Quality & Regulatory Jobs in Pharma & Biotech

Join the Medtronic Cardiac Ablation Solutions (CAS) regulatory affairs team of innovators who bring their worldview, unique backgrounds, and individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, and we believe that this drives healthcare forward and sets us apart as a global leader in medical technology and solutions. Cardiac Ablation Solutions is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care, cardiac mapping, and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives...

Purpose The QA Validation Analyst/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...

Purpose This position leads and maintains compliant Documentation Quality Systems (QS) according to AbbVie policies, procedures, and applicable government regulations by managing the documentation review board to process and update complaint plant procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation. It also provides leadership to a team for the creation and/or update of material codes in the SAP inventory system and the electronic batch record recipes in POMs system. The Quality Systems and Third-Party Contractor (TPC) role also is the main QA point of contact with TPC to manage regulatory compliance and business continuity requests in a...

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

This role will support manufacturing operations and will be primarily responsible for the review and labeling of raw material and review of printed material documentation. This Quality Assurance colleague will ensure documentation for these two areas are complete and compliant. Additionally, this role will serve to update and maintain Master Data within SAP, review occasional production batch records. The ideal candidate will have ability to maintain detailed focus while reviewing paper documents for significant portions of their workday. The Quality Assurance Senior Technician will also work closely with other members of Quality Assurance as well as internal and external customers...

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 Validation Engineer will lead validation efforts to support the Radiopharmaceutical facility and GMP operations in Indianapolis. This role is responsible for the development, execution, and management of commissioning, qualification, and validation (CQV) documents and protocols for...

About the role The primary responsibility is to serve the operations support group by ensuring compliance with procedures and regulatory requirements on the floor. You are responsible for investigations and escalation on the floor promptly to continue uninterrupted production. You are responsible for sample management (sterility, stability, etc.) and preparing shipments of those samples. Additional responsibilities include and are not limited to Triage, Deviation/CAPA initiation and investigation, raw material investigations, QOTSF, online batch documentation review, and serve as an SME for processes. How you will contribute Responsible for sample management (Sterility, stability, etc.) to appropriate facilities and responsible for the...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to...

WHAT YOU’LL DO We are recruiting for a Regulatory Operations Specialist I I, to join our team in the Plymouth, MN location. In this ro le, you will be re sponsible for specialized level work assignments and/or analyses, evaluation, preparation, and management of global regulatory product releases and ge neral 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...

Careers That Change Lives In this exciting role as a Senior Quality Systems Manager, you will have responsibility for QMS Data Analytics, Data Reporting and managing multiple Digital based improvement initiatives within the Quality Transformation organization that will systematically evaluate and transform the capability of the Quality Management System (QMS) to better meet the needs of its stakeholders, both internal and external. Quality Data steward, supporting Data analysis and reporting methodologies Leading a team of Data analysts to support specific analysis where needed to perform advanced data analysis, dashboarding, and reporting in support of quality improvement goals ...

Vertex is seeking an experienced Regulatory Affairs Advertising & Promotion Director to provide strategic and tactical regulatory direction for the review and approval of product, pipeline, and disease state communications for its pain assets in the US. This role is critical in ensuring that all promotional and nonpromotional communications meet regulatory requirements and support Vertex’s business objectives. The Director will collaborate cross-functionally to develop viable communications and implement processes that drive compliance and business success. Key Duties and Responsibilities Serve as a regulatory expert on US statute, regulations, and relevant guidance governing product promotion and related communications, including pipeline and...

The CQAD is the first point of contact on quality and compliance matters for the Oncology Site Management and Monitoring (SMM) function. They are responsible for developing, tracking and analyzing quality metrics at country level. They provide direction and advice on how to apply GCP principles to SMM Oncology personnel so that their work can be conducted while meeting high quality standards. The CQAD utilizes regulatory guidance, globais standards and SOPs to provide compliance advice to SMM Oncology. When appropriate, the CQAD recommends and communicates improvement opportunities to the Business Process & System Owners (BPOs). CQADs supports SMM Oncology management...

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society. THIS POSITION IS FOR 3rd SHIFT M-F 10pm - 630am. Accountabilities Support specific Quality Operations processes within assigned area External Audit Readiness - support the preparation activities for internal and external inspections, including...

Responsibilities may include the following and other duties may be assigned. Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards. Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle. Conduct risk assessments and manage risk mitigation activities in accordance with ISO 14971 and other applicable standards. Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections. Oversee validation and verification activities, including the...

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,...

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...

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...

In this exciting role as a Quality System Manager - Change Control, you will have responsibility for leading the QMS change control process for the Medtronic Diabetes business. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we...

A Senior Laboratory Technician, Quality Control/Senior QC Lab Tech is responsible for performing advanced laboratory procedures independently for the testing of veterinary biologicals according to strict government and company-imposed guidelines. Technicians may work with a variety of technical equipment while completing Quality Testing. At all times technicians must follow Good Manufacturing Practices and Standard Operating Procedures (SOPs) and adhere to all safety and company policies, perform duties assigned by department management. A Senior QC Lab Tech must possess thorough knowledge of the underlying principles used in testing procedures and understand the material being evaluated, i.e. virus, bacteria, cell line, etc....

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

Materials Operations is a regulatory compliant service operation that is responsible for the safe and secure, Receipt, Storage, Shipping and Transport of Sanofi materials and products. Materials Operations is also responsible for supply chain security compliance, hazardous materials, import/export, inventory management & control, warehouse operations and other value-added logistics. Operations compliance engineers main functions are leading deviation investigations and managing CAPA implementation, partnering with direct APU staff for enhancing and improving the APU instruction set, overseeing and supporting APU training program, and identifying and managing continuous improvement initiatives. Senior Operations Compliance Engineer uses expert knowledge of compliance and GXP processes...

The Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations, and materials management for the internal programs at Vertex Manufacturing Center (VMC), Boston, MA. The position will be a part of the QA operation floor support team. This role will review & support activities related to product disposition, including batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation. The Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs. The position will support multiple production functions (from Quality operations to Quality...

Strategy & Capability Building Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. Own continuous improvement of the operating model and capability roadmap for the CMC RA function. Creating and implementing functional business strategies Improving performance and operational excellence Centralizing key activities to support each team’s global product, pipeline, and people’s ambitions Operations & Cross-Functional Leadership Design, build, and lead a high-performing organization to drive strategic initiatives, centralize activities, and foster cross-functional support of CMC RA’s processes, systems, data, and tools. Define and track Key Performance Indicators for CMC RA. Collaborate with...

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will The Manufacturing Quality Operations Senior Associate provides Quality Assurance (QA) support to all modalities manufactured on site including clinical, commercial, and contract manufacturing operations providing QA Operations Floor oversight. The role ensures adherence to regulatory expectations,...

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. Role Summary The Associate Director Quality Compliance supports strategic and operational...

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 Associate Quality Assurance Engineer will provide support to Operations for a variety of functions such as material receipt, production, process validation, facility qualification, and test method validation to determine the acceptability of material and the process in...

Quality Assurance Manager (Bogdanoff) As a Quality Assurance Manager for Complaint Investigations, they will be responsible for sustaining the complaint investigation operation, while developing a team and leading projects to advance the lab for future expectations with regards to compliance, capabilities, and workforce output. This role oversees engineers and leads for direct and indirect labor to sustain complaint investigations, and complaint returns. This role is responsible for establishing an operation that performs consistently to maintain requirements for investigation timeliness, and develop processes for new or updated products, while ensuring ongoing compliance and audit readiness per Abbott's Quality Policies and...

Quality Engineer II, Risk Management As a Quality Engineer II, Risk Management you will work closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation. Ensure risk management assessments and evaluations for products conform to established standards and agency regulations What You’ll Work On Perform risk evaluations associated with complaints, manufacturing non-conformances and new product design activities. Proactive in finding quality improvements related to Risk Management processes. Works cross functionally with Engineering, Marketing, Manufacturing and Regulatory to establish product risk documentation. Work collaboratively with operations engineering, complaint handling team, product development...

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

Quality Engineer II This position works out of our St Paul, MN location for our Electrophysiology medical device business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As a Quality Engineer, you’ll play a key role in ensuring product excellence by investigating software/hardware-related customer complaints. Your work will directly impact product reliability and customer satisfaction. You’ll collaborate closely within a small to medium-sized team and across departments to uncover root causes and drive improvements. What You’ll...

In this exciting role as an Audit Compliance Manager, you will have responsibility for leading the compliance audit program for the Medtronic Diabetes business. The Audit Compliance Manager is responsible for managing the compliance audit program, for internal, external and supplier audits at the Diabetes sites. This position is an exciting opportunity to work with Medtronic's Diabetes business. This role is instrumental in contributing to defining the direction and plans for process improvement and ensuring the site is audit ready. The individual in this role must be comfortable coaching all employees on audit readiness and working professionally with others to...

Our Research & Development Division Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world. Our Research & Development Division QA Clinical Quality (CQ) provide independent assurance that our Company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials. Primary Responsibilities Leads their own specific...

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. When it comes to research and development, our goal is to...

Sr. Supplier Quality Engineer Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Temecula, CA , currently has an opportunity for a Senior Quality Engineer . This role will serve as liaison between internal Abbott third party manufacturers and Abbott Vascular. Ensures effective implementation of quality and compliance requirements between multiple quality systems and sites. THIS IS AN ON-SITE DAILY ROLE. WHAT YOU'LL DO Position Responsibilities Work...

Use Your Power for Purpose This position will oversee the Quality Control Laboratory in Rochester, MI. The Rochester Quality Control Laboratory performs Assay, Viscosity, Breakloose & Extrusion, Sterility, Gas chromatography, pH, LOD, Bacterial Endotoxin, Karl Fischer, and multiple other analytical technologies used to determine quality attributes for Rochester manufactured Drug Products. The selected candidate will lead the laboratory to meet defined quality standards and QO objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the laboratory and department. Provides guidance and...

POSITION SUMMARY Robotics and Digital Surgery, a division of Johnson & Johnson Medtech Surgery Group, seeks a Head of Quality and Compliance for the Monarch platform. The role oversees Design & Development, Manufacturing/Operations, Quality & Compliance, and Post Market Surveillance, reporting to the Global VP of Q&C Robotics and Digital Surgery at the Santa Clara campus in California. This role is responsible for overseeing Quality and Compliance, with a focus on product design, manufacturability, and reliability throughout Product Development, Operations, Distribution, and Commercial processes. The position involves collaboration with teams including quality associates, engineers, and managers, who carry out product...

As a Senior Quality Engineer at Medtronic, you will champion our commitment to continuous improvement and operational excellence by proactively identifying opportunities for innovation across our processes and systems. Embedded within the Airways DC Quality support team, you’ll deliver dedicated support to daily logistics operations, driving best-in-class results through standardization, simplification, and a relentless pursuit of quality. In this role, you’ll focus on detecting gaps and issues, providing actionable solutions, and ensuring full compliance with Medtronic’s rigorous Quality procedures and governing regulations—all while embodying our Mission to alleviate pain, restore health, and extend life. This role is 100% onsite in...

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...

Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of...

The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for working collaboratively to plan and carry out regulatory activities related to the Basic Energy and Access and Instrument product portfolio. This role involves preparing and submitting regulatory documents, such as 510(k) applications and CE technical files, conducting regulatory change assessments, and supporting the implementation of the EU Medical Device Regulation (MDR). The Sr. RAS translates regulatory requirements into actionable project or product requirements and works closely with multiple departments to ensure that all regulatory deliverables are completed accurately and on schedule. The position is best suited for individuals who have...

As a CAPA 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 CAPA 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 matter expert (SME) for one or more Quality System elements in compliance with FDA...

Position We are seeking an experienced Senior Director, Regulatory Affairs, to lead our regulatory strategy and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to guide product development and market entry strategies while maintaining a steadfast commitment to regulatory integrity and transparency. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical...

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

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

Responsibilities may include the following and other duties may be assigned. Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families Accountable for and owns the Risk Management Files for assigned product families within the Robotic Surgical Technologies business. Maintains Risk Management Files for assigned product families Conducts product Risk Analysis (PHA, RAC, SSRCI/System & Use FMEAs) in compliance with ISO14971 Evaluates product Risk Management Files against field data to ensure accuracy and correctness of predicted risks; validating pre-market Benefit Risk Analysis and updating the Risk Management Files...

Material Compliance Associate What you will do In this vital role you will be responsible to assist the Brand Marketers build and monitor their projects through the Material Approval and Compliance (MAC) review process. The MCA will quality check files submitted for review, collect “live” edits during compliance review/approval meetings, and edit submission documents within the electronic review system, Veeva. They will ensure all materials submitted adhere to Amgen MAC Standards and FDA requirements throughout the process. Responsibilities Quality check submissions for review to ensure alignment with internal standards Work with agencies and internal staff, including training on next...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to...

Johnson & Johnson is currently recruiting for Associate Director, Centralized Compliance Services ! This position can be located in Raritan, NJ, Horsham, PA or Beerse, Belgium. 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-044264 Beerse Belgium-Requisition# R-045004 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as...

We are seeking a highly motivated and digitally fluent Quality Metrics & Digital Insights Specialist to join the PT Quality (PTQ) organization. In this impactful role, you will partner across global sites and functions to design and deliver data-driven solutions, dashboards, and advanced analytics that power decision-making and promote a culture of continuous improvement across the Pharma Technical (PT) network. You will help translate complex quality and operational data into meaningful insights that inform strategy, support regulatory compliance, enable proactive risk mitigation, and unlock business value. Working at the intersection of Quality, Data Science, and Digital Innovation, you will be...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. As Quality Manager (QA) of CMO within External Manufacturing & Supply (EM&S), you will be responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs), and/or Business Partners (BPs) involved in the manufacture, testing, and transport of Sanofi products. EM&S QA interacts with functional units within the entire Sanofi organization, both within EM&S and with global to ensure compliance with internal and regulatory requirements for the disposition of...

Responsibilities Provide ongoing software quality engineering support throughout the software development life cycle Provide support to development, engineering and manufacturing functions for validation planning and transfer activities Assist teams in determining verification and validation needs and requirements Provide support for software development projects in the manufacturing areas by review/approval of software deliverables Software Development Plans, Verification Plans, Validation Plans User Requirements, Functional/Software Requirements Configuration Specifications, Software Architectural and Design Documents, Peer Reviews Risk Management Documents Test Protocols, Requirement Traceability Matrices, Summary Reports Provide review and approval of software related change orders Ensure successful transfer of software from development into manufacturing...

This position works out of our Abbott Park IL (preferred) or any Abbott's manufacturing location. What You’ll Work On Our location in Lake Bluff, IL currently has an opportunity for a Program Quality Manager in Complaints, Vigilance and Product Actions. The function of the Quality Program Manager is to provide corporate-level leadership and guidance for Quality Systems matters related to complaint management, medical device reporting/vigilance and product actions (corrections and removals), as well as supporting other Abbott Quality System elements as it relates to post market surveillance. This includes but is not limited to providing global support to Abbott Businesses/Divisions,...

Job Title Supplier Quality Engineer We are seeking a Supplier Quality Engineer to work at our Temecula, CA location in our Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Temecula, CA currently has an opportunity for a Supplier Quality Engineer. The Supplier Quality Engineer is responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. Must be able to...

The Sr. Regulatory Affairs Manager hired in this role will work out of the Lake Forest, IL location 4-5 days a week in the office. This role will require some travel up to 25% to Abbott locations potentially in and outside of the US. This is part of the Infectious Diseases Division at Abbott Rapid Diagnostics. This role reports to the leader that also leads Global New Product Introductions and US Regulatory. 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...

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

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of...

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will Evaluate and review clinical and commercial product batches to ensure compliance with established specifications. Approve investigations and change control activities to maintain compliance with configuration management policies. Contribute to moderately complex projects, managing time effectively and...

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

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Executive Director — Biologics Quality Control (Grade 34) KEY RESPONSIBILITIES The Executive Director, Site Quality Head is responsible for leading all Quality functions at the pharmaceutical manufacturing site, ensuring compliance with global regulatory standards, driving...

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

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. Sr. Principal Infrastructure Architect – Manufacturing & Quality Systems At Lilly,...

We are seeking a Regulatory Affairs Manager to join Abbott’s Heart Failure Division on-site in Pleasanton, CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the...

Purpose The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks...

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 The Associate Director, Global Quality and Compliance Excellence uses advanced subject matter expertise of global quality standards, cGMP, and external agency regulations to lead preparedness for regulatory inspections and audits at AbbVie sites across the global network. Drives the development and maintenance of a quality culture by closely collaborating with AbbVie Manufacturing Site leadership, Quality Lab leadership, global functional groups, and Third Party Manufacturers to conduct mock audits, coach site leadership on opportunities identified, maintain roles and responsibilities, identify potential project gaps, and obtain an in-depth understanding of the quality, compliance, and resource needs at each site. Responsible for...

