Quality & Regulatory Jobs in Pharma & Biotech

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...

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 . Role Overview The intern will support...

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

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....

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...

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...

OBJECTIVES Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business units and affiliates. Contributes to and implements the engagement strategy among R&D, Business Units and affiliates and Quality to ensure a global framework and robust quality systems are in place for the transition of R&D pipeline to the commercial space. Drives a fit-for-use global Quality framework that elevates the capabilities in the business units and the affiliate and enables them to deliver their clinical research and pharmacovigilance-related regulated activities with high compliance and agility. Establish and maintain relationships with key stakeholders outside...

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...

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...

Are you looking for an internship to learn and develop, take a peek into the professional world while bringing in your individual contribution? Would you like to experience working in one of the biggest multinationals in the pharmaceutical industry? We are looking for a graduating student or Master student; you must be searching for a challenging but fulfilling internship in our innovative company. We work in a dynamic and collaborative team in the regulatory affairs department and will give you the opportunity to contribute to team challenges in main regulatory affairs activities product registration, product life cycling management, scientific translation,...

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...

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 quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. 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 real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of...

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...

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...

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...

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...

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...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Quality Engineer to be located in San Lorenzo, PR. Purpose Reports to Quality Operations Lead, Quality Operations Leader or designee and with the objective of maintaining high quality standards for the product manufacturing process and the compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations and Quality Assurance during...

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....

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...

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...

OF POSITION This position is responsible for ensuring regulatory filings of animal health products in pursuance of licensure and marketed animal health products are submitted in compliance with applicable USDA regulations and is within the Global Regulatory Affairs Bio team. This position is based in the US however closely working together with the GRA team located in the EU. In this role, you participate in cross functional teams on maintenance of our products to provide support/drive filings for marketed animal health products in compliance with applicable USDA regulations and regulations for relevant export regions. MAJOR ACTIVITIES AND RESPONSIBILITIES All major...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Animal Health Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Our Company is offering one summer internship opportunity with our Animal Health Research & Development Quality Assurance team at our Rahway, New Jersey site. Quality Assurance is a critical function in the pharmaceutical industry providing support to the business through partnership with key business stakeholders, process improvement, and more. In this role, the...

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...

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...

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...

Purpose Manages Quality Engineers and Quality Trainer engaged in activities to support Product Surveillance for Medical Devices and Combination products. The Global Compliance Manager is responsible for the management and coordination of a team of Quality Engineers and Quality Trainer. Manages project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates in maintaining quality system documentation including but not limited to Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and...

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...

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...

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...

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...

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...

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. Our Global Regulatory Team is involved in developing regulatory product strategies for the therapeutic area, leading regulatory efforts in the development stage and post marketing of drug products. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of...

The Principal Compliance Audit Specialist – Software and Product Cybersecurity position focuses on auditing regulated medical device software, product cybersecurity, and risk management. We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers. Responsibilities may include the following and other duties may be assigned. Must have experience, subject matter expertise (SME), and technical knowledge working with regulated medical device software and product cybersecurity requirements. Remain informed on Regulatory requirements for...

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...

The Principal Regulatory Affairs Specialist (Prin. RAS) is responsible for developing regulatory strategy, preparing US and EU submissions and obtaining approval to introduce and maintain Medtronic Diabetes products and therapies to US and EU markets. This role focuses on drug delivery hardware based devices and software products within the Medtronic Diabetes Group. In this role, you will have primary RA responsibility for multiple Class II and Class III products in the US and EU, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence. Position is 100% remote. Ability to...

Use Your Power for Purpose At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our life-saving treatments reach those in need, ultimately contributing to the betterment of global health. In this role, you will Provide strategic product direction and interact with regulatory agencies...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. This role is responsible for developing and maintaining quality systems and/or key process(es) pertaining to Risk Management while providing quality engineering support within new product development, manufacturing, system/services support and/or post market support. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element. Interprets regulations and requirements to...

Are you looking for a patient-oriented, innovation-driven role that inspires you and promotes your career? Then take your future in your hands and become part of our team as a Senior Manager Clinical Program Quality You will oversee quality assurance for global clinical research across multiple business units, focusing on continuous inspection readiness. This role acts as a strategic quality advisor, partnering with clinical teams and stakeholders to guide risk-based decisions in research quality. How you will contribute Provide expert GCP compliance guidance, training, and recommendations to program teams and leadership. Develop, implement, and manage risk-based audit strategies and conduct...

