Quality & Regulatory Jobs in Pharma & Biotech

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As an Associate Director of Quality Assurance, you are responsible for Job Responsibilities Serve as a lead quality engineer for medical device combination product development projects, with a strong emphasis on design control and risk management activities. Oversee design control, risk management, platform, or statistical techniques improvement initiatives Collaborate with device engineering on new combination product development, supporting design verification, validation, and transfer activities. Contribute to quality improvement initiatives and ensure compliance with relevant regulations and...

Key Responsibilities Contribute to validation projects by developing schedules, master plans, impact assessments, risk assessments, validation protocols, reports, and requirements trace matrices for complex systems supporting clinical and commercial manufacturing. Perform Computer System Validation (CSV) elements for equipment, utility systems, facilities, processes, and automation systems. Author validation master plans, risk assessment documents, protocols, technical reports, and requirement trace matrices. Embed data integrity principles into daily operations and validation programs. Coordinate validation activities with cross-functional teams to ensure timely and budget-conscious execution. Foster collaborative relationships across teams to deliver high-performance validation programs. Identify and drive continuous improvement initiatives for compliant and...

Use Your Power for Purpose At Pfizer, we are committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer vaccines. By maintaining high standards and adapting to regulatory changes, you will play a key role in ensuring that our life-saving treatments reach those in need promptly and safely. What You Will Achieve ROLE SUMMARY This Director, Global...

The PDMB Regulated Bioanalytics Department is seeking a Director to lead the Compliance team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required...

The PDMB Regulated Bioanalytics Department is seeking a Scientist for the Late Development Vaccines Compliance team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g., PCR), serology (e.g., ligand binding immunoassays), and cell-based assays (e.g., neutralization assays) will be utilized to generate pivotal safety and efficacy clinical patient data...

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...

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

Careers that Change Lives The Contract Compliance Analyst will be responsible for ensuring that all contracts and agreements comply with contract requirements, company policies, industry regulations, and legal requirements. This role involves reviewing, analyzing, and assisting in the management of compliance-based contracts. The Contract Compliance Analyst will work closely with various departments, including legal, finance, and operations, to support contract management processes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part...

Medtronic is seeking a motivated and forward-thinking Quality Engineer with a primary focus i n the areas of mechanical, equipment, and tooling to join the team in North Haven, CT . This role is responsible for supporting manufacturing operations by ensuring quality processes and compliance with regulatory standards. The ideal candidate will have a strong foundation in mechanical engineering principles, problem-solving skills, and a commitment to continuous improvement. This role will support the Advanced Surgical Instruments operating unit supporting products including (but not limited to) Surgical Stapling, Robotic Surgi cal Devices, and Powered Instrumentation. Key Responsibilities Support the development, validation,...

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 Solutions (RAD) is recruiting for a Quality Engineering Spring 2026 Co-Op, located in Santa Clara, California 6-month Term (January-June) As a Co-op in the Quality Engineering organization, you will have the chance to Use innovative tools and take advantage of training courses offered on-site. Perform testing, experimentation, verification, and validation to support product design. Assist in developing laboratory...

This is an onsite position Monday through Friday business hours, with occasional weekend and off-shift support required About This Role The Biochemistry Manager will lead the Biochemistry function at our biologics drug substance manufacturing facility with a team of direct reports. This role is essential for overseeing release and stability testing, as well as supporting analytical method transfer and validation activities. What You’ll Do Lead and manage the site Biochemistry team, including hiring, training, and performance management Provide expert technical guidance and mentorship, supporting investigations, analytical method validation, and process improvements in QC Biochemistry Ensure compliance with Biogen policies, regulatory...

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

About the role As a Quality Assurance Specialist I, you will manage Deviations (Events) and Corrective and Preventive Actions (CAPAs) within Takeda's Quality Systems program. It involves collaborating with plasma suppliers to ensure ongoing communication and to monitor the resolution of identified discrepancies. Furthermore, we are looking for the tracking and trending of relevant data, as well as the preparation and presentation of monthly and quarterly metrics in alignment with established Key Performance Indicators (KPIs). You will report to Supervisor Quality Systems. This is currently a hybrid role, requiring in-office presence three days a week. How you will contribute Manage...

Purpose The Quality Assurance Analyst position supports the activities and initiatives of the Quality Manager to implement and manage the Quality System. This includes support on policy and procedures, program management, patient record review, internal/external audit, and metrics, trend analysis and reporting. Responsibilities Responsible for implementing and maintaining the effectiveness of the quality system. Provides effective quality controls to support call center, pharmacy and insurance hub operations. Monitors compliance with all AbbVie Complete Access policies and procedures in addition to all federal/state/local governmental and pharmacy laws and regulations. Develops QA training programs and materials and provides training to departmental personnel....

The QA Validation Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager, this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level. The Validation Engineer responsibilities may include the review of commissioning and validation documentation completed by others, leading, authoring or reviewing investigations and implementation of preventive and corrective action, review and authoring of plant standard operating procedures, review and approval of critical planned maintenance...

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...

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, 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...

TCP - Quality Testing Documentation Specialist Our location in Abbott Park ( Lake Bluff), IL currently has an opportunity for Test Control Procedure (TCP) Specialist. This team member will conduct quality-related activities to deliver consistent; high quality documents; services; products and processes. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the quality system. Create, analyze and process electronic Quality testing documents in compliance with QSR, ISO13485 and other applicable standards. Initiate Document Change Requests and associated packages relating to electronic documents and verify for correctness of the submitted Change in alignment with testing site requirements....

Quality Technician II This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer Technician II, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership...

