Quality & Regulatory Jobs in Pharma & Biotech

Sr Manager Information Systems - Law and Compliance Technology What you will do In this vital role you will lead and manage multiple technology platforms that support the Law Department at Amgen. This includes Matter Management System, eBilling, Intellectual Property and Trademark Management System, Contract Lifecycle Management Systems and related systems that enable efficient, compliant and secure legal operations. This role will engage directly with business owners to manage the technical product vision and roadmap and lead the Agile Product Team to deliver scalable, user-centric solutions. You will collaborate with key customers to identify business needs, develop technology roadmaps,...

The Diabetes Group The Sr Program Manager - Development Process & Compliance will be responsible to lead/co-lead the Product Development processes encompassing design controls. Responsibilities may include the following and other duties may be assigned Leads or leverages cross functional teams to evaluate, develop and manage projects for existing product development processes and ongoing PDP lifecycle process management. Identifies and leads PDP improvement initiatives including stakeholder management, driving vision to implementation and training strategies. Oversees and manages the operational aspects of ongoing projects and serves as liaison to project teams to represent the PDP process. Manages the development and...

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....

As a Principal Regulatory Affairs Specialist at Medtronic, you will play a critical role in shaping the global regulatory strategy for innovative medical technologies. You will provide strategic input and technical guidance to ensure our products meet evolving domestic and international regulatory requirements. This high-impact role involves leading regulatory submissions, maintaining compliance, and driving collaboration across teams to support product development and lifecycle management. Your expertise will directly influence patient access to life-changing therapies worldwide. Key Responsibilities Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering global regulations. Lead or perform coordination and...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This position sits in the regulatory organization of Medtronic Diabetes and is charged with cross-functional collaboration to help build and advocate for innovative global clinical regulatory strategies for next generation diabetes devices, reimbursement, post-market surveillance activities, and expanding indications in the US, EU, and rest of world. These strategies will require a global mindset and critical thinking skills related to evolving global regulations. In...

At Medtronic, we are driven by our Mission to alleviate pain, restore health, and extend life for patients around the world. As a Regulatory Affairs Specialist, you will play a vital role in supporting ongoing product compliance by assessing changes to existing medical devices and ensuring all necessary regulatory actions are taken. This includes evaluating change impacts, preparing and submitting regulatory filings, and maintaining documentation in accordance with global regulatory requirements. You’ll be part of a collaborative, diverse, and innovative team that values integrity, inclusion, and a commitment to making a meaningful impact in healthcare. This role offers the opportunity...

We are looking for a detailed, organized, customer-focused Grants & Donations Compliance Specialist for Medtronic’s Cardiac Rhythm Management (CRM) business, the largest business within our Cardiac & Vascular Group (CVG). In this role, you will serve as the primary liaison among CRM business partners, health care organizations and societies, and the CRM Grants & Donations Committee. In addition, you will serve as a liaison with the CVG field organization regarding the grants and donations process. 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...

Johnson & Johnson, Vision Jacksonville, FL is recruiting for a Senior Software Validation Quality Engineer, Quality Operations, location in Jacksonville, FL. The Senior Software Quality Engineer is primarily responsible to manage the development & implementation of software validation policies and procedures. They will manage and conduct software validation projects in support of existing computerized systems in the Jacksonville campus. Project responsibilities will be focused on medium to large validation projects. This position may also oversee software qualification activities related to contract repackaging and contract manufacturing projects. Key Responsibilities Facilitates and leads software validation activities/projects with specific focus to manufacturing systems....

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

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. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was...

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...

Purpose The Quality Assurance Supervisor I is responsible for the organization, administration, and supervision of Quality Assurance employees within the manufacturing operations. Responsible for properly overseeing the day-to-day operations by prioritizing shop floor presence and receiving guidance and direction from more senior leaders. This includes delivering high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team. Ensures that appropriate controls are developed and maintained for new, intermediate and finished products. Responsible for GMP compliance, manufacturing quality, product...

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...

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...

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

Compliance & Ethics Senior Director (EG-160) Reports to Chief Compliance & Ethics Officer Location Princeton Pike, Lawrenceville, New Jersey, USA Team Size 4 Direct Reports The Senior Director, Compliance & Ethics Policy, Culture & Communication (EG-160) is a key leadership position responsible for advancing and sustaining the organization’s global compliance and ethics culture. This leader oversees compliance communications, the creation and governance of global-level corporate policies, and partners with the Global Learning team to develop and implement a comprehensive global Compliance & Ethics education strategy. The Senior Director manages a team of four professionals and closely collaborates with business...