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca , we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet...

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

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented...

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, Global Regulatory Affairs, Global...

The Senior Quality Systems Manager drives the evolution of Medtronic’s product development processes to set new industry-leading standards serving as a domain expert in Design Control. Lead our team by coaching internal customers across our diverse product portfolio, to elevate Design Control capabilities throughout the organization. In this role, you will proactively identify and implement large-scale initiatives that enhance rigor, productivity and user experience by leveraging cutting-edge technologies and innovative methodologies. This is an on-site position that requires candidates to work in the Mounds View, MN, Lafayette, CO, Boston, MA, Memphis, TN, or Santa Rosa, CA office 4-days per week...

The Medtronic Structural Heart & Aortic Operating Unit focuses on developing innovative, minimally invasive therapies for treating structural heart diseases, including conditions affecting the heart’s valves and chambers. We are pioneering technologies such as transcatheter aortic and mitral valve replacement, as well as repair solutions that help restore proper heart function and improve patient outcomes. By combining advanced engineering with deep clinical expertise, the Structural Heart team aims to address unmet clinical needs and enhance quality of life for patients worldwide. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do....

Purpose Serves as the lead for the evaluation, implementation, and continuous improvement of laboratory technologies, workflows, and systems supporting New Product Introductions (NPIs), existing product enhancements, and lab transformation initiatives. Serves as the key liaison between QC laboratories, IT, and global functional stakeholders to drive high-impact projects. Provides subject matter expert guidance on test method validation and transfer, lab efficiency, safety, and compliance strategies while mentoring peers and championing innovation across laboratory operations. Responsibilities Leads planning and execution of New Product Introductions (NPIs) within the QC laboratories including evaluation of test methods, instrumentation, lab readiness, and training strategies. Primary point...

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...

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

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

As a Quality Engineer II, where you'll play a pivotal role in driving quality excellence and continuous improvement. Reporting to the Post-Market Quality Manager, you'll lead trend analysis of complaints and quality data, conduct Product hold, field action activities, and manage quality improvement projects. Based in Colorado, this position offers the opportunity to work in a dynamic, innovative-driven environment where your analytical skills will directly impact product quality and patient safety. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials...

The Sr. Quality Systems Supervisor is responsible for leading and overseeing the implementation, maintenance, and continual improvement of quality systems within the organization. This role ensures that all processes comply with regulatory, corporate, and customer requirements, and supports business objectives related to quality assurance. Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or...

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

This role is part of National Contract Operations and Supply Chain (NCOSC), which delivers end-to-end services that enable affordable patient access, deliver insightful customer experiences, and support enriching employee experiences across IAM Contract Management, Service Agreement, Account Management, and Channel Strategy lifecycles. The Integrated Account Management (IAM) team holds direct account and contract responsibility across the U.S. health care system — including pharmacy benefit managers (PBMs), health plans, state Medicaid agencies, pharmacies/wholesalers, and infusion companies — for our Company's commercial and government business. Our success depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. We...

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

Provides leadership & strategy for a group of IT professionals supporting a major organizational unit responsible for the definition, development, implementation, operation and support of computer-based systems and related processes and tools which provide information for reporting, operations, and decision making for the Quality Non-Complaints, LMS (Learning Management), DMS (Document Management), and Global Engineering Systems (GES) within the Quality-Regulatory-Engineering Services BSS Organization. What You'll Work On Creates and manages Corporate Quality Non-Complaints, LMS, DMS & GES Strategies and Architectural Framework in partnership with Divisional BRM’s Aligns department priorities appropriately, determines critical success factors, evaluates and pursues initiatives, investments and opportunities...

Senior Quality Professional Validation At Molecular Diagnostics, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. Position Senior Quality Professional – Validation Location Molecular Diagnostics Business Unit, Des Plaines, Illinois The Senior Quality Professional – Validation is responsible for ensuring compliance with applicable Corporate and Divisional policies and procedures. This role manages all validation activities, including protocol development, document review, controlled document storage, and resolution of problem reports....