Sr. Quality Technician Senior Quality Technician responsible for bioanalytical and/or platform quality testing within the WWLIMS or QIMS system and SAP system. Provides inputs to facilitate CAPA investigations as required. Will be required to own and approve any testing events. Maintains product and testing inventory and complies with the quality system. Undertakes the role as Senior Quality Technician and executes daily activities with minimal supervision. Becomes a point of contact for lab issues and may be called on to aid with scheduling activities. Provides input on testing and is an SME (Subject Matter Expert) on their certifications. May provide...

Johnson & Johnson is currently recruiting for a Principal Supply Chain Quality (SCQ) Systems Engineer to be located in either Jacksonville, FL; Raynham, MA; Bridgewater, NJ; Warsaw, IN; Palm Beach Gardens, FL; Irving, TX or Athens, GA. 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 MedTech Supply Chain Quality Excellence is bringing new capabilities to the organization with our Digital Transformation program. The Principal Engineer will lead...

Johnson & Johnson is currently seeking a Design Quality Engineering Co-op to join our new Product Development Team at Abiomed located in Danvers, MA . 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...

Johnson & Johnson is currently seeking a Software Design Quality Engineer Co-op to join our Digital Design Quality Engineering Team located in Danvers, MA . 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...

Your skills could be critical in helping our teams accelerate progress. The Director, Global Regulatory Affairs – Global Labeling Strategy is responsible for leading the development and implementation of global labeling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios. This role provides functional leadership and oversight for one or more therapeutic areas and may supervise or mentor Global Labeling Strategists. The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development plans, including guidance on Phase 2 and Phase 3...

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly...

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. Lilly recently announced a $4.5 billion investment to create the Lilly...

The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities that are necessary in obtaining and/or maintaining regulatory clearance/certification within the United States and Europe for powered surgical devices. This position is largely responsible for sustaining activities and ad prom review. Sustaining activities include, but are not limited to, review of all change control activities related to assigned product family and performing regulatory assessments. Additionally, this role will be responsible for the LTF, 510(k)s, technical documentation updates, and EU change notices that result from the regulatory assessment. This role is also responsible for labeling and ad...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. The Sr. Quality System Specialist position is one of development, improvement, and innovation, through cross functional collaboration. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality systems support in development and maintenance of medical device products across the Acute Care and Monitoring [ACM]...

SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR Onsite Position Located at Our UCI Facility with a Minimum of 4 Days Onsite In the Neurovascular Operating Unit, we are committed to delivering meaningful innovation to advance stroke treatment. You can view more about the business and our products at Medtronic Neurovascular. Our goal as an operating unit is to ensure that we utilize the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference Provide strategic input and technical guidance...

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable...

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable...

In this highly collaborative and strategic role, you will lead global initiatives that shape the learning culture for Regulatory Affairs across Medtronic , elevat ing regulatory knowledge and capability, strengthen ing functional identity, and enhanc ing the impact of regulatory affairs across the company. You will serve as the functional lead and subject matter expert for educational platforms , including learning series , resource library , and the annual regulatory summit . Your daily work will involve partnering with global regulatory leaders, subject matter experts, regulatory policy leads, and cross-functional teams (including R&D, Clinical, Quality, and Medical) to design, curate,...

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

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. Lilly is currently constructing an advanced manufacturing facility for production of...

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

This is an internship position in Patient Safety (PS). Through this position we provide education through job training across a variety of fields within patient safety. Our group is responsible for activities including but not limited to driving innovation across patient safety, process improvement, data analysis & reporting support, vendor management and risk management services. PS is transforming from a volume-based to value-based learning organization, with predictive, insights-driven, patient centric information capabilities. In this position, we are seeking a self-motivating student, who is keen on gaining relevant real-world experience within the pharmaceutical industry. The intern will work closely with professional...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Senior Specialist, External Manufacturing Quality Assurance is responsible for quality oversight of the Contract Manufacturing Organization (CMO) operations for Radiopharmaceutical products in accordance with business agreements, regulatory standards, and RayzeBio procedures. The scope includes clinical and commercial...

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. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of...

As a Senior Quality Engineer supporting manufacturing operations, you’ll work at the front lines of product quality and compliance. You will collaborate closely with production, engineering, and quality teams to support daily operations, drive process improvements, and ensure that all products meet Medtronic’s high standards and regulatory requirements. Your focus will be on ensuring consistent quality of manufactured products and resolving production challenges efficiently and effectively. This role is 100% onsite at our Brooklyn Park, MN site. Responsibilities may include the following and other duties may be assigned. Serve as the quality point of contact for manufacturing lines, providing guidance...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Within M&S and Global Engineering (GE) Technologies and Standards team, the Head of Commissioning, Qualification & Validation (CQV) is responsible for developing, maintaining and implementing a harmonized and digitized methodology for the planning and execution of Commissioning, Qualification & Validation (CQV) activities under Global Engineering perimeter. The Head of CQV...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Validation Associate III will participate or lead a variety of validation functions including protocol generation, validation execution, and summary report generation. This role will support project teams during the design transfer process and continuous improvements projects as...

Digital Chemistry, Manufacturing, and Controls ( dCMC ) is a cross-divisional digital transformation initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes . dCMC intends to deliver Increased productivity and speed to clinic/market Accelerated timelines for site, filing, and launch readiness Improved access to product and process data Streamlined transfer of process and product knowledge with reduced error rates A key enabler of these outcomes is implementation of digital solutions that will install the foundational capabilities needed to realize dCMC’s vision of frictionless flow of data from...

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...

Job Title Quality Engineer This position works out of our Liberty, SC location. This is an onsite role . The Quality Engineer is involved in all aspects of the manufacturing operation from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes. The Quality Engineer is also expected to assist in the identification and resolution of quality related issues. 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 Work On Interfaces with Safety Regulatory Agencies...

