equipment issues. The QC Sr. Associate is expected to be a strong contributor to the Microbiology testing programs, with the ability to work independently and lead by example while performing in a highly dynamic, team environment. Perform sample collection, sample handling, and Microbiological testing to support GMP... | |
Sr. Associate II, Quality Assurance (Quality Systems)Aug 7 $91,000 - $118,000 Research Triangle Park, NC Apply →Sr. Associate II, Quality Assurance (Quality Systems)Apply →Aug 7 $91,000 - $118,000
Research Triangle Park, NCAbout This Role As a Sr. Associate II, Quality Assurance (Quality Systems), you will play a pivotal role in ensuring the compliance and efficiency of quality systems at our Biogen RTP facility. Your expertise will be vital in overseeing Quality Control compliance of exceptions and CAPAs, contributing to the issuance and management of GMP documents, and supporting internal operations. This role is integral to maintaining GMP standards and will involve collaborating across functions to drive continuous improvement and global alignment. You'll be responsible for authoring key site reports and facilitating critical meetings and governance boards. Your contributions will support regulatory... | |
Senior Manager Regulatory Affairs - Global Regulatory ServicesAug 7 $128,000 - $256,000 United States - California - Santa Clara Apply →Senior Manager Regulatory Affairs - Global Regulatory ServicesApply →Aug 7 $128,000 - $256,000
United States - California - Santa ClaraThe Senior Manager Regulatory Affairs will work for our Global Regulatory Services division within Leveraged Services. As a Senior Manager, the individual 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 support key digital health technology activities (i.e., software, cybersecurity, telehealth, digital solutions, etc.) and be recognized as an expert and resource within the division. The individual should have a strong understanding of the software lifecycle management and software development, including design, validation, and maintenance in the device regulatory environment. Demonstrates... | |
Quality Technician II This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer Technician II, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership... | |
Associate Director Regulatory Affairs - Global Regulatory ServicesAug 7 $146,700 - $293,300 United States - California - Santa Clara Apply →Associate Director Regulatory Affairs - Global Regulatory ServicesApply →Aug 7 $146,700 - $293,300
United States - California - Santa ClaraThe Associate Director Regulatory Affairs will work for our Global Regulatory Services division within Leveraged Services. As an Associate Director, the individual 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 support key digital health technology activities (i.e., software, cybersecurity, telehealth, digital solutions, etc.) and be recognized as an expert and resource within the division. The individual should have a strong understanding of the software lifecycle management and software development, including design, validation, and maintenance in the device regulatory environment. Demonstrates... | |
Quality Engineer I This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer I , you will assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. You will support new... | |
Supplier Development Quality Engineer IIAug 7 $60,000 - $120,000 United States - Minnesota - St. Paul Apply →Supplier Development Quality Engineer IIApply →Aug 7 $60,000 - $120,000
United States - Minnesota - St. PaulSupplier Development Quality Engineer II This position works out of our St. Paul, MN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Supplier Development Quality Engineer II , you’ll have the chance to develop components and associated quality requirements for new product initiatives. This position is responsible for managing supplier relationships, qualifying components and developing incoming controls that will drive the quality of future components. This will include technical support... | |
Associate Director – Data, Analytics & AI (Quality)Aug 6 $124,500 - $182,600 US, Indianapolis IN Apply →Associate Director – Data, Analytics & AI (Quality)Apply →Aug 6 $124,500 - $182,600
US, Indianapolis INAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly’s Purpose At Lilly, we unite caring with discovery to make... | |
Technician – Warehouse Quality AssuranceApply →Aug 6 $17 - $39
US: Research Triangle Park NCAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. We make... | |
The Associate Regulatory Affairs Director (RAD) , Regulatory Science & Execution will be accountable for the develop ment, implement ation and maintenance of regulatory strategies for assigned project(s)/ product (s) and regulatory jurisdiction ( s ) , with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide tactical and strategic input to and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working... | |