Purpose The primary responsibility for the Quality Validation Specialis t is the Quality oversight and overall approval of validation and engineering change management activities. The Validation engineering department, will support the implementation of the Validation quality program, and will be expected to independently manage 5+ key projects simultaneously. Responsibilities Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility Executes tasks as required to implement the Validation Master Plan and...

The Strategic Global Labeling Manager in Regulatory Affairs is responsible for developing and delivering patient-centered global product labeling for the safe and effective use of AbbVie products. The key responsibilities include leading cross-functional teams to develop comprehensive label strategies and create accurate labeling for development and marketed products, ensuring compliance with company procedures and applicable regulations. Responsibilities Develop and maintain target labeling and prescribing information, including company core data sheets, and US and EU labeling documents, through the product lifecycle. Make recommendations to proactively optimize labeling language, including effective use of target labeling as applicable, for assigned products. Product portfolio...

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality assurance background to join our Quality Assurance (QA) team. The successful candidate will contribute to the advancement of our product pipeline by performing QA batch record review, label review and verifications, document archival of records, and other assigned tasks. You will also be expected to independently organize and manage timelines for batch record reviews. You will be expected to provide support for both the Santa Monica, CA and Tarzana, CA sites as needed. Responsibilities include, but are not limited to Reviews routine manufacturing batch documentation and quality control...

Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed in alignment with our incredibly high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Line Oversight Program at West Point is an entry level 2 year program with 8 month rotations focused on providing hands-on experience in pharmaceutical quality assurance supporting our Company’s largest and most complex...

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 Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at...

Project Leader Quality Assurance – Ingredient Supplier Quality This position works out of our Columbus, OH location in the Nutrition Division . Our Global Supplier Quality Assurance (GSQA) group in Columbus, OH currently has an opportunity for a Project Leader, Ingredient Supplier QA. The primary function of the GSQA group is to ensure a high-quality supply of incoming materials through evaluation, monitoring and development of Abbott Nutrition ingredient and packaging suppliers worldwide. GSQA is responsible for working and communicating with suppliers as part of an ongoing supplier management process. GSQA supports systems such as supplier qualification, supplier development, supplier...

Johnson & Johnson is currently recruiting for a Senior Manager External Quality! This position can be located at any J&J Internal Medicine site in the US, with a preference for New Jersey or Pennsylvania. In this position you will be responsible for providing quality leadership and oversight of external manufacturers in the North America region, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards. Key Responsibilities Ensure effective and compliant execution of quality systems at external manufacturing sites Participate in the selection, qualification, and ongoing monitoring of external partners Provide leadership in the...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at We are searching for the best talent for a Manager, SOX Compliance to join our team in Raritan, NJ . **There is a pre-identified...

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. Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi MA BioCampus facilities. QA’s main responsibility is to ensure adherence to cGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities. The QA Process-Centric Unit (PCU) is a team that is...

The Senior Director, Quality Assurance leads the site’s independent Quality Assurance organization, accountable for an effective, risk‑based PQS, final batch disposition, inspection performance, and a culture of continuous improvement and data integrity. Partners with the Site and global Quality leaders to assure supply and compliance. FOCUS AREAS Quality Leadership & Strategy Demonstrate ownership of a site Pharmaceutical Quality System (PQS) aligned to our Quality Manual, including policy/standards oversight, CAPA/change control governance, data integrity, risk-based approaches and periodic management reviews . Able to run an independent QA function , with authority for final batch disposition , QA oversight of manufacturing/testing, and...

At Medtronic, our Mission is to alleviate pain, restore health, and extend life for patients worldwide. As a Regulatory Affairs Project Specialist, you will play a crucial role in maintaining ongoing product compliance by assessing changes to existing medical devices and ensuring all necessary regulatory actions are executed. Your responsibilities will include evaluating the impact of product changes, preparing and submitting regulatory filings, and maintaining comprehensive documentation in line with global regulatory requirements. You’ll be part of a collaborative, diverse, and innovative team that values integrity, inclusion, and a commitment to making a meaningful impact in healthcare. This role provides...

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

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 Manager, QA for QC is responsible for quality oversight of the Quality Control (QC) Analytical and Quality Control Microbiology laboratory operations at the RayzeBio facility in Indianapolis in accordance with RayzeBio policies, standards, procedures and global...

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...

Job Title Associate Quality Engineer This position works out of our Arecibo location in the CRM division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Shift First- Monday to Friday As the Associate Quality Engineer, you will provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. The Associate Quality Engineer will work with line supervisor, manufacturing engineer, and other team...

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. Responsibilities The Senior Director, Global Process Owner for Supplier Quality Management,...

This role will support the Global Privacy Office in developing, executing, and enhancing AbbVie’s privacy compliance monitoring and analytics program, including the maturity of monitoring initiatives of privacy controls across the enterprise and the execution and adoption of privacy analytics tools and systems to manage and mitigate risk. This role sits in North Chicago with a hybrid in office schedule . Key Responsibilities Responsible for informing, executing and adjusting the annual, Privacy Global and Local monitoring plans leveraging data analytics and performing data analysis to inform our on-going understanding of potential Privacy risks, and providing guidance for monitoring the compliance...

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...

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

Responsibilities may include the following and other duties may be assigned. Develops, implements, administers and certifies compliance policies, procedures, and practices. Ensures alignment with legal and ethical standards of the organization. Provides compliance advice, investigates complaints and verifies deficiencies are corrected. Develops employee communication and training programs that focus on the elements of a companywide compliance program. Enforces anti-bribery and anti-competition laws. Analyzes metrics and audits functional compliance program. Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program. Must Have Minimum Requirements Bachelors degree required Minimum of 2...

Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Careers That Change Lives In this exciting role as the Senior Quality Systems Program Manager , you will lead strategic initiatives to improve the Neuromodulation and Pelvic Health Quality Management System (QMS), focusing on enhancing customer experience through innovative solutions. Additionally,...

Our Purpose Within the CRDN Design Assurance Laboratory at Medtronic’s Mounds View site, we focus on providing Quality support across all aspects of PDP from pre-market product development to post-market product surveillance. We participate in the design process to ensure the performance and safety of the complex electromechanical devices we develop are assured and maintained throughout the product lifecycle. 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...

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...

Job Title Compliance Manager This position works out of our Sylmar, CA location. This is an onsite role . Sets strategy for internal, clinical, and external audits (Regulatory Agencies, Corporate, Certification bodies, and major clients) ensuring sites are audit ready at all times. The incumbent manages a team of auditors across the sites and acts as a change leader, responsible for management of major global improvement activities to improve quality systems, audit readiness, and compliance. Represents the division within Abbott through Corporate based advocacy forums as well as external Regulatory Intelligence Forums such as the Notified Body Audit Coordination...

Quality Compliance Senior Manager What you will do In this vital role you will be responsible for driving Global Quality Compliance Audits and assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks. Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies. Implements risk assessments. Ensure...

Johnson & Johnson is currently recruiting for a Senior Regulatory Compliance Specialist ! This position can be located in Cornelia or Athens, Georgia. Under the supervision of the Regulatory Compliance Manager, the Senior Regulatory Compliance Specialist is responsible for maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements . The Regulatory Compliance Specialist will lead and maintain the internal audit program to help the site sustain a state of readiness to applicable regulatory requirements . Leads and maintains assigned Compliance functions to ensure compliance to applicable regulations...

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...

Global Patient Safety, Oncology TA Intern Overview 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. The Global Patient Safety, Oncology Therapeutic Area (TA) Intern will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical industry. The intern will support the enhancement of clinical safety insights by leveraging reverse translatability to improve non-clinical capabilities (e.g. complex in vitro models (CIVM) or...

Global Patient Safety, Specialty TA Intern Overview 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. Global Patient Safety, Specialty TA Intern Overview 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. As a Global Patient Safety, Specialty Therapeutic Area (TA) Intern at AbbVie, you will spend your summer engaged...

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

Johnson & Johnson is recruiting for a Quality Control Analyst- Microbiology Lentiviral Vector (LVV). This position will be located in Raritan, NJ! At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at . ...

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,...

Johnson & Johnson is recruiting for a Supervisor Quality Control- Microbiology! This position will be located in Raritan, NJ! At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at Supervises individual contributors, and...

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 have an opening for a Sr. Quality Engineer at our Minnetonka, MN site within our Electrophysiology division. This position will provide Process/Quality Engineering support to manufacturing for commercially released product, helping to ensure delivery of highest quality product to the customer. What You’ll Work On Reduces and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing...

AbbVie’s diversified portfolio provides a unique mix of pharmaceutical products and direct-to-consumer aesthetic products and devices. This allows for distinct opportunities for AbbVie professionals to learn and operate in both spaces, gaining an understanding of the different industries and associated business models. The Global Compliance Audit Associate Director has the primary function to lead/manage global sales and marketing, corporate functions, and other healthcare compliance audits. The role will assist the Director with annual risk assessments and be expected to form relationships with a broad spectrum of stakeholders to understand business risks for US/International locations and recommend a thoughtful audit approach....

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

About the role The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's mission to provide better health and a brighter future. This role is located in Cambridge, MA and it is Hybrid (not remote). R elocation Benefit is available to support your transition. How will you contribute Ensure compliance to Regulatory Intelligence Procedures by executing the...

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 Manager, Quality Assurance Investigations at the Cell Therapy Facility (CTF) in Devens, MA will be responsible for providing quality...

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 entering an exciting period of growth, and we are...

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 The Associate Director, Quality Control, will serve as site-based...

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

Quality Control Technician II The Quality Control Technician is responsible for bioanalytical quality testing within the Quality Information Management System and SAP system. Provides inputs to facilitate CAPA investigations as required. Owns and approves any testing events. Maintains product and testing inventory and complies with the quality system. Executes daily activities with minimal supervision. Provides input on testing and is an SME (Subject Matter Expert) on their certifications. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the Quality system. Complete Quality testing as appropriate for products per procedures and review all data to determine conformance...

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide. At Medtronic, we must work with a sense of purpose and ownership, knowing there is a human life on the other side of every decision. 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....

This is a fully 100% on-site position supporting the Global Operations & Supply Chain unit located at the Boulder, CO Manufacturing site. Responsibilities may include the following and other duties may be assigned. Attend daily tier meetings with other core team members Provide backroom support during internal and external audits Lead and facilitate Quality Walks with Engineering and Manufacturing personnel 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,...

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

The Opportunity We are seeking a motivated and experienced Quality Assurance Specialist to join the Synthetic Molecule Analytical Chemistry (SMAC) department in Genentech Research and Early Development on the South San Francisco campus. The specialist will be a member of the SMAC Equipment and GMP Operations Group. This role will be responsible for Qualification of GMP equipment and associated compliance documentation, writing qualification protocols, working with QA to obtain protocol approval, and executing validation activities. Manage equipment lifecycle activities and documentation such as system risk assessments, decommissioning, and periodic review; serving as department SME for data migration and archival; initiating,...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. The Compliance Engineer organization supports the Engineering and Maintenance (EM) department by performing investigations and supporting the completion of CAPAs and change controls at the Sanofi, Framingham manufacturing facilities. Responsible for managing a compliance EM department supporting and coordinating Compliance efforts for the EM Department consisting of Engineers and specialists. Supports manufacturing facilities and manages staff performance against department’s operational goals. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to...