Senior Quality Technician This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. The Senior Quality Technician is responsible for inspection and for ensuring all product specifications are met to comply with regulatory IDEV standards. What You’ll Work On Perform routine and First Article mechanical and visual inspections of procured materials, manufactured product, tooling and/or processes per IDEV documentation (drawings, specifications, procedures, workmanship standards and...

Director - Global Quality Auditing and Supplier Management The Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program Responsibilities Perform comprehensive and detailed GMP compliance audits of animal health sites, contractors, business partners, and suppliers, requiring approximately 50% worldwide travel. Develop and maintain Technical Quality Agreements. Design and build Business Continuity Process and Quality Risk Assessment Module in Reliance. Implement standard Supplier Qualification process across sites. Implement efficiency and productivity improvements in the Supplier Audit Program,...

Johnson & Johnson Neurovascular is recruiting for a Sr Design Quality Engineer, Life Cycle Management in Irvine, California. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The position provides quality technical and compliance expertise as part of teams tasked with modifying existing designs, supplier changes, internal manufacturing support, and other lifecycle management activities. The use of engineering and supply chain knowledge to assist in the execution of cross-functional projects in...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Senio r Quality A uditor is responsible for planning, executing, and reporting on internal and external audits to ensure compliance with applicable GxP regulations (GMP, GLP, GCP), internal procedures, and industry standards. This role supports the continuous improvement...

At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. The Wilmington Biotech Campus will play a pivotal role in the manufacture of our company's biologics-based medicines, including in the area of immuno-oncology. This site will establish our company's internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029. This facility will be a significant supplier of Antibody Drug Conjugates and High Potent Compounds and will also be 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. Organization Overview For 140 years, Lilly has manufactured medicines that improve...

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

Are you passionate about ensuring the highest standards of quality in a dynamic and innovative environment? Join our team in Tempe, AZ, as a Controlled Environment Area Quality Assurance Technician! In this critical role, you’ll leverage your expertise in electronic, mechanical, electromechanical, and optical systems to construct, troubleshoot, calibrate, and maintain complex equipment and components. Working from schematics, engineering drawings, and instructions, you will perform essential calibration, alignment, and testing activities—ensuring our processes and products meet rigorous industry standards. We’re looking for a detail-oriented professional with hands-on experience in controlled environments, who thrives in multidisciplinary teams and is committed to...

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

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 Software Reliability Engineering Program Manager - Quality Core Team Member 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...

Are you passionate about ensuring the highest standards of quality in products that save and improve lives? Medtronic is seeking a Quality Engineer II to join our dedicated team at our Rice Creek, Minnesota facility , where we design and manufacture Rice Creek Combination devices that make a direct impact on patients worldwide. At our Rice Creek site, you’ll find a collaborative, mission-driven culture where quality and innovation go hand-in-hand . You’ll work alongside talented engineering and manufacturing professionals, applying your expertise to uphold rigorous quality standards while advancing life-saving cardiovascular technology. This role is 100% onsite at our Rice...

Quality Assurance Senior Manager What you will do In our mission to serve patients, speed is absolutely critical. We’re rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team – working toward our mission of advancing high potential programs for cancer patients around the world. The position serves as the Quality Alliance Lead and the primary Amgen Quality point of contact for coordination interactions with Amgen business partners. This position will also support Portfolio Strategy Quality responsibilities. Responsibilities include Responsible for leadership and coordination of...

About the Role Responsible for coordination (pick-up, receipt, aliquot, distribution and shipping) of in-coming bulk, intermediate, final containers, final package, stability and validation samples. Perform data entry and data collection. Perform daily lab support activities (e.g. material, supply and chemical inventory and replenishment, kitting, glassware washing, autoclaving, depyrogenation of labware, biohazardous waste removal and QC Documentation Control) to ensure availability of samples, materials and documentation for QC Labs to meet operational testing turnaround times using Lean Principles. Review and revise documents as needed. Emphasis on continuous improvement and cost effectiveness in daily activities. Participate and/or drive completion of responsible tasks...