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

The Regulatory Affairs Director (RAD) , Global Regulatory Strategy will be responsible for the development and implement ation of global regulatory strategies for all assigned products and therapeutic areas, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Program and/or Medicine Teams (GPTs/GMTs) deliverables . The individual will also ensure effective communication and constructive working relationships with business partners and representatives of...

This Compliance Specialist role is designed to support GSK's key investment initiative at the Marietta site (DP Project) by helping expand drug product capacity. The position plays an essential part in ensuring quality and compliance during the site's growth, driving change control, deviation investigations, and the implementation of corrective actions to maintain high standards throughout the expansion process. In addition, this role will not only lead and coordinate end-to-end (E2E) activities for the parts of project but will also provide support throughout the installation, qualification, validation, and Process Performance Qualification (PPQ) phases. The Compliance Specialist will help the team organize...

This position works out of our Abbott Vascular Plant in Barceloneta, Puerto Rico at the second shift Monday to Friday. The Supervisor Quality Control is responsible for the performance of the quality technicians and meeting daily production / operational / department demands. He/she will work with line supervisor, manufacturing engineer, quality engineer, and other team members, to address all opportunities found in the manufacturing lines and will the primary quality representative for the quarantine area. The individual performing this role will have to ensure proper management of resources while ensure quality and compliance of employees/equipment, promotion of safe and positive...

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

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

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

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. Your job, as QA Batch Release Lead within our Quality Assurance team, will be to lead and drive quality over the batch release process to market for the Swiftwater Site. This role provides leadership and direction for quality oversight of the vaccine drug product manufacturing. This leadership role collaborates with...

Job Responsibilities Supports management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental metric targets and maintenance of associated tracking tools/databases. Responsible for sending periodic reminder notifications to leads/coordinators. Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required. Supports the maintenance and improvement to quality systems processes, as needed Works directly with operating entities and internal clients to ensure follow-up of quality issues. Support Quality System Governance activities and participation in Governance boards as required. Independently conduct,...

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

OBJECTIVES/PURPOSE Reporting to the Head, Global Regulatory Information, Data & Systems, the Head of Regulatory Data & Systems Strategy will be responsible for leading the business systems owners, data governance, and data-related enhancements to support Takeda’s regulatory systems. The Head will be responsible for coordinating regulatory business systems, defining an innovative vision and roadmap, identifying areas for data and capability enhancement, and implementing such initiatives in partnership with R&D DD&T. Further, the Head will be expected to collaborate cross-functionality with business and technical stakeholders, drive partnership with Regulatory Business Operations to drive business prioritization and then work closely with Takeda’s...

OBJECTIVES/PURPOSE Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information, Data and Systems (GRIDS) is responsible for developing and implementing a comprehensive GRIDS strategy. This pivotal role ensures Takeda’s regulatory data integrity while driving the adoption and efficiency of Regulatory systems globally. This role involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the enterprise. Additionally, the role leads accurate and timely reporting for both common and ad hoc...

As the Director of Regulatory Affairs, you are a critical leader and the ultimate regulatory authority within the Acute Care & Monitoring (ACM) operating unit for the product portfolio within your scope. Your day is focused on setting strategic direction, managing a portfolio of high-impact devices, and delivering excellence through a world-class team. A significant part of your day is dedicated to mentorship and talent development, ensuring your team has the resources and guidance they need to excel. You will work closely with other leaders to align regulatory strategy with enterprise-wide goals, such as market expansion, product innovation, and M&A...

Biosense Webster , Inc., part of the Medical Devices sector within Johnson & Johnson , is recruiting for an intern for its Medical Devices Regulatory Affairs organization . At Johnson & Johnson , we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health...

This Principal Regulatory Affairs Specialist – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This Principal Regulatory Affairs Specialist position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market. What You’ll Work...

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021. We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in...

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...

About This Role As a Principal IT Analyst - Veeva Quality, you will play a critical role in designing, building , implementing, and maintaining Veeva Vault Training Learning Management System. Biogen is undergoing a business transformation with technology as a core enabler. Veeva Vault Training is a critical component of this transformation, and y ou will be the ultimate driver , leveraging your expertise to ensure high-quality service delivery, optimal system performance, and seamless user experiences. Acting as the IT System Owner for Veeva Vault Training , you will collaborate closely with cross-functional teams, including business analysts, technical architects, system...

#LI-Remote At Novartis, we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) - a powerful fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are seeking passionate, purpose-driven individuals to join our mission of delivering life-changing therapies to patients around the world. The RLT Quality Operations Lead US, is a senior leadership role accountable for the end-to-end quality operations across all US RLT manufacturing facilities. This position sets the operational model for US quality operations, ensures compliance to international cGMP standards, Novartis rules and applicable market regulatory requirements, drives inspection...

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Specialist Quality Control Support - Change Control and Deviations What you will do In this vital role, you...

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

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

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. Opportunity Overview Lilly is on the cusp of a transformative expansion,...

This position works out of our Santa Clara, CA location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. The Staff Component Supplier Quality Engineer drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers, acceptance criteria for materials and component qualification at the supplier. Provides technical support to drive supplier corrective action, manufacturing yield issues and field failures. Project focused, specifically on...

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...

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Manager, Regulatory Medical Writing to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business. The position may be in...

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 Associate Director of Validation is responsible for leading the validation function to ensure that manufacturing facilities, utilities, equipment, processes, and computerized systems comply with regulatory and company standards for pharmaceutical/radiopharmaceutical production. This role oversees validation activities from...

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

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...

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, Swiftwater, PA site is the vaccines division of Sanofi. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is located in northeast Pennsylvania and is home to the production of over 140 million doses of vaccine each year. The...

Johnson & Johnson Innovative Medicines is recruiting for the Director, Quality Assurance Operations– CAR-T Manufacturing. This position will be based in Raritan, NJ. At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina. Our mission...

Abiomed a member of the Johnson & Johnson Family of Companies, is currently seeking a highly skilled and motivated individual to join our team as a Manufacturing Quality Engineer! This position will be located in Danvers & Woburn, Massachusetts. In this role, you will have the unique opportunity to contribute to manufacturing life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts. Danver Abiomed manufacture Impella heart Pump. Woburn Abiomed produce Sensors and Optical bench which are used for Impella...

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

As a member of Supplier Quality Engineering at Medtronic Energy and Component Center (MECC), you will be responsible for partnering with Development Engineering and Sourcing to identify, develop, qualify and release to manufacturing cost effective components/materials for use in Medtronic Cardiac Rhythm Management, Neuromodulation, Pelvic Health, or Surgical Innovations product. In this area of new product development, the Senior Supplier Quality Engineer will be required to drive multiple aspects of component/material development and approval with suppliers as a member of a cross-functional team. Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart...

Lead the Future of Regulatory Strategy for Rare Diseases! Are you a strategic regulatory leader ready to shape the development and lifecycle of innovative therapies for rare and serious diseases? Do you thrive in fast-paced, high-impact environments where science, strategy, and global health intersect? At Alexion, AstraZeneca Rare Disease , we’re seeking a Director of Regulatory Affairs – Strategy & Execution to drive the regulatory vision and execution for our most complex and groundbreaking therapies. This is your chance to make an impact at the intersection of cutting-edge science and global health and help patients with urgent unmet medical needs...

Gilead Sciences is seeking a Head of Digital Quality dynamic, experienced, and visionary leader to serve as the Executive Director of Digital Quality. The incumbent will lead a team of over 30 highly technical digital and AI experts that will drive the digital future of Global Quality. This pivotal role is also responsible for shaping and executing the digital quality vision beyond Global Quality and will be an essential partner in the Gilead digital strategy, with strategic influence spanning Quality, IT, Regulatory, Clinical, and Product Development functions. The ideal candidate will bring deep expertise in GxP digital systems, regulatory compliance,...

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 designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and 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 who rely on our products. What You Will Achieve In this role,...

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. 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 Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters....

The Director, International Regulatory Affairs Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. The Director will design and deliver optimized global regulatory strategies, plans and dossiers that align with AbbVie’s overall business strategy. The Director is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds.The Director will interface with International Marketing, Global Legal and Office of Ethics and Compliance with regard...

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. Organization Overview At Lilly, we serve an extraordinary purpose. We make...

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

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are looking for the best talent in Enterprise Quality for 2026. We are seeking highly motivated and meticulous Sophomores, Juniors and rising Seniors for Spring Co-ops within the Enterprise Quality organization. We work on a “hybrid model”. This means that you will be asked to report on site three (3) times a week and can work remotely two (2) times a week. If...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Quality Assurance Auditor- Parenterals (Third Shift) to be located in Gurabo, PR. As the QA Auditor, you will be accountable for ensuring the compliance with material specifications, current Good Manufacturing Practices,...

Johnson & Johnson is currently recruiting for an Analyst Quality Assurance! This position will be located in Titusville, NJ. Quality Assurance supports stability site efforts to remain compliant with corporate and regulatory requirements. They are responsible for ensuring the Janssen US Stability sites maintain a state of inspection readiness through audits and by assuring compliance with regulatory and J&J requirements. Quality Assurance maintains a high level of quality knowledge with understanding of the quality and technical content of reports, investigations, and corrective and preventative actions that are documented by the group. Tasks/Duties/Responsibilities Quality & Compliance Maintains inspection readiness system...

Johnson and Johnson is recruiting a Senior Manager, ATSC External Quality located in Gaitherburg, Maryland. Key Responsibilities Provide quality leadership and technical support to ensure effective and compliant execution of quality systems at external manufacturing sites working in the CART space Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners Provide oversight for tech transfer and new product introduction activities in the CART space; lead PAI readiness activities, and support associated health authority filings and approvals Daily management and coordination of the EQ work team supporting the EM as needed Lead...

About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for...

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

About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for...

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. In this exciting role as a Quality Technician III supporting the Cardiac Ablation Solutions organization, you will have responsibility for the inspection and testing of returned products as part of the complaint handling process. The Technician will be capable of supporting...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product...

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

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

Quality Assurance Engineer III The Quality Assurance Engineer III will serve as the primary QA representative on new product design and on-market development / change teams. Build and maintain successful cross functional relationships with internal departments such as R&D Engineering, Operations, Quality and Regulatory Affairs. Provide support, as needed, to Clinical Material Release, Quality Control, and Calibration programs. 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 Monitor and report to upper management on design control related projects. a. Project...

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...

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 and dedicated colleagues while developing and expanding your career. The Executive Director, Chemistry, Manufacturing & Controls ( CMC) , Pre-approval Pharm will bring scientific and regulatory expertise, innovative approaches, and strong industry and FDA connections to our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and...

This opportunity is an exciting and challenging role that will be key to Gilead's success as we work towards bringing new combination products, such as pre-filled syringes and autoinjectors, to market. As the Manager, Quality Assurance , you will be a key Quality person supporting these new product lines in the commercial stage, starting with collaborating with the design and development team on Design Transfer. We are looking for a Quality professional to ensure that we have end-to-end Quality support of our combination products. Roles and Responsibilities Develop key relationships and interface extensively with internal stakeholders and contract manufacturers to...

Summary The Manager, CSV Cell Therapy supports the successful implementation and support of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses strong analytical skills to recognize and solve common problems of various degrees of complexity and scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. The Manager,...

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

The Specialist in the Global Quality Biological Critical Reagents (LM-BCR) group will be responsible for supporting the BCR programs. This position will potently perform hands-on laboratory work in biochemistry, virology, and/or cell biology techniques for biological critical reagents, such as antibodies and antiserum, using cell based assay, ELISA, SDS-PAGE; coordinate testing lab or quality control lab to qualify testing for the biological critical reagents, strong knowledge of immunology, biology, vaccine, and assay developentment, be able to have the ability to trouble shooting for testing assay. Under limited guidance, the incumbent will independently support the entire lifecycle of BCRs, from generation...

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 serve an extraordinary purpose. We make a difference...

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. U.S. Import Export Compliance (USIEC) – Enhancing Trade Compliance The USIEC...

Regulatory Affairs Specialist Our location in Columbus, OH or Abbott Park, IL currently has an opportunity for a Regulatory Affairs Specialist . WHAT YOU’LL DO Primary Function/Primary Goals/Objectives Provide support for the regulatory department to ensure efficient and compliant business processes and environment. Execute regulatory tasks and exercise influence generally at the middle management level. Maintain current registrations by preparing documentation required and submitting documentation on schedule as directed. Major Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs. Support maintenance of Regulatory Affairs quality system documentation Provide regulatory input to product lifecycle...

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. This...

We are seeking an experienced Senior Quality Engineer who will play a pivotal role in maturing Element’s Quality Management System (QMS) towards ISO 13485 compliance and provide quality engineering expertise on Element’s on-market products. This is an incredible opportunity for someone who is passionate about being a leader that can work with significant autonomy and independent judgement to achieve our Quality goals and lead continuous improvement projects with cross-functional teams. We are looking for candidates with a solid background in medical devices (Class I-II). Experience with developing strong working relationships with both internal and external customers to influence and enable...

R&D Quality is seeking an Associate Director, Vendor Quality Management (VQM) to join our high-performing team that supports Clinical Development, Pharmacovigilance & Medical Affairs programs at Gilead. In this role you will be responsible for providing quality advice, direction, and leadership for quality and compliance oversight of GxP vendors. You will partner closely with business functions in applying a risk-based approach to key vendor activities which include vendor risk assessments, qualification/requalification and issue escalation.You will work closely with external quality groups to ensure vendor commitments & services meet Gilead standards and comply with regulations. You will act as the Quality...

Sr Associate QA Plant Quality Assurance (PQA)- Night shift What you will do Let’s do this! Let’s change the world! In this vital role Amgen North Carolina (ANC) Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching,...

Quality Compliance Manager What you will do Let’s do this! Let’s change the world! We are hiring a Quality Compliance Manager, which will operate within the General Medicine & Obesity Quality Therapeutic Area. In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program. (protocol development, database lock, and regulatory submissions/ approvals). Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting...

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

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

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

In this exciting role as a Compliance Manager, you will have responsibility for leading the compliance audit program for the Medtronic Diabetes business. The Compliance Manager is responsible for managing the compliance audit program, for internal, external and supplier audits at the Diabetes sites. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash...

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

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. The Technician II will be responsible for daily manufacturing support to manage...

Your skills could be critical in helping our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and disease-related materials for assigned products. As the product expert, this individual helps to develop and implement regulatory strategies related to promotional and advertising campaigns for marketed products and development projects. Provides input into labeling strategies for investigational and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global healthcare company with one...

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

This position works out of our Plymouth, MN location in the EP 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 a Staff Quality Engineer, you'll have the chance to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or...

We are seeking an Associate/Director, Regulatory Operations and Intelligence who will play a critical role in supporting global regulatory submissions, overseeing submission processes, managing regulatory documentation and gathering regulatory intel to keep programs and organization updated with latest regulatory trends. Additionally, this role involves managing regulatory submission and publishing systems used in Regulatory Affairs. Collaborate with Regulatory Leads to support the development of submission/content plans (planning, reviewing, publishing, and timelines - e.g., pre-submissions, INDs/CTAs) to global regions (e.g., US, UK, EU). May contribute to the authoring of administrative submission documents. Perform critical reviews of documents for consistency and quality, identifying...

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...

Dallas Validation Supervisor This position works out of our Dallas, TX location in the Transfusion Medicine , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Dallas Validation Supervisor will provide direct supervision to 4-5 validation specialists and will oversee their day-to-day activities. The supervisor will monitor and evaluate employee performance and ensure that goals are met. The supervisor will also assign priorities and...

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

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. Diabetes The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly...

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do...

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Summary of the role The Quality Assurance Operations Specialist will be supporting QA Operations for Caribou’s CDMO cell therapy manufacturing...

Johnson & Johnson is hiring for a Sr. Supplier Quality Engineer – 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...

About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Manager Quality Systems, Site Data Integrity Lead is responsible for ownership and oversight of the Data Integrity (DI) Program...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited...

About the role Join Takeda as a Senior Manager, USBU Ethics & Compliance Learning & Engagement, where you'll champion ethical behavior and help mitigate risk through impactful learning, communications, and digital innovation. Reporting to the Ethics & Compliance (E&C) Learning & Engagement Head, US Business Unit (USBU), you'll collaborate across Global E&C teams and partner with business stakeholders to design engaging training, manage strategic communications, and lead key projects like SharePoint site development and training dashboards. This dynamic role blends creativity and technology—leveraging tools like Articulate 360, Vyond, and AI—to simplify processes and enhance compliance across the USBU organization. How...

Responsibilities may include the following and other duties may be assigned. Support review of advertising and promotional material to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved to support business needs. Act as SME for Neurovascular Ad Promo process, providing guidance to authors and reviewers on regulatory and internal policy requirements. Support the preparation of US and International promotional labeling material, including the creation of a claims matrix database and claims objects. Lead AI/ML adoption in content and claims management to support...

Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory guidance to cross-functional partners in support of various programs. What You’ll Work On Prepares robust regulatory applications to achieve departmental and organizational objectives. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise on complex worldwide strategies with the help of international regulatory affiliates. Compile,...

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our location in Irving, TX current has an opportunity for a Customs and Trade Compliance Manager . This individual will provide leadership and direction to ensure site compliance with all relevant customs regulations and trade laws and other US regulatory agency requirements. They will be responsibility for the development of a...