Quality Control Inspector IV - 2nd ShiftAug 6 $18 - $37 United States - Georgia - Atlanta Apply →Quality Control Inspector IV - 2nd ShiftApply →Aug 6 $18 - $37
United States - Georgia - AtlantaThis position works out of our Atlanta, GA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The inspector provides an independent, unbiased evaluation of materials or the work of others. The results of the Inspector's evaluation are documented and communicated to organizational stakeholders with an interest in the evaluation's outcome - typically, this is supplier development and/ or manufacturing. The Inspector's approval certifies the work, or material meets the division's quality system requirements. Will... | |
Sr. Analyst, Office of Ethics and ComplianceAug 6 $86,700 - $173,300 United States - California - Sylmar Apply →Sr. Analyst, Office of Ethics and ComplianceApply →Aug 6 $86,700 - $173,300
United States - California - SylmarThis position works out of our Sylmar CA or Austin TX facilities. What You’ll Work On Abbott is currently seeking an experienced professional to provide Support for developing, updating and maintaining basic and routine elements of Abbott’s compliance program at the franchise, business unit, divisional or corporate level. Assists with the revision and administration of OEC education and training (including supporting materials) and assists with the implementation and administration of division monitoring plan. Core Job Responsibilities The Senior Analyst performs the following with moderate supervision from the OEC Manager/Director Supports and communicates with the business to provide OEC and divisional... | |
Cybersecurity Compliance ManagerAug 6 $111,300 - $222,700 United States - Illinois - Abbott Park Apply →Cybersecurity Compliance ManagerApply →Aug 6 $111,300 - $222,700
United States - Illinois - Abbott ParkThis Cybersecurity Compliance Manager position can work remotely within the U.S . We are seeking a leader to develop and manage a centralized, standardized framework for medical device cybersecurity compliance. This role will drive alignment across people, processes, and technologies to support Abbott divisions and product teams in mitigating medical device risks. The successful candidate will establish and lead a cybersecurity compliance program, oversee a team of specialists, and ensure adherence to relevant laws, regulations, and industry standards through audits, risk management, and expert guidance. What You’ll Work On Provide strategic leadership in developing and executing a product information security... | |
Incoming Quality Assurance Technician - Casa Grande, AZAug 6 $19 - $37 United States - Arizona - Casa Grande Apply →Incoming Quality Assurance Technician - Casa Grande, AZApply →Aug 6 $19 - $37
United States - Arizona - Casa GrandeThis position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment to innovation and excellence. But we’re more than just a... | |
Associate Director, Regulatory AffairsAug 6 $126,500 - $199,100 USA - Pennsylvania - Philadelphia (Ludlow WeWork) Apply →Associate Director, Regulatory AffairsApply →Aug 6 $126,500 - $199,100
USA - Pennsylvania - Philadelphia (Ludlow WeWork)Associate Director, Portfolio & Program Management (PPM) The Associate Director in Regulatory Planning and Publishing works closely with various stakeholders to drive the identification, planning, execution, and management of activities that deliver high quality and timely regulatory and safety submissions for approval. The incumbent will be responsible for translation of regulatory strategy into an execution plan and is expected to have excellent project management skills with a strong track record of demonstrated leadership on cross-functional regulatory teams. Should be capable of independent management of all submission projects and documents, at any level of complexity, across all submission types throughout the... | |
Director, Quality Control (RTP Pharma)Aug 6 $167,000 - $230,000 Research Triangle Park, NC Apply →Director, Quality Control (RTP Pharma)Apply →Aug 6 $167,000 - $230,000
Research Triangle Park, NCAbout This Role As a visible member of the RTP Pharma Site Leadership team as well as the Global Quality Control Leadership team, you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in our Parenteral Filling , Oral Solid Dose (OSD) , and Antisense Oligonucleotide operations at RTP Pharma. You will develop and manage QC budget plans... | |
This is a full time, on site position with M-F business hours About This Role A Sr. Associate I, Quality Assurance is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral facility. Specifically, this role will have primary quality oversight of the following activities (1) Batch Records, (2) Exceptions/Investigations and (3) QA Controlled Documentation What You ’ll Do Batch Record Review/Product Disposition Review documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production... | |
