Quality & Regulatory Jobs in Pharma & Biotech

About the Role Takeda is seeking an experienced Associate Director, Head of IMP Quality to lead quality operations for investigational medicinal products (IMPs) from clinical development through to commercialization. This role provides strategic, industry-leading oversight of Takeda’s quality processes, ensuring compliance with global regulations, cGMP standards, and corporate policies. As the head of a highly skilled team, you will define quality standards, oversee audits, manage deviations, and lead process improvement initiatives. You will play a key role in supporting Takeda’s mission to deliver high-quality, safe, and effective therapies to patients worldwide. How You Will Contribute Provide strategic leadership and oversight...

About the Role We are seeking a highly skilled Senior Manager to join our dynamic team supporting biologics regulatory submissions. In this role, you will serve as the lead author for key Module 3 Common Technical Document (CTD) sections. You will apply your analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory submissions. You will be an integral member of cross-functional teams, collaborating closely with Quality Control, Quality Assurance, Regulatory, Analytical Research and Development, and Chemistry, Manufacturing and Controls (CMC) colleagues to deliver submissions to support commercial approval. The ideal candidate will have extensive analytical...

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...

USE YOUR POWER FOR PURPOSE Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients. The Quality Compliance Engineer supports the Quality Organization by ensuring compliance with applicable regulatory requirements, company quality systems, and current Good Manufacturing Practices (cGMP). This role plays a key part in driving continuous improvement initiatives, leading quality‑related projects, and partnering cross‑functionally to strengthen compliance, efficiency, and inspection...

Use Your Power for Purpose Our dedicated manufacturing logistics and supply team ensures that customers and patients receive the essential medicines they require precisely when they need them. By embracing challenges, envisioning new possibilities, and taking decisive action, you will contribute to delivering medicines to the world with greater speed and efficiency. What You Will Achieve In this role, you will Plan and manage the efficient flow of products and services through the Pfizer supply chain cycle, ensuring compliance with in-country and international regulations. Ensure efficient operations by maintaining proper system interfaces between Pfizer and other required parties, monitoring the...

Job Title Sr. Engineer Supplier Quality We are seeking a high caliber Senior Engineer Supplier Quality. This position works out of our Temecula, CA location in the AVD Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. The Senior Engineer Supplier Quality drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers for...

This is not a remote opportunity Traveling up to 5 % What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Manage import/export process and develop effective internal controls to ensure site compliance with corporate and regulatory requirements. Provide leadership and direction to ensure site compliance with all relevant customs regulations and trade laws and other US regulatory agency requirements. Develop a staff of experts in the import/export compliance field that will serve the current and future demands of the supply chain operation. Act as subject matter expert and advisor regarding compliant importation and/or exportation...

Job Title Quality Assurance Tech I We are seeking a QA Tech I for our Temecula, CA location for our Vascular division. This role is fully onsite. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. What You’ll Work On Provides technical assistance to engineering to support complaint investigation efforts by performing manufacturing record reviews and root cause analysis. Assists engineers in developing methods and procedures to control or improve complaint investigation processes. Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional policies and procedures. Assists engineering by performing root cause analysis...

The Professional Education Compliance Lead is based out of Austin, TX position within the Cardiac Rhythm Management Division. This is a fully onsite role. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. The Professional Education Compliance Lead is responsible for overseeing all compliance aspects of professional education programs involving physician engagement and payment. This role ensures adherence to U.S. and global regulatory requirements and internal policies, and serves as a key partner to the Office of Ethics and Compliance, Legal, Finance,...

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - This position will be located in Raritan, NJ! The role will operate under the following shift Wednesday- Saturday 2pm-12am. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech

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

The Senior Manager of Global Trade Compliance (GTC) – Technical Compliance will support Vertex commercial, clinical, research supply chains by ensuring the uninterrupted, compliant and efficient movement of product across Vertex’s global drug supply, clinical and research network. This individual has a global remit for building and maintaining the detailed technical compliance processes and governance needed to support the trade operations managers, and for assisting in solving detailed operational questions as needed. Areas of focus will include customs valuation and export controls but will also be responsible for product classification (HTS, ECCN & PGA), country of origin (non-preferential & preferential),...

Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy Introduction to role Are you ready to set the global regulatory vision for pioneering cell and gene therapies and turn breakthrough science into real options for patients? This role leads high-impact programs across cancer, immune-mediated and rare diseases, guiding them from current stage through licensure with clear, competitive pathways to approval and labeling. You will shape strategy for complex, visible programs, bringing clarity, pace and rigor that accelerate access for patients. You will report to the Executive Director, Cell and Gene Therapy Regulatory Affairs and act as a franchise global...

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...

Join Early Oncology’s Translational Medicine (TM) Global Operations team to drive on quality across our Translational Medicine and Biomarker Science & Technology (BST) organizations, including Labs, Biomarker Operations, and Translational Strategy. As a key quality partner , y ou will advise on compliance and risk, lead continuous improvement, and champion a culture of quality excellence that delivers high-quality science to patients . Key Responsibilities Review, assess, and communicate the status of the Quality Management System (QMS) for TM and BST teams, partnering with stakeholders and business process owners to recommend continuous improvements aligned to AZ Global Standards, ICH GCP and...

Job Title Director, Regulatory Affairs Strategy - Cell and Gene Therapy Introduction to role Are you ready to steer global regulatory strategy for cell and gene therapies that redefine standards of care for patients? In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases—translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets. You will join a high-performing, cross-functional environment where regulatory insight is central to program decision-making. Partnering with senior leaders and global teams, you will lead strategy across key milestones—from...

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease...

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease...

The Executive Director, Chemistry, Manufacturing, Control for Biologics (Biologics-CMC) is accountable for managing a team of CMC professionals and ensuring rigor in CMC regulatory strategy as well as delivery of high quality CMC submissions for late phase new modality biologics products. The Executive Director, as a Senior member of the Global Regulatory Affairs and Clinical Safety Chemistry, Manufacturing and Control organization ( GRACS CMC), will also manage significant projects as an extension of the overall GRACS CMC Leadership Team. This lead plays a critical role in driving alignment and execution globally across Regulatory CMC (Chemistry, Manufacturing & Controls), GRACS (Global...

Our Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs and maintain licensure for the General Medicine portfolio worldwide. We seek a leader with a growth mindset, demonstrated by intellectual curiosity and the ability to navigate complex regulatory challenges with rigor and professionalism. Position The Executive Director, Regulatory Affairs Liaison reports to the Vice President (VP), General Medicine, and is accountable for defining and executing global regulatory strategy for assigned ophthalmology...

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. This position is onsite 4 days per week in North Haven, Connecticut. Our Medtronic Surgical team is working to bring the benefits of minimally invasive surgery (MIS) to more people and places through a portfolio of robotic and digital solutions. Together,...

About the Role Takeda is seeking a legal leader to join our Global Transactions & Contracting Legal (GTC Legal) team. As Head Counsel, GTC Legal – Global Supply & Quality (GSQ) and a valuable member of the GTC Legal leadership team, you will lead a team of attorneys and legal professionals supporting transactions and contracts for Takeda’s GSQ organization. This is a highly visible leadership role where you will lead novel, complex, high‑impact, high‑risk transactions while empowering Procurement and the business on routine contracting matters. You and your team will partner closely with Procurement and business stakeholders to drive business...

About this role Join Takeda as a Head of Global Regulatory Affairs – Oncology where you will provide global regulatory oversight for the assigned therapeutic area, focused on non-clinical and clinical aspects of drug development and associated regulations. You will provide asset-level responsibility for both US and EU HA interactions and procedures (including direct reporting lines). As part of the Global Regulatory Affairs team, you will report to the Head of Global Regulatory Affairs and provide core input to Global Program Team(s) throughout development programs. How you will contribute Provide enterprise-level leadership and vision for global regulatory affairs across the...

This position will support the Surgical Sutures’ Manufacturing business within Medtronic’s Surgical Innovations group located in North Haven, CT. We are seeking a Senior Quality Engineer to join our team in North Haven, CT. This role is integral to ensuring the highest standards of quality and compliance in our medical device manufacturing processes. As a key member of our Quality team, you will collaborate cross-functionally to enhance product reliability, optimize processes, and uphold regulatory compliance. 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...

An engineering/analyst professional who applies engineering and/or scientific knowledge, mathematics, and ingenuity to complete basic assignments related to a specific technical field or discipline. Responsible for compliance with applicable regulations and standards for Quality; Environment, Health, and Safety (EH&S) Global Policies; AbbVie Engineering Standards; and other governance areas as applicable. Identifies areas of risk with respect to compliance. Assists in development and revision of procedures and standards Facilitates the definition of a project scope with stakeholders. Converts goals to tasks and steps. Within structure, plans own work, manages several, often concurrent, tasks to accomplish assigned tasks to meet or exceed...

We are seeking a Senior Supplier Quality Engineer to help strengthen our supplier quality systems and ensure the highest standards of compliance, reliability, and performance across our global supply base. In this role, you will partner with suppliers and cross-functional teams to proactively identify risks, resolve quality issues, and drive continuous improvement. Responsibilities Monitor the performance of suppliers on a continuous basis and escalates any potential issues to supplier quality management. Supports the completion of supplier risk assessments and updates supplier quality database accordingly. Ensures supplier quality database is updated timely with any new information/addition, and ensures its accuracy, i.e....

POSITION SUMMARY Associate Quality Engineer (AQE)supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software.The AQE works with senior level QE’s to address supplier issues, nonconformances and corrective actions that impact the CLIA laboratory operations.This position may also represent QA on product development projects. PRIMARY RESPONSIBILITIES Support internal and external audits (CLIA/CAP, ISO 13485, customer) Support CAPA, Deviation, Change Requests and Nonconformance investigation and reporting Write/revise procedures and forms Perform statistical analysis/hypotheses testing (AQL’s etc) as required Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA Participate in the...

Gilead Sciences is seeking a highly motivated and experienced Sr. Quality Assurance Specialist to join the Corporate Engineering and Facilities (CEF) team in Foster City, CA. This role is responsible for providing quality oversight and hands-on ownership, authoring, and execution for GxP quality records associated with CEF activities including facilities, utilities, equipment, instruments, and engineering systems. The Sr. Quality Assurance Specialist is responsible for ensuring compliance with applicable quality objectives, regulatory requirements, and current Good Manufacturing Practices (cGMP), and serves as the primary owner for applicable deviation investigations, corrective and preventive actions (CAPAs), effectiveness checks, and related change controls. This...

Global Quality Compliance, Senior Manager What you will do Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks. Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to...

In this exciting role as the Senior Quality Systems Specialist, you will use data analysis skills and CAPA experience to support the quality function completing audits at the Mystic, CT facility. 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 5 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. Responsibilities may include the following and other duties may be...

In this role, you'll partner across Engineering, Manufacturing, Operations, and Quality teams to develop and maintain robust quality systems, drive continuous improvement initiatives, and ensure products and processes consistently meet regulatory, customer, and business requirements. You'll leverage technical expertise , data-driven decision-making, and cross-functional collaboration to solve complex quality challenges and help deliver safe, effective products to market. This position is based onsite in Danvers, MA. We believe in the value of in-person collaboration and operate with a minimum 5-day-per-week onsite schedule to support innovation, learning, and cross-functional partnership. Key Responsibilities Lead the development, implementation, and maintenance of quality...

The Quality Engineer I – New Product Introduction (NPI) is responsible for ensuring product and process quality throughout development, validation, process transfer, and production readiness for machining and selected secondary operations such as anodizing and final pack. This role provides quality oversight to cross-functional teams to ensure manufacturing processes, equipment, components, and documentation meet design intent, regulatory requirements, and Medtronic Quality Management System expectations. Key responsibilities include leading and supporting risk-based validation activities (IQ/OQ/PQ), confirming process and equipment readiness for production release, and ensuring effective component qualification, change control, and lifecycle support. The role is expected to drive compliance with...

About the role This position supports the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. How you will contribute Lead the execution of CD/PQ/CV/PV/RV activities. Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts. Supervise and manage contractors or consultants as needed. Participate in change control review board. Track and trend...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Triage Order Quality Associate Level II (TOQII) position is responsible for the accurate and timely work of filing insurance claims for Exact Sciences. T his role will demonstrate medical insurance knowledge by determining initial and/or ongoing eligibility,...

Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy Location Gaithersburg, MD Introduction to role Are you ready to set the global regulatory direction for first-in-class cell and gene therapies and turn science into approved medicines? Do you see yourself steering complex programs to competitive labels and rapid, global patient access? This role leads the strategy for our most visible and complex cell and gene therapy programs, translating breakthrough science into timely approvals and meaningful labels that unlock lifecycle value. You will work across discovery through commercialization, bringing clarity and pace to decision-making and ensuring our therapies reach patients...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities Provide direct shop floor quality support to ensure manufacturing activities are performed...

As an individual contributor, the International Regulatory Affairs Specialist I performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for product market entry. This individual will work on-site at our Plymouth, MN location. What You’ll Work On Assists in the preparation of regulatory applications to achieve departmental and organizational objectives, specifically for Asian geographies. Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to regulatory management....

The Senior Supplier Quality Assurance (SQA) is responsible for developing and executing supplier quality strategy, ensuring compliance with global regulatory requirements, and improving supplier performance across a diverse supply base. This role leads supplier auditing, qualification, risk management, and issue resolution, partnering closely with Procurement, R&D, Manufacturing, Regulatory Affairs, and other departments within the quality organization. This role will also learn to balance supplier requirements between medical device and consumer businesses. The individual will serve as the primary escalation point for critical supplier issues and supports major regulatory inspections across the business. This position will be located out of our...

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

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be based in Titusville, NJ. Purpose The Senior Manager, Health Care Compliance Officer serves as a strategic healthcare compliance partner to Johnson & Johnson Innovative Medicine teams, enabling compliant growth through risk-based, principles-driven guidance and decision support. This role operates within a dynamic and highly regulated environment, translating evolving legal, regulatory, and policy requirements into clear, practical, and actionable guidance that supports both business objectives and ethical standards. Consistent with the Innovative Medicine compliance strategy, this position helps advance the evolution from a rules-based...

Johnson & Johnson MedTech is recruiting for a Technical Transfer and Validation Director located in Irvine, CA! An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at About 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...

About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

The Robotics and Digital solutions (RAD) group, part of the Johnson & Johnson family of companies, is recruiting for a Sr. Compliance Engineer (Safety). What We Do At Johnson & Johnson MedTech, we are building the future of robotic surgery and healthcare through innovation and technical excellence. Our goal is to develop advanced robotic platforms that are precise, reliable, and accessible. Our team focuses on creating solutions that empower surgeons and improve patient outcomes worldwide. for Pay Transparency

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans....

Purpose Primarily responsible for ensuring adherence to GLP regulations and developing an organizational model for the Quality Assurance Unit. Manage a team of audit professionals responsible for quality oversight of all GLP-regulated studies. Poor decisions could present significant risks to patients in clinical trial programs, jeopardize the outcome of pre-clinical or clinical trials with resulting adverse business impact, or result in rejection of regulatory filings owing to compliance issues. These outcomes would adversely affect sales, margin, and stockholder value. Responsibilities Manage auditing for compliance of all GLP-regulated in-house studies and regulatory dossiers prior to filing. Collaborate with GXP...

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

The Director, Quality Compliance and Audits (QCA ) reports to the Executive Director, Quality Compliance & Audits and provides strategic leadership and governance for Gilead’s global GMP and GDP audit program. This role leads and develops a team of auditors and ensures consistent, high‑quality audit execution across Gilead’s global manufacturing and supply network, including internal manufacturing facilities, external contract manufacturers, laboratories, suppliers, distributors, and other third‑party partners. The Director is accountable for oversight of the end‑to‑end audit lifecycle, including development and execution of the annual audit plan, and ensures audits are performed as systematic, independent, and objective assessments of compliance...

POSITION OVERVIEW The Executive Director, Head of Precision Medicine Regulatory is responsible for defining and leading enterprise-wide regulatory strategy for precision medicine, including companion diagnostics (CDx), in vitro diagnostics (IVD), and biomarker-driven development across all Gilead therapeutic areas. This role ensures seamless integration of diagnostic and therapeutic development strategies from early discovery through global registration and commercialization, while maintaining direct accountability for regulatory strategy and execution of CDx/IVD programs. The position operates at the intersection of enterprise leadership, technical regulatory expertise, and operational execution to enable scalable, compliant, and innovative precision medicine across the Gilead and Kite portfolios. You will...

As a Manager, IT Risk and Compliance – DOJ Data Security Program , at Gilead you will ... Th e Manager, DOJ Data Security Program is part of Gilead’s Security Risk & Compliance (SRC) Governance team and leads efforts to ensure ongoing compliance with Department of Justice (DOJ) Data Security Program (DSP) requirements. This role partners across IT, Security, Legal, Privacy, Compliance, and business teams to ensure controls are effective, risks are managed, and the organization maintains a continuous state of audit readiness. The position combines regulatory knowledge, control oversight, and cross-functional collaboration to drive a proactive compliance program. The...

Quality Control Specialist, Microbiology What you will do In this vital role, you will provide technical and operational leadership for the QC Microbiology and Environmental Monitoring laboratories, leading microbial identification activities, environmental monitoring investigations, and laboratory operations in a highly dynamic, team-oriented environment. In this role, you will be responsible for Lead microbial identification activities, organism assessments, and support routine and non-routine microbiological testing. Provide leadership for microbiology laboratory operations, coordinate daily priorities, supervise laboratory staff, and support weekend laboratory operations. Own and lead complex microbiological investigations, deviations, environmental monitoring excursions, and contamination events, including root cause analysis, risk...

Senior Associate Quality Assurance What you will do Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements. Duties include but are not limited to Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments...

In this vital role, you will be part of the Supply Chain team and report to the Senior Manager. You will participate in multiple cross-functional initiatives for Amgen Ohio (AOH) leading to the warehouse quality process applying enterprise-wide programs. In addition, you will organize, drive, and/or support the identification and implementation of related Warehouse systems and processes. This role is also responsible for identifying, establishing, modeling, and monitoring key performance measures that will ensure the achievement of Best Practices across Amgen sites. The Manager, Warehouse Quality Systems, will serve as a key representative on various cross-functional task forces and teams...

Associate Quality Control - Incoming What you will do In this vital role the successful candidate will work with a team responsible for the Incoming Quality Control sampling and inspection processes of primary/secondary components, devices and raw materials. In addition, will be responsible for raw material sample shipments, testing and batch record's review per standard operating procedures or guidelines. Will also work cross-functionally to support multiple customers and stakeholders including Supply Chain, Quality Assurance, Process Development, Engineering and Quality Control. Specific responsibilities include but are not limited to Complete onboarding and all required training qualifications. Perform routine sampling and...

Opportunity Medical Director, Senior Patient Safety Physician Based in Gaithersburg, USA As a Medical Director, Senior Patient Safety Physician , you are a senior leader within Patient Safety and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca products. You also have a role in shaping the culture of the department; and will act as a coach and mentor to more junior Patient Safety staff. You will also ensure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. We encourage you to closely follow medical developments within assigned areas to...

Associate Director, External Quality Location Boston, MA Hybrid 3 days/week Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next generation radio conjugates (RCs) as precision medicines. Fusion has multiple pipeline programs entering early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support these programs, Fusion has a fully operational radio conjugate manufacturing facility. It is brand new and GMP compliant to meet the demand for our growing pipeline of RCs. AD, External Quality –...

In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying , and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Cell Therapy Supply Chain team tasked with supporting critical...

The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in some cases a regional regulatory lead, for development and/or commercial product(s) within the Vertex portfolio and contribute to the global regulatory strategy for the assigned program(s). This role requires advanced understanding of regulatory affairs frameworks in the US, Europe, or other international markets, drug development, and related concepts, and the ability to translate this knowledge into effective regulatory planning and strategy development. Key Duties and...

Brief Description of Position The Associate Director Quality Systems & Compliance within Device Quality & Regulatory will support our company's Manufacturing Division QMS Topic 3.3 – MDCP Design Controls and lead continuous improvement initiatives that support every aspect of our business processes, systems, and data. The Associate Director will collaborate with cross-functional teams to identify opportunities for improvement, address internal/external audit observations and tackle challenges, balancing effective operations with transformative initiatives. The Associate Director will work with the manufacturing division's Topic 3.3 Owner and Business Owner and has responsibility for oversight and lifecycle management of procedures related to this specific...

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans....

Senior Quality Specialist Change Control / Document Control is responsible for leading and supporting Global Compliance activities related to change control and document control processes. This role provides subject matter expertise (SME) to support the integration of new projects into enterprise systems and leads initiatives to enhance system capabilities and operational efficiency. The position serves as a key liaison for system support and troubleshooting (e.g., EDMS/PLM), while collaborating cross-functionally to ensure all change control and documentation activities are accurate, timely, compliant, and audit-ready. Key Responsibilities Oversee daily operations supporting Global Compliance Change Control / Document Control activities. Provide subject matter...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Service and Repair Sr. Quality Engineer role to be located at Danvers, MA. Due to significant growth, Abiomed is working to develop and enhance Commercial and Service and Repair (S&R) capabilities globally, including Quality support to these functions. The incumbent will be responsible for supporting multiple workstreams in support of this development activity,...

The Sr. Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development. Responsibilities Launch and stabilize new product launches through concept, design, development, and steady-state processes. Drives the development of product requirements, verification strategies, and validation strategies. Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction. Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical support...

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 onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. The Medtronic Global Operations and Supply Chain (GOSC) organization is seeking a Quality Engineer II to join our growing Quality Operations team in Irvine, California. In this role, you will support key programs within our Quality Management System and help drive day-to-day quality and...

Are you a people leader who thrives at the intersection of quality, rigor, and impact? Medtronic is seeking a Business Process Improvement Manager focusing on Clinical Quality to lead and elevate how clinical quality and compliance show up across daily work and deliverables within the Surgical organization. This role offers a unique opportunity to lead a team that plays a critical role in protecting patients, strengthening trust, and ensuring operational excellence in a highly regulated environment. In this leadership role, you will develop and empower a high performing team through clear prioritization, coaching, and readiness for training and inspections—while proactively...

Job Title Quality Engineer We are seeking a Quality Engineer for our Westford, MA location for our Vascular division. This role is fully onsite. The Quality Engineer provides Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provides Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. This role will include primarily working on and leading project teams to drive process/Quality improvements. What You’ll Work On Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the...

This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Supplier Quality Enginee r II drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You’ll Work On Assess potential new suppliers for technical, quality and...

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

About the role The Senior Manager, Software Device Quality is a seasoned quality and technical leader responsible for supporting software medical devices and combination products across the full product lifecycle - from design and development through manufacturing, distribution, and post-market support. This role ensures compliance with all applicable quality and regulatory requirements and provides leadership across key quality processes. How you will contribute Partner with product development teams to lead quality activities across design controls, including risk management, design inputs/outputs, verification/validation, and design transfer Provide quality oversight and approval for change control activities, including design updates, enhancements, bug fixes, and...

Título del Puesto Regulatory Affairs Analyst Ubicación Ciudad de México Modelo de trabajo híbrido Acerca del Puesto Como Regulatory Affairs Analyst , tú apoyarás la ejecución de la estrategia regulatoria para los productos asignados, gestionando registros, renovaciones, modificaciones posteriores a la aprobación y materiales promocionales, con el fin de obtener las autorizaciones sanitarias requeridas para las distintas unidades de negocio. Además, garantizarás la preparación y presentación de expedientes regulatorios completos ante las autoridades sanitarias locales, asegurando procesos de revisión efectivos que permitan obtener aprobaciones oportunas y contribuir al cumplimiento de los objetivos del negocio. ¿Listo para comenzar? ¿Listo para superar...

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

The Associate Principal Quality Partner provides leadership and direction for Quality Assurance activities within Operations and serves as a senior quality resource for assigned functional areas. This role is accountable for driving effective implementation of quality systems, compliance oversight, and sound quality decision-making across the area of responsibility. The position focuses on product and process compliance, issue resolution, quality governance, and strategic quality improvement. This role partners closely with Operations, Manufacturing, Development, Regulatory, and other stakeholders to ensure compliance with AbbVie Quality Systems, cGMP requirements, and applicable regulatory expectations. The role is expected to maintain strong quality performance while driving...

Purpose Primarily responsible for leading the management of GCP quality activities in support of studies and projects across one or more clinical programs to drive proactive quality management, and ensure compliance with corporate policies and functional procedures and applicable global regulations. As the primary GCP quality interface cross-functionally in R&D for the product, this individual will influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy game plan, informal surveillance, assessments as appropriate, design and execution of a “fit for purpose” audit program with the goal of submission-ready quality data, first pass approvals by health authorities...

The Senior Manager of Quality System will report to the Director of Compliance and Quality within the Strategic Operations function of AbbVie Patient Services. This role is responsible for supporting leadership to develop and oversee APS PSP governance to ensure compliance and adherence to AbbVie guiding framework and policies. Role builds procedures & processes in alignment with Legal, OEC, Privacy and Regulatory to ensure all PSPs that are launched, modified or sunset are appropriately governed and executed. Responsibilities Be a champion of establishing the environment of process and continuous improvement. Work to integrate quality into all we do in APS,...

The Director, US Advertising and Promotional Compliance, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional material. The Director will also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials. Accountabilities Reviewing...

Senior Compliance Specialist This position works out of our Altavista, VA 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. Altavista, Va. , is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 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 will have access to Career development with an international company where you can grow the career you dream of. Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term...

This position works out of our corporate Abbott Park, Illinois location, or other applicable Abbott location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbotts Manufacturing sites. Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring executive management is aware of compliance business risks and regulatory...

Senior Associate Quality Control - Microbiology What you will do Let’s do this. Let’s change the world! In this vital role, you will support the QC Microbiology and Environmental Monitoring team by performing activities including microbial investigations/assessments, microbiological and analytical testing, sample and data management, equipment and instrumentation operation and maintenance, sample and equipment troubleshooting, and the review and authorization of documents and samples while performing in a highly dynamic, team-oriented environment. Responsibilities include Perform microbial assessments and other GMP documentation as required (reports, assessments, SOP revisions). Support microbial and other QC laboratory investigations. Perform Microbiological testing to support GMP...

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease...

Summary This position is critical to maintaining quality oversight and ensuring GMP compliance in day-to-day manufacturing operations. The Senior Field QA Specialist is responsible for reviewing Manufacturing Batch Records (MBRs), performing real time on-the-floor exceptions reviews and logbooks, conducting GMP area walkthroughs, and supporting timely return-to-service (RTS) walkthroughs to confirm that manufacturing areas and equipment are properly cleaned, calibrated, and ready for production use. The role also working closely with Manufacturing Operations to investigate and resolve manufacturing issues as they arise. Additionally, this position contributes to authoring and revising quality SOPs, supporting the review and closure of no-impact manufacturing deviations,...

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 A candidate has been pre-identified for consideration. However, all applications will be considered. We are searching for the best talent for an Quality Control Analyst based in Raritan, NJ . The Quality Control Analyst is responsible for conducting biochemical,...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Senior Quality Engineer to be located in Raynham, MA. The Senior Quality Engineer provide an overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. Also, conducts audits to good manufacturing practices, international organization for standardization and any other applicable standards. You...

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 Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the...

At Medtronic, we A career at Medtronic is purposeful, mission-driven, and unlike any other. We are committed to alleviating pain, restoring health, and extending life for millions worldwide. As a Supplier Quality Engineer based in Irvine, CA you will support the Neurovascular Operating Unit by ensuring externally sourced materials, components, and services consistently meet Medtronic quality and regulatory requirements. This role partners closely with Neurovascular R&D, Manufacturing, Operations Quality, and Sourcing to qualify and develop suppliers, support new product introductions and design changes, and resolve supplier-related nonconformances that could impact product performance or patient safety. You will lead investigations...

At Medtronic, we A career at Medtronic is purposeful, mission-driven, and unlike any other. We are committed to alleviating pain, restoring health, and extending life for millions worldwide. As a Supplier Quality Engineer based in Irvine, CA you will support the Neurovascular Operating Unit by ensuring externally sourced materials, components, and services consistently meet Medtronic quality and regulatory requirements. This role partners closely with Neurovascular R&D, Manufacturing, Operations Quality, and Sourcing to qualify and develop suppliers, support new product introductions and design changes, and resolve supplier-related nonconformances that could impact product performance or patient safety. You will lead investigations...

We are seeking a qualified individual to join our R&D Quality Assurance Analytics & Tech Systems (AnTS) team. This role will be responsible for supporting both AI governance activities and quality systems management. The successful candidate will work closely with our business stakeholders to build our GxP AI Framework and lead demand discussions for our Veeva quality systems modules. They will need to be able to communicate information in a clear, concise, and timely manner and implement the use of negotiation, business analysis, project management, data analytics, and other applicable skills to resolve complex issues. Key Responsibilities Support QA AI...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Complaint Quality Approver (2 openings) to be located in Gurabo, PR. The Complaint Quality Approver is accountable for independent, objective review and approval of complaint records to ensure investigations are...

We are searching for the best talent for a Regulatory Law Paralegal to primarily support the Innovative Medicine Regulatory Legal Team (IMRLT) in the Global Legal Organization (GLO). This position is based in either New Brunswick, NJ; Titusville, NJ, or Horsham, PA. The Regulatory Law Paralegal contributes to the achievement of key Johnson & Johnson GLO priorities by providing proactive and professional support to the IMRLT and its business partners. You will be responsible for Working closely with regulatory lawyers and business partners to assist in the support and review of commercial and compliance programs and materials, which could include...

Associate Director Strategic Planning & Operations - Quality Strategy Organization What you will do Let’s do this! Let’s change the world! As a member of the Global Quality Strategy organization team, this individual will manage projects and initiatives in Global Quality portfolio in support of the end-to-end GxP operating model. The role involves cross-functional partnership and influence to ensure successful execution and lifecycle management of continuous improvement and strategic projects. Key Responsibilities Partner with cross functional senior management to ensure successful execution, tracking and value realization of critical initiatives and projects aligned with Global Quality GxP operating model. Stand up,...

Senior Specialist Quality Assurance (Supplier Quality) This position works out of our Des Plaines, IL location in the Abbott Molecular , 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 Senior Specialist Quality Assurance (Supplier Quality) will support in the selection, approval, and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or...

Quality Assurance Manager This position works out of our Westfield, IN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. The Quality Assurance Manager is accountable for the Quality Operations Organization and leads a team of Quality supervisors/technicians/inspectors/specialists to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements. What You'll Work On Implements a staffing...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Sr Manager Quality Assurance – GMP Operations at Gilead, you will provide Quality leadership and direct quality oversight of Manufacturing...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Associate Director, Quality Assurance – GMP Operations provides senior Quality leadership and direct quality oversight of Manufacturing and Quality Control (QC)...

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

An engineering professional that works with project owners, automation engineers, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified automated systems 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 primary objective is to design and execute robust evaluation, testing, and documentation strategies that support risk management, commissioning, and validation in alignment with product, regulatory, and quality requirements. The role also contributes to optimizing automated systems, process controls, and related technical workflows...

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

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

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

About This Role As a Senior Associate II, Technical Quality, you will play a critical role in ensuring quality and compliance across manufacturing, laboratory, engineering, and quality operations. You will lead and support investigations, change controls, quality oversight activities, and continuous improvement initiatives that strengthen operational performance and regulatory compliance. This position serves as a key technical quality subject matter expert, partnering cross-functionally to solve complex problems, assess risk, and implement effective quality solutions. You will provide quality assurance oversight for quality control activities, technology transfers, material management, and regulatory inspection readiness. This role helps drive a culture of quality,...

Johnson & Johnson is recruiting for a Manufacturing Quality Engineering Manager , located in Danvers, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Manufacturing Quality Engineering Manager is responsible for leading manufacturing quality engineering activities that support regulatory compliance, production quality, and manufacturing and supply chain operations. This role provides leadership to a team of quality engineering professionals, supports robust quality systems and data-driven decision making, and partners...

Johnson & Johnson is currently recruiting a Sr. Program Manager Quality Systems . This position will be located in Santa Clara, CA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Sr. Program Manager Quality Systems will be responsible for leading multiple Quality System programs and projects that optimize processes and support business objectives while enhancing compliance. This role will ensure overall execution to meet project objective and timelines. Key...

Abiomed is recruiting for a Sr Manufacturing Quality Engineer located in Danvers, MA . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our facilities expansion. In this role, you will have the unique opportunity to contribute to manufacturing life-saving medical devices....

USE YOUR POWER FOR PURPOSE Candidate will be responsible to provide leadership for will be responsible for managing a team of Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity within the Rochester Quality organization. Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Job Summary The Associate Director, Patient Safety-Virology provides strategic pharmacovigilance leadership for one or more products, compounds, or indications across the development...

Job Title Associate Quality Engineer This position works out of our Caguas location in the SH Division as a global leader we focus on innovative technologies that can improve the way doctors treat people with heart. As the Associate Quality Engineer, you will provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer by assisting in the identification and resolution of quality related issues. The Associate Quality Engineer will work with line supervisor, manufacturing engineer, and other team members, to address all opportunities found in the assigned manufacturing line and will...

Quality Engineering Manager This position works out of our Altavista, VA 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. Altavista, Va. , is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you...

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

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

The GMP Quality Operations Manager is recognized internally as an expert in the principles and application of quality assurance, compliance, and AI-enabled quality operations. The Quality Manager will provide QA support of manufacturing operations for the external manufacture of Cell & Genetic Therapeutic programs. This role will drive, review, and support activities related to product disposition, including review of batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation, while advancing intelligent digitized solutions for backlog triage, metrics generation, records reconciliation, and archiving to improve operational efficiency, compliance, and data integrity. Key Duties...

A Day in the Life In this meaningful role as a Quality Engineer II supporting Cardiac Ablation Solutions (CAS), you will play a vital part in ensuring product quality, safety, and reliability through post‑market activities. You will perform complaint investigations, partner closely with engineering teams to identify and escalate risk file signals, and support data‑driven decisions that protect patients and clinicians. This role supports the development and continuous improvement of procedures, processes, tools, and techniques used for product analysis and returned product evaluation. You will devise and implement inspection and testing methods for returned product, support test method validation efforts,...

Information Systems Sr. Manager – Technology Regulatory Compliance Lead Live What you will do In this vital role, you will lead the delivery of high-quality, robust, and reliable digital technologies and services within the Technology Organization, ensuring seamless support for business, project, and daily operations. You will be accountable for the computer systems compliance framework of the technology function, ensuring adherence to global regulatory requirements and Amgen procedures. You will lead the strategy for computer system validation (CSV), regulatory compliance, and inspection readiness for the technology team, proactively driving a culture of quality and continuous compliance. Serving as the...

Quality Compliance Associate Director - Microbiology What you will do In this vital role, you will serve as a Quality Compliance microbiology subject matter expert supporting contamination control, QC microbiology, manufacturing microbiology, inspection readiness, and technical consistency across Amgen Operations. This role partners with Quality, Manufacturing, Process Development, Regulatory Affairs-CMC, Cellular Sciences, site laboratories, and global technical networks to ensure science-based, compliant, and practical microbiology decisions. This is a full-time remote position Specific responsibilities include but are not limited to Serve as a microbiology and contamination control subject matter expert for Quality Compliance, QC laboratories, manufacturing, and site teams....

Quality Compliance Associate Director – Aseptic Processing What you will do In this vital role, you will serve as a Quality Compliance microbiology subject matter expert supporting contamination control, QC microbiology, manufacturing microbiology, inspection readiness, and technical consistency across Amgen Operations. This role partners with Quality, Manufacturing, Process Development, Regulatory Affairs-CMC, Cellular Sciences, site laboratories, and global technical networks to ensure science-based, compliant, and practical decisions. This is a full-time remote position Specific responsibilities include but are not limited to Serve as a aseptic processing and contamination control subject matter expert for Quality Compliance, Manufacturing, and site teams. Support...

Drug Substance Quality Assurance Specialist What you will do In this vital role within the Plant Quality Assurance organization, the Drug Substance QA Specialist provides quality oversight and compliance support for Drug Substance manufacturing operations at Amgen. Under minimal supervision, this role ensures adherence to cGMP requirements, quality systems, and regulatory expectations while partnering closely with Manufacturing, Facilities & Engineering, and other cross-functional teams to support safe, compliant, and reliable operations. The Drug Substance QA Specialist will be a member of the Drug Substance Plant QA team and provide Quality oversight for Drug Substance Manufacturing and supporting Facilities &...

Key Responsibilities Strategic Leadership & Sterility Assurance Governance Embed control contamination and aseptic assurance strategy and aseptic-by-design principles into future processes and product development programs Lead remediation plans following regulatory observations, ensuring proactive installation of appropriate aseptic assurance standards (QMS and standard work) across the business Champion continuous improvement initiatives including KPI trending and capability development in aseptic and sterility assurance domains and process confirmations Own and periodically review BMS's Global CCS as a living document, ensuring it reflects current regulatory requirements Establish, own, and govern BMS's global sterility/aseptic assurance and CCS performance metrics framework, including KPI definitions, network-level escalation...

Key Responsibilities Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management. This will involve collecting all the relevant inputs from the RBM framework (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections. As part of the upstream protocol authoring process, partner with Drug Development, in particular the CORM function, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure...

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by playing a crucial role in Quality Control Operations including sample management, equipment management and reagent management in the AstraZeneca Quality Control Laboratory. This position is essential for ensuring that the laboratory meets the high standards required for CGMP Quality Control Operations. This position operates on the following shift, and is subject to change Monday to Friday, 5X8, 9AM-530PM Responsibilities The candidate will be primarily responsible for...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – US Specialty combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – US Specialty combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications...

The Senior Manager, Regulatory Affairs US Advertising and Promotion – US Specialty combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications...

The Principal Quality Engineer – Automation and AI Enablement is responsible for ensuring that AbbVie's IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role provides leadership in defining, implementing, and optimizing quality systems through digital enablement and AI-driven solutions, collaborating directly with cross-functional teams. Focusing on modernizing communications, metrics management, SLC monitoring activities, and providing end-to-end audit and Corrective and Preventive Action (CAPA) support, the incumbent leverages automation and AI to strengthen cross-functional integration and quality oversight. They drive improvement initiatives, support audit readiness, ensure effective issue tracking and resolution, deliver actionable insights...

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...

About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

In this exciting role as a Senior Supplier Quality Engineer in CardioVascular Surgery (CVS), you will work on supplier quality deliverables and lead supplier control activities for new product development programs for the Aortic portfolio. You will be responsible for supporting supplier quality excellence to enable the successful development and launch of programs supporting the Aortic portfolio of the business. This role collaborates with cross-functional teams and suppliers to ensure effective component development, qualification, and release processes that align with program timelines and regulatory requirements. The ideal candidate will have strong experience managing supplier changes during NPD programs, effectively communicating...

Join us as a Director Quality Assurance , where you will lead and direct the Site Quality Assurance Operations at our Cell Therapy 9950 MCD Rockville manufacturing site. This role offers an opportunity to develop strategic and operational plans, lead high-level projects, and define innovative solutions within complex areas of the business. You will be working on diversified tasks with a global team, providing you with exposure to new ways of thinking and helping us grow collectively and as individuals. What you will do Lead the new Quality Assurance team at the Commercial Cell Therapy Facility, supporting facility start-up 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...

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

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

The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational excellence initiatives across Global Regulatory Affairs (GRA). The role is responsible for identifying, designing, and implementing process improvements that enhance efficiency, consistency, and quality across GRA processes. As a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. The Director applies deep subject-matter expertise and hands-on operational excellence experience to shape objectives and drive transformation aligned with GRA and corporate goals. This is a Boston based, hybrid position requiring 3 days/week onsite....

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 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...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements. What You’ll Work On Contributes to the development, maintenance and improvement of division supplier development quality program...

This is not a remote opportunity Traveling up to 5% Our team is looking for a Customs and Trade Compliance Analyst to be based out of our office in Irving, TX. Responsible for providing technical and analytical support for customs and trade compliance matters at the site/division level, ensuring compliance with all relevant customs regulations and trade laws including, 19CFR, 15CFR, FDA, USDA, other PGAs and data metrics. FTZ Operations and Compliance Administer and maintain FTZ operations in compliance with CBP regulations (19 CFR Part 146) and FTZ Board guidelines. Manage FTZ admissions, withdrawals, transfers, and inventory movements within the...

This role with lead CRM global Quality System Management and Audit, as well as CRM global Microbiology & Sterilization oversight, including direct oversight of the Sylmar Microbiology/Sterilization based team and operation for production manufacturing. WHAT YOU’LL WORK ON Organizing, hosting, and executing regulatory audits across the global CRM network. Develop and drive audit strategies and plan across CRM global network/sites, in alignment with increasing complexity from global regulatory agencies. CRM network microbiology and sterilization oversight, as well as direct leadership responsibility over Sylmar based micro/sterilization team and production operation. Drive sterilization acceptance approaches / compliance with appropriate standards across the...

The Senior Specialist, QA Investigations , is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines. Responsibilities Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems. May author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the...

About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

We are searching for the best talent for a Director, Health Care Compliance Officer, Global Functions, for the Innovative Medicine business with responsibilities for areas within the Global Commercial Strategy Organization (GCSO) and Global Business Development. This role will primarily be based in Raritan, NJ. 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...

Senior Specialist, Quality Risk & Governance What you will do Let’s do this. Let’s change the world! At Amgen, quality is more than compliance — it is a strategic capability that enables innovation, operational resilience, and trust across the product lifecycle. We are seeking a Senior Specialist, Quality Risk & Governance to help strengthen and evolve our enterprise GxP Quality Management System through proactive risk management and effective governance practices. This role combines a strong emphasis on Quality Risk Management (60%) with strategic and operational support for GxP Governance (40%) , helping ensure enterprise-wide visibility, escalation, decision-making, and continuous improvement...

About This Role As the Head of Quality for Device and Combination Products, you will lead the development and execution of the global quality strategy, focusing on devices and combination products. This role involves establishing cross-functional roles and serving as the primary quality representative for drug-device combination engagements. You will oversee the Global Quality Device organization, ensuring quality management across all stages from design to lifecycle activities. Your role is critical in ensuring inspection readiness and aligning regulatory regulations within Biogen's quality system, integrating engineering design and risk management. Your leadership will drive compliance with regulatory and quality standards while...

Principal Specialist, Software Quality Assurance This position works out of our Lake Forest, IL location in the Core Lab , 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. As the Principal Specialist, Software Quality Assurance , you’ll be the division subject matter expert for the non-product software lifecycle, Data Integrity, and cybersecurity compliance. This position reviews and assesses software activities (e.g., suppler evaluations, lifecycle...

Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QA Site Director. Responsibilities Manages the Quality Control (QC) laboratory including direct reports and budgetary responsibilities Member of the Laboratory Center of Excellence (COE) Serves as the standalone laboratory systems and site Maximo administrator Reviews and approves raw materials and commodities including ERP approval Exception Report (ER) investigation, writing, review, and approval including ensuring effective CAPAs...

This position ensures products meet safety, regulatory, and quality standards throughout the product lifecycle, from design and development to post-market surveillance for medical devices within combination products. Responsibilities include risk management, participation in root cause analyses, process validation, and maintaining Design and Development Files (DDF) related to medical devices. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products. Maintain and improve risk management files (ISO 14971) and Design...

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. The role works with a high degree of independence to provide QA Analytical support for commercial product stability programs and executes routine tasks and activities in support of QA Analytical function. Key Duties and Responsibilities Provides QA review of the GMP data in support of commercial product stability as required. Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support...

Join Genentech in South San Francisco, CA as a Principal Healthcare Compliance Manager, Advisory! Seeking a highly experienced senior compliance professional for a strategic role with significant organizational impact. As a Principal Healthcare Compliance Advisor, you will serve as the primary consultant for multiple business units, advising on and developing policy, guidelines, and training for complex risk areas. This role holds full strategic responsibility for understanding business priorities and advising across the compliance ecosystem. You will proactively research evolving regulations, influence the development of long-range plans and overall objectives for Genentech, and represent the department on high-impact cross-functional committees. Decisions...

The Counsel, AI Governance, Law & Compliance provides day-to-day legal and compliance support for the design, development, deployment, and ongoing oversight of AI systems across the enterprise. Sitting within the AI, Data and Privacy Law and Compliance department and reporting to the Head of AI Governance, Law and Compliance, this role partners closely with Business Insights and Technology (BI&T), Privacy, Data Governance, and business stakeholders to operationalize the company's global AI governance framework. The Counsel translates evolving AI laws, regulations, and standards (e.g., EU AI Act, OECD Principles, NIST AI RMF, ISO/IEC 42001, CPPA ADMT, China PIPL) into practical guidance,...

Position Responsibilities In close partnership with the regional strategists / liaisons and/or GRL Team leader, develop strategic and operational plan for the development and the registration of assets across Therapy Area. Lead development of strategy and content for US dossier in partnership with marketing application submission teams for indications that are at the regulatory filing stage; Develop contingency plans in conjunction with the GRL or Team Leader for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRT Develop and execute approaches to resolve regulatory issues and appropriately drive speed to patients. Develop predictions for expectations and...

We are searching for the best talent for a Director, Health Care Compliance Officer (HCC) supporting the U.S. Innovative Medicine (Pharmaceutical) business to be based in Titusville, NJ. This role provides strategic leadership for healthcare compliance within a highly dynamic and regulated environment, enabling compliant growth while advancing a modern, risk-based, and principles-driven compliance program. Purpose The Director, Health Care Compliance Officer will set strategic direction, provide compliance oversight, lead complex risk management initiatives, and drive operational excellence across the U.S. Innovative Medicine organization. This leader will serve as a trusted advisor to senior business and functional leaders, exercising sound...

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. The Quality Engineer II partners with Manufacturing, Operations, Engineering, and Quality teams to ensure products consistently meet quality, regulatory, and customer requirements. This role provides quality engineering support for manufacturing operations through investigation, analysis, risk assessment, continuous improvement, and quality system activities. The Quality Engineer II independently manages routine and complex quality activities while driving timely resolution of...

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input...

Quality Technician I This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. The Quality Technician I provides technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions. Assists engineers in developing methods and procedures to control or improve manufacturing processes. What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Assists engineering in...

Inspector II Quality Control This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. T he inspector provides an independent, unbiased evaluation of materials or the work of others. The results of the Inspector's evaluation is documented and communicated to organizational stakeholders with an interest in the evaluation's outcome - typically, this is supplier development and/ or manufacturing. The Inspector's approval certifies the...

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. We are recruiting for a Senior Regulatory Affairs Manager to join our team on-site in Alameda, CA. In this role, you will combine knowledge of scientific, regulatory and business issues...

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. The Senior Quality Engineer serves as the quality leader for assigned manufacturing operations and provides technical leadership across quality engineering activities. This role drives quality strategy, mentors quality engineers, leads complex investigations and improvement initiatives, and serves as a key partner to Operations leadership in achieving quality, compliance, and business objectives. What You’ll Work On Strategic Quality Leadership...

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. We are recruiting for a Senior Manager, Quality Systems to join our team on-site in Alameda, CA. In this role, you will ensure effectiveness of the quality system and consistent...

Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes worldwide....

The Associate Director is responsible for the review and approval of all US promotional materials and serving as the promotional regulatory expert with legal, medical and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company's policies, and support business objectives. Serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB, including complex regulatory questions and submissions for advisory comment. Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. Provide regulatory consultation in the development and implementation of US marketing strategy...

Employer Shockwave Medical, Inc. Senior Quality Engineer Job Code A011.10369 Job Location Santa Clara, CA Job Type Full-Time Rate of Pay $145,205 - $155,369 Job Duties Provide Design Quality Assurance to efficiently deliver safe and effective medical device designs for manufacturing. Provide Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP and other applicable regulations, Work closely and partner with internal departments to ensure designs are aligned with company policies and procedures. Participate in design reviews and...

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

Johnson & Johnson is recruiting for a Senior Manager, ERP Quality - Global Product Lead , located in New Brunswick, JN or Raynham, MA! About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose The Senior Manager will be a part of the MedTech Supply Chain Digital organization, a transformation office aiming at modernizing our end-to-end Supply Chain digital capabilities by harmonizing our disparate ecosystem of 40+ major global MT ERP...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find...

Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionizing the way we do R&D. We’re uniting science, technology and...

Beam is seeking an experienced Clinical Quality professional at the Associate Director / Director level to join our grown Quality Team. Reporting to the Senior Director, Clinical Quality Assurance, this role will provide strategic and operational leadership for inspection readiness, program quality oversight, and vendor oversight as Beam advances toward its first regulatory submission and potential associated inspections. Responsibilities Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans. Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities. Support health authority inspections, including document review, response coordination, and follow-up remediation activities. Serve as the...

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

Johnson & Johnson is currently recruiting for a Senior Analyst- Data Quality & Automation to to be based in Raritan, NJ. Consideration will also be given to Mexico and Bogota. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) Mexico City, Mexico- Requisition Number R-081827 Bogota, Columbia - Requisition Number R-081827 Remember, whether you apply to one or all of...

US Analytical Technology Solutions (US-ATS) supports all Animal Health sites globally in analytical method development, improvement, validation, transfer as well as in all kinds of analytical investigations This position will lead and oversee all aspects of analytical life cycle management activities for in-line licensed products including collaboration with cross-functional teams to ensure that deviations are resolved in a timely manner, and that corrective actions are effectively implemented. The Analytical Technical Solutions (ATS) Site Lead provides strategic, scientific, and operational leadership for analytical development activities across US sites. The role ensures compliant, efficient, and innovative analytical support for biologics, vaccines, and...

The Senior Device Quality Engineer provides quality and compliance leadership for manufacturing and packaging equipment at the Zebulon, NC site, ensuring systems and processes used to produce respiratory and solid dose medicines operate in full compliance with FDA, ISO 13485, GxP and GSK Quality Management System (QMS) requirements. This role supports new product introductions and site expansion , owns key elements of the device/equipment quality lifecycle (qualification, validation, change control, deviations, CAPA), and acts as a primary quality interface with Engineering, Production and Technical teams to maintain a strong safety and quality culture and inspection readiness. This role will provide...

The GRS-CMC Director is responsible for overseeing management of multiple development and life-cycle management projects of varying priorities and complexities. Represent GRS-CMC on cross functional teams, governance committees, and due diligence /in-licensing projects. Represent BMS at Health Authority meetings. Serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities. Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external regulatory engagement for themselves and/or members of their team. Duties/Responsibilities Develop and communicate strategic direction based on global regulatory guidelines and experience Prepare or oversee preparation of CMC submissions while ensuring...

The Director, Operational Excellence – Internal Quality is a people leader who owns the vision, strategy, and operating model for Operational Excellence across Internal Quality. This role ensures strong strategy‑to‑execution alignment, delivering sustained improvements in compliance, efficiency, cycle time, cost, and right‑first‑time outcomes across Quality Assurance and Quality Control while maintaining inspection readiness and patient safety in a GxP environment. The role serves as the enterprise Operational Excellence leader for Internal Quality, aligning priorities to Quality and enterprise strategy, governing delivery, enabling the OE network, and ensuring measurable value realization across a portfolio of initiatives. This role will sit in...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will report to the Associate Director, Quality Assurance within the PDM External Quality...

About This Role The Sr. Associate II, Compliance plays a critical leadership role in ensuring the RTP Drug Substance Manufacturing site maintains a strong state of compliance and inspection readiness. This position partners closely with Site Leadership and Quality teams to oversee inspection management, data integrity, and quality systems, while driving continuous improvement across local and global processes. This role is instrumental in ensuring adherence to regulatory requirements and strengthening a culture of quality and compliance across the organization. What You’ll Do Lead site compliance and inspection management activities, including planning, execution, and regulatory response coordination Ensure the site remains...

About this role The Sr. Associate III, Compliance - Data Integrity is a key leadership role supporting the RTP Drug Substance Manufacturing site, with a strong focus on ensuring data integrity, compliance, and inspection readiness. This individual partners across Quality, Manufacturing, and Site Leadership to strengthen data integrity practices, oversee quality systems, and ensure adherence to global regulatory standards. The role plays a critical part in driving a culture of compliance, continuous improvement, and operational excellence across the site. What you’ll do Lead data integrity compliance initiatives across manufacturing and Quality Control environments Ensure compliance with global regulatory requirements including...

About This Role As the Head of IT Quality, you will spearhead the strategic direction for ensuring that Biogen's digital systems meet global quality and compliance standards, while facilitating efficient and cost-effective delivery. You will lead enterprise-level quality oversight of business-critical IT systems, including governance of GxP processes, system validation, and IT change control in line with regulatory expectations such as FDA guidance and EU standards. Your role will also establish oversight of quality policies related to Artificial Intelligence, ensuring compliance with emerging global frameworks and industry best practices. Moreover, you will be responsible for defining and driving the enterprise...

About This Role As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality oversight of design control and risk management activities for combination products and medical devices. This senior-level position requires you to work closely with device development teams, medical device suppliers, and testing partners during the design and development phases, extending your support throughout the device lifecycle. Your expertise will drive the development, implementation, and continuous improvement of device-related quality processes and procedures, ensuring compliance with relevant standards and regulatory requirements. By providing strategic guidance and oversight, your role will be integral...

About this role The Sr. Associate III, Compliance – Risk Management provides operational leadership for Biogen’s RTP drug substance manufacturing site, with a focus on quality risk management (QRM), inspection readiness, data integrity, and compliance systems. This role is responsible for ensuring the site always remains in a state of control and inspection-ready, supporting both domestic and international regulatory expectations. As a key member supporting site leadership, this individual will drive continuous improvement across quality systems while promoting a strong compliance culture aligned with cGMP and Biogen Quality Management System standards. What you’ll do Lead and manage the site Quality...

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. MAIN PURPOSE OF THE ROLE The Quality Control Inspector I p erforms inspection and testing of purchased materials, components and products in accordance with policy and procedures MAIN RESPONSIBILITIES Performs visual, dimensional and functional...

ROLE SUMMARY Our Global Cybersecurity Governance, Risk, and Compliance (GRC) team defines the blueprint for cybersecurity excellence by embedding governance, risk management, and compliance into every layer of the organization. The team enables consistent, risk‑based decision‑making and ensures that security, privacy, and regulatory requirements are seamlessly integrated across Pfizer’s global operations. We are seeking an experienced Director to serve in a strategic leadership role within the Security GRC organization, acting as the primary security representative for mergers, acquisitions, and divestitures. This role is accountable for ensuring security risk identification, regulatory alignment, and secure integration across the full transaction lifecycle—from diligence...

Manager QA What you will do In this vital role you will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support GMP Manufacturing and to manage change in an effective, efficient and compliant manner. This individual will be responsible for overseeing our Day shift Plant Quality Assurance teams, who work 7am-7pm. Additional Responsibilities Independently determine approach to managing daily operations; guided by general policies and management guidance Develop or contribute to the development of procedures and standards by which others will operate. Interpret and execute standards and procedures directly affecting work activities Develops...

The Senior Quality Engineer – IVD Devices is a senior subject matter expert responsible for ensuring the quality, safety, and regulatory compliance of IVD devices across the full product lifecycle—from early development through commercialization and lifecycle management. Partnering with the Senior IVD Director, this role requires deep technical and regulatory expertise including EU IVDR, FDA 21 CFR Part 809/812/820, ISO 13485, ISO 18113, and ISO 15189. The incumbent serves as a strategic quality partner to cross-functional teams including R&D, Regulatory Affairs, Manufacturing, Clinical, and Laboratory Operations, providing expert guidance on design controls, analytical validation, clinical performance evaluation, and post-market quality...

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...

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

At 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...

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 seeking a Senior Director of Global Cyber Compliance to...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities Covers all GXP audit in areas of current, Good Clinical Practices (GCP),...

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 onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. The Senior Quality Systems Specialist will serve as the primary interface between Medtronic and external customers for a designated business, while owning and optimizing the Quality Management System (QMS) processes that support customer-related activities. This role combines hands-on customer support (orders, changes, complaints, RMAs)...

In this exciting role as a Senior Quality Engineer on the Plymouth Nathan Lane sustaining and project quality engineering team, you will be responsible for being the quality voice and executing on a broad range of projects. Projects supported in this role to support the Peripheral Vascular Health (PVH) platform can span from capacity expansion, equipment end of life replacement, yield improvement, technology change implementation, quality improvement, and lean transformation initiatives. This role will collaborate with a wide cross-functional group both inside and outside the facility. This is an in-person/on-site role with very limited travel required. At Medtronic, we bring...

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

The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams. This On-Site...

Johnson & Johnson is currently recruiting for a Manager – Data Quality and Automation to be based at Raritan, NJ. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at About the Role This role will own strategy, governance, and execution of data quality across J&J’s global supply chain data ecosystem with key focus on forward-looking AI implementation and efficiency gains via automation. The role will ensure that data powering supply chain...

We are searching for the best talent to be a Senior Counsel, Regulatory Law, MedTech. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at The Johnson & Johnson Global Legal Organization (“GLO”) is recruiting for a Senior Counsel, Regulatory Law, MedTech to support Johnson & Johnson MedTech. This position can be based in New Brunswick, New Jersey, Washington, D.C., Santa Clara, California, or Danvers, Massachusetts . Purpose This Senior Counsel position...

About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to...

As the Global Regulatory Lead on our Global Regulatory Affairs, Oncology Team, you’ll be fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi’s diversified portfolio in order to meet corporate and business objectives. The GRL is the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT). Ready to get started? Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions....

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

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...

Manager , Quality Control Analytical , Cell Therapy Sunday - Wednesday (4x 10 hour day shift) Role Overview The Manager , QC A nalytical , provides managerial , operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability testing . The role focuses on right ‑ first ‑ time analytical assay execution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell ‑ based assays) and end ‑ to ‑ end laboratory readiness, including people and equipment oversight . Responsibilities span management of a routine testing team, testing execution, laboratory operations management,...

Manager , Quality Control Analytical , Cell Therapy Wednesday - Saturday (4x 10 hour day shift) Role Overview The Manager , QC A nalytical , provides managerial , operational and technical leadership for a cGMP Quality Control laboratory supporting cell therapy lot release and stability testing . The role focuses on right ‑ first ‑ time analytical assay execution (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell ‑ based assays) and end ‑ to ‑ end laboratory readiness, including people and equipment oversight . Responsibilities span management of a routine testing team, testing execution, laboratory operations management,...

Senior Regulatory Affairs Specialist This position works out of our Itasca or Chicago, IL (Willis Towers) location in the Abbott Molecular Division . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are 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. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, North America Regulatory Liaison. This position is a hybrid role and will be located in Spring House, PA. