Quality & Regulatory Jobs in Pharma & Biotech

This role provides quality oversight of the Batch Release Protocol (BRP) process and final release to market. This role will perform final review and approval of all batch release protocols for both foreign and domestic submissions. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. Benefits of working in this role Be part of an inspiring mission to create life-saving vaccines Leading a skilled and motivated team of quality professionals The work environment is a highly collaborative and technical...

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business...

Own the lifecycle management, validation, and sustained operation of digital quality systems and related capabilities. Serve as the Quality subject-matter expert and system owner for digital quality technologies, ensuring solutions are compliant, fit for purpose, inspection-ready, and aligned with cGMP, data integrity, and electronic records/electronic signatures requirements. Responsibilities Lead Quality ownership of digital quality systems, including implementation, enhancement, lifecycle management, and operational support for quality-related capabilities. Act as the Quality system subject-matter expert, translating business, cGMP, data integrity, and electronic records/electronic signatures requirements into clear system requirements and operational controls. Partner with Quality, Manufacturing, IT, Engineering, Validation, and other stakeholders...

About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. Please note that this position can be...

Serves as primary Quality Assurance associate supporting the day to day manufacturing operations in the Jacksonville IOL manufacturing site. The individual performing this role will have to create a strong network base with the line supervisor(s), technicians and engineers to address all the opportunities found in the assigned manufacturing line or quality system process Overall responsibilities include planning, conducting and directing engineering projects or studies requiring general technical knowledge. Applies basic engineering principles and practices within assigned areas. Utilizes basic Quality Engineering tools and practices to support the effective and efficient development, transfer and maintenance of products/processes throughout the product...

Johnson & Johnson is currently recruiting for a Staff Quality Engineer. This position will be located in Irving, TX. JOB SUMMARY The Staff Quality Engineer serves as a senior technical leader within Quality Operations, providing strategic direction and subject matter expertise across Quality Systems, Nonconformance Management, CAPA, Process Validation, Risk Management, and Continuous Improvement. This role leads complex cross-functional quality initiatives, drives systemic process improvements, ensures regulatory compliance, and mentors quality professionals while influencing stakeholders across Operations, Engineering, Supply Chain, Manufacturing, and Regulatory functions. The Staff Quality Engineer is expected to lead high-impact quality investigations, identify and address systemic issues,...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson Robotics and Digital (RAD) is recruiting for a Quality Engineering Spring 2027 Co-Op, located in Santa Clara, California 5 to 6 month term (January-June) As a Co-op in the Quality Engineering organization, you will have the chance to · Use state of the art tools and take advantage of training courses offered on-site. · Perform testing, experimentation, verification, and...

This position is based on our Abbott Park, IL location in the OEC (Office of Ethics and Compliance). This is an onsite position. As Sr. Compliance Specialist , you’ll have the chance to work in the Abbott’s Compliance Training team that is responsible for Abbott’s worldwide compliance training strategies, including managing its compliance learning training system (LERN). This position will work under supervision of, and report directly to, the Compliance Training Manager, interacting with Abbott personnel around the world at all levels. What You’ll Work On Support Abbott’s Office of Ethics and Compliance (OEC) compliance training strategy and global implementation....

This position supports Operations within the Cancer Diagnostics business. As a Quality Assurance Engineer, you will partner with Facilities, Service & Metrology, Process and Controls Engineering, Instrument Production, Reagent Manufacturing, Quality Control, and other areas of Operations. Depending on the assigned area, you will provide Quality oversight of products, materials, manufacturing and QC laboratory equipment and processes, instrumentation, facilities, utilities, and associated systems through qualification and validation, risk management, investigations, change control, and continuous improvement. What You'll Work On Provide Quality Engineering oversight of manufacturing processes, instruments, equipment, facilities, utilities, and automated systems throughout their lifecycle, including qualification, validation, maintenance,...

Gilead Sciences is seeking an experienced validation leader to head the Manufacturing Validation function at the Foster City site. This role will establish and lead an integrated, risk-based validation program for the facilities, utilities, equipment, automation, and computerized systems supporting a new state-of-the-art biologics facility. In partnership with Engineering, Manufacturing, Quality, Automation, IT, and project teams, this leader will define the validation framework, build the capabilities required for execution, and ensure the new facility is compliant and inspection-ready from startup through routine operations. The successful candidate will also lead and integrate the existing validation team supporting the site’s small-molecule clinical...

We anticipate the application window for this opening will close on - 3 Nov 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Regulatory Affairs Specialist supports international regulatory...

We anticipate the application window for this opening will close on - 27 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Supplier Quality function partners with external...

We anticipate the application window for this opening will close on - 31 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Careers that Change Lives This individual will...

Quality Compliance Senior Manager What you will do Let’s do this! Let’s change the world! The Senior Manager leads the Quality Intelligence Center (QuIC) integrated quality oversight operating model and the governed signal-to-action lifecycle through which QuIC-generated signals, trends, dashboard outputs, and emerging quality insights are reviewed, contextualized, triaged, routed, monitored, and closed. The role leads the QuIC team and establishes business standards, review routines, governance inputs, decision pathways, and cross-functional ways of working required to embed QuIC into R&D Quality oversight. Key responsibilities Lead the day-to-day operation of the QuIC function and manage a professional team responsible for portfolio-level...

MANAGER QUALITY CONTROL I – NIGHT SHIFT NOTE This is a Wednesday - Saturday schedule night shift. What you will do In this vital role you will play a key role in the Quality Control team as the Manager for night shift support. Reporting directly to the Director of Quality Control, the Manager, Quality Control I (Night Shift) is an experienced QC professional who provides independent technical execution and shift-level leadership within a GMP-regulated laboratory environment. This role is accountable for leading night shift QC operations, ensuring accurate sample management, timely analytical testing, and sustained compliance with GMP, data...

Life at BMS At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams,...

Life at BMS At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams,...