About the Role This position will provide guidance in validation strategy to the site and global projects. The position will have engineering validation signatory responsibility for approval of cleaning cycle development and cleaning validation protocols and final report documents. This position is responsible for assessing and validating cleaning processes. Primary tasks include development of protocols, coordination of validation activities, execution, preparing final reports and assembly of final validation packages; generation of project plans. Responsibilities will consist of both initial validation efforts as well as revalidation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final...

Oversight of and participation in the development and execution of Computerized System Validation Life-Cycle documents / protocols, including but not limited to Validation Compliance Assessments, Validation Plans, Qualification Protocols, User Acceptance Tests, Change Controls, Periodic Validation Reviews, Audits, and Corrective Actions for audit findings for automated systems at the Marietta, R&D, Clinical Drug product site. Ensure both technical and procedural content of computerized system validation deliverables reflect current GSK Policy and procedures, government regulations, and industry practices. Coordination of validation activities with internal business partners / key stakeholders in a manner that satisfies procedural and operational requirements. Supervision, management, and...

JOB SUMMARY Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global development that changes patient lives throughout the product life cycle. The Vice President, Internal Medicine Regulatory Strategy, serves as a senior regulatory leader who has global mindset and expertise of drug development and product lifecycle processes in support of Pfizer’s Internal Medicine portfolio including metabolic disease, cardiovascular risk, diabetes and cachexia. The goal of position is to provide, maintain and direct regulatory resources in the provision of regulatory guidance to projects and products to optimize input to development and commercial decision-making...

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

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. Position Brand The Sr. Principal Associate - Quality Auditor is...

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

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 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...

This is an onsite role located in 1420, Harbor Bay Parkway, Alameda, CA. This is not a remote role/opportunity. The IT Process Architect - Global Quality and Regulatory plays a pivotal role in shaping and optimizing enterprise-wide business processes to support strategic transformation and operational excellence. This role partners with cross-functional teams to design scalable, service-oriented process frameworks that align with business goals, improve efficiency, and enable innovation. The Process Architect ensures that business capabilities, value streams, and workflows are clearly defined, integrated, and continuously improved to drive measurable outcomes across the organization. Core Job Responsibilities Process Architecture & Optimization...

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 Experienced Analyst, Quality Control to be located in Malvern, PA. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products?...

The Manager, Quality Systems is responsible for supporting the ownership and oversight of Devens Cell Therapy quality systems, such as CAPA, Investigations per established local and global standards. This position supports the overall compliance and performance of Devens Cell Therapy Quality Systems Management as it applies to the site level, including periodic assessments of process performance and continuous improvement opportunities Duties/Responsibilities Review and approve complex site quality system deliverables and risk assessments associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems. Ensure quality system deliverables are robust and adequately address requirements and risks, by...

We are seeking a dynamic and experienced Associate Director to join the Global Supplier Quality team within External Quality Operations. This leadership role will provide strategic direction and operational oversight for biologics-related material categories (e.g., single-use systems, resins, filters, media, excipients). The Associate Director will serve as a key quality leader, driving supplier performance, risk mitigation, and lifecycle management across a global network. This role requires strong technical expertise, external relationship management, and the ability to influence cross-functional teams and senior stakeholders. Job Responsibilities Provide strategic quality leadership for biologics material suppliers across internal and external manufacturing networks Lead supplier...

Objective / Purpose The Head of Research Quality holds the highest leadership role within the Research Quality organization and serves as a key member of the R&D Quality leadership team. This executive is fully accountable for defining and executing the global strategic vision for Research Quality, overseeing a global team of experienced subject-matter experts dedicated to ensuring integrity, compliance, and ethical excellence in non-clinical research activities, studies, and processes supporting Takeda’s R&D pipeline. Through strategic leadership, impactful stakeholder engagement, and championing an enterprise-wide quality culture, the Head of Research Quality drives organizational success and reinforces Takeda’s commitment to industry-leading standards....

OBJECTIVES/PURPOSE Drive the design, implementation, and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures. Lead and develop a global organization, fostering talent, accountability, and high performance to advance quality, ensure regulatory readiness, and drive innovation and operational excellence and execute Takeda’s global Quality strategy for medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, geographies, and therapeutic modalities spanning Takeda’s development pipeline and lifecycle management of marketed products. Drive inspection-ready and escalable, compliant, and...

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...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Oncology Products Policy Research (75%) Conduct research on novel and innovative oncology approaches, including topics such as the contribution of components in PD-L1 combination strategies, validation methods for novel endpoints, and biomarker investigations. Draft science-based articles intended for review, consideration, and presentation to regulatory agencies. Regulatory Intelligence...

Intern - IT Quality Assurance As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Work as a member of the IT Quality Assurance (QA) team, and collaborate with IT engineering functions, to Develop data-driven solutions that enhance IT QA operational efficiency and decision-making. Develop solutions that support the automation of IT QA manual processes using technologies...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following A summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus of Gilead Sciences. The candidate should be enrolled in an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject. The summer...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Create custom innovation solutions using different artificial intelligence, analytics and automation platforms to solve business problems and inefficiencies. Work closely with SMEs and leaders in various functions within Regulatory, Safety and Quality to understand and identify routine, repetitive process steps that could be improved using various technologies....

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following This position provides essential support across all areas of the IT Risk & Compliance program. The internship offers hands-on experience in IT Security, Risk, and Compliance activities, including exposure to governance frameworks, regulatory requirements, and enterprise risk management practices. Interns will gain practical knowledge of industry standards...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following The Office of Ethics and Compliance Intern will assist in a variety of initiatives that strengthen our ethical culture and compliance framework. The intern may be involved in areas such as compliance training development, systems and analytics projects, transparency reporting operations, data privacy activities, and integrated risk...