Quality Engineer 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 around...

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...

Careers That Change Lives In this exciting role as a Quality Technician III , you will have responsibility for supporting quality and sterility assurance related activities for sustaining manufacturing production and supporting new product introduction projects in compliance with regulations, standards, company policies and procedures . Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. Performs a variety...

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...

Johnson & Johnson is searching for the best talent for Senior Counsel, Regulatory Law, MedTech to join our Global Legal Organization located in New Brunswick, NJ or Washington, D.C. 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 This Senior Counsel position is for an attorney within the Global Regulatory Legal Team of the GLO. The responsibilities of this Senior Counsel involve providing strategic legal counsel on a wide range of regulatory and...

About the role Join Takeda as Senior Manager, Ethics & Compliance Operations, Oncology, where you will ensure ethical behavior, driving compliance and risk mitigation. You will oversee and execute day-to-day risk assessments, monitoring, training, and data analytics initiatives to identify and address potential compliance issues and ensure adherence to Takeda's policies and standard operating procedures. Your responsibilities will include developing Oncology Business Unit (OBU) specific monitoring protocols and processes, managing action plans from compliance risk assessments (CRA), preparing data-driven presentations, and collaborating with stakeholders to share actionable insights and drive meaningful results. You will lead operational components of the OBU...

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

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

This role is designated as the Business Process Owner for Issue Management, Risk Management, and Quality Plan processes. The Q&C organization now functions under a matrix model, allowing all roles to execute processes within the QMS framework. Key responsibilities include participation in Health Authority Inspections, oversight of the Issue Management Process—including execution and completion of corrective and preventive actions (CAPA)—as well as involvement in Knowledge Management, Continuous Improvement initiatives, Risk Management Plans, evaluation of Risk Acceptances, and management of O.P.S. Issues when necessary. Additionally, the position leads Communities of Practice for individuals outside O.P.S. who implement QMS procedures governed by...

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

Job Title Quality Manager This position works out of our Sylmar, CA location. This is an onsite role . Leads a global team overseeing Supplier Quality Engineering. Reports to the Director of Quality Systems for Abbott’s Cardiac Rhythm Management division. This position provides leadership and guidance for the supplier quality engineering department; responsible for developing goals, objectives, procedures, policies and systems that are in line with company goals and objectives, mission and vision and FDA/ISO regulations. Daily responsibilities include managing the resolution of supplier quality/process issues, ensuring a continuous supply of high quality components to production and supporting product...

Purpose Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting and resolution of PV audits. Ensuring alignment with RDQA policies and procedures wherever possible and leading the development and implementation of the AbbVie quality system. Leadership and oversight of key audit program (system, process or affiliate) level risk-based decision making to assure a comprehensive audit program. Provision of advice and support on PV and quality topics to business partners to ensure compliance with worldwide PV requirements and expectations. Responsibilities · Assures quality and compliance in a regulated environment that includes worldwide regulations, country specific...

#LI-Remote At Novartis, we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) - a powerful fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are seeking passionate, purpose-driven individuals to join our mission of delivering life-changing therapies to patients around the world. The Global Head of Quality Compliance RLT is the enterprise leader responsible for designing, governing, and continuously improving the quality compliance strategy for radioligand therapies (RLT) across manufacturing, testing, release, distribution, and post-market surveillance. This role ensures global adherence to GxP requirements (GCP, GMP, GLP, GDP), nuclear/radiation safety...

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...

Develop and execute strategies to oversee and improve all quality-related activities for Contract Manufacturers (CMs). Build and maintain a robust strategy for managing CMs, ensuring alignment with business objectives and quality standards. Collaborate with CMs to develop and maintain technical quality assurance systems such as MSAs, SPC, Quality Plans, and FMEAs. Support continuous improvement initiatives to enhance supplier quality processes globally. Lead Production Part Approval Process (PPAP) qualifications for CMs. Drive Supplier Optimization and Risk Reduction (SOAR) initiatives. Manage qualifications of changes, including process, material, or tooling changes, and oversee associated change control activities. Implement and monitor CM development initiatives...

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...

Engineering Director - Supplier Quality | Diabetes This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. This position will be located on-site...

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...

Director, Global Customs & Trade Compliance Location New Brunswick, NJ We are seeking a Director of Global Customs & Trade Compliance to lead our customs strategy and ensure adherence to international trade regulations. This leadership position is responsible for driving global alignment, optimizing duty savings, and managing compliance across all our operations. You'll work closely with regional teams to develop and implement effective trade strategies that support our global supply chain. Responsibilities Strategic Leadership Influence and execute the strategic direction for global customs compliance. Process Optimization Partner with Regional Compliance Leads to standardize and optimize global trade activities, policies, and...

Position Validation Engineer Location Devens, MA Key Responsibilities Responsible for implementing the design, implementation and maintenance of a robust validation lifecycle for process equipment, SIP/CIP processes, critical process equipment & utility systems, process automation systems and manufacturing execution system recipes, computer systems, and laboratory instrumentation. Implement validation philosophies and master plans required to drive the validation lifecycle of a fully automated biologics manufacturing facility. Responsibilities include oversight of validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from change controls, shutdown/changeover management related to validation, and management of the revalidation and cleaning monitoring programs....

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...

The Senior Manager role within Q uality Assurance & Governance (QAG) serves as a Research and Development Quality and Compliance ( RDQC ) representative providing expert auditing, inspection support and quality governance support to Biogen Research, Development and Medical (RD&M) stakeholders. The position directly supports the RD&M GxP Audit Program by contributing to planning, conduct, approval and close-out of audits, and supporting GxP /GVP audit strategy, risk assessment and annual audit planning using a risk-based approach for selection of internal and external audits. Additionally, they will have responsibility for implementing a culture of quality and compliance across RD&M, contributing to...

This position works out of our Atlanta,GA 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. As a Senior Quality Manager, the individual will play a crucial role within Abbott’s Heart Failure organization with primary focus to maintain overall Quality Management System compliance to internal policies, applicable standards and external regulatory requirements. What You’ll Work On The incumbent defines and develops strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications etc) to...

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

Position As a member of the Company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and for the Company's Research & Development division. For our Company Clinical Supply, act as the Quality Unit representative for information technology products such as infrastructure, business applications, laboratory instrument systems, manufacturing automation systems and data analysis packages. Endorse and build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness. Develop and maintain a subject matter expert level of understanding for the...

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

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. The Quality Control Technician position is available at our Animal Health facility in Elkhorn, Nebraska, located on the West end of Omaha. The Elkhorn facility is expanding operations to manufacture animal vaccines and biologics. Looking for talented individuals to join our Production teams using key technologies for cell...

Are you looking for an opportunity to lead and inspire Site Quality teams toward the pursuit of operational excellence in manufacturing practices while building a high-performance network? If so, this is the role for you. As Site Quality Lead Director , you will provide strategic leadership and direction for the site's Quality function, ensuring the highest standards of product quality and compliance with GSK corporate policies and regulatory standards. The role is accountable for the quality of all products released from the site and for representing GSK in health authority interactions. This role will provide YOU the opportunity to lead...

Our location in Temecula, CA, currently has an onsite opportunity for a Quality Engineer. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. What You’ll Work On Support project planning and perform assessments and mitigations with cross...

Summary We are seeking a highly skilled and motivated Senior Engineer – IT Computer System Validation (CSV) to join our team at the Devens Cell Therapy Facility (CTF). The Senior CSV Engineer will be responsible for managing the computerized system validation (CSV) activities for major projects to comply with regulatory requirements and industry standards. This role will be focused on development, execution, and maintenance of validation lifecycle documentation and helping support routine run the business operations related to computerized systems. This position work closely with the Digital Plant (IT/Automation) subject matter experts and other key stakeholders, such as Manufacturing Science...

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 and...

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

This position is onsite Monday – Friday, 2nd shift. 330pm - 1130pm Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. Performs a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance. Performs required inspections, checks, analysis and documentation of studies. Prepares and monitors...

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...

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

Sr. Quality Engineer Risk Management As a Sr. Quality Engineer – Risk Management , you will serve as a Subject Matter Expert (SME ) responsible for developing and maintaining quality systems, subsystems, and key processes related to Risk Management. You will also provide quality engineering support across new product development, manufacturing, and/or system and service support. What You’ll Work On Implement and maintain the effectiveness of the Risk Management Quality System element Interpret regulations and requirements to lead, coach, and mentor teams on Risk Management Serve as SME for domestic and international sites and affiliates regarding Risk Management Estimate...

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...