At Reporting to the Associate Vice President, Clinical and Development Digital Solutions (CDDS IT), the Executive Director, Digital Regulatory and Safety, will lead our efforts in transforming regulatory submissions and pharmacovigilance through modern platforms and responsible generative AI. Primary Responsibilities Develop and promote a multiyear product strategy for Digital Regulatory & Safety, aligning with IT and Research and Development (R&D) priorities, including prioritized roadmaps and investment cases to deliver enterprise value, focusing on innovation, risk, regulatory compliance, and scalability. Act as a senior technology business partner to various stakeholders, translating strategic needs into product investments. Define and drive adoption...

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a QC CRS Analyst at the Malvern facility. 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 Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi has been one of the leaders in the vaccine industry for more than 100 years and a globally recognized partner in the prevention of infectious diseases. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is the reference site...

This is an onsite position, Monday through Friday, with occasional weekend and off-shift support required About This Role We are seeking a highly experienced and motivated QC EM/UM and Contamination Control Specialist to oversee the Environmental and Utilities Monitoring and Contamination Control Strategy programs at our state-of-the-art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, supporting regulatory compliance, and driving improvement in contamination control strategies. What You’ll Do Lead cross functional initiatives across low bioburden drug substance manufacturing areas, including cleanroom qualification, environmental and utilities monitoring, and personnel...

Do you have expertise in, and passion for, Regulatory Affairs ? Would you like to apply your expertise and channel the scientific capabilities in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person....

Senior Corporate Counsel, Quality Law Position summary The Senior Corporate Counsel role will have the opportunity to join the dynamic Global Manufacturing, Supply and Corporate Transactions Law team at BMS. In part, the team provides critical support and partnership to the Company’s Global Product Supply & Development organization, helping to deliver on our mission to serve patients in need. The team provides comprehensive legal support for the Company’s manufacturing operations, supply chain, import/export, customs and trade, facilities and engineering, product development, EHS and Occupational Health matters, and Quality. The Senior Corporate Counsel will support the Global Quality organization. Primary...

Your skills could be critical in helping our teams accelerate progress. Our Global Regulatory Team is involved in developing regulatory product strategies for the therapeutic area, leading regulatory efforts in the development stage and post marketing of drug products. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions. The Regulatory strategist...

Your skills could be critical in helping our teams accelerate progress. Our Global Regulatory Team is involved in developing regulatory product strategies for the therapeutic area, leading regulatory efforts in the development stage and post marketing of drug products. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions. The Regulatory strategist...

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...

As a Validation Lead/Validation Engineer at Recursion, you will be at the forefront of ensuring the overall quality performance and compliance throughout the organization by defining, implementing, and maintaining a risk-based computer system validation and assurance program (CSV/CSA). Your role will directly support Recursion's mission to decode biology by enabling cutting-edge research and innovation through reliable IT services. From ensuring operational excellence in systems performance to driving proactive solutions for security and compliance, you’ll play a key role in empowering teams across the company to achieve their goals. Please note This is a 6-month contract role. In this role, you...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. This is a people leader role within the QA Packaging and Labeling team in Gilead's External Quality Operations department. The ideal candidate will have established people leader experience and some packaging/labeling experience. This is an onsite position based at our headquarters in Foster City, CA. Knowledge D emonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards. Demonstrates excellent verbal, written and interpersonal communication skills. Experience as an effective people leader,...

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...

Johnson and Johnson is recruiting for a(n) Manager Facilities Management (FM) Calibration Compliance . The role can be located within US, Puerto Rico or Europe . 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 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...

Johnson & Johnson is currently recruiting Director External Quality Operations & OpEx ! This position can be performed globally at any J&J location with a preference for Horsham, PA, Titusville or Raritan, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) North America- Requisition #R-039897 Beerse Belgium– Requisition #R-R-042470 Remember, whether you apply to one or all of these...

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson is recruiting for a Manager, RA Submissions . The position can be located in Springhouse, PA, Titusville, NJ or Raritan, NJ. The position will manage Clinical Trial Applications as a member of the Next Generation Submissions (NGS) organization. Key...

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 Description The Quality Management System Deviation Lead provides strategic oversight...