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

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include but not limited to the following Independently support development and execute GMP method validation. Run experiments according to test methods, specifications, and protocols. Execute laboratory techniques such as Water Content by Karl Fischer, Dissolution and Liquid Chromatography. Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts. Participate in meetings, present and interpret data. Conduct...

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

Purpose The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks...

The function of Audit and Compliance Auditor is to performs comprehensive audits for compliance with US and foreign regulation requirements, providing constructive evaluation of quality related systems for AbbVie plants, affiliates, quality service areas and/or suppliers that provide materials, services, and products to AbbVie. Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness, and safety of our products. This position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and...

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

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following Supporting activities related to Packaging and Labeling of Phase 1 materials in Foster City Helping develop process flow maps Developing manufacturing instructions for labeling Supporting SOP and WRK instruction updates or creation Showcase your work with a final presentation (PPT) near the conclusion of your internship Required...

Johnson & Johnson is currently seeking a Quality Engineering Team Lead to join our team in Raynham, MA. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of...

We are searching for the best talent for Supplier Quality Indirect Material Lead to join our Supplier Quality team located in Horsham, PA, Spring House, PA, Raritan, NJ, or Gurabo, PR. Please note onsite presence is required. Within the J&J IM segment the Supplier Quality group has responsibilities for supplier lifecycle management of >4500 GmP commercial and clinical suppliers including API, Direct, Indirect Materials and associated services on behalf of our internal network of J&J IM sites globally. Supplier Quality Indirect Material Lead Within the Supplier Quality group the Global Indirect Materials and Services team is tasked with lifecycle management...

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...

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,...

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Intern – Global Quality Control Biologics – Lifecycle Management Key Responsibilities will include, but are not limited to the following Research and document the full QC product lifecycle activities, including method validations and transfers, specification establishment, reference standard and critical reagent management, and the responsibilities of a QC product lead. Interview subject matter experts (SMEs) within QC and...

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

RPM&SP partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals. Oversees and provides regulatory operational support for programs in the Therapeutic Area Unit (TAU). Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning . The intern will support the Gastrointestinal...

Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc. Responsibilities Primary driver for the quality and compliance aspects of product transfer and on-market change management. Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside...

Global Development Compliance ensures quality and compliance in Clinical Development in partnership with R&D Quality and GCP Functions. We champion continuous improvement, foster innovation, and maintain an efficient, inspection-ready clinical development model. Embracing technology and automation, we aim to enhance efficiency, streamline processes, and accelerate the delivery of medicines to patients. As GDC Intern, you will have the opportunity to contribute to focused projects for Takeda’s R&D and GCP Functions that help drive efficiency, streamline processes, and accelerate the ways we work. Key responsibilities may include GCP Continuous Improvement Projects Support overall development of new or revised Good Clinical Practice...

At Takeda’s Brooklyn Park, MN, Facility, we manufacture Entyvio and Adcetris — monoclonal antibody therapies that help patients live healthier, brighter lives. The Engineering Validation team plays a key role in ensuring our systems and processes meet strict regulatory standards. As part of the Engineering Department, we collaborate with multiple departments and functions to safeguard product quality and patient safety. Validation is essential to earning regulatory approval and delivering trusted therapies. Interns will gain hands-on experience in a purpose-driven environment where science and teamwork come together to make a real-world impact. As an Engineering Validation Intern, you will contribute to...

Quality Control (QC) Microbiology ensures the safety and integrity of pharmaceutical products by performing critical testing & sampling such as bioburden, endotoxin, sterility, and environmental monitoring. The team supports manufacturing operations by managing the site’s contamination control strategy, monitoring cleanroom conditions, critical utility sampling/ testing and product in-process and final container testing and ensuring compliance with regulatory standards. Through robust microbial testing and data analysis, QC Microbiology plays a vital role in maintaining product quality and patient safety. How You Will Contribute As a QC Microbiology Intern, you will have the opportunity to… Assist with microbiological testing such as environmental...

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...

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. Background 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...

This position works out of our Tbilisi, Georgia location in the Established Pharmaceuticals business. As the Administrative and regulatory affairs assistant, you’ll have the chance to provide assistance and support to the country manager and other members of the company by handling day to day administrative tasks and contributing to the department projects and regulatory affairs projects. What You’ll Do Provide administrative services for all members of the company. Sending correspondence Preparing orders Office support (stationery, paper, water, tea, coffee, milk, organization of equipment repair , refilling cartridges, organization of office cleaning , minor repairs) ...

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

The Associate Director, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics, including but not limited to vendor key performance indicators, vendor quality metrics, and a vendor risk scorecard, to QA and to key business partners at the enterprise and program levels. The role also drives continuous improvement in Vertex vendor quality processes and governance to assure Vertex remains adherent to regulatory expectations and supports QA operational quality oversight and management...

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

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. Join Medtronic as a Senior Software Quality Engineer and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and...

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

Compliance Quality Software Lead As a Compliance Quality Software Lead , your role will include responsibilities such as ensuring that SWQA computerized systems used in the support of the Quality System and development of ADC customer facing products, are developed, validated and maintained in compliance with regulatory and corporate requirements. You will provide quality engineering expertise to investigate, audit, analyze, propose improvements, and manage processes in the Quality Management Systems and development of ADC consumer products and mobile applications. Identify and implement initiatives for continuous improvement. Author, change and update software QA procedures as applicable. Ensure compliance with all...