Associate Director, X-TA Regulatory Medical WritingRemote
Aug 5 $137,000 - $235,750 Spring House, Pennsylvania, United States of America Apply →Associate Director, X-TA Regulatory Medical WritingApply →Remote
Aug 5 $137,000 - $235,750
Spring House, Pennsylvania, United States of AmericaAt Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent... | |
Manager, X-TA Regulatory Medical WritingRemote
Aug 5 $115,000 - $197,000; $115,000 - $197,800 Spring House, Pennsylvania, United States of America Apply →Manager, X-TA Regulatory Medical WritingApply →Remote
Aug 5 $115,000 - $197,000; $115,000 - $197,800
Spring House, Pennsylvania, United States of AmericaOur 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 Manager, Regulatory Medical Writing to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business. The position may be in... | |
Associate Director, Regulatory Affairs Devices and Combination Products (Hybrid or Remote)Remote
Aug 5 $137,500 - $261,000 Irvine, CA, United States Apply →Associate Director, Regulatory Affairs Devices and Combination Products (Hybrid or Remote)Apply →Remote
Aug 5 $137,500 - $261,000
Irvine, CA, United StatesThe Associate Director, Regulatory Affairs Devices and Combination Products works with internal and external partners to deliver products to patients. Supports regulatory objectives for the company’s development and marketed device/combination products including coordination, management of device global submissions, and CE technical files/design dossiers. Provide support to submission activities for a variety of device regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), DE NOVO, post-approval reports, annual reports, export certificates, establishment registrations and device listings. Support the development of the device regulatory strategy and provide device input into the preparation and maintenance of chemistry, manufacturing, and controls (CMC)... | |
Compliance Operations Lead, Associate Director (Hybrid)Aug 5 $153,600 - $241,340 Boston, MA Apply →Compliance Operations Lead, Associate Director (Hybrid)Apply →Aug 5 $153,600 - $241,340
Boston, MAOBJECTIVES 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... | |
Quality Engineer IIAug 5 $76,800 - $115,200 North Haven, Connecticut, United States of America Apply →Quality Engineer IIApply →Aug 5 $76,800 - $115,200
North Haven, Connecticut, United States of AmericaThis 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 Quality Engineer II, you will Provide hands-on, proactive quality engineering support within a dynamic manufacturing environment. Support and lead validation activities for new products... | |
Senior Associate Quality Control Support - StabilityAug 5 $81,082 - $98,151 US - North Carolina - Holly Springs Apply →Senior Associate Quality Control Support - StabilityApply →Aug 5 $81,082 - $98,151
US - North Carolina - Holly SpringsBe 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 Support -Stability What you will do In this vital role, you will be responsible... | |
Director, US Regulatory Affairs - Advertising and PromotionAug 5 $172,500 - $249,167 Cambridge, MA Apply →Director, US Regulatory Affairs - Advertising and PromotionApply →Aug 5 $172,500 - $249,167
Cambridge, MAYour skills could be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports. In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice... | |
Clinical & Regulatory Medical Writing Senior Manager (Hybrid)Aug 5 $136,700 - $205,100 Boston, MA Apply →Clinical & Regulatory Medical Writing Senior Manager (Hybrid)Apply →Aug 5 $136,700 - $205,100
Boston, MAThe Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. This role may represent Medical Writing Science as a cross-functional team member for study-level and program-level activities. Key Duties and Responsibilities Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, documents to support meetings with regulatory agencies, and sections of marketing authorization applications) in partnership with key stakeholders Serves as the lead Medical Writing Scientist for complex or pivotal clinical studies for multiple programs or therapeutic areas... | |
Principal Quality EngineerAug 5 $119,200 - $178,800 Minneapolis, Minnesota, United States of America Apply →Principal Quality EngineerApply →Aug 5 $119,200 - $178,800
Minneapolis, Minnesota, United States of AmericaIn this exciting role as a Principal Quality Engineer, you will have responsibility for manufacturing validation, quality systems, and product quality for new product and process development, and manufacturing site transfer at the Rice Creek Pharma Operations Manufacturing site in Fridley, MN. The product portfolio includes new technologies and next-generation products in the combination drug/device product space. Manufacturing Central Platform employs the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. The Manufacturing Central Platform offers devices and therapies to treat abnormal heart rhythms, as well as cardiac... | |
