Quality & Regulatory Jobs in Pharma & Biotech

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

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...

We anticipate the application window for this opening will close on - 18 Mar 2026 Position Sr. Quality Engineer for Medtronic, Inc located in Brooklyn Park, MN. Responsible for developing and maintaining quality standards for processing materials, collaborating with engineering and manufacturing teams, and implementing process improvements. The position also includes conducting quality assurance tests, performing statistical analysis, and ensuring corrective measures meet reliability standards. Responsible for technical assessments and compliance activities to ensure that reliability and safety is proactively designed into our products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. Perform...

As a Senior Regulatory Affairs Program Manager, you will be the strategic linchpin that drives operational excellence across the different arms of the RA function within the Acute Care & Monitoring (ACM) operating unit. Your day will be a dynamic mix of strategic planning and tactical execution. A significant portion of your day will involve facilitating program-level meetings with leadership, where you will use your expertise to guide strategic discussions, manage through risks, and drive critical decisions to ensure the functional commitments are met. You will also dedicate time to analyzing and interpreting complex performance data, balancing resource demand across...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This This position has the responsibility and authority to support the development and implementation of the overall objectives and long-range regulatory strategies that impact both the introduction of new products and the market status of existing products. The Principal Regulatory Affairs Specialist will exercise a leadership role and serve as a mentor to help develop regulatory depth...

The purpose of this document is to outline the job description of the QA Specialist at Janssen Biotech, Inc in Wilson, North Carolina. The QA Specialist reports to the Senior Manager, Quality Assurance. Essential Job Duties and Responsibilities QA Specialist, Compliance This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures through the following duties and responsibilities Responsible for execution of Risk Management Program through the identification, assessment, and management of quality risks. Implement appropriate preventive measures and corrective actions to minimize potential quality issues....

Johnson & Johnson is recruiting for a Quality Engineer, located in Palm Beach Gardens, FL. The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. Our rapidly growing Velys Enabling Tech Operation is in need of a Quality Engineer who provides overall quality assurance leadership of on-site manufacturing areas. Ensures manufacturing areas are...

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 Quality Control Supervisor to be located in Athens, GA . The Quality Control Supervisor is responsible for managing and coordinating the activities of the Quality Control associates engaged in receiving, testing,...

Johnson & Johnson is recruiting for a Staff Quality Engineer, located in Palm Beach Gardens, FL. The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. Our rapidly growing Velys Enabling Tech Operation is in need of a Staff Quality Engineer who provides overall quality assurance leadership of on-site manufacturing areas. Ensures manufacturing...

The Laboratory Operations Quality Specialist- AVS provides quality oversight of the Airflow Visualization Studies at the West Point vaccine manufacturing site. The Specialist, with guidance from the Associate Director of Environmental Monitoring Site Support, ensures AVS are performed per the required schedule; meeting the necessary acceptance criteria. The individual will be responsible for scheduling, written documentation, video recording, and video editing of the studies. This position works closely with the vaccine manufacturing departments and Engineering/Maintenance to ensure timely completion of tasks with emphasis on right first time. The specialist will become knowledgeable in regulatory requirements and cGMPs to assure the...

QC Chemistry performs testing in support of Framingham Manufacturing. The new Framingham Manufacturing facility is one of the first of its kind worldwide and puts Sanofi at the forefront of bio-manufacturing. The whole industrial process is digitalized, paperless, and is 80 times more productive than a traditional factory. Our Framingham facility leads the way in delivering the next generation of biologics manufacturing. The Team is a diverse group and will be able to offer their own experiences and knowledge that others don’t possess. They communicate openly with each other, sharing their thoughts, opinions, and ideas. They offer each other support...

Company AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. Our impact spans immunology, oncology, neuroscience, eye care, and the Allergan Aesthetics portfolio. Locations Irvine, CA; Lake County, IL; Ludwigshafen, Germany preferred Job Purpose The Quality Toxins Office (QTO) provides compliance strategy, design, implementation, and continuous improvement to support global toxin quality strategy across Therapeutics and Aesthetics. The QTO assures robust global compliance programs to assure quality oversight, controls, compliance, and defining quality standards across AbbVie’s toxin enterprise. The Associate Director, Quality Toxins Office...

Responsibilities This role is primarily responsible for reviewing data to ensure accuracy, compliance, and completeness within the team or department, while also providing people leadership. Key responsibilities include leading and developing team members, evaluating and interpreting data from various sources, ensuring adherence to regulatory and organizational standards, and identifying trends or discrepancies. The position involves coaching and supporting team members, fostering professional growth, and handling personnel issues as needed. Additionally, this role supports continuous improvement initiatives, prepares technical reports, and collaborates with both internal team members and external stakeholders to resolve data-related issues and maintain high standards of data integrity....

2026 Summer Internship - External Quality Department Summary External Quality is responsible for the Quality and Compliance of externally sourced raw materials, supply from CDMOs, and distribution quality from Roche sites to Affiliates, including the certification for the EU market. We serve our patients through external partnerships because access to quality products is every patient’s right. We leverage external partners to offer flexibility to our internal capacity at the correct cost and quality. We enable our external partners to reliably deliver compliant, quality products to our supply chain customers so that we can deliver to patients worldwide. We do this...

The Specialist, Validation, will be responsible for completion of validation execution activities at the West Point site as part of the Bio-Sterile Validation (BSV) team. The primary responsibility of the individual will be providing validation support to the Integrated Product Teams (IPTs). The Specialist will prepare, review, approve and execute validation documentation (including but not limited to; protocols, periodic assessments, and final reports) related to new or existing manufacturing projects to ensure successful completion is in alignment with West Point validation requirements. Also, when required the Validation Specialist will be required to train other Validation personnel. Additional responsibilities include the...

The Quality Environmental Monitoring (EM) Associate Director (P4) reports to EM Quality Lead and provides direct Quality support to operational areas as part of a Quality Integrated Production Team (IPT) Operating model for assigned E2E/IPTs. With guidance from Quality IPTs Leadership team, the Associate Director will ensure compliance and quality of products/processes and perform responsibilities to facilitate the release of product to the marketplace. Key Responsibilities Accountable for the oversight and sustained state of environmental control per the Environmental Monitoring Plan for Classified Areas; performing job functions located in classified operational, Controlled Non-Classified areas and within office settings. Works closely...

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

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

Leads the site’s metrology and equipment implementation program across analytical, manufacturing, facilities, and safety equipment. Manages end-to-end deployment, qualification, calibration, maintenance, troubleshooting, scheduling, and workflow. Drafts and maintains maintenance, operation, and calibration documentation to meet business and regulatory needs. Provides expert guidance on asset management systems and ensures inspection readiness in a GMP environment. Accountabilities Resource and Service Delivery Ensure the right internal and external resources are in place to deliver metrology, calibration, and maintenance services that meet customer commitments and drive equipment reliability. Firstline Decision Making Troubleshoot equipment and process issues, resolve scheduling and technical conflicts, and escalate risks...

Director, Global Patient Safety Physician, US About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AZ, we’re proud to have an exceptional workplace culture that encourages innovation and collaboration. Here, employees are empowered to express diverse perspectives – and made to feel valued, energized and rewarded for their ideas and creativity. AZ is a place where passionate people can immerse themselves in their work and make significant contributions...

Post Market Quality Engineer II Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do...

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-052414 Switzerland Req# R-052854 Belguim/Netherland Req# R-052851 Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the pharmaceutical, and medical technologies professional markets. J&J employs approximately 126,500 people worldwide, deployed in more than...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Sr. Software Design Quality Engineer role to be located at Danvers, MA. The Senior Software Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a key role in product risk management, cybersecurity, change controls, test reviews, and design controls. The engineer should excel in an environment...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Technician, Quality Control to be in San Angelo , TX . Purpose Responsible for conducting complex test and analysis to assure that product comply with established specifications. What you will be responsible for Carries out routine calculations and prepares documentation that shows the results for test performed. Responsible for ensuring personal and...

Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the pharmaceutical, and medical technologies professional markets. J&J employs approximately 126,500 people worldwide, deployed in more than 250 operating companies in 60 countries. Reporting to the Vice President, Innovative Medicine Regulatory Compliance Leader, this role leads a team of compliance professionals and is part of the IM Compliance Leadership Team. This Senior Director is the GMP compliance leader for CAR T-cell therapies (autologous) across the Advanced Therapy Platform and is accountable for inspection readiness,...

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. Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 large-scale therapeutic protein or vaccine manufacturing facility. Operations’ main functions are leading deviation investigations and managing CAPA implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing, and supporting manufacturing’s training program, and identifying and managing continuous improvement initiatives. Principal Manufacturing Compliance Engineer...

The Manager, Quality Engineering at the Cell Therapy Facility (CTF) in Devens, MA will be responsible for providing Quality oversight of qualification and validation activities and change control for the startup and continuing operations of the Devens Cell Therapy Facility, including commissioning, qualification, and validation (CQV), computer systems validation (CSV) and process validation per established local and global standards. Duties/Responsibilities Review and approve commissioning and qualification lifecycle documentation associated with manufacturing site facilities/equipment/and utilities, including but not limited to system/component impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, requalification etc. Review and approve computer systems validation lifecycle documentation...

We have an immediate opportunity for a Senior Auditor, Global Compliance Audit in our Willis Tower, Chicago, IL location. Embark on a rotational career path within Abbott’s Audit team. Position leads to potential career opportunities in any of Abbott’s four global businesses as well as Corporate roles. This role has primary responsibility for executing the following duties Identify opportunities for improvements in sales & marketing practices against Corporate policies, local procedures, industry standards and laws/regulations. Analyze data and document findings and recommendations in audit reports. Effectively communicate, present professionally, and collaborate with the highest level of Corporate and Divisional management,...

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we...

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of Quality Control, CAR-T Manufacturing! This position will be located in Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone...

Abiomed is recruiting for a Sr Manufacturing Quality Engineer located in Danvers, MA . 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 At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our facilities expansion. In this role, you will have the unique opportunity to contribute to manufacturing life-saving medical devices....

Senior Associate Quality Assurance - PQA What you will do The Amgen North Carolina (ANC) Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance. The...

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate...

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. This role offers the opportunity to apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables . This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global...

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...

Beam is seeking a highly skilled Specialist I/II to join our growing Digital Quality & Data Integrity team and play a pivotal role in shaping the future of digital compliance. Unlike traditional QA roles, this position focuses on advanced computerized systems quality assurance and data integrity across local embedded computerized systems and global platforms—including SaaS, IaaS, and PaaS—critical to our digital transformation. As a trusted Subject Matter Expert, you will partner with Manufacturing, Quality Control, Validation (CQV and CSV), IT, and Automation teams to ensure seamless qualification, validation, and automation activities that meet GxP and regulatory standards. This is your...

We are seeking a strategic, experienced, and proactive Ethics and Compliance Program Manager to help design and build the global compliance program for Medtronic Diabetes – a $2.8 billion medical device business that has recently announced that it will be spinning out into a standalone public company. Reporting to the company’s Chief Compliance Officer, the Compliance Program Manager will play a pivotal role in helping the company prepare for and operate successfully as a publicly traded company, aligning compliance programs with public company standards and shareholder expectations. In this role, you will support the execution of key operational initiatives that...

This position is located in Lafayette, CO as part of the Acute Care & Monitoring (ACM) group. The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Bispectral Index™ (BIS™) monitoring product portfolio within the Acute Care and Monitoring operation unit. This role is fit for an established, productive individual contributor and leader who works independently on moderately to highly complex projects or programs with limited general supervision. In the position, you will set objectives for your own work to align with broader project goals and actively contribute to key milestones....

We are seeking a strategic, experienced, and proactive Compliance Program Manager to help design and build the global compliance program for Medtronic Diabetes – a $2.8 billion medical device business that has recently announced that it will be spinning out into a standalone public company. Reporting to the company’s Chief Compliance Officer, the Compliance Program Manager will play a pivotal role in helping the company prepare for and operate successfully as a publicly traded company, aligning compliance programs with public company standards and shareholder expectations. In this role, you will support the execution of key operational initiatives that enhance the...

Abiomed is recruiting for a Director, US Plant Quality located in Danvers, MA . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Site Quality Leader (Director) has the responsibility for driving continuous quality improvements, maintaining supply chain compliance, providing franchise support, and presenting internal and external customer facing needs to Site Leaders and Business Unit partners. This includes leadership in the delivery of critical Quality Control initiatives in manufacturing,...

Johnson and Johnson Innovative Medicine is recruiting for a Quality Assurance Specialist to be located in Athens, Georgia . 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 This position is responsible for ensuring compliance in all cGMP API Manufacturing Facilities at the J&J Innovative Medicine, Athens Georgia...

Auris health Inc a member of the Johnson & Johnson Family of Companies is recruiting for a Principal Regulatory Compliance Specialist ! This position will be located in San Jose, California. Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, endoluminal intervention and general surgery. This includes the MONARCH®, OTTAVA and Polyphonic platform, a first-of-its-kind robotic technology and digital solutions. Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years...

This position will be hybrid to our San Francisco, CA site About This Role The Sr. Manager, Global Regulatory Affairs (GRA) supports the regulatory strategy and execution for assigned programs, working closely with the Global Regulatory Lead (GRL) and cross-functional teams. This role contributes to the development and implementation of regulatory submissions across multiple regions, ensuring alignment with global regulatory requirements and timelines. The Manager also serves as a key point of contact for regulatory operations and external partners (e.g., CROs), and provides backup support for regulatory activities within the team. What You'll Do Collaborate with the GRL to support...

This is a remote-based position, candidate must be located within the USA About This Role The Principal Medical Writer serves as a scientific communication and innovation leader within Biogen’s Medical Writing department, focusing on leveraging Generative AI (GenAI) technologies to transform regulatory writing. In this role, you will combine your expertise in regulatory document strategy with forward-looking approaches to content generation, automation, and AI-enabled writing support. You will author and oversee preparation of high-quality clinical regulatory documents (e.g., clinical summaries, CTAs, INDs, and briefing packages) and collaborate closely with cross-functional teams to ensure clarity, accuracy, and consistency. Additionally, you will...

Medtronic is seeking an FDA/Life Sciences paralegal as a member of the Enterprise Legal Regulatory (ELR) team with knowledge and experience navigating requirements for regulated industries. The Enterprise Legal Regulatory team supports corporate functions, business units, and regions around the globe. As a member of this team, this individual will conduct the first line legal review of advertising and promotional materials for medical devices. They will also work with other team members to provide proactive legal advice and risk management counsel related to the promotion of medical devices. Key attributes this individual must possess include strong legal and analytical skills...

MAIN PURPOSE OF THE ROLE Provide leadership to inspectors and technicians that support receiving, in-process and final inspection, tool inspection/qualifications and first article inspections. MAIN RESPONSIBILITIES Assure timely inspections that support materials, product releases and in-process inspections. Maintain staff and equipment to assure appropriate technical capabilities. Monitor inspection procedures for effectiveness. Monitor compliance to appropriate regulatory standards. Effectively communicate with and provide support to other departments as necessary. Maintain a department culture of continuous improvement. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies...

Johnson & Johnson is currently recruiting for a Staff Quality Engineer! This position will be located in Cincinnati, Ohio. This position will support New Product Development or Lifecycle Engineering within the Energy Quality organization, based in Cincinnati, OH This position will support the Energy franchise that may include Harmonic, Advanced Bipolar, Capital and Megadyne. Defines, leads and implements state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations. Influences the company's business, tactical directions, and financial results through a sharing of technical expertise. Performs complex design analysis...

Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed aligned with our high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Assurance Manager will direct QA activities and provide support and expertise to the Millsboro, DE site. Collaborates with Quality Control, Regulatory Affairs, Manufacturing, EHS (Safety), R&D, BTS (Bio-process Technology Support) and ATS (Analytical Technology Support)...

Position Senior Manager Validation Engineering Location Devens, MA Key Responsibilities Lead functions within the Validation Engineering group responsible for the qualification lifecycle of facility, utility and processing equipment systems. Leads functions responsible for installation, operational and performance qualification (I/O/PQ) of systems arising from projects and change controls. Leads the site Periodic Assessment and Requalification program by establishing procedures aligned with BMS directives and industry guidance. Ensures execution of program to predefined schedule. Establish validation project plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination...

Position Principal Compliance Engineer, ECQ Location Summit West, NJ Purpose and Scope of Position The Principal Compliance Engineer, Equipment Commissioning & Qualification (ECQ), supports the successful operation of facility, laboratory, and business functions at Summit, NJ. This role involves interaction with internal team members, peer-level customers, and external service providers. The Principal Compliance Engineer will lead a team of contract or full-time personnel responsible for performing periodic reviews of equipment, policies, and procedures to ensure they remain in a validated state. Responsibilities include performing gap analyses, and leading small and large-scale projects to achieve departmental objectives. Required Competencies Knowledge,...

Position Senior Manager Cleaning Validation Location Devens, MA Key Responsibilities Provide strategic oversight and management of the cleaning validation program, ensuring alignment with regulatory requirements and industry best practices. Develop, write, and execute cleaning validation protocols, reports, and risk assessments. Establish acceptance criteria and sampling plans for cleaning verification and validation. Delegate tasks and coordinate the execution of cleaning studies, ensuring timely and effective completion. Optimize and update cleaning validation strategies and procedures to reflect current industry standards and regulatory expectations. Perform swab and rinse sampling, cleanability, degradation and sampling recovery studies reviewing analytical results against acceptance limits. Support...

This highly impactful role leads the effort to manage daily import/export compliance and operational activities, and support Neurocrine’s compliance with all applicable global import / export regulations as well as ensuring reliable and timely delivery of international and domestic clinical and commercial shipments of drug products including APIs. Key responsibilities include supporting the daily import/export transactions, coordinating activities with the customs brokers, contract manufacturing organizations (CMOs), vendors, and internal stakeholders. This position requires knowledge of import / export operations, customs requirements, valuation, tariff classification and export and import licensing as well as experience in the area of global logistics including...

Purpose The primary responsibility for the Validation Specialist I is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists Responsibilities Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility Executes...

Purpose Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility. Responsibilities Maintains the...

Compliance Specialist uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within Engineering & Maintenance operations. Engineering & Maintenance Compliance Team is responsible for managing change controls, CAPAs and deviation intake and closure across GMP activities in the following areas - Metrology, Engineering, Facilities, Utilities, Validation, Automation and Capital Projects. The responsibilities of the team primarily extend to owning deviations relating to facilities, equipment and utilities and their associated systems. The Senior Compliance Specialist is responsible for developing programs and metrics to ensure all aspects of engineering and maintenance are compliant. We deliver 4.3...

The Associate Director, RBQM – HOCT, ICN will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. Key Responsibilities Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management...

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...

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,...

Director, Regulatory Affairs - In-Vitro Diagnostics (IVD) What you will do Amgen is seeking a Director of Regulatory Affairs to work in their Thousand Oaks, CA location. The Regulatory Affairs division establishes sustainable processes, assures informed relationships, and delivers strategic outcomes. In this vital role, you will lead and manage the team responsible for developing and implementing optimal regulatory strategies and processes for in-vitro diagnostics (IVDs) and companion diagnostics (CDx). Key responsibilities will include Responsibilities Manage and mentor the IVD regulatory affairs team, fostering talent retention and promoting a culture of inclusion, diversity, and collaboration. Oversee resource allocation and...

About Vision Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime....

Senior Quality Assurance Specialist will be responsible for approving key quality records including deviations, change controls and corrective/preventative actions (CAPA) at the La Verne site. This role will involve close collaboration with cross functional teams and subject matter experts (SMEs) to review and support impact assessments and risk evaluations. The Specialist will provide guidance to ensure that investigations, changes, and improvements are properly assessed for regulatory and operational impact, supporting a culture of continuous improvement and adherence to GMP requirements. Responsibilities Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Participates in writing...

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

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. Monday-Friday, day shift. 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 people’s lives. Main Responsibilities Ensuring that activities in his/her scope are conducted in...

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

Job Title Quality Engineer We are seeking a Quality Engineer to work at our Temecula, CA location in our Vascular division. What you’ll do Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. EDUCATION AND EXPERIENCE YOU’LL BRING Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 1. Learns to identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root...

We are searching for the best talent for Manager, Supply Chain Quality to join our DePuy Synthes Quality and Compliance organization located in Palm Beach Gardens, FL. 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...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Sr. Design Quality Engineer role to be located at Danvers, MA. The ideal candidate for the Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. This engineer should excel in an environment that embraces...

Typical Accountabilities Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions Provides strategic regulatory advice support for product developments regional therapy area Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and...

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

The Site Analytical Sciences Specialist role is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations, biochemistry, and microbiology. This role requires 2nd shift hours in supporting the West Point Laboratory Operations. Activities Within Role Technical expertise to support New method introduction (Validation /Tech Transfer). New technology introduction. Assessment and implementation of changes for existing methods...

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...

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 Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position works a Monday to Friday schedule, Day shift. This position will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. In the capacity of Shop Floor QA, the Senior Specialist shall serve as one of the Shop Floor Representatives interacting with Manufacturing, Supply Chaing, Quality Control and other supporting teams. The Senior Specialist, Shop Floor QA, is accountable to monitor...

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson is recruiting for a Senior Quality Engineer, NPS CSV located in Santa Clara, CA. This is an onsite role. The Senior Quality Engineer- NPS CSV provided Quality Assurance oversight for non-product software systems used in GxP regulated environments including systems supporting Manufacturing, Quality, Clinical and R&D Operations. Working closely with cross-functional stakeholders, the Senior Quality Engineer ensures NPS are validated, controlled,...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Director, Quality and Compliance to be located at Plymouth, MN. The Director of Quality & Compliance establishes policy to ensure compliance with respect to domestic and international regulations. Also, plans, coordinates, and directs product development and manufacturing quality programs designed to ensure products are consistent with established standards by performing the following duties...

The Quality Systems Lead oversees the day-to-day operations of the Quality Systems staff. Oversees the development and implementation of processes, procedures, audits and corrective actions. Ensures effective communication and training are deployed throughout the business. The Quality Systems Lead is responsible for the overall management and effectiveness of the site Document Control, Records Management, Nonconformance (NC) and Corrective and Preventive Action (CAPA) programs including Administration of the Document Control, Records Management, NC, and CAPA systems, facilitation of the local Data Review Board and Management Reviews, coordination and support of NC and CAPA project teams, data trending and Change Management/NC/CAPA reporting...

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a S taff Regulatory Compliance Specialist to be located in Raritan, NJ. Purpose The position of the Staff Regulatory Compliance Specialist is responsible for establishing and maintaining robust Compliance Programs at Ethicon Raritan HQ site and will be supporting the other Ethicon sites as needed in order to ensure compliance to local, national and international regulatory...

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...

This is a full time, on-site position with a schedule of 12 noon to 12 midnight on a rotating 2-2-3 schedule About This Role The QA Associate III has the working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures in order to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems. The QA Associate III has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The QA Associate...

Senior Manager Quality Assurance – Incoming Quality Assurance Raw Materials /Disposition What you will do Let’s do this! Let’s change the world! In this vital role, you will lead a team of Quality professionals supporting the Disposition and Incoming Quality operations at our North Carolina site. You will provide technical quality leadership and oversight of Disposition and Incoming Quality, partnering closely with cross-functional teams to build, enhance and sustain compliant commercial operations. Specific responsibilities include but are not limited to Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for Disposition and Incoming...

Our location in Sylmar, CA, Pleasanton , CA or Minnetonka , MN currently has an on-site opportunity for a Staff Auditor, Quality Systems professional. This new team member will be a leader and mentor responsible for implementing internal audits required for compliance with global regulatory standards and collaborating with Abbott Medical Device Business Units for external inspection preparation and support. What You’ll Work On Internal audit planning, developing audit schedules and plans, performing and documenting audits and managing related following up activities including related KPI and metrics reporting. Support the development, training, and supervision of auditors to improve their ability...

The Regulatory Compliance Senior Analyst supports Illumina’s global compliance framework through the execution and continuous improvement of compliance auditing and monitoring activities. This role ensures that Illumina’s operations, quality systems, and regulatory programs meet applicable global requirements and uphold the company’s high standards of ethical and compliant conduct. The position focuses on performing compliance reviews, supporting audit preparation and execution, maintaining documentation, and tracking corrective actions. Operating in a highly matrixed, global environment, the incumbent partners with Legal, Compliance, Quality, Regulatory Affairs, and other business functions to monitor adherence to regulatory requirements and contribute to inspection readiness. *This is a...

You will be responsible for Business Unit level Quality Assurance division activity, including Supplier Development / Supplier Quality / Third Party Manufacturing, Division Quality Engineering, quality program management, & quality data science developments. You will be the key contact to coordinate cross-functional success with division Procurement, division Operations Engineering, and R&D Transfers to commercial Manufacturing. WHAT YOU’LL WORK ON Technical & strategic guidance to the Division Quality Assurance team / engagement & alignment with key cross-functional partners in Operations, Engineering, and R&D Evolve and engage the Supplier Development / Supplier Quality / Third Party Manufacturing to improve yield and cost...

The Compliance Associate Director assists in implementing and further enhancing the anti-corruption/anti-bribery Compliance program. Reporting to the Executive Director Head of Global Compliance Program Strategy, Assurance and Management, the Compliance Associate Director will be responsible for executing compliance-related investigations and supporting the company’s global healthcare fraud and abuse assurance program and activities, including auditing and monitoring, both transactional and live. The Compliance Associate Director will serve as the initial point of contact for business colleagues for these activities, will support department initiatives globally and must have knowledge of the biotechnology/pharmaceutical industry, anti-bribery/anti-corruption laws, and experience executing compliance-related investigations as well...

The Associate Director, Regulatory Affairs will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China) . Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. May manage direct reports. What You’ll Do Responsible for developing and executing global regulatory strategies...

The Regional Distribution Quality Specialist is responsible for ensuring the quality of distribution operations across the Americas, focusing on warehousing, order fulfillment, product returns, and value-added services such as labeling, boxing and recharging. This role will provide quality support and oversight to ensure compliance with internal and external regulations, standards, and guidelines, specifically ISO 13485, and 21 CFR 820, across multiple 3PL distribution centers in the Americas in support of Medtronic Minimed. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation...

About This Role As the US Regulatory Lead, you will be responsible for developing and executing US regulatory strategies as part of the Global Regulatory Affairs team. You will also oversee the preparation, submission, and management of regulatory filings interactions with the FDA. This role requires outstanding collaboration abilities, as you will play a key role in proactively identifying regulatory risks and developing mitigation strategies ensuring compliance with relevant regulatory requirements, company policies, and industry standards, ensuring impactful outcomes and solutions for patients. This is a hybrid role, requiring 3 days office attendance per week. What You’ll Do Direct US...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Assist the Global Inflammation Regulatory Affairs Liaison team with projects to support department goals and objectives. Interns will assist with regulatory submissions and activities, including but not limited to potential submission of clinical study reports, study protocols and protocol amendments, and assist with activities in preparation for...

As a Talent Acquisition Compliance Specialist on the Operations and Innovation team, you will focus on TA Compliance reporting to the TA Compliance Lead. This position will be responsible for all facets in compliance with internal hiring guidelines, pre-employment requirements such as background checks and external regulations set by EEOC and OFCCP. Key Responsibilities Responsible for maintaining Offer Compliance including adherence to compensation guidelines and documentation including Letters and Employee Agreements for pre employment compliance Serve as Talent Acquisition’s subject matter expert in the offer preparation process including working closely with Total Rewards, Recruiters, and Candidates Serve as Talent Acquisition’s...

Positions Summary The Manager, Quality Assurance Disposition Support, Devens Cell Therapy role is responsible for the support of the overall Devens Disposition organization, inclusive of systems, metrics, Quality System Records, and deployment of priority projects. This individual will provide support to all functions reporting through the Quality Disposition organization, including incoming materials QA and disposition, systems, drug product disposition, and Material Review Board. This individual will provide oversight of projects with Disposition impact, APQR data compilation, Disposition metrics, CAPAs owned by Disposition, Deviations owned by Disposition, Change Control Impact Assessments, Change Controls owned by Disposition, product and will perform routine...

Use Your Power for Purpose At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world. What You Will Achieve In this role, you will Lead the completion of assigned complex projects, meet agreed targets and develop plans for work activities on...

Position Overview We are seeking a strategic leader to establish and lead our new Regulatory Intelligence organization. The Sr. Director, Head of Regulatory Intelligence will set the strategic direction for the team, oversee the integration of regulatory insights into organizational decision-making, and represent the organization at the highest levels. This role is pivotal in shaping our regulatory intelligence strategy, setting key initiatives, and delivering actionable insights on emerging regulatory guidance and health authority enforcement trends. Key Responsibilities Set strategic direction and priorities for the Regulatory Intelligence team to ensure alignment with organizational goals. Represent the organization at the executive level,...

Employer Johnson & Johnson Health Care

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 Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our Team in Spring House, PA. This position is part of the Site Engineering Team, which is the asset-management team consisting...

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

The Associate Director, Quality Control within our Research and Development Division Device Quality & Regulatory is responsible for providing QA/QC oversight of the company's Device Network design verification laboratories. This role will provide quality oversight for the qualification, calibration and maintenance of analytical laboratory instruments and equipment, method validation, and associated documentation for design verification laboratories in Rahway and the Center for Packaging & Device Analytics (CPDA). Key responsibilities include 1. Serve as quality oversight for design verification laboratories Quality oversight for qualification, maintenance and calibration of laboratory equipment, instrumentation and test methods used to support design verification. Provides quality...

The Quality Software Engineer II is an established individual contributor responsible for ensuring software systems meet rigorous quality standards throughout the development lifecycle. This role involves defining, implementing, and maintaining quality processes, conducting evaluations, and supporting verification and validation activities to ensure compliance with project, process, and contractual requirements. A strong background in robotics and experience analyzing software logs for quality and reliability are highly valued. Responsibilities Perform detailed software log reviews to identify anomalies, ensure compliance, and improve system reliability. Collaborate with cross-functional teams, including robotics engineers, to achieve quality objectives and project milestones. Develop, modify, apply, and maintain...

The Director, Regulatory Programs will join our Global Regulatory Operations team and lead portfolio management of regulatory programs across medical device business units, international regulatory teams, and global regulatory operations. This role provides strategic leadership and stewardship to ensure alignment with division strategies and business objectives. The Director will be responsible for developing, maintaining, and reporting on timelines, budgets, and regulatory activity tracking. Additionally, they will lead initiatives aimed at improving efficiency and effectiveness within regulatory processes. By applying best practices in program management, the Director will help achieve—and exceed—medical device division goals. This position serves as the primary point...

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

Typical Accountabilities Accountable for the development and implementation of the regulatory strategy for a product/ group of products, and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients Accountable for product maintenance, supply and compliance activities associated with marketed brands Delivers all regulatory milestones including assessment of the approvability of the program together with risk mitigation measures Leads the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation...

KEY RESPONSIBILITIES The Senior Director, Quality Policy and Advocacy is a recognized expert both inside and outside the business and is responsible for leading various global aspects of internal and external-facing advocacy as applicable to support the Gilead portfolio. This leader will represent the business externally and will be focused on influencing while developing and advocating policy positions (internally and externally) for Quality Policy issues in conjunction with the Gilead CMC Regulatory Policy Office. The role will be focused primarily on the North American policy landscape, with appropriate alignment and involvement in the global policy landscape and will be responsible...

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

SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Saving lives is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for a passionate Senior Regulatory Affairs Specialist who has direct experience submitting regulatory submissions for both the Americas and the EU....

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. Envisions the future by using global marketplace, technology and business knowledge. Collects and analyzes issues and trends that affect the business. Identifies and acts upon cross-organization or cross-business opportunities. Possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and future business needs....

About GenerateBiomedicines GenerateBiomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform...

The Sr Quality Engineer is responsible for ensuring the quality and safety of our genomic products and services by assisting in the maintenance of the quality management system (QMS) that complies with ISO 13485 and ISO 14971. This position is also responsible for conducting risk assessments, developing, and implementing corrective actions, and providing technical support to the R&D team. What You’ll Be Doing Maintain a QMS that complies with ISO 13485 and ISO 14971. Conduct risk assessments to identify and assess potential hazards associated with genomic products and services. Develop and implement corrective actions to address identified hazards and prevent...

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

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Senior Compliance Engineer located in Santa Clara, CA. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics and Digital Solutions was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in...

We are seeking a highly skilled Risk Management Expert with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety, regulatory compliance, and effective risk mitigation throughout the product lifecycle. Develop and maintain comprehensive strategies for risk management activities, including Creating and managing risk management plans and reports, as well as conducting regular risk reviews. Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures. Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential...

The incumbent will be part of the Microbiological Quality & Sterility Assurance organization, a Quality Assurance group that has global responsibility for microbial control and sterility assurance related topics. In the Associate director role, the incumbent will provide subject matter expertise for microbiology and/or virology related topics in biologic, vaccine sterile, non-sterile manufacturing and/or testing laboratories for assigned topics. Supports the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our Manufacturing Division is compliant to cGMPs for these topics. Supports divisional projects across internal and external sites. Supports development of strategy to drive compliance...

The incumbent will be part of the Microbiological Quality & Sterility Assurance organization, a Quality Assurance group that has global responsibility for microbial control and sterility assurance related topics. In the Associate Director role, the incumbent will provide subject matter expertise for microbiology and/or virology related topics in biologic, vaccine sterile, non-sterile manufacturing and/or testing laboratories for assigned topics. Supports the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our company is compliant to cGMPs for these topics. Supports divisional projects across internal and external sites. Supports development of strategy to drive compliance and...

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

Sr. Manager, Supplier Quality This role manages the Quality System for third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance. The role is responsible for keeping all the QS elements consistent and effective for its purpose. Ensures implementation of TPM related Quality Assurance policies and procedures generated conform to predetermined Corporate/Division standards and specifications. What You'll Work On Manage the Quality System for US third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance, systems include Nonconformance and CAPA Change control ...

careers.bms.com/working-with-us To lead the simplification of the QA oversight process. The role will evaluate and identify key fields from existing QA interventions that should be the focus by QA oversight, instead of evaluating the whole process. The role will involve leveraging inputs such as improvement of the QA Oversight process and streamline the QA intervention process. Program dates June 1, 2026 – August 7, 2026. The hourly compensation for this assignment is $15/hr. Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not BMS). Factors influencing this decision...

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Principal Regulatory Compliance - Lead Auditor to be in Danvers, Massachusetts The position of the Principal Regulatory Compliance is responsible for establishing and maintaining robust Compliance Programs at the designated Abiomed sites in order to ensure compliance to local, national and international regulatory requirements, company policies and procedures and J&J corporate requirements. The Principal Regulatory Compliance...

Quality Assurance Specialist This position works out of our Sturgis, MI location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. For over 70 years, Abbott’s Sturgis, Mich. , has been impacting its community while producing products that provide essential nutrition to millions of families...

Your skills could be critical in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions. The RS provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives...

Your skills could be critical in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions. The RS provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives....

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 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...

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...

Undergrad Co-op - Quality, Manufacturing, Operations and/or Engineering What You Will Do Ready to make an impact? Join us in redefining the world through innovation! We are offering multiple co-op opportunities starting in January 2026. As a co-op, you'll collaborate with cross-functional teams, gaining hands-on experience and advancing your professional skills. You’ll work on meaningful projects and initiatives, contributing to the team’s success while developing your own potential in our Operations organization centralized in Puerto Rico's End-to-End Manufacturing Site. Measure and analyze current system and process performance. Drive improvements in operational efficiency and productivity across the organization, maximizing AI and...

Location Remote Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Build and manage a Regulatory Operations team to support submission planning, publishing, and lifecycle management. Oversee/lead planning, tracking, publishing, compilation, and archiving efforts in support of regulatory submission activities including INDs, NDAs, BLAs, IND amendments, IMPDs and CTA submissions, EU and Rest of World (ROW) submissions. Lead the implementation and optimization of Veeva Vault RIMs, ensuring alignment with regulatory and business needs. Establish and maintain SOPs, work instructions, and best practices for regulatory operations. Monitor global regulatory operations requirements and ensure compliance with evolving...

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...

Performs quality laboratory testing required for the manufacturing process, utilities, raw materials, in process samples and final product following specifications in both the microbiological and analytical laboratories. Performs microbiological and analytical testing such as bio burden, endotoxin, TOC, pH and conductivity to water samples used in the product manufacturing process and to the final product. Performs in process product testing such as bio burden, and endotoxin and analytical testing (HPLC, Gel Electrophoresis, DNA), among others. Performs other microbiological lab testing such as growth promotion and identification of microorganisms. Provides support in method transfer, equipment/instrument qualification and process validation. Understand Regulations...

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...