Reports to Head, Regulatory Data Vanguard (RDV) and accountable for the oversight & execution of global data management activities spanning multiple regions, products etc. in support of new and remediation activities. Also accountable for the overall integrity and quality of Pfizer Global regulatory data through the oversight of data quality, completeness and timeliness, working in close partnership with the relevant BPO’s to inform procedural and process updates. Accountable for measuring, experimenting and driving GRS towards data excellence through innovation and improvement, utilizing existing and new capabilities such as AI, data science, automations and reports in support of optimizing data quality...

Overview This role serves as a key member of our company's research division Ethics & Compliance Leadership Team and as a trusted counselor and advisor to the Global Clinical Development (GCD) organization, with particular focus on the Value and Implementation (V&I) team. The Executive Director reports to, and partners closely with, the head of our company's manufacturing and research divisions Compliance, representing the Ethics & Compliance Office (ECO) in counseling senior leaders within GCD and V&I. The Executive Director is accountable for the execution of key compliance initiatives and is tasked with understanding and advising on the legal and practical...

Brief Job Profile Description This role will be responsible to guide and support the execution and continuous improvement of site Quality Systems and Compliance activities. The individual will serve as a key point of contact for deviation and CAPA management, change control governance, Quality Management Review preparation, and Annual Product Quality Reviews for an autologous cell therapy manufacturing site with products in clinical development and commercial manufacturing. This person will be responsible to execute site self-inspections and coordinate inspection readiness activities for regulatory inspections, corporate audits, partner audits by ensuring the compliant execution of established procedures including (but not limited...

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying , and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our fervor for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. The Specialist, Quality ensures compliance with quality system's procedures and assessing...

Purpose As an Associate Specialist on the Operations Risk and Governance team, you will focus primarily on managing background checks and supporting Talent Acquisition Compliance for specialized recruitment. In this role, you will partner closely with Compliance Leads, Recruiters, Legal, and other internal stakeholders to ensure background check processes are completed accurately, efficiently, and in compliance with AbbVie policies and applicable laws. This position requires strong attention to detail, sound judgment, and the ability to manage multiple priorities in a fast-paced environment. Responsibilities Manage the background check process for a high volume of requisitions across business functions using AbbVie’s applicant...

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...

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...

POSITION SUMMARY The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. PRIMARY RESPONSIBILITIES Understands and interprets U.S. and EU and international medical device and in vitro diagnostic device (IVD) regulatory requirements. Provides guidance on requirements to product development teams. Develops strategies...

Life at BMS At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams,...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Engineer, IT Compliance works cross-functionally to lead compliance-related activities for GxP electronic systems and applications. This role is primarily an...

Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. This position will interact with cross functional teams working with all levels of employees. Activities will include developing, documenting, and maintenance of technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical...

Located at our global headquarters in Foster City, CA or Parsippany, NJ, as a Director, Ethics & Compliance Investigations , at Gilead you will... The Director, Ethics & Compliance Investigations, plays a key role in promoting Gilead's culture of integrity, transparency, and accountability. We are seeking a dedicated and experienced investigator to join Gilead's Ethics & Compliance Investigations team. This position will lead and manage internal investigations into potential violations of law, regulation, or company policy, ensuring that each investigation is handled promptly, confidentially, and in accordance with company policies and regulatory requirements. The successful candidate will bring high emotional...

Engineer - Process Development (Commissioning, Qualification, and Validation) What you will do In this role, you will support the commissioning, qualification, and validation (CQV) of GMP equipment and processes that enable Final Drug Product (FDP) operations at the Amgen Ohio (AOH) site. You will apply strong engineering and scientific principles to ensure new and existing systems meet Amgen and regulatory requirements throughout the validation lifecycle. As a key contributor to AOH’s growth, you will play an essential role in technical transfer, equipment startup, process validation, and continuous improvement across automated device assembly, packaging, and FDP manufacturing operations. Your work...

Location Cambridge MA Internal Director LI#-Hybrid This role oversees the Study Quality and Compliance team within the Toxicology line function of PCS. This team is responsible for handling samples and data associated with both internally and externally conducted toxicology studies; maintaining departmental SOPs, and oversight of training records for departmental personnel; and interfacing with the archives function to ensure proper storage of toxicology-related materials and records. A major part of this role will be to identify and implement a software system that enables effective tracking and analytics of study-related information that this group is responsible for overseeing. Key Responsibilities...

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

Innovation doesn't happen by doing more of what we've always done. This role is for a regulatory professional who is ready to challenge assumptions, question what we've stopped questioning, and help us accelerate how we bring medicines to patients. You will be part of building something new - a function that transforms how Sanofi conceives, builds, and delivers regulatory submission and obtains authorizations – our mission is to create awareness, clarity and capabilities that enable teams to make better choices to accelerate regulatory authorizations. What makes this role unique You will help build a brand-new function from the ground up....

We anticipate the application window for this opening will close on - 31 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Careers that Change Lives This individual will...

We anticipate the application window for this opening will close on - 27 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Quality Engineering function partners across manufacturing,...

As a Co-op in the MedTech (MT) Quality Engineering organization, you will have the chance to Collaborate with teams across J&J MedTech on Quality Engineering projects. Support and/or perform risk management activities. Learn and apply various statistical techniques to analyze data. Develop and contribute to training materials including procedures and work instructions. Strengthen presentation, communication, and leadership skills. Work with a diverse team of quality, development, test, and design engineers. Take advantage of training courses offered at J&J. Support project teams in ensuring the product being developed is safe and effective for patient use. The Quality Engineer Co-op will Have...

As a Co-op in the MD Quality and Compliance (Q&C) Digital Solutions organization, you will have the chance to Use state of the art tools and take advantage of training courses offered at J&J. Collaborate with teams internal and external to the advanced analytics to implement customer-centric solutions for data analytics and process improvements Perform software development and validation to support medical device quality system digital solutions. Learn and apply various software development and lifecycle management techniques. Promote digital culture and capabilities across J&J medical devices Strengthen communication and leadership skills. Work with a diverse team of data scientists, analytics...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Director, North America Regulatory Affairs Leader based in Raritan, NJ, Titusville, NJ, or Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by...