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... | |
Manager, IT Risk and ComplianceAug 5 $146,540 - $189,640 United States - California - Foster City Apply →Manager, IT Risk and ComplianceApply →Aug 5 $146,540 - $189,640
United States - California - Foster CityGilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. The Manager , IT Risk and Compliance is a key member of the Security Risk Compliance (SRC) - DP team and works closely with the legal Privacy & Data Ethics (P&DE) team, and other IT teams to ensure privacy program and controls are in place. They will serve as a subject matter expert on Information Security and Privacy principles; company policies and standards; and regulatory requirements as they pertain to data privacy. The person in this position will be required... | |
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. We are seeking an experienced, high caliber Senior Technician for Supplier Quality to assist engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. What You’ll Work On Ownership of Nonconforming Material Records (NCMRs) for supplied components and sub-assemblies and assist in the resolution of... | |
Senior Director, Regulatory Affairs - CMCAug 5 $241,768 - $293,000 Indianapolis - RayzeBio - IN Apply →Senior Director, Regulatory Affairs - CMCApply →Aug 5 $241,768 - $293,000
Indianapolis - RayzeBio - INRayzeBio, 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 . We are seeking an experienced and motivated Senior Director, Regulatory Affairs - CMC (Manufacturing) . This position will report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility... | |
Quality Assurance Specialist I - PackagingAug 5 $56,000 - $88,000 USA - GA - Social Circle - Hwy 278 Apply →Quality Assurance Specialist I - PackagingApply →Aug 5 $56,000 - $88,000
USA - GA - Social Circle - Hwy 278About the Role Responsible for providing Quality on the shop floor support for the IG/Albumin Purification, and/or Fill/Finish Operations. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules, guidelines and the company quality practices. How you will Contribute Provides on-the-floor support to IG/Albumin Purification, and/or Fill/Finish in an ISO 8 environment. Will work with a cross-functional personnel to achieve defined quality goals in an efficient, accurate and timely manner. Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be... | |
Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director)Aug 5 $208,200 - $327,140 Boston, MA Apply →Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director)Apply →Aug 5 $208,200 - $327,140
Boston, MAAbout the role The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Operations, Compliance & Process Excellence is accountable for overseeing Global Regulatory Affairs Operations across the entire PDT BU portfolio of products. As the Head of Global Regulatory Affairs Operations, Compliance & Process Excellence, you will Play a key strategic role in supporting the Global RA business by overseeing all PDT regulatory submissions globally to ensure proper resourcing, planning and on-time execution from a project management and submission support... | |
Senior Development Quality EngineerAug 5 $86,700 - $173,300 United States - California - Menlo Park Apply →Senior Development Quality EngineerApply →Aug 5 $86,700 - $173,300
United States - California - Menlo ParkThis position works out of our Menlo Park, CA 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 Senior Development Quality Engineer, you'll be responsible for ensuring that risk management is effectively implemented throughout the product life cycle. This position provides oversight and guidance for application of Risk Management principles, ensuring that Risk Management requirements are built into the quality system processes and procedures and execution of risk management decisions and activities.... | |
Associate Director – TS/MS ValidationAug 4 $118,500 - $173,800 US, Pleasant Prairie WI Apply →Associate Director – TS/MS ValidationApply →Aug 4 $118,500 - $173,800
US, Pleasant Prairie WIAt 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 Associate Director, Validation is responsible for staffing, training, and... | |
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better... | |
Regulatory Affairs Director - Oncology Cell & Gene TherapyAug 4 $168,664 - $252,997 US - South San Francisco - CA Apply →Regulatory Affairs Director - Oncology Cell & Gene TherapyApply →Aug 4 $168,664 - $252,997
US - South San Francisco - CAAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. AstraZeneca’s pipeline of industry-leading innovative medicines is consistently growing, and we are investing in our capabilities to become leaders in the delivery of next-generation cell and gene therapies. At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about... | |