Specialist Quality Assurance The Specialist Quality Assurance Engineer will analyze quality standards for components, materials or services. You will apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You’ll Work On Apply quality principles, analyzes quality records, prepares reports and recommends improvements. Conduct inspection, verification and validation of components or materials used in development processes. Identify and address recurring problems either with the quality of the product...

Johnson & Johnson MedTech Orthopedics (a member of the Johnson & Johnson Family of Companies) is currently seeking a Quality Engineer II to join our outstanding team located in Warsaw, Indiana. 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 Quality Engineer II position will apply leadership, interdependent partnering, and Quality Engineering expertise to ensure efficient and effective quality & compliance and continuous improvement in our end-to-end business with a...

The Laboratory Specialist within the Quality Operations department, with guidance from the Associate Director of Quality Operations, provides support to Laboratory Operations. The Laboratory Specialist will support sample tracking and scheduling, perform performance trends, manage inventory, facilitate collaboration meetings, engage in project work, and support other business needs at the direction of the Associate Director. The Laboratory Specialist will work closely with the assigned laboratory in a team environment to ensure timely turnaround of laboratory testing and to ensure that documentation is completed right the first time. The Laboratory Specialist will work with Laboratory Operations staff and management coordinate day-to-day...

EM and S Vaccines and Large Molecules GenMed Head of Transversal Quality Location Cambridge, MA, Framingham, MA, Morristown, NJ About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. External Manufacturing & Supply Vaccines and Large Molecule GenMed is responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in...

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...

That’s what makes us Genentech, a member of the Roche Group. The Pharma Development Regulatory (PDR) is a flexible, bold, and distinctive regulatory organization. We make decisions quickly and strategically as the environment & landscape evolves. We innovate. Within the PDR Program Management Chapter, we are responsible for delivering global regulatory strategy and end to end execution of clinical projects in the Roche portfolio, in order to develop and maintain Roche product permits/licenses to meet the needs of our patients. We deliver the regulatory components of clinical development and registration programs for products both pre- and post-licensing. We do this...

to make a real difference in the lives of many About Lingo Abbott's rich history in developing cutting-edge health technologies is evolving with its new venture into b iowearables . The b iowearables segment is poised to represent the future of the organization, with the potential to generate over $1 billion in revenue within the next five years, supported by Abbott’s robust R&D and financial resources. At Lingo, we are committed to transforming health management with our cutting-edge biowearables that monitor glucose levels and other critical metabolic biomarkers. Our products integrate seamlessly with other health indicators such as sleep, exercise,...

We anticipate the application window for this opening will close on - 20 Nov 2025 Position Sr. Quality Engineer for Medtronic, Inc., located in Billerica, MA. Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Navigate various government and industry regulations including ISO 9001. Develop and execute protocols including Installation Qualification (IQ), Operational Qualification (OQ), and...

Purpose The primary focus of this position is the medical review of clinical trial SAEs including causality assessment and company analysis development combined with therapeutic area leadership. Responsibilities Contributes above the level of individual case review through leadership of individual project or initiative. Provides overall leadership to one therapeutic area in primary role; may also serve in secondary role for additional therapeutic area. May have people management responsibilities with one or more direct reports. Performs medical review of clinical SAEs. Develops Company Analysis for SUSARs. Responsible for accurate and timely communication with all clinical trial stakeholders. Performs causality...

Purpose Purpose The QC Validation Manager provides leadership and direction to the Quality Control organization pertaining to new product introduction of clinical and commercial projects. Expectations that the QC Validation Manager will maintain high quality levels on all aspects of their job while achieving high levels of efficiency. Responsibilities Communicates with Management for Quality Management Review, Quality Initiatives, etc. Attends, coordinates and presents at internal and external teleconferences pertaining to new product introductions Responsible for coordinating cross-functional activities to ensure validation timelines stay on target. Leads and influences peers and colleagues within the scope of their work Leads method validation...

Johnson and Johnson is recruiting for a Quality Management Platform Analyst, located in Wilson, NC. We need a forward-thinking, data analyst, to evaluate, road map and construct an area within our workspace in Kneat to house our method verification and transfer execution worksheets protocols and reports. 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...

Cerenovus, Inc ., part of the Medical Devices sector within Johnson & Johnson , is recruiting for an intern/Co-op for its Medical Devices Regulatory Affairs organization . At CERENOVUS, we are proud to be on the front lines of stroke care – where every second counts – and strive to give patients a new lease on life after stroke. 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...

JOB TITLE Validation Manager LOCATION 50 Northern Ave, Boston, MA, 02210 OPENINGS 1 DUTIES Provides direction and technical leadership to validation contractor(s) to achieve effective and efficient resources utilization . Employs a “hands-on approach” to leading the team, managing people, systems and equipment validation activities. Ensures that validation work follows all safety standards, conforms to end-user requirements/specifications, cGMP compliance, and that validation activities are tracked and completed within guidelines and schedule. Expected to execute tasks and responsibilities with minimal guidance demonstrating outstanding multi-tasking, problem solving and excellent communication skills, in a dynamic and challenging internal manufacturing environment....

This position is responsible for providing investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes. Applicants must comply with Corporate and HR Policies, Security Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function Duties/Responsibilities Perform investigations, using eQMS (Infinity) system, for Supplier Complaints including but not limited to BMS and Supplier’s processes. Create and execute Corrective Actions and Preventive Actions (CAPA) Prepare, submit and discuss finding of the investigation process with key stakeholders. Lead global investigations in collaboration with Global Quality Supplier...

Are you a strategically focused Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet...

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...

Senior Associate Quality Control “Team D” (Tuesday-Friday from 945pm – 815am) What you will do In this vital role you will will provide testing support for the QC Night Shift “Team D” (Tuesday-Friday from 945pm – 815am) at Amgen Rhode Island. Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with safety guidelines, cGMP (Good Manufacturing Practices) practices and other applicable regulations Generates complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks Operates laboratory equipment and instrumentation Performs review and approval of assays, documents and records Supports troubleshooting and problem solving Alerts management of...