Purpose The Director of Global Compliance Audit leads the global compliance audit function, reporting to the VP of Internal Audit, who leads team of 43. This role provides global audit assurance services and, to a lesser extent, advisory services, primarily focusing on the various global aspects of pharmaceutical and health care compliance, supported largely by AbbVie’s Office of Ethics and Compliance (OEC). The Director and function assess AbbVie’s controls and processes supporting areas such as data privacy, interactions with health care providers, anti-bribery and anti-competition (e.g. FCPA), and adherence to industry regulations, such as transparency reporting. The Director and their...

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

We are looking for a motivated and strategic regulatory professional to join our growing regulatory team at Relay Tx. You will contribute to the development and execution of innovative regulatory strategies to support the advancement of our transformative pipeline. You will support the global regulatory lead to drive regulatory planning and execution for our development programs. You will collaborate with cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions. Your Role You will work closely with research and development colleagues to support the development and execution of innovative regulatory strategies for programs ranging...

This position works out of our Livermore, California 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 position provides regulatory compliance leadership for the business, ensuring the policies, procedures, and practices of the business remain compliant to regulatory and contract requirements. What You’ll Work On Directly manages team responsible for following CMS enrollment, Medicaid enrollment, state licenses, Joint Commission accreditation, payor contract review, and quality systems Develops and participates in setting compliance strategies and...

The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Continuously expands TA knowledge in obesity and ensures strategic messaging and content of global regulatory dossiers. Proactively anticipates and mitigates regulatory risks. Ensures compliance with Global regulatory requirements. Manages compounds in the obesity TA through all phases of development, including post approval and through the...

Envision 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’s Co-Ops. The Quality Assurance Validation department is responsible for plant validation including validated system (Equipment/Process), risk/design and change control compliance. Our team ensures alignment with Global Quality Systems for validation and related functions, e.g. engineering, risk management. Key Responsibilities Include The Validation Engineering position will support the planning and execution of tasks reporting into the QA Validation department. This role will support various areas of manufacturing and/or Quality Control (QC)...

Envision 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’s Co-Ops. The Quality Assurance Validation department is responsible for plant validation including validated system (Equipment/Process), risk/design and change control compliance. Our team ensures alignment with Global Quality Systems for validation and related functions, e.g. engineering, risk management. Key Responsibilities Include The Validation Engineering position will support the planning and execution of tasks reporting into the QA Validation department. This role will support various areas of manufacturing and/or Quality Control (QC)...

The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain market approval for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Continuously expands TA knowledge in obesity and ensures strategic messaging and content of global regulatory dossiers. Proactively anticipates and mitigates regulatory risks. Ensures compliance with Global regulatory requirements. Manages compounds in the obesity TA through all phases of development, including post approval and through the...

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. We are looking for a "quality always" minded team member who...

Job Title Quality Tech II This position works out of our Minnetonka, MN location. This is an onsite role . This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. What You’ll Work On Perform inspection of production operations, including documenting inspection and audit results. Perform final product inspections against specification and procedural requirements. Document...

Johnson & Johnson is currently seeking a Supplier Quality Engineer Co-op to join our Supply Chain Quality Team located in Danvers. 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 . Requirements Are...

Johnson & Johnson is currently seeking a Quality Inspection Engineer Co-Op to join our Quality Team located in Danvers, MA . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at . REQUIREMENTS Data...

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research and Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution team is seeking a summer intern. The intern will be a fully-functioning member of the team and will be assigned to lead a variety of process improvement projects within Global Regulatory Affairs and Clinical Safety in support of business development...

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

GCP Quality Compliance Manager What you will do Let’s do this! Let’s change the world! In this vital role you will provide critical support to the Process Quality function by assisting in the implementation, monitoring, and continuous improvement of Amgen’s R&D Quality Management System (QMS) and Regional Quality Oversight. Accountabilities Assist in maintaining and improving the QMS by helping to track, document, and implement quality initiatives, ensuring that procedures and processes meet regulatory requirements. Contribute to the collection, analysis, and reporting of quality metrics (KPIs, KQIs), helping to identify trends, risks, and areas for continuous improvement. Provide hands-on support to...

Act as the key point of ethics and compliance support for relevant Gilead Commercial. Partner with leaders across Legal, Commercial, Medical, Clinical Development to build and integrate the compliance program into the US Gilead organization. Knowledge and experience in practices related to interactions between commercial, medical affairs and market access. Invest time and effort in building strong relationships with relevant stakeholders. Act as a trusted advisor and cultivate a collaborative enviro. based on mutual respect and understanding Approach challenges with a problem-solving mindset Respond promptly to inquiries, requests, or concerns raised by business stakeholders. Demonstrate a sense of urgency in...