Quality Manager, Monograph Donorship ProgramAug 4 $106,500 - $202,500 North Chicago, IL, United States Apply →Quality Manager, Monograph Donorship ProgramApply →Aug 4 $106,500 - $202,500
North Chicago, IL, United StatesPurpose The Manager will be responsible for driving activities related to the planning and execution of AbbVie's Monograph Donorship Program. Responsibilities Lead the creation and alignment of the Monograph Donorship Long Range Plan. Manage the execution of the Monograph Donorship Long Range Plan, including the creation of monographs. Work cross-functionally to collate the required information for monograph creation from relevant functions. Develop monograph drafts. Serve as the primary point of contact for Monograph Donorship, both internally and externally (towards applicable pharmacopoeia). Lead cross functional team review and approval for monograph submission (e.g. operations leadership, legal, etc...). Lead quarterly Monograph Donorship... | |
Manager Quality Control ((Tuesday-Friday from 9:45pm – 8:15am)Aug 4 $117,706 - $139,820 US - Rhode Island - West Greenwich Apply →Manager Quality Control ((Tuesday-Friday from 9:45pm – 8:15am)Apply →Aug 4 $117,706 - $139,820
US - Rhode Island - West GreenwichManager Quality Control The Quality Control (QC) Manager will be responsible for leading the QC Night Shift “Team D” (Tuesday-Friday from 945pm – 815am) . The QC manager will be responsible for oversight and execution of routine tasks and testing including but not limited to time sensitive samples from Manufacturing (Titer/ MMV/ Mycoplasma/ Endotoxin/ Bioburden/ TOC/ Conductivity), Centralized Raw Material testing (compendial testing & microbiology), Environmental Monitoring and Critical Utilities, Sample Receipt and Aliquot. What you will do Leading, supervision, and development of staff Collaborates across QC to coordinate the weekly testing schedule Prioritizes daily work tasks Partner with cross-functional... | |
Manager Quality Control (Saturday - Tuesday from 9:45pm – 8:15am)Aug 4 $117,706 - $139,820 US - Rhode Island - West Greenwich Apply →Manager Quality Control (Saturday - Tuesday from 9:45pm – 8:15am)Apply →Aug 4 $117,706 - $139,820
US - Rhode Island - West GreenwichManager Quality Control What you will do The Quality Control (QC) Manager will be responsible for leading the QC Night Shift “Team C” (Saturday - Tuesday from 945pm – 815am) . The QC manager will be responsible for oversight and execution of routine tasks and testing including but not limited to time sensitive samples from Manufacturing (Titer/ MMV/ Mycoplasma/ Endotoxin/ Bioburden/ TOC/ Conductivity), Centralized Raw Material testing (compendial testing & microbiology), Environmental Monitoring and Critical Utilities, Sample Receipt and Aliquot. Collaborates across QC to coordinate the weekly testing schedule Prioritizes daily work tasks Partner with cross-functional areas (Mfg, F&E) to...
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Senior Manager, Quality Engineering - InformaticsAug 4 $127,300 - $254,700 United States - Illinois - Lake Forest Apply →Senior Manager, Quality Engineering - InformaticsApply →Aug 4 $127,300 - $254,700
United States - Illinois - Lake ForestSenior Manager, Software Quality and Cybersecurity – Informatics The Senior Manager, Software Quality and Cybersecurity – Informatics role will lead global software quality and cybersecurity for Informatics, ensuring compliance with regulatory standards and driving continuous improvement across software development, validation, and security practices. Collaborate cross-functionally to secure medical device and non-medical device software and IT systems, aligning with industry frameworks and regulatory requirements. What You’ll Work On Oversee software quality assurance and validation programs across software systems. Ensure compliance with global regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, ISO 27001, NIST 800-53). Provide... | |
Associate Director - Site Systems and ComplianceAug 4 $122,250 - $179,300 US, Indianapolis IN Apply →Associate Director - Site Systems and ComplianceApply →Aug 4 $122,250 - $179,300
US, Indianapolis INAt 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... | |
Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow. As a member of our team, you will get the chance to play a pivotal role to positively impact patients’ lives while developing professionally to achieve your own career goals. This role is a key role in CSO organization to ensure day-to-day compliance within the... | |
Facilities Management Compliance LeadAug 4 Salary N/A Wilson, North Carolina, United States of America Apply →Facilities Management Compliance LeadApply →Aug 4 Salary N/A
Wilson, North Carolina, United States of AmericaAbout Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson is currently seeking a Facilities Management Compliance Lead to join our team. The role will be located in Wilson , North Carolina . As the FM Compliance Lead you will be responsible for the compliance and... |