Senior Associate Quality Control I “Team C” (Saturday - Tuesday from 945pm – 815am) What you will do In this vital role you will provide testing support for the QC Night Shift “Team C” (Saturday - Tuesday from 945pm – 815am) at Amgen Rhode Island. Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with safety guidelines, cGMP (Good Manufacturing Practices) practices and other applicable regulations Generates complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks Operates laboratory equipment and instrumentation Performs review and approval of assays, documents and records Supports troubleshooting and problem...

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our Diabetes division currently has an opportunity for a Software Data Validation Engineer II. What You'll Do Investigate and report unexpected events, issues or software bugs through the data output from production telemetry. Investigation may include marco quality issues spanning multiple months of data...

Job Title Supplier Quality Engineer This position works out of our Sylmar, CA location. This is an onsite role . 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 Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements Assist in the...

Job Title Quality Inspector II This position will work out of our Minnetonka, MN location in our Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION. As the Quality Technician II, you will be responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. What You’ll Work On Perform first article incoming inspection of purchased components and inspection of production operations, including documenting inspection and audit results. Perform final product...

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...

JOB TITLE GMP Operational Quality Senior Specialist LOCATION 50 Northern Ave, Boston, MA, 02210 OPENINGS 1 DUTIES Supports the principles and application of quality assurance and regulatory compliance. Supports or executes a wide range of standard activities and supports new/existing project initiatives. Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations and Out of Specification (OOS)/Out of Trend (OOT) investigations ensuring appropriate CAPA actions are implemented/identified. Supports change control assessments, implementation and closure. Identifies and facilitates continuous improvement efforts for quality procedures and systems. Supports drafting and revising Quality...

About Cardiovascular 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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for...

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 and Johnson is seeking a Senior Investigation Quality Leader, located in Athens, GA. The Senior Investigation Quality Leader is responsible to ensure the generation and completion of robust investigation reports (i.e Nonconformance and Root Cause investigations). This includes,...

As a Quality Engineer, you will be developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. WHAT YOU’LL DO Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Lead, coach, and mentor non-exempt and entry level exempt personnel Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Design and conduct experiments for process...

Partners closely with the Regulatory Portfolio Manager. Liaises with Global Regulatory Leader and other members of the Regulatory Strategy Team to deliver the asset’s book of work within the overall drug development process. Additionally, collaborate within Regulatory Innovation & Enterprise Delivery on above project initiatives . The full-time internship will take place June - August 2026. Key Responsibilities Responsibilities include but not limited under the direction of the Regulatory Portfolio Manager (Senior Manager I) guidance Global Regulatory Support Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team...

Associate Director, Clinical Regulatory Writing Location Boston, MA Introduction to role Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. Accountabilities As a Clinical Regulatory Writing Associate Director, you will...

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. 2026 Quality & Compliance Intern- Patient Service (Pharm D) reports to the Associate Director of Quality & Compliance for US Patient Services. This role is responsible for assisting in the development of quality and compliance strategies, methodologies, and roadmaps to enhance process improvements. The objective is to ensure a superior experience for both internal and external stakeholders involved in patient services across all brands. Key responsibilities...

SENIOR REGULATORY AFFAIRS SPECIALIST Location Minnesota Rice Creek East Facility (Minimum of 4 days onsite) 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...

Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Join us for a career in IT that changes lives. Careers that Change Lives A Day in the Life POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY...

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

This position works out of our Pleasanton, CA location in under the Medical Device, Heart Failure Division. As the Supplier Development Quality Engineer Lead you will be responsible for implementing and maintaining an effective Quality System, planning, executing, and documenting audits of external suppliers to ensure compliance with FDA, ISO 13485, and internal quality standards. This role drives supplier performance improvements and collaborates cross-functionally to uphold regulatory and operational excellence. What You’ll Work On Work cross-functionally to lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, product and process planning, quality audits, and...

WHAT YOU’LL DO We are recruiting for a Regulatory Operations Specialist I, to join our team in the Sylmar, CA location. In this role, you will be responsible for specialized level work assignments and/or analyses, evaluation, preparation, and management of global regulatory product releases and general support of global regulatory activities. Responsibilities Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives . Responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs) and tender support and overall regulatory...

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

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Validation Engineer II will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The Validation Engineer II will be responsible for the drafting and executing commissioning, qualification, and validation (CQV) documents and protocols which support the...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families The Facilities 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 and Capital Projects. The responsibilities of the team primarily extend to owning deviations relating to facilities, equipment and utilities and their...

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....

Customs & Trade Compliance Junior Analyst This position works out of our Columbus, Ohio Easton Square location in the Nutrition Division . Primary Function/Primary Goals/Objectives Provide technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws and regulations, including 19CFR, 15CFR, FDA, USDA, and other US regulatory agency requirements. Operates with general direction and supervision from the Manager. Incumbent is accountable for compliant importation of goods and services (including machinery), as well as proper classification and valuation. Failure to comply is a violation of law...

PURPOSE The Supplier Risk Management, Senior Specialist is a member of the Supplier & Vendor Quality group in R&D Quality (RDQ). This role is to assist in the execution of GxP supplier risk management activities to ensure quality of the GxP system, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. May lead targeted activities as directed by SVQ management MAIN REPONSIBILITIES | DUTIES Main responsibilities will include, but are not limited to Business Advisor & Portfolio Oversight Manage the Janssen R&D Approved Supplier List (ASL) including addition of newly qualified suppliers, maintenance of...

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

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

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Specialist, Associate Process Validation Engineer, Cell Therapy provides process validation support to the Devens Cell Therapy Facility (CTF). The...

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals Within our Research Labs division, the Quality Assurance group is seeking 1 co-op who will work collaboratively in a team environment to help advance Quality throughout the drug development life cycle. Global Development Quality Co-Op Opportunity (1 position) The role of Global Development Quality (GDQ) within our Company's Research...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Within our Research Labs division, the Quality Assurance group is seeking 2 interns who will work collaboratively in a team environment to help advance Quality throughout the drug development life cycle. Global Development Quality Intern ship Opportunit y ( 2 position s ) The role of Global Development Quality (GDQ)...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities can provide you with great development and a chance to see if our company is the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for summer 2026 Interns. GCTO is a global organization operating in over 50 countries and is responsible in the delivery of our company's diverse development portfolio. It is critical that for all company-sponsored clinical trials that patient safety, high quality data and compliance with company requirements...

The Data Governance – compliance specialist is vital to ensuring robust governance of consent and sample management for both primary and secondary sample uses across QM&G. This role is responsible for reviewing and optimizing Informed Consent Forms (ICFs), overseeing sample collection, retention, and withdrawal of consent processes, and ensuring adherence to all relevant internal and external regulations. The specialist collaborates closely with Legal, R&D, and QM&G teams to coordinate cross-functional governance projects, facilitate continuous process improvement, and drive operational excellence in sample governance. Additionally, the role provides critical operational and project support across various governance initiatives, aiding in the planning,...

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

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

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. 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...

This position works out of our Santa Clara, CA location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Sr. Technician , you’ll support manufacturing in the Structural Heart Division of Abbott, reporting to the Manager of Quality. Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions Responsible for performing in-process and final components, subassembly and product inspection. Measure component dimensions per requirements or inspection plans. Records inspection and...

About the Role The Quality Engineering (QE) Senior Associate I is responsible for the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The QE Senior Associate I will perform all duties in a manner consistent with site and corporate policies, cGMPs, safety, environmental and human resources policies and procedures and be proficient in their understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality Systems cross-functionally. The QE Senior Associate I will provide quality oversight of Engineering, Manufacturing, Maintenance and Facilities...

Summary Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. We are seeking a highly experienced and dynamic Head (VP) of Regulatory Affairs and Pharmacovigilance to lead regulatory and safety strategies at the Biogen West Coast Hub (WCH). This leader will be accountable for shaping and executing comprehensive regulatory strategies to enable timely, successful interactions with global health authorities. You will lead and...

Director, Regulatory Affairs Department Regulatory Affairs Location San Diego We are seeking an experienced and innovative Director in Regulatory Affairs (clinical and nonclinical). This Global Regulatory Lead (GRL) position will report to the Head of Regulatory Affairs and will oversee and/or manage regulatory functions and direct reports within RayzeBio . Responsibility expectations will be commensurate with experience. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Global Regulatory Lead for a cutting edge RPT program Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing and nature of global regulatory interactions....

You will act as the Global or Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned a portfolio of products or projects or key Gilead assets to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance...

Job Responsibilities Independently and proactively initiate and drive the planning, execution, and completion of change management projects Develop and implement strategies to mitigate risks within the change management process and change control system. Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations. Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals. Develop, deliver, and improve the change management program for various levels of the organization, while also ensuring training...

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 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 teamwork,...

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

Reporting to the VP of Human Biology, the Head of Target Validation is responsible for leading the global Target Validation group within the Target Discovery Department . This team is responsible for designing and executing in vitro biology studies to validate novel targets from functional genomics based approaches linking target modulation to a disease phenotype . This team works in partnership with chemical biology, drug discovery platform teams and the research units to generate target data packages to support C2TV and C2T decisions for our priority disease areas, including respiratory, hepatology, neurodegeneration, oncology, renal and infectious diseases. Responsibilities Leading and...

The Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients. Prepares device 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 RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. Additional Responsibilities Include Prepares device regulatory product strategies. Prepares and manages regulatory submissions, including new applications...

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 Quality Analyst to be located in Shepherdsville, Kentucky. The Quality Analyst is responsible for the oversight and execution of Quality Management Systems and compliance at the Distribution Center. The Quality...

This position works out of our Santa Clara, CA, location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We are seeking a skilled Quality Engineer to assume primary responsibilities in test method validation. The ideal candidate will possess extensive knowledge in this area. Additionally, the QE may be tasked with equipment/tooling logistics responsibilities, contingent upon their expertise and organizational needs. The role also encompasses supporting receiving inspections, in-house manufacturing inspections, and managing nonconformance reports....

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...

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Position Description This is a day/night shift position, 12.5 hour ( 600 AM - 630 PM; 600PM-630AM) rotation ( 2-2-3). The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with expertise working in aseptic production and manufacturing operations. The Lead Technician is a...

The primary responsibilities include, but are not limited to General secretarial/clerical tasks including scheduling of complex meetings, management of calendar, filing of monthly expense reports for multiple therapeutic area regulatory liaisons. General support of the Upper Gwynedd‐based staff, as needed, with ordering supplies, ad‐hoc meeting support, good office management practices, etc. to ensure a well‐functioning environment. Scheduling domestic and complex, multi-leg and international travel, including processing of Visas/Passports. Supporting Team Sites, SharePoint Sites, and other communication channels. Coordination and collaboration with other team members across the organization, including coordination of special projects within the division/area. Education High School Diploma required....

Job Tite Summer 2026 Intern - Validation Team Location Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our team is looking for a summer intern to assist in lab experiments, development and validation studies for cleaning and shipping validation with different vaccine products. In addition, the intern will also support collecting and analyzing...

Job Title Quality Assurance Manager This position will work out of our Temecula, CA location in our Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION. Manages experienced QA professionals who exercise latitude and independence in their assignments. Often heads one or more sections/functions or a small quality department. Interprets policies , processes and procedures that may affect sections and subordinate work units. Assignments are defined in terms of activities and objectives. Work is reviewed for adequacy in meeting objectives. MAIN RESPONSIBILITIES Interacts frequently...

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

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Regulatory Affairs Intern will support the Regulatory Affairs team in preparing documentation, tracking submissions, and assisting with project coordination. This internship offers exposure to regulatory processes in the pharmaceutical industry and provides hands-on experience in a cross-functional...

The Senior Specialist, Quality Assurance , is accountable to monitor and track process performance related to key Shop Floor quality assurance quality tasks and other operational tasks through data and analytics; to own, review or approve Floor Quality GxP records including but not limited to procedures, CAPAs, change controls, impact assessments, documentation, or deviations; and represents SFQA at relevant governance forums. Additionally, the incumbent shall to support deviation approval, alarm approval, other Quality System Records, or batch record review as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. The Manager , IT Risk and Compliance is a key member of the Security Risk Compliance (SRC) - DP team and works closely with the legal Privacy & Data Ethics (P&DE) team, and other IT teams to ensure privacy program and controls are in place. They will serve as a subject matter expert on Information Security and Privacy principles; company policies and standards; and regulatory requirements as they pertain to data privacy. The person in this position will be required...

Manager, Quality Assurance Key Knowledge and Skills Proficient in GMPs and/or GLPs. Proficient in application of QA principles, concepts, industry practices, and standards. Demonstrates ability to effectively manage multiple projects/priorities. Has proven analytical and conceptual skills. Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes Demonstrates excellent verbal communication, technical writing and interpersonal skills. Demonstrates working knowledge and good proficiency in Microsoft Office applications. Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial. Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or...

Job Responsibilities Maintains overall project portfolios across Global Quality Monitors progress, manage risks, and ensure projects are delivered on time Drive end-to-end planning and execution of global quality initiatives, including detailed project plans, timelines, and resource management Collaborate with Project Leads and Quality leadership to monitor progress, manage risks, and communicate outcomes across the network Captures and manages Quality Systems enhancements and integrations to various platforms and ensures timely and effective implementation Support the annual Quality Planning process in alignment with corporate objectives Facilitate regular project updates, steering committee meetings, quality forums, and executive reporting Develop, organize, and maintain comprehensive...

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 Manager, Regulatory Medical Writing to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business. The position may be in...

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent...

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

This is a summer internship position on the MSAT Aseptic and Environmental Controls (AEC) Validation team. The primary focus of the MSAT AEC team is to ensure the compliance of aseptic processes and environmental control systems for Cell Therapy Manufacturing Operations at Bristol Myers Squibb’s GMP facility in Bothell, WA. The internship position will focus on creating training tools and job aids for AEC-owned processes such as aseptic process simulation (APS), cleanroom reclassification (CRC), environmental monitoring performance qualification (EMPQ), and non-routine simulation (NRS). The internship will focus on creating educational resources and training tools to enhance cross-functional understanding of AEC...

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

The Brooklyn Center facility also known as Medtronic Electronics Components Center (MECC) supports the production of components used in devices for a variety of Medtronic Operating Units (OUs). This role reports to the Operations Quality Manager at MECC. Key aspects of this role include being a Quality team member on multiple new product development projects as well as existing manufacturing lines, collaborating with customer sites (downstream Medtronic facilities), participating in a culture of collaboration and compliance in one of the Components Focus Factory (Includes Connectors/Molding, Capacitors, TDCO, and Feedthroughs), execute day to day operations, and execute continuous improvement to reduce...

Software Engineer - Data Quality This Opportunity Patients, doctors, and medical researchers deserve the same cutting-edge technological innovations that have transformed other industries. We're on the lookout for passionate software engineers who are eager to apply their skills to revolutionize healthcare. If you're excited by the challenge of using technology to improve lives and drive real change, we’d love to have you join our team. In this position, you will be building online services, automation, and tooling to monitor and ensure our data continues to meet Truveta’s high quality standards. This opportunity requires creative problem solving and...

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

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 position will support a swing shift of 12 noon to 12 midnight on a rotating 2-2-3 schedule About This Role The Quality Assurance Associate III (Swing Shift) is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. Activities include but are not limited to review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, GxP Quality systems-related training, identify gaps in existing Quality systems and propose solutions to site management. What You’ll...

Johnson & Johnson is recruiting for a Tax Technology Manager – Tax Reporting and Compliance Solutions to be located in New Brunswick, NJ. Key Responsibilities Lead a team of administrators supporting Tax Reporting and Compliance Tools (e.g. OneSource Tax Provision, Corptax, J&J Audit Manager, etc.) Serve as product owner and administrator for GTW and manage external resource supporting GTW maintenance. Identify, evaluate and execute solutions to transition GTW capabilities to new tools and decommission GTW. Ensure tax tools & infrastructure are sox complaint and operating effectively to support timely reporting and compliance cycles. Evaluate and deploy tax technology and process...

Quality Engineer II This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Quality Engineer II, you’ll have the chance to provide process/quality engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Also provide process/quality engineering support to product development teams, helping to ensure development of highest quality new products....

Technician I Quality Assurance The Incoming QA Specialist will serve as a key contributor to the Princeton Quality Operations team, with the potential to evolve into the Incoming QA Process Owner and Subject Matter Expert (SME). This role is designed to centralize and enhance incoming quality processes, driving operational excellence and sustainable performance. It also serves as a developmental pathway for future leadership opportunities, including succession into the Quality Supervisor role. What You’ll Work On Performs visual, dimensional and functional inspection and testing according to documented policies and procedures and records them as prescribed. Assists engineering in providing manufacturing...

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

The Senior Director, Regulatory Submission Management champions functional and cross-functional project and submission management excellence. The incumbent is expected to apply deep subject matter expertise in project and submission management to lead and identify opportunities, shape objectives and drive execution of key functional and corporate objectives. This role will be responsible for driving timeline risk mitigation and contingency planning. Key Duties and Responsibilities Provide strategic and operational project, submission and program leadership activities at all stages of the lifecycle (initiation through closeout). Drive communication cross-functionally and with senior leaders on project, submission and program planning topics including timelines, status, risks...

Job Title Customer Quality Statistician This position works out of our Sylmar, CA location. This is an onsite role . 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. MAIN PURPOSE OF ROLE The Statistician performs data analysis according to requirements of statistical plans and seeks to design meaningful studies to assess the performance of implantable products within the Cardiac Rhythm Management business unit (e.g., leadless pacemakers, defibrillators, cardiac leads). The statistician uses statistical software, such as R or Minitab, to...

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 looking for the best talent in Enterprise Quality for 2026. We are seeking highly motivated and meticulous Sophomores, Juniors and rising Seniors for Spring Co-ops within the Enterprise Quality organization. We work on a “hybrid model”. This means that you will be asked to report on site three (3) times a week and can work remotely two (2) times a week. If...

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

The Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients. Prepares device 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 RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. Additional Responsibilities Include Prepares device regulatory product strategies. Prepares and manages regulatory submissions, including new applications...

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

In partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be accountable for the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach....

This internship position in Research & Development Quality (RDQ) offers education and exposure across various fields, including, Non-Clinical Quality, Product Development Quality, Clinical Quality, Pharmacovigilance Quality, Quality Risk Management, and Innovative Capabilities. We are seeking a self-motivated student eager to gain real-world experience in the pharmaceutical industry. The intern will work closely with professional mentors to hone their skills and build a professional network. Location New Brunswick, NJ and Princeton, NJ area. The starting hourly compensation for this assignment is within the range of $23.00 to $34.00/hr. Please note that the final individual compensation and any applicable benefits will be...

Johnson & Johnson is recruiting for a Manager, Compliance Data Enablement, Global Operations. This position can be located at any US J&J location with a preference for Westchester, PA Titusville or New Brunswick, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) North America- Requisition #R-030032 Beerse Belgium & High Wycombe, UK – Requisition# R-032583 Bogota Colombia- Requisition#R-032584 Remember,...

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

Manager, Quality and Validation This position works out of our Lake Forest, IL location in the Transfusion Medicine 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. As the Manager, Quality and Validation , you’ll have the chance to lead the team of Quality supervisors/engineers/technicians to support Manufacturing, Supplier Development, New Product Development, and Quality Systems. Directs projects to ensure the manufacture of high-quality product and...

Quality Assurance Specialist 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 primary function of the Quality Assurance Specialist is to help manage the audit process. Acts as a team member to complete assigned site audit / compliance projects including all interrelated activities. Identifies and elevates critical issues. Participates in...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Our company's Global Pharmacovigilance Quality (PV QA) team is focused on advancing patient care and promoting safe and effective use of our companies' medicinal products and vaccines. The team ensures that the pharmacovigilance (PV) activities performed by Research and Develpoment and Human Health (HH) comply with the relevant procedures and regulations across...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Manufacturing Division can provide you with great development and a chance to see if we are the right company for your long-term goals. 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 dedicated to delivering a...

The Global Quality Large Molecule Analytical Sciences (GQLMAS) team is responsible for the establishment and performance of commercial large molecule analytical techniques, including method development, validation, troubleshooting, transfers as well as stocking and supplying critical reagents to global laboratories. We collaborate with both internal teams and outsourced partners. Our team is fast paced, highly motivated, and focused on advancing our Company’s large molecule pipeline as well as supporting growth and performance of existing licensed products. Specific job responsibilities could include analytical method development, troubleshooting, validation, sample testing supporting process development/changes, and logistical support for sample management and shipments, all while...

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals Team Overview The Global Regulatory Affairs and Clinical Safety ( GRACS ) Regulatory Digital Health (RDH) team assists in bringing new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Join us at our company Research Labs for an exciting summer internship opportunity within the Global Regulatory Chemistry, Manufacturing and Controls (CMC) group. As a summer intern, you'll have the chance to make a meaningful impact on public health by contributing to the regulatory processes of our company medicines and gain comprehensive...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Regulatory Data Science Service is part of the Operations, Process and Systems team within Global Regulatory Affairs and Clinical Safety. The Regulatory Data Science Service team employs Machine Learning, AI and advanced analytics and statistics to evaluate large business and regulatory datasets to drive predictive/prescriptive analytics, trend analyses and other strategic...

Our Manufacturing Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. The 2026 Global Supplier Quality Internship will have a duration of 10-12weeks during the summer months. The Supplier Quality Intern, with guidance from the Director/ Associate Director, will have the opportunity to work on strategic goals for the business. The incumbent will have the opportunity to drive project(s) through the organization, participate on...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development 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 Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution team is seeking a summer intern. The intern will be a fully-functioning member of the team and will be assigned to lead a variety of process improvement projects within Global Regulatory Affairs and Clinical Safety in support of business development...

The Future Talent Program offers internships lasting up to 12 weeks, featuring one or more projects designed to enhance your skills and provide insight into our company’s culture and long-term opportunities. These internships within our Research and Development Division offer valuable professional development and an opportunity to explore if our company aligns with your career goals. The Regulatory Planning and Publishing (RPP) team is dedicated to driving innovative quality planning, ensuring excellence in publishing and delivery, and maintaining compliance for regulatory submissions worldwide. Regulatory Planning and Publishing drives innovation through collaboration, and a commitment to quality and compliance in alignment...

Specific Education & Experience Requirements 5+ years of experience in Regulatory Affairs or other relevant industry experience. Degree in a scientific field is preferred. Specific Job Responsibilities Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorizations), original, marketing authorization applications for territories other than the US and EU and for...

Specific Education & Experience Requirements 10+ years of experience in Regulatory Affairs or other relevant industry experience. Degree in a scientific field is preferred. Specific Job Responsibilities Responsible for preparing and/or overseeing the preparation of technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. May direct others in accomplishing Corporate Objectives. Responsible for submitting complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original...

We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN or Plano, TX. This position performs three 1-year rotations that include 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. Additionally, during certain rotational periods the position may be responsible for regulatory operations activities such as logistics management of global product release, and maintaining tools needed for managing global regulatory...

We empower healthcare professionals with world-class technology to personalize patient care, anytime, anywhere. Through connected solutions seamlessly integrated into clinical practice, we help predict and prevent dangerous and costly complications, from hospital to home. We are the leader in the equitable delivery of care, committed to reducing disparities in outcomes, expanding access, and helping to protect more patients in more places. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of...

Your skills could be critical in helping our teams accelerate progress. The Submission Lead is responsible for the planning, co-ordination and tracking of regulatory submission activities for assigned programs at Sanofi. The Submission Lead is a senior team member with the expectation and accountability to drive Global Simultaneous Submission (GSS) filing execution plans for Sanofi’s priority portfolio. The Submission Lead is also the GRO Submissions Management focal point for Mergers & Acquisitions integration and Joint Venture project teams and is directly involved in relationship building, ensuring achievement of business goals and protecting business continuity We are an innovative global healthcare...

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. The Submission Lead is responsible for the planning, co-ordination and tracking of regulatory submission activities for assigned programs at Sanofi. The Submission Lead is a senior team member with the expectation and accountability to drive Global Simultaneous Submission (GSS) filing execution plans for Sanofi’s priority portfolio. The Submission Lead is also the GRO Submissions Management focal point for Mergers & Acquisitions integration and Joint Venture project teams and is directly involved in relationship building, ensuring achievement of business goals and protecting business continuity. About Sanofi We’re an R&D-driven, AI-powered...

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. Intern will be joining the Regulatory Affairs U.S. Advertising and Promotion (USAP) Standards Team. The Standards Team leads USAP through department-wide initiatives, influences process improvements and fosters the review of compliant promotional and R&D communications. Key responsibilities may include Learning the FDA Regulations on Drug Advertising & Promotion Understanding the detailed USAP activities Creating reports, including metrics, department highlights and communications Attending meetings Creating presentation materials...

Purpose Promotes risk management strategy excellence through the development and application of a structured, iterative, end-to-end lifecycle risk management framework. Responsibilities Serve as the subject matter expert on Risk Management Strategy, advising and participating in various scientific discussions and activities with internal stakeholders. Advise Product Safety Teams (PST) and relevant AbbVie asset strategy teams on risk management strategies, medication error prevention, and benefit-risk assessments to support product development programs, new marketing applications, and marketed products. Collaborates with the TA leads and PST leadership on early drug development approaches to anticipate and further characterize specific risks for an asset, risks that...

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

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 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. Operation’s main functions are leading deviation investigations and managing CAPA Implementation, partnering with direct manufacturing staff for enhancing and improving...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi is an innovative global healthcare company with one purpose to pursue scientific miracles to improve lives. Our team strives to transform the practice of medicine, connecting our science to communities in meaningful ways. Within our Sanofi Manufacturing & Supply Ambition, we’re redefining our strategy, culture, and processes to make...

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

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities can provide you with great development and a chance to see if we are the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for summer interns. GCTO is a global organization operating in over 50 countries and is responsible in the delivery of our company's diverse development portfolio. It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are...

Quality Technician I As the Quality Technician I, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This role is for the 2nd shift. What You’ll Work On Ensures that all evidence documentation complies with governing procedures. Audits and verifies processes such as line verification or...

Quality Technician I As the Quality Engineer Technician I, you will support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott’s Quality Management System. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. What You’ll Work On Ensures that all evidence documentation complies with governing procedures. Audits and verifies processes such as line verification or environmental conformity to prevent quality system...

About BioLife Plasma Takeda offers a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. We are certified...

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

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Specialist, QC Compliance is responsible for leading QC deviation, laboratory investigations, CAPAs and change control. Shift Available Sunday -...

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 Manager, Regulatory Program Manager - Oncology. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; Horsham, PA; or Spring House, PA. The Manager,...

Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. Performs a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance. Performs required inspections, checks, analysis and documentation of studies. Prepares and monitors quality statistics and reports. Reviews production records for conformance to procedures. Conducts...

As part of product development teams, executes product registration submission s , progress reports, supplements, and amendments. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle. Participates in some of the following product plan development and implementation, regulatory strategy, risk management . Ensures timely approval of new medical devices and continued approval of on- market products and product changes . Serves as regulatory representative to marketing, research teams and regulatory agencies. Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Core Responsibilities Prepares robust...

This position works onsite in our Sylmar CA location in the Cardiac Rythym 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. The Software Quality Engineer II is responsible for Software Quality relative to the design and development of company products, software reliability, developing and maintaining processes and procedures, and assuring adherence to the software development lifecycle across Abbott. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting...

About the Role As a Quality Control (QC) Supervisor at Takeda, you will lead daily QC laboratory operations with a focus on microbiological testing, compliance, and process excellence. You will help ensure product integrity through method execution, investigations, and project leadership—directly supporting Takeda's mission to deliver high-quality therapies to patients. We ask that you have hands-on microbiology expertise, method troubleshooting, and leadership in regulatory environments. Swing Shift Monday – Friday 200 PM – 1030 PM How you will Contribute Oversee routine and complex laboratory testing to support manufacturing operations, validation studies, and batch release—especially in microbiology. Perform and support microbiological...