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

General position summary Biomarker Operational Quality Associate director provides Biomarker quality leadership and oversight across GxPs-related to research and development, implementation into clinical trials and potential commercialization of clinical biomarkers into IVDs. The incumbent will collaborate with business partners and GCP Operational Quality to drive quality outcomes and operational excellence, through supporting operational management oversight for these areas. The Associate Director will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs. The Associate director, Biomarkers Operational Quality will also collaborate with the Biomarker Operations team to review and...

The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio. This role provides strategic leadership for complex regulatory CMC activities, oversees Health Authority engagement, and ensures regulatory requirements are effectively integrated into development and commercialization plans. The Director drives organizational excellence through talent development, process innovation, and the application of digital and AI-enabled capabilities to enhance the quality, consistency, and efficiency of regulatory decision-making, document preparation, and submission execution. Key Duties and Responsibilities Leads development and execution of global CMC...

Role Overview - Rockville, Maryland The Specialist, QC Analytical, performs routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) with high quality and data integrity, maintains accurate documentation, and participates in laboratory investigations. The QC Specialist collaborates within the QC team and with cross-functional partners to meet testing timelines and ensure compliant operations. This position is for a 4 days per week, 10 hours per day shift, Sunday through Wednesday. Role Responsibilities Analytical testing Execute QC...

Role Overview - Rockville, Maryland The Specialist, QC Analytical, performs routine and non-routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) with high quality and data integrity, maintains accurate documentation, and participates in laboratory investigations. The QC Specialist collaborates within the QC team and with cross-functional partners to meet testing timelines and ensure compliant operations. This position is for a 4 days per week, 10 hours per day shift, Wednesday - Saturday Role Responsibilities Analytical testing Execute QC...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. A Senior Laboratory Technician, Quality Control/Senior QC Lab Tech is responsible for performing advanced laboratory procedures independently for the testing...

Join GSK’s Quality Control Laboratory Associate Apprentice Program – US, 2027 Help us get ahead of disease together GSK Apprenticeships are full-time entry level opportunities that offer high school graduates and community college students the opportunity to begin their career while studying towards their associate degree. This associate degree is fully funded by GSK, which means NO COLLEGE DEBT! Education required High School diploma or equivalency diploma by June 2027. High school GPA 2.5 (“B”) or above (4.0 scale) High school Algebra and Geometry or 2 units equivalent of academic math (GPA 2.5 or above in each case) High school...

Purpose The Office of Ethics and Compliance (OEC) Strategic Execution and Initiatives Senior Analyst will be responsible for project management and execution of strategic initiatives advancing the global OEC program, including (1) assessing OEC support needs, and planning and executing risk-directed projects, including project plans, stakeholder engagement, communications/training, risk-focused information sharing, notes, and supporting the draft, coordination, and finalization of critical compliance reporting materials (e.g., Risk Assessment) to support execution of identified projects; (3) capturing OEC accomplishments and socializing for awareness against Strategic Initiatives, Powering What’s Next and other OEC or AbbVie priorities; (4) leading the management of OEC resources...

The Manager Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes pharmaceutical products, medical devices, cosmetics, combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of responsibility may include supplier qualification and approval, supplier risk management, , supplier change management, , and Approved Supplier List (ASL) governance. This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates. This position will ensure that all product, process or system related quality activities from raw material inspection through...

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...

In this key role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans Conduct the formal review and approval of authored documents, following applicable standard operating procedures With limited supervision,...

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

We aspire to be the premier research-intensive biopharmaceutical company. At Join us in our mission to promote transparency, accountability, and ethical use of data and AI. The Associate Director, Governance Risk and Compliance for Data, Data Products and Digital Solutions will lead the development and implementation of governance, compliance, privacy, and responsible AI practices across data, data products, and digital solutions. This role partners with cross-functional teams to embed practical controls and standards throughout the data and AI lifecycle, ensuring solutions are developed and used in alignment with company policies, enterprise standards, and applicable regulations. The position supports the...

It is critical that consistent, accurate, high-quality data is generated and maintained from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the CQOM is responsible for the execution of clinical quality oversight activities within an assigned trial. This includes proactive quality management, risk-based quality oversight, and clinical trial inspection management activities. The CQOM will provide clinical quality operations support to Trial Teams (TTs) to proactively embed quality into sponsored trials, ensure robust supplier oversight, and address critical quality issues as needed. The incumbent will assist with the overall strategy for maintaining...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Global Support Functions Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Global Safety & Environment Intern - Environmental Compliance, Sustainability & Stewardship (ECSS) Team – will provide support to Company facilities globally related to environmental compliance and sustainability programs (air, water, waste, remediation, sustainability). Projects may include Assisting with environmental compliance program implementation and improvements. Supporting environmental activities at Company sites, including...

We anticipate the application window for this opening will close on - 30 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Bring your talents to an industry leader...

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative...

We are currently seeking a highly qualified individual to join our team as a Quality Systems Specialist at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC). 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 Essential Job Duties and Responsibilities This position is responsible for leading and/or supporting Quality...

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

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for cGMP Compliance and Investigations Lead to join our Innovative Medicine team in Spring House, PA. Purpose The cGMP Compliance and Investigations Lead provides technical and compliance leadership for deviation, non-conformance, assay-failure,...

This position works out of our Lake Forest, IL location in the Core Lab , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Regulatory Affairs Manager provide regulatory review and strategic guidance for advertising and promotional materials and activities, including digital, customer-facing, and external communications supporting U.S. and global marketing initiatives across medical devices, in vitro diagnostics (IVDs), Digital Health solutions, automation platforms, software-enabled...

Incoming Quality Technician I The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health. Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics. Our location in Irving, TX, currently has an opportunity for Incoming Quality Technician I. Under general supervision, the IQA Technician I performs inbound material inspections and tests that evaluate...