We partner with the business to ensure we maintain our company’s values and high ethical standards, comply with the law, protect our people, and enhance our reputation. We strive to foster an environment that is inspiring, supportive, and diverse. As a key member of the Human Health (HH) Ethics and Compliance Leadership Team, the Executive Director serves as a trusted partner and active participant in the strategic and tactical business decisions of the Sales and Marketing organizations for various business units, as well as several enterprise support teams, and is tasked with understanding the legal and practical implications of the...

Takeda is committed to innovation, efficiency, and continuous improvement. We believe in empowering our team members with the tools, skills, and resources they need to excel. As part of our Global Regulatory Affairs (GRA) Operations team, you will collaborate with stakeholders across Research & Development departments to deliver projects that drive meaningful results for both our personnel and our patients. Embark on a transformative journey where your curiosity meets innovation, and your ambition catalyzes organizational growth. As the business landscape continues to evolve, the ability to adapt and enhance processes through intelligent technology becomes paramount. We are searching for forward-thinking...

The Global Regulatory Affairs, Chemistry, Manufacturing, and Controls (GRA CMC) team resides within Takeda’s R&D organization. We are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing our R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. In an ever-changing and increasingly complex regulatory environment, we partner to develop and execute innovative CMC regulatory strategies to provide high-quality medicines and technologies to patients throughout the product lifecycle. This internship will allow the intern to learn about various...

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

Employer Vertex Pharmaceuticals Incorporated JOB TITLE Operational Area Quality Manager LOCATION 50 Northern Ave., Boston, Massachusetts, 02210 OPENINGS 1 DUTIES Responsible for generating performance metrics and identifying trends. Provide QA support of change controls, investigations, CAPA’s and effectiveness checks. Lead meetings as necessary and collaborate with customer groups to ensure quality systems are monitored and established metrics are met. Participates in compliance walkthroughs of the site and help to drive the closure of any observations. Responsible for identifying risks and communicating gaps for process/systems. Participate in continuous improvement of department processes and ensure the team continues to...

Sr. Manager, Regulatory Information Management About This Role Are you passionate about regulatory systems and business process excellence? As the RIM Senior Manager, you’ll be at the heart of our global Regulatory Information Management team. You’ll partner with business process owners and IT to ensure our RIM systems are accurately evaluated, documented, and maintained in a compliant state. This role is pivotal in enabling seamless business systems operations, supporting global users daily, and driving the success of our regulatory ecosystem. You’ll report to senior leadership and play a key role in shaping the future of regulatory information management within our...

About the role As a Quality Control Analyst, you will execute and review routine in-process, drug substance, and stability test methods. You will maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal) and conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. You will own and author quality system events (i.e., laboratory investigations, deviations, CAPA's and change controls). How you will contribute Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and...

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

As a Senior Quality Systems Specialist , you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters. As a Senior Quality Systems Specialist, you will Lead and support Quality System processes , such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control. Serve as a subject matter expert (SME) for one or more Quality System elements in compliance with FDA...

Johnson & Johnson is hiring for a Supplier Quality Engineer II – Shockwave Medica l to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at...

You will oversee and manage initiatives within the IVD Regulatory Center of Excellence (COE), supporting oncology regulatory strategy programs across the drug development lifecycle. You’ll collaborate with cross-functional teams and external partners to drive high-quality IVD co-development program timelines, dashboards, and tools, enabling accurate reporting and decision-making. Your expertise will help resolve project issues, guide operational teams, and facilitate agreements across the enterprise. How You Will Contribute Oversee a global portfolio of IVD regulatory projects, ensuring timely initiation and execution of cross-functional study start-up activities. Plan and schedule project timelines and milestones using appropriate tools prior to study start-up. Forecast...

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 Third-Party Quality team delivers strategic leadership and comprehensive oversight for Third Party Quality compliance across the MA BioCampus. Our focus is on ensuring excellence in quality standards and regulatory adherence in all external partnerships. The Third-Party Management Specialist is responsible for overseeing Third Party Quality for the MA BioCampus. This role is crucial in maintaining high-quality standards and ensuring compliance in our relationships with external partners. About Sanofi We’re an...

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...

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

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including antibody-drug conjugates (ADCs), complex biologics and small molecules. Our goal is to accelerate access...