We have an immediate opportunity for a Analyst, US Trade Compliance, in our Lake County, Abbott Park, IL location. As the Analyst, your primary role is to conduct audits of Abbott’s U.S. import/export operations to ensure compliance with the applicable U.S. customs regulations. What You'll Work On Perform transactional testing/audits as a member of the US trade compliance audit team. Perform periodic spot checks to assess the timeliness and effectiveness of the site/division post-entry/post-export review processes. Conduct quarterly risk-targeting analysis. Provide analytical support for disclosures and other reporting requirements. Monitor site/division compliance improvement plans to ensure timely implementation and close-out....

The intern will be joining the Lab Excellence Team, a group focused on advancing quality, efficiency, and compliance within the QC laboratories. The team partners across both chemistry and microbiology operations to deliver high-impact projects such as equipment onboarding, data trending and analysis, investigation support, and continuous improvement initiatives. By collaborating with QC, validation, project management, and quality assurance functions, the Lab Excellence Team plays a key role in strengthening laboratory operations and driving sustainable improvements that support both day-to-day testing and long-term strategic goals. The Quality Control Continuous Improvement Intern will support a dynamic special projects team within the...

At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more

Global Quality Systems Management & Improvement is responsible for overseeing critical business processes that ensure quality measures for the entire enterprise. Takeda is in the middle of a major process transformation of critical business processes, with a heavy emphasis on digitalization and new ways of working. You will have the opportunity to learn about important business processes used across the industry, but think creatively as a fresh set of eyes to help is challenge the status quo and embrace a digital and AI-powered ways of working. How You Will Contribute As a Quality Systems Improvement Intern, you will have the...

The US Medical Advertising & Promotion Regulatory (Ad/Promo) team ensures that all promotional communications for Takeda’s marketed pharmaceutical products meet FDA regulations and industry standards. The department provides strategic regulatory guidance to cross-functional partners to support compliant and effective commercial activities. In addition to reviewing promotional materials, the Ad/Promo team conducts regulatory research, tracks FDA enforcement trends, and drives process improvements. The Ad/Promo Regulatory Intern will gain practical experience applying FDA regulations and guidance to pharmaceutical advertising and promotional activities. This role includes conducting regulatory research, supporting evaluation of promotional strategies, and assisting with key projects that impact marketed products....

Global Development Compliance (GDC) ensures quality and compliance in Clinical Development in partnership with R&D Quality and GCP Functions. We champion continuous improvement, foster innovation, and maintain an efficient, inspection-ready clinical development model. Embracing technology and automation, we aim to enhance efficiency, streamline processes, and accelerate the delivery of medicines to patients. As a GDC Intern, you will have the opportunity to contribute to focused projects for Takeda’s R&D and GCP Functions that help drive efficiency, streamline processes, and accelerate the ways we work. Key responsibilities may include Support overall development of new or revised Good Clinical Practice (GCP) and...

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...

This is an ONSITE opportunity at Medtronic Neurovascular located in Irvine, California. 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 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 at Medtronic – both in the lives of others and your career. Join a diverse team 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. Organization Overview Lilly is currently constructing an advanced manufacturing facility for...

About This Role The Sr Associate I will support and lead team initiatives regarding compliance, documentation, writing deviations, lab exceptions, Actions, and environmental excursions. The Sr Associate I must have practical knowledge of current regulations and cGMPs to ensure all work is performed in a cGMP manner, with adherence to regulatory regulations. What You'll Do Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions Author technically sound moderately complex reports with minimal guidance Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels...

The “Automation Validation Lead” will be responsible for oversight and hands-on execution of the automation system lifecycle for all GxP-Regulated Automation Computerized Systems, ensuring compliance with regulatory requirements, Automation Computer Systems Validation (ACSV) and Lifecycle procedures with Data Integrity requirements. Primary Responsibilities Oversight and Execution of Automation CSV Activities Provide comprehensive oversight and execution of all automation CSV activities across both Beam NC and Cambridge sites,ensuring compliance with regulatory requirements and internal SOPs. Plan, organize and lead the development, execution, and approval of all validation documentation,including Validation Plans Requirements Specifications System Impact Assessment Installation/Operational/User Acceptance Testing (IQ/OQ/UAT) Traceability Matrices Validation...

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

Associate Director, Risk Based Quality Management (RBQM) Global Development | Clinical Operations Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products. Residing within Clinical Operations, Risk Based Quality Management (RBQM) Strategy & Operations is responsible for implementing RBQM in support of the Gilead portfolio. The Associate Director, RBQM...

The QC Microbiology Director is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides strategic leadership and oversee daily microbiological operations. Responsibilities include leading the microbiology QC team supporting both clinical and commercial programs for biologics and small molecule sectors. This individual is committed to personnel interactions (approachable) and mentoring of staff for timely project completion and regulatory compliance. The leader collaborates with cross-functional teams, works with CTLs, and fosters a culture of continuous improvement. Job Responsibilities Lead the development and implementation of end-to-end Quality Control (QC) microbiological strategies for Gilead’s...

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...

Electrical Engineering experience preferred, PCBA manufacturing/testing/designing experience preferred, supplier quality engineering experience preferred, position may be located at North Haven, CT or Lafayette, CO Careers that Change Lives A career Medtronic is currently searching for a Senior Quality Engineer to join the New Product Development team at the North Haven, CT facility or the Lafayette, CO facility. You’ll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities. Key Responsibilities Supplier selection and qualification while ensuring suppliers...

This Principal Regulatory Affairs Specialist – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health 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. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market. What You’ll Work...

This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health 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. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. In this role, you will combine knowledge of scientific, regulatory, and business issues to enable products...

About the role As a Quality Control Analyst II, you will build and review routine in-process, drug substance, and stability test methods promptly. You will use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower). You will report to Team Lead Quality Control. This position is for the 2nd shift, with working hours from 200 pm to 1030 pm, Monday through Friday. How you will contribute Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal). Conduct test methods including samples generated for...