That’s what makes us Genentech / Roche! In Pharma Development Quality (PDQ), we strive for confidence in the integrity of our data and processes, agility, and unrivaled transparency with health authorities, patients, and society. Our work provides leadership, know-how, and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates, and global regulated processes. This role supports the Roche/Genentech Organization by developing and delivering Quality Assurance strategies, audits, and conclusions for post approval products, affiliates and processes, based on a risk-based approach. Quality Assurance strategies are based on the Critical to Quality framework, encompassing Good Clinical Practice...

As a trusted validation engineer, you will influence projects from concept through operational release, partner across Manufacturing, Laboratory, Facilities, Quality, Engineering, MS&T, and IT, and help build a culture in which quality, innovation, and compliance strengthen one another. Typical Accountabilities Lead/coordinate validation strategies and lifecycle deliverables that translate risk, regulatory expectations, and business needs into clear plans, robust testing, traceability, and defensible conclusions. Guide the qualification and continued control of GMP facilities, utilities, equipment, temperature-controlled storage units, manufacturing systems, and laboratory equipment that support dependable operations. Direct protocol planning and execution, evaluate installations and changes, and integrate...

Purpose The Senior Manager, Quality provides leadership and direction to the Quality Function they are responsible for within Operations. This Sr. Manager role is responsible for the effective implementation of AbbVie Quality Systems for which they are responsible for. This could include Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Quality Control, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives. The Sr. Manager of Quality would be expected to manage a budget and leads a team of quality professionals who are responsible for compliance and quality oversight for...

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...

Director, Security and Compliance Job Overview The Director of Security and Compliance is a strategic, highly technical leader responsible for designing, scaling, and overseeing our global information security and regulatory compliance programs. Reporting to the CIO, this role bridges the gap between technical security engineering, legal requirements, and business operations. Key responsibilities include defining our security posture, leading Governance, Risk, and Compliance (GRC) initiatives, and ensuring continuous alignment with industry frameworks. The ideal candidate for this role is someone who doesn't just manage checklists but actively translates complex regulatory policies into practical, testable technical controls that allow our engineering and...

Specialist Quality Assurance – Major Deviations What you will do In this vital role you will will serve as a Quality leader accountable for the investigation and resolution of major deviations, safeguarding product quality and patient safety through sound judgment, strong ownership, cross‑functional collaboration, and effective risk management in a dynamic drug product manufacturing environment. Specific responsibilities include but are not limited to Serve as Quality investigation lead and decision-maker for major deviations, maintaining accountability for designation, documentation quality, timeliness and closure. Actively participate in deviation meetings, managing multiple concurrent deviations and driving effective resolution. Provide Quality oversight to...

In GBS we dare to change the way we work—being brave, resilient, and focused on simplifying how we deliver value. Through our global scale and diverse services, we drive outcomes with innovation and expertise. This requires a team that sees no boundaries, collaborates across functions, challenges the norm, and feels empowered, motivated, and engaged. The Senior Director, Compliance and Legal Services will lead the global build-out and maturation of a cohesive service portfolio spanning Compliance, Privacy, Legal Operations, and eDiscovery within GBS. Reporting to the Head of GBS Operations & Enabling Functions Services, this role supports strategy build, is the...

Location Kendal Square, Boston Hybrid 3 days a week on site Medical Director, Senior Safety Physician We are seeking an experienced physician to provide medical leadership for clinical safety and benefit-risk management across the lifecycle of assigned products and development programs. This role is accountable for shaping and executing safety strategy, evaluating emerging safety data, and ensuring the effective communication of safety information to internal and external stakeholders. Working within a global, cross-functional environment, you will collaborate with experts across Clinical Development, Regulatory Affairs, Epidemiology, Safety Science, Risk Management, and Medical Affairs to protect patient safety and support the successful...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives. Main Responsibilities Supporting the implementation and maintenance of the complaint (Third Party/Product Technical) management process Assisting...

Sanofi delivers 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. By driving its own transformation, Global MSAT fulfills an important function...

Specialist, Global Analytical Instrument Validation Specialist, Pharmaceutical Analysis & Digital Technologies The Pharmaceutical Analysis & Digital Technologies (PADT) Analytical Capabilities and Operations (ACO) department of our Research & Development Division is seeking applicants for a Validation Specialist position available at the West Point research facility. The Analytical Instrument Validation Specialist will work as part of the integrated Validation and Compliance team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The Analytical Instrument Validation Specialist role oversees and/or supports the validation of novel computerized analytical instrumentation within the GMP...

Johnson & Johnson is hiring for a Regulatory Affairs Specialist, Ops 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 Cardiovascular Solutions from Johnson...

Johnson & Johnson, Vision a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Validation Quality Engineer, Quality Operations. This position will be located in Jacksonville, FL The Senior Quality Engineer is primarily responsible for ensuring operational compliance to FDA/GMP and ISO 9001 regulations. Analyzes quality trends and reports conclusions. Reviews and applies trend results to prioritize resolution of process, equipment and/or system problems in order to prevent re-occurrence. Utilizes tools to track quality performance and identify key opportunities. In addition, the Sr. Quality Engineer provides support in the planning, development, implementation, and maintenance...

POSITION SUMMARY The Sr. Quality Specialist leads robustness of investigations and approvals, ensuring timely triage, thorough root-cause analysis, and effective corrective/preventive actions. This skilled and competent Quality Approver role will support monitoring progress, provide feedback to investigation owners, resolve stakeholder conflicts, and escalate issues to senior management when required. Investigation Quality System Investigation Process Execute quality reviewer/approver duties, review evidence, and approve closure of investigation records. Conduct investigation record quality reviews for documentation completeness, robust root-cause analysis, and compliance with procedures. Provide coaching and actionable feedback to issue owners on best practices, system usage, and investigation execution. Facilitate the progression...

About This Role As a Senior Associate II in Quality Audits, you will play a pivotal role within the Corporate Quality team, focusing primarily on audits in the Regional Americas. You will independently conduct risk-based audits to ensure compliance with regulatory requirements, international standards, and company quality expectations, primarily under ISO 13485 and applicable GxP regulatory frameworks including FDA and EMA guidelines. Your role will enhance our audit program by supporting inspection readiness and supplier qualification, while contributing to the continuous improvement of our Quality Management System (QMS). With a degree of autonomy and professional judgment, you will collaborate closely...

About This Role Every clinical trial depends on investigational medicine arriving at the right place, at the right time, and in the right condition. As Clinical Supply Lead Specialist – Bulk Logistics & Quality, you will play a key role in making that happen for Biogen's clinical programs, across two areas. In Bulk Logistics, you will plan and manage the global movement of drug substance, drug product, and finished goods between manufacturing sites, contract partners, and warehouses, working closely with planners, manufacturing, quality, and logistics partners around the world. In Quality Operations, you will help keep our clinical supply operations...

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our Vascular Division team on-site in Temecula, CA. In this role, you will support EU and US regulatory activities and collaborate with the global regulatory organization to maintain regulatory compliance for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities. This role requires strong attention to detail,...

This position works out of our Pomona, CA location in the CMI Business Unit , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Supplier Quality Engineer will be responsible for quality engineering activities that address product/process changes, product/process quality issues, and compliance issues. This person will partner with operations for process improvement and continuous improvement initiatives and perform process audits of the operations...

Associate Qulity Engineer This position works out of our Arecibo, PR location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. This is an exempt role; supports the first shift operations. The Associate Manufacturing Engineer will serve as the primary engineering personnel supporting manufacturing operations in PR. The individual performing this role will have to create a strong teamwork with the line supervisor, Quality Engineer and operators to address all the opportunities found in...

This position works out of our Dallas, TX location in the Transfusion Medicine , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Engineer Quality Systems is responsible for developing and maintaining quality systems and providing quality system support for the division (e.g., commercialized products, new product development, manufacturing, and/or system compliance). What You’ll Work On Provides Quality System Body of Knowledge support to...

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

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...

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects. PRIMARY RESPONSIBILITIES Strategic Study Design and Analysis Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.) Regulatory Compliance Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical...

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects. PRIMARY RESPONSIBILITIES Strategic Study Design and Analysis Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.) Regulatory Compliance Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical...

We are looking for an experienced Manager of Quality Management Systems to build, maintain, and improve our ISO 13485-certified QMS. In this role, you will own our internal and external audit program and our quality training program. You will keep the QMS compliant across all disciplines and support regulatory initiatives. You will also design and maintain quality programs that meet customer requirements for each product line.The ideal candidate brings deep ISO 13485 expertise, hands-on audit experience, and a strong understanding of the genomics or life sciences space. What You’ll Do Implement and maintain QMS procedures that comply with ISO 134852016...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of . Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings...

Quality Engineer. This position will support the Structural Heart business and will be based in Caguas, Puerto Rico. On-site position. This position will provide support to our Medical Devices / Structural Heart business . Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. 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...

Use Your Power for Purpose Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety. What You Will Achieve In this role, you will Evaluate corrective and preventive action (CAPA) responses to internal and external audit observations for adequacy, effectiveness, and timely completion. Ensure Quality Assurance policies, procedures, and quality system records remain current...

About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at . Transcend is a global business transformation program that will modernize our foundational transactional processes and harmonize them into one “clean” ERP as a standardized platform for growth and efficiency gains. This program will simplify the Pharmaceutical ERP landscape...

We are searching for the best talent for a Manager, External Quality, External Contract Laboratories (ECL) Americas located in either Horsham, PA, Malvern, PA or Raritan, NJ . About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Purpose Drives Quality Assurance, Compliance and Technical Support for External Quality...

Johnson & Johnson Healthcare Systems, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting a Trade Compliance Operation Analyst! This position will be located in New Brunswick, New Jersey, with considerations given to alternate New Jersey J&J locations at the discretion of the business. Johnson & Johnson Health Care

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). USA Req# R-103874 Belgium/Ireland Req# R-105117 Switzerland Req# R-105118 The Senior Director, Quality Digital & Analytics is responsible for defining and executing a comprehensive strategy that leverages digital transformation and advanced analytics to enhance quality management and compliance across the Innovative Medicine sector. This position will oversee the establishment of...

About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

Biosense Webster , Inc., part of the Medical Devices sector within Johnson & Johnson , is recruiting for an intern for its Medical Devices Regulatory Affairs organization . 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...

We anticipate the application window for this opening will close on - 21 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

We anticipate the application window for this opening will close on - 26 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

We anticipate the application window for this opening will close on - 30 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Design Quality Engineer II in Released...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. We are seeking a highly skilled and detail-oriented Process Quality Analyst to join our Process Engineering team. As the Quality Analyst,...

Life at BMS At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams,...

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by performing QC analytical method qualification, execute lot release testing, sample management and other assigned tasks. This position is essential for ensuring that the laboratory meets the high standards required for CGMP Quality Control. This position includes weekend technical support and may require non-traditional work schedules to support operational and business requirements. Scheduled work hours and shift assignments are subject to change. Essential Responsibilities Perform CGMP release...

Responsible to perform adequate and comprehensive qualification and validation of equipment, processes, products, and facilities at the Redwood City site to support the site goals and targets. Key Accountabilities Work effectively with others from diverse backgrounds and demonstrate capability to adapt to new, different, or changing requirements. Display strong moral principles and work ethics while demonstrating initiative. Maintain a professional presence and display responsible behaviors Knowledge and experience developing and leading CSV and Life-cycle management activities to support GxP conforming systems, facilities, manufacturing and laboratory systems Evaluate equipment and processes to identify critical parameters based upon potential impact on product...

Job Profile Description Provides independent, visible Quality Assurance leadership at the source of cell therapy manufacturing. This is a shift-based role scheduled for four days per week, Wednesday through Saturday. Partners with Manufacturing and supporting functions to apply risk-based quality judgment, resolve issues within established frameworks, and support reliable, compliant execution. Operates independently across qualified routine and moderately complex situations, influences cross-functional decisions, and strengthens quality culture through practical coaching, clear communication, and disciplined follow-through. Specific quality-system responsibilities and approval authorities are defined through applicable procedures, qualifications, and delegated authority. This is a shift-based role scheduled four days per week,...

The Senior Manager / Associate Director of Clinical Quality Assurance (CQA) will provide leadership for the qualification and ongoing quality oversight of CROs and other clinical service providers while providing clinical quality support for assigned studies. This role will partner cross-functionally to implement risk-based vendor oversight, monitor and address vendor quality and compliance risks, and provide pragmatic GCP guidance to study teams. This position will also support quality investigations, audits, CAPAs, and inspection readiness activities to ensure effective sponsor oversight and sustained clinical trial compliance. Responsibilities Lead and manage the qualification and ongoing quality oversight of CROs and other GCP/GCLP/GVP...

Quality Manager, CAPA The function of the Quality Manager, CAPA is to provide corporate-level leadership and guidance for Quality Systems matters related to nonconformance, investigation and C orrective And P reventive A ction (CAPA) processes and other related Abbott Quality System elements. This includes Business/Division support, quality and technical expertise and consulting activities globally. The incumbent must have a working knowledge of global regulations and industry standards related to nonconformance, investigation, and Corrective And Preventive Action (CAPA) processes. The incumbent should also have working knowledge and understand the relationship to other related Quality System elements, e.g., management responsibility, risk...

Our location in Sylmar, CA currently has an opportunity for an Electrical Development Quality Engineer II . This is a fully onsite role . A Development Quality/Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. WHAT YOU’LL DO Execute...

The Site Quality Leader is the senior quality authority for the site and a key member of the Site Leadership Team. The role is accountable for ensuring that all products manufactured, tested, and released from the Plymouth, MN and St. Paul, MN Structural Heart facilities meet global regulatory requirements and conform to the Abbott Structural Heart Quality System. In addition, the position is responsible for establishing and leading the quality strategy, driving regulatory compliance, and maintaining the Quality Management System for finished Structural Heart devices and components manufactured at Minnesota facilities. Establish and implement a site quality strategy aligned with...

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Specialist, Technician Biologist | Quality Control with In Vivo Release Testing (IRT) in our Manufacturing Division Quality Laboratory Operations Team. Position Responsibilities This role will perform testing in support of releasing vaccines...

The Specialist, WPLO Equipment Support Group (ESG) is responsible for the implementation, lifecycle management, and administration of laboratory equipment within assigned areas of Laboratory Operations. This position provides technical support for routine business activities and applies the Risk-Based Asset Management (RBAM) process to evaluate high- and medium-risk equipment. The incumbent partners with the Small Capital point of contact to develop forecasts and align funding for future risk mitigation, participates in projects as a lead or team member, and supports operational improvements, instrument qualification, implementation, and decommissioning activities. The Specialist serves as point of contact for assigned IPT laboratory areas and...

The Senior Specialist, WPLO Equipment Support Group (ESG) Senior Specialist IPT Lead is responsible for the implementation, life cycle management, and administration of laboratory equipment utilized within assigned areas of Laboratory Operations. Responsibilities include provide technical expertise to support run the business daily activities L e verage the RBAM (Risk Based Asset Management) process to assess high / medium risk equipment, collaborate with the Small Capital POC to work on forecasts to align funds for future risk mitigation, lead projects, implement operational improvements, support and / or have oversight over instrument qualification and implementation, and decommissioning. The ESG Senior Specialist...

We are searching for the best talent for a Counsel, Regulatory Law, Government Programs, to be based in Washington, DC or Raritan, NJ. Purpose Federal and state governments play a significant role as purchasers and payors of Johnson & Johnson products. This attorney will serve as an enterprise-oriented legal advisor who shapes strategy, influences decisions across organizational boundaries, and creates clarity in complex and rapidly evolving legal and regulatory environments pertaining to government transactions, federal procurement, pricing, transparency and compliance requirements affecting Johnson & Johnson operating companies. The role requires practical, solutions-oriented advice that supports business objectives while managing legal,...

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

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Quality Operations Technician. Purpose Responsible for conducting technical quality assurance inspections, quality issue resolution, product containment, and supporting quality improvements for production processes and standards. You will be responsible for Supports v Quality Operation functions including CAPA/NC initiatives, Quality...

DePuy Synthes is recruiting for a Sr. Source Regulatory Compliance Specialist, located in Palm Beach Gardens FL, Raynham MA, Warsaw, IN or West Chester PA. Job Overview The Manager, Technology Regulatory Compliance, is responsible for leading compliance activities related to technical and regulatory requirements across the organization in support of product and non-products systems. This role ensures that technical processes, documentation, and system implementations align with applicable regulatory standards, quality system requirements, and internal policies. The position plays a critical role in managing compliance risk, conducting audits and assessments, supporting audit inspection readiness, and enabling compliant execution of technical initiatives...

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

We anticipate the application window for this opening will close on - 22 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward...

We anticipate the application window for this opening will close on - 30 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Supplier Quality Engineering team within Cranial...

We anticipate the application window for this opening will close on - 21 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life This role supports Supplier Quality within Medtronic,...

The Quality Control Associate III will support the management team to ensure that laboratory and Quality systems within the QC Chemistry department remain in compliance with Biogen Idec and industry cGMP standards. Additionally, the Associate III will actively support the completion of all departmental milestones associated with clinical and commercial product manufacture and testing. The Quality Control Associate III has frequent interaction with the Supervisor, Manager and Associate Director of QC Chemistry as well as peers (Associate I, II, III) with the purpose of performing release/stability testing, leading investigations, discussions pertaining to strategic initiatives, personnel development, and testing-related issues. Importantly,...

This position reports to the Senior Director/Director, US Ethics & Compliance Advisor and is hybrid, located onsite in Foster City, CA. As an Associate Director, U.S. Ethics & Compliance Advisor, Medical Affairs at Gilead, you will... Work with the Senior Director to provide expertise in healthcare compliance ensuring that Medical Affairs activities align with the highest ethical and compliance standards. Partner with leaders across Legal, Commercial, Medical, Clinical Development to build and integrate the compliance program into the US Medical Organization. Participate in activity reviews consistent with established policies and processes, advising on ethics and compliance insights and recommendations, including...

The Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Responsibilities Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements. Responsible for implementing and maintaining the effectiveness of the Quality...

Position In partnership with the Director of Process Management for Clinical Research & Development, to whom this role reports, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality management and inspection readiness activities across assigned clinical programs within Eikon’s clinical development portfolio. The CQOM oversees clinical quality operations across assigned clinical programs, embedding quality-by-design (QbD) principles, risk-based quality plans, and vendor oversight into Eikon’s clinical trials. This includes ensuring consistent execution of QbD principles across assigned clinical studies, facilitating identification of Critical to Quality (CtQ) factors and associated risk assessments, and establishing and actively maintaining...

This position works out of our New Brighton, MN location on our Structural Heart team. Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements. What You’ll Work On Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms. May provide coaching and mentoring for technical team personnel. Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers...

We are recruiting for a Regulatory Affairs Operations Specialist to join our Abbott Vascular team on-site in Temecula, CA. This is a unique role where you will partner with external and internal stakeholders to maintain the quality system current and effective in alignment with the dynamic regulatory landscape and new/evolving requirements. The position is within the Regulatory Affairs Operations organization rather than direct regulatory submission preparation; this role involves supporting Quality System and Compliance initiatives such as Audit Readiness Program Management, including coordination of audit requests, Emerging Regulatory Issues and implementation of conformance, needs involving multiple therapies or device families,...

The position of Quality Control Team Leader is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will perform work required to ensure Company product quality is maintained at standards set forth by Company Quality System and mandated by regulatory agencies such as the FDA, ISO, and USDA. The focus areas for a Quality Control Team Leader include but are not limited to overseeing and coordinating the work of QC technicians; enforcing policies, procedures and work rules; manufacturing batch record review and approval. 2nd Shift 2pm-1030pm M-F What You'll Do Coordinates, facilitates and...

This position works out of our Des Plaines, IL location in the Abbott Molecular , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Specialist Quality Assurance - Supplier Quality will support in the selection, approval, and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities. What You’ll Work On...

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bring our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need...

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We...

That’s what makes us Genentech / Roche! The Opportunity Are you ready to shape the future of quality management in healthcare? As a Quality Lead within our Pharma Development Quality (PDQ) division, you will support the Roche/Genentech organisation by developing and delivering robust Quality Assurance strategies, audits, and conclusions across molecules in development, post-approval products, and global processes. You will act as a trusted partner, ensuring our operations maintain the highest standards of compliance while directly influencing how we bring innovative therapies to patients safely and efficiently. In this dynamic role, you will apply a risk-based approach to Quality Assurance...

The Senior Regulatory Affairs Specialist will be an instrumental member of the Regulatory Affairs team supporting on-market in vitro diagnostic (IVD) products in the United States and international markets. This role is responsible for supporting post-market regulatory compliance activities, including adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments. The individual will serve as a key regulatory partner to cross-functional teams, providing guidance on regulatory requirements, risk evaluations, and reporting obligations. Key responsibilities include conducting timely assessments of potential adverse events and field actions to determine regulatory reportability, supporting MDR and recall decision-making, coordinating regulatory reporting activities, developing...

The Senior Director, Quality — Post-Market Surveillance and Innovation Excellence is a senior quality executive responsible for shaping and executing the quality strategy that supports the Heart Recovery platform and Innovation Excellence organization. This leader provides enterprise-level direction for Complaint Management and Post-Market Surveillance, with accountability for organizational capability, governance, regulatory compliance, and sustained operational performance. The role establishes an integrated product lifecycle management framework that connects post-market intelligence with risk management, design controls, change control, CAPA, manufacturing, and supply chain quality to protect patient safety, strengthen product performance, and enable timely, risk-based business decisions across the marketed product portfolio....

We anticipate the application window for this opening will close on - 19 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Quality Engineer II will support...

We anticipate the application window for this opening will close on - 24 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Our Neuroscience portfolio includes the Neuromodulation and...

We anticipate the application window for this opening will close on - 30 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Responsibilities may include the following and other...

The Director, Translational Operations and Regulatory Integration is a leadership role responsible for enabling the successful execution, regulatory readiness, and operational excellence of Sarepta's Translational Biology portfolio across gene therapy, RNA, and emerging genetic medicine programs. This individual serves as a strategic connector across Research, Translational Biology, Clinical Development, Development Operations, Regulatory Affairs, and external partners to ensure biomarker and translational strategies are translated into actionable, compliant, and execution-ready plans. The role provides leadership for translational operations, regulatory integration activities, and cross-functional program execution, ensuring that key milestones, regulatory commitments, clinical biomarker activities, and organizational priorities remain aligned and on...

This position is office based/hybrid located in Foster City, CA or Parsippany, NJ. As the Sr Director, U.S. Ethics & Compliance Advisor, Medical Affairs, you will report into the Executive Director, U.S. Ethics & Compliance Advisor and you will... Act as the key point of ethics and compliance support for relevant US Medical Affairs activities Partner with leaders across Legal, Commercial, Medical, Clinical Development to build and integrate the compliance program into the US Medical Organization. Advise and provide guidance on Ethical Medical-Commercial interactions Participate in activity reviews consistent with established policies and processes, advising on ethics and compliance insights...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Regulatory Affairs Intern will support the Regulatory Affairs team in preparing documentation, tracking submissions, and assisting with project coordination....

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

2027 Spring Intern - PTQ Quality Processes Department Summary Global Quality and Compliance (PTQ) ensures we deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is a competitive advantage for Roche. You will report to the US Internship Program Manager in the PTQ Quality Metrics and Business Insights Function. The ideal candidate is a self-starter deeply curious and energized by learning. You should be comfortable with working through ambiguity and are able to prioritize and manage multiple demands and commitments. Your role will be to help...

SENIOR ENGINEER, SYSTEM OWNER COMPLIANCE What you will do In this vital role you will partner across Facilities & Engineering, Manufacturing, Quality, Validation, Environmental Health & Safety, Supply Chain, Digital Technology & Innovation, and Capital Projects to ensure engineering activities support operational excellence while maintaining a constant state of inspection readiness. The successful candidate will demonstrate strong engineering judgment, ownership, technical leadership, and a continuous improvement mindset while driving compliance, reliability, and exceptional customer service. Provide system ownership for Biopharmaceutical compliance programs. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the facility systems. This may include...

Johnson & Johnson is currently seeking a Experienced Engineer - Thermal to join our Manufacturing Science and Technology team located in Wilson, NC. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. Our expertise in Innovative Medicine is informed...

Johnson & Johnson is currently seeking a Experienced Engineer, Process Engineering to join our Manufacturing Science and Technology team located in Wilson, NC. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. Our expertise in Innovative Medicine is informed...

Johnson & Johnson is currently seeking a Experienced Engineer- Process Validation Support (PVS) to join our Manufacturing Science and Technology team located in Wilson, NC. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. Our expertise in Innovative Medicine...

Why Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world’s most complex health challenges and transforming society. The Opportunity As the Principal Clinical Quality Compliance and Policy Lead, you will serve as a strategic advisor embedded across Early Clinical Development (ECD) study teams. In this leadership role, you will champion a proactive quality culture, translating complex global regulatory requirements into pragmatic, robust clinical compliance strategies that advance our groundbreaking early-stage clinical trial pipeline....

Why Genentech We’re passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world’s most complex health challenges and transforming society. The Opportunity As a Quality Partner within Early Clinical Development (ECD) Quality, you will champion a proactive, risk-based quality culture that enables innovative science to move safely and efficiently to patients. You will serve as the primary Good Clinical Practice (GCP) quality advisor and strategic partner to early-stage clinical trial study teams and external partners. In...

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

The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible for strategic and operational Quality oversight across multiple complex programs. This role leads day-to-day quality operations, supports the execution of new initiatives, and applies sound judgment to resolve complex quality and compliance issues. The role provides Quality oversight for drug substance disposition from development through process performance qualification, ensuring decisions align with patient safety, product quality, regulatory expectations, and business continuity. This role serves as a visible Quality partner to Product Quality Leads, MSAT, Regulatory Affairs, operational stakeholders, CDMOs, and suppliers. The successful candidate...

In this vital role the Senior Engineer-Validation will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the site’s Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance. Responsibilities Lead a team responsible for implementing and maintaining the facility cleaning validation and sterilization program. Provide technical support and...

This position works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Specialist Quality Assurance - Biochemistry leads quality assurance initiatives by ensuring regulatory compliance, managing risk, driving quality system effectiveness, supporting product lifecycle quality activities, and providing technical leadership across cross-functional teams. What You’ll Work On Maintain and...

We anticipate the application window for this opening will close on - 19 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Surgical Sutures Manufacturing business within Surgical...

In the race for the future of health – The Sanofi mRNA Center of Excellence (CoE) At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before. That’s why we’re looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We’re investing €400M a year into the new Center, hiring a team of 450...

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

At AstraZeneca, we are united by a shared commitment to transform the lives of patients through science. Within our Cell & Gene Therapy organization, we are building next-generation capabilities that combine scientific innovation, advanced manufacturing, digital technologies, and regulatory excellence to deliver potentially life-changing medicines. As Manager, Regulatory & Technical Writing, you will play a critical leadership role in translating complex CMC and technical data into clear, compelling, and submission-ready regulatory documentation supporting AZD0120 and future Cell & Gene Therapy programs. This position offers a unique opportunity to contribute directly to BLA readiness, global regulatory submissions, health authority interactions, and...

Schedule This onsite position operates on 10-hour shifts from Sunday through Wednesday during the first shift (8AM-6PM), with some occasional support required outside of those hours. About This Role We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this...

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered...

The Opportunity Reporting to the Executive Director, Head of Regulatory Project Management, you will support the planning, coordination, and execution of complex global regulatory filings activities across the development portfolio. You will serve as a strategic partner to Regulatory Affairs leaders and cross-functional teams, ensuring regulatory strategies are translated into integrated, actionable plans that support successful health authority interactions and major submission milestones. You will facilitate alignment across functions, proactively identify risks and dependencies, and ensure teams remain focused on critical deliverables and timelines. You will play a key role in advancing Regulatory Project Management best practices, supporting...

The Head of US Patient Safety is accountable for the overall strategic direction, operational execution, and holistic performance of the PV system for the USA, ensuring full alignment with International Patient Safety (IPS) priorities and business needs. Operating in close partnership with Genentech, the Head of US Patient Safety serves as the primary steward of the affiliate PV system and safety risk management. In this role, core responsibilities will include Strategy Lead the Affiliate Patient Safety strategy, collaborating with cross-functional leaders to prioritize initiatives that maximize patient and business impact. Additionally, serve on the IPS Leadership Team to co-own...

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team...

Life at BMS At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams,...

Senior Associate Quality Assurance What you will do Let’s do this. Let’s change the world! The role is fully onsite in Thousand Oaks, CA, and requires the ability to lift 30+ pounds and pass a vision assessment for inspection work. Candidates must be comfortable working with raw materials and components, mainly chemicals, and may have to work in the sampling suite for extended periods of time. Previous experience with GMP is a plus but not mandatory, as training can be provided. Candidates of all backgrounds and experience levels will be considered if they demonstrate the right attitude and interest in...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find...

The Contract Compliance Analyst III will facilitate contract implementation and revenue pull-through activities, both proactive and reactive, with internal and external parties. This position will ensure the public and private payer reimbursement. The role is also fundamental in reviewing that billing and payment processes are efficient, timely, and in compliance with corporate goals, contracts and/or regulations. This position will facilitate and manage contract implementation for operations and partner with Managed Care to develop and maintain agreements that provide medical providers and patients with access to our assays while aligning with Exact Sciences goals and objectives. Location This is a remote...

We anticipate the application window for this opening will close on - 23 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Design Quality Engineer II in Released...