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure (HF) division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in heart failure, allowing people to restore their health and get on with their lives. We are recruiting for a Program Manager- Global Quality to join our Heart Failure (HF) Quality Assurance Team working out of our locations in Pleasanton, CA, Burlington, MA, Atlanta, GA, or Orlando, FL. This is a high growth business division working on Mechanical Circulatory Support and Pulmonary Pressure Measurement Systems. You will be responsible...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation...

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...

The Regulatory Data Governance Lead will ensure Regulatory information and data standards are aligned with Takeda’s strategic business requirements — including Master Data Management (MDM), Regulatory strategy, Industry standards, and evolving Health Authority (HA) expectations. In addition to supporting ongoing governance and data quality initiatives, this role will play a critical coordination role in Mergers & Acquisitions (M&A) activities , ensuring that data from acquired entities, products, and systems are properly assessed, migrated, and governed within Takeda’s Regulatory Information Management (RIM) ecosystem. The ideal candidate is a strong collaborator with an analytical mindset, experienced in metadata and data catalog management,...

About the role The Associate Director, Clinical and Safety Quality 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...

Compliance Senior Manager, U.S. Rare Disease What you will do Let’s do this! Let’s change the world! The Senior Manager, Rare Disease Compliance, will serve as one of the compliance business partners for the Amgen Rare Disease Business Unit (RDBU), serving on a team that works closely with that organization’s leadership to uphold the reputation of Amgen and drive ethical solutions for the patients it serves. As a member of Amgen’s Worldwide Compliance & Business Ethics organization, the Senior Manager, Rare Disease Compliance, will work with various cross-functional organizations including Law, Regulatory, and Privacy to appropriately advise the business on...

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

The Senior Quality Specialist ensures product/process quality system adherence and batch record review, completes quality checks and SAP transactions required to release product. The role performs process document audits for accuracy and completeness and works in a team environment to ensure timely review and documentation is Right First Time. The successful candidate provides support to include oversight for adherence to cGMPs and is knowledgeable in federal and other regulatory agency requirements and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance and will train on and gain competency in activities to ensure quality and compliance...

This position works out of our Plymouth, MN location in the Electrophysiology Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. The Supplier Quality Engineer I role will provide engineering support for receiving inspection processes and material non-conformances. Drives improvement and corrective action in the quality of components sourced from outside suppliers to eliminate recurrence of non-conformances. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Maintains incoming...

This position works out of our Plymouth, MN location in the Electrophysiology Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. The Supplier Quality Engineer II role will drive improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers...

Quality Systems Analyst II The Quality Systems Analyst II will be responsible for supporting trend escalations, ensuring that potential product or process issues are thoroughly assessed and effectively managed. This includes applying structured root cause analysis (RCA) methodologies such as 5 Whys, Fishbone diagrams, and 6M frameworks to identify underlying drivers, validate findings, and reach well-supported conclusions for investigations. 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 Support complaint investigation activities related to glucose meters, ensuring compliance with procedures...

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

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. Our team is involved in developing regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage of drug products. The Regulatory Strategist provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering...

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...

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

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead. Represents and...

The Senior Director of Cell Therapy Quality Automation Services will report to the Executive Director of Cell Therapy Global Product Quality and serve as a key leader within the GCTQ Organization. This role will lead a global team of quality professionals focused on ensuring the highest standards of cGMP compliance, product quality, and regulatory readiness as BMS automates Cell Therapy manufacturing, testing and release. The Senior Director will play an integral role in supporting the implementation of advanced manufacturing, testing and quality systems platforms—including the Automated Manufacturing System (AMS), Automated Quality Control (AQC) system, Gene Delivery Manufacturing/Testing, Quality Management Systems...

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

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

Purpose The Associate Director, Compliance is a key leader in the Risk & Compliance team responsible for strategically developing and implementing procurement policy and requirements. This role oversees procurement compliance, leading the deployment of changes in policy and requirements and collaborating with cross-functional teams to adapt policy. The role leads Compliance Managers, sets clear objectives, and cultivates a team environment that values strategic thinking innovative problem-solving, and AI-enabled compliance policy management. Responsibilities Develop and implement a risk-based compliance model integrating AI-driven monitoring and analytics along with procurement policy and requirements, to align with organizational objectives and industry best practices to...

The Senior Director, Regulatory CMC will lead and evolve Apellis’s global Chemistry, Manufacturing, and Controls (CMC) and Regulatory Device strategies to support the company’s innovative therapeutic pipeline and marketed products. This position is responsible for developing, executing, and maintaining high-impact CMC regulatory strategies across development and commercial stages, ensuring global compliance while driving innovation and operational efficiency.The role will oversee both Regulatory CMC and Regulatory Device functions, serving as a key cross-functional leader who leverages data-driven systems, AI-enabled document management, and digital regulatory tools to enhance submission quality, accelerate timelines, and ensure inspection readiness. The successful candidate will be 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...

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...

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...

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...

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 API External Manufacturing (API EM) supports the delivery...

Material Compliance Manager What you will do In this vital role you will manage the materials review process for assigned business units and/or products. The manager will represent material compliance in process discussions with sponsors and reviewers and maintains integrity of neutrality while managing needs of all MAC stakeholders. The manager contributes to Amgen’s compliance initiatives by ensuring that all required promotional materials have undergone MAC review. Responsibilities Leads new and ongoing MAC process improvement efforts Provides guidance and direction to MAC Cross Functional team members Anticipates process issues and provides solutions for special circumstance reviews due to product...

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. Bristol Myers Squibb is seeking a Manager, QC Sample Management at the Cell Therapy Facility (CTF) in Devens, MA. This role...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead. Represents...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative...

This position works out of our Lake Forest IL facility. What You’ll Work On The function of the Quality Program Manager is to provide leadership, oversight, and project management covering Abbott's Quality System. This includes division / business support and quality expertise and consulting activities. MAIN RESPONSIBILITIES Provide leadership and direction for furthering the development of the Abbott-wide Inspection Readiness Program. Act as a strategic partner for ensuring that our business locations are effective in the full life cycle of a third party inspection (preparation, execution, and response). Provide direction and consultation for third-party inspections including the identification and review...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a Director, Quality Site Lead located in Foster City, CA. Job Functions Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Strategic Gilead CXO partners/sites. Assure CXOs meet Gilead’s quality, regulatory and compliance standards, to ensure a sustainable delivery of quality products to patients. Key member of Business Review Meetings with CXO as Quality’s voice for the contract organizations’ oversight. Maybe member or backup member of Joint Steering Committee. Ensure contract...

This role will represent the business on cross functional teams delivering several projects in Gilead’s Commercial Manufacturing Organization. In this role, the individual will be responsible for ensuring initiatives and projects meet the core business requirements and impacted business processes are updated for internal manufacturing and serialization & traceability. These global business processes are applicable or used by internal sites, business functions, Commercial Manufacturing Organizations (CMOs), third party logistics (3PLs) providers, and alliance partners. Responsibilities Supports business analysis for changes and new initiatives within the commercial manufacturing organization for internal manufacturing and global serialization & traceability enterprise systems Responsible for...

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

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

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Responsibility for daily operation of laboratory including coordination of testing and data review to meet due dates. Participates in continuous improvements, lean activities, kaizens and other process improvement initiatives. Performs Quality sampling,...

A career at Medtronic is like no other. We’re purposeful, committed, and driven by our Mission; alleviate pain, restore health, and extend life. The Quality Technician III is a seasoned quality professional with experience in quality and operations. This individual will be responsible for working directly with supplier quality engineering and receiving inspection associates to investigate product issues, to perform containment on potentially nonconforming product, and to document results in technical reports. In addition, aligning product acceptance activities to the associated patient impact. This is a 2nd shift role at the MECC location in Brooklyn Center, MN. Preferred schedule would...

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

Do you have expertise in, and passion for Patient Safety in Oncology or Haemato-Oncology ? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into innovative life changing medicines? Then AstraZeneca might be the one for you! AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. W e a re more than one of the world’s leading pharmaceutical companies. Working with one of the broadest cell therapy...

Do you have expertise in, and passion for Patient Safety in Oncology ? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into innovative life changing medicines? Then AstraZeneca might be the one for you! AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. W e a re more than one of the world’s leading pharmaceutical companies. Working with one of the broadest cell therapy pipelines in...

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

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of...

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 ...

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

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

We anticipate the application window for this opening will close on - 30 Dec 2025 Position Sr. Regulatory Affairs Specialist for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for developing strategies for worldwide product registration with global regulatory agencies to introduce Wound Management devices to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, design/manufacturing change notifications, QMS audits, and Manufacturing site registrations. Provide Regulatory Affairs support for maintenance of Core Suture Portfolio including regulatory activities throughout the entire product lifecycle,...

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...

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

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our Team/Overview The GoGemba GMP Walkthrough Program team is responsible for ensuring compliance with Good Manufacturing Practices (GMP) across the organization through systematic walkthrough s. Our mission is to maintain high quality standards and drive continuous improvement in our manufacturing processes. We are an innovative global healthcare company with one...

Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. Assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. This position will support the Neuroscience therapeutic area. Responsibilities Responsible for a product(s) or products with multiple driver...

The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for BMS Jump site records management. Responsibilities include but are not limited to receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records. Key Responsibilities Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed. Assist with managing the Document Center Archive room Thorough Knowledge of Records Management, Scanning and organization functions Follow Policies, SOPs, and work instructions to support the document...

As a Senior IT Quality & Regulatory Assurance Manager , you will lead SQA for US-based programs (e.g., Digital, Complaint Management, Salesforce). As the Process Owner of the BTS Software Lifecycle, ensures the applicable regulatory requirements are incorporated, oversees the execution to those requirements, and monitors the effectivity with consideration to evolving technologies, platforms, and compliance. Partners with vendors to ensure reliable, compliant, and cost-effective SQA support is provided for operations and audit support, while scaling for programs and initiatives. Provides the US-based SQA leads with direction and resources to enable compliance and effective program delivery, support, and inspection readiness....

The USDA Compliance Subject Matter Expert (SME) – Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead. The responsibility of this position is across all Animal Health operating units; however, the position will focus on US Quality activities related to governance by the USDA. The role will require collaboration with manufacturing sites, contractors, and suppliers. Primary Responsibilities Provide Subject Mater Expertise to ensure our company’s manufacturing sites adhere to compliance standards established in 9CFR and enforced by USDA-APHIS-CVB Inspection and Compliance (IC), and Policy, Licensing and Evaluation (PEL). Develop and maintain global Quality Management 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 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. Organization Overview Verve Therapeutics, a wholly owned subsidiary of Eli Lilly...

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....

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory Lead (GRL) on Global...

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...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead will support our growing Oncology Portfolio. You will be accountable for management of all assigned programs/products as the internal expert on US Codes, guidance, and industry standards pertaining to prescription medicine promotion. How you will contribute Serve...

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

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 Associate Director - Quality Engineer Position Type Full-time Location...

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Senior Supplier Development Quality Engineer are responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Supplier Development Quality Engineers drive improvement and corrective action in the quality of components sourced from outside suppliers. This position contributes to the development, establishment and maintenance of...

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...

OBJECTIVES/PURPOSE Advance strategic quality leadership by embedding global standards across Clinical, Pharmacovigilance, and Medical Quality (CPMQ), ensuring regulatory alignment and operational excellence. Drive innovation and transformation through organizational planning, digitalization, and capability building—enhancing systems, analytics, and process efficiency across CPMQ and R&D. Strengthen quality oversight and risk management, leading compliance strategies, monitoring systems, and continuous improvement initiatives that mitigate systemic risks and foster resilience. Serve as a strategic partner and change agent, shaping clinical trial delivery transformations, guiding GCP strategy, and aligning quality initiatives with enterprise priorities and a culture of learning. ACCOUNTABILITIES Identify and lead innovative transformation initiatives across...

Location Lake County, IL (AbbVie Headquarters) and open to other AbbVie office locations in the US. Purpose Medical Device Safety Physician leads the safety oversight relevant to her/his assigned products to determine and advise the course of action necessary to meet the safety goals and objectives of specific products and projects. Works in close collaboration with cross-functional teams and counterparts in quality systems, regulatory affairs, medical writing, clinical development, clinical operations, manufacturing, epidemiology, marketing and other functional areas to identify, evaluate, and communicate safety issues. May contribute relevant clinical safety input to new product design teams as needed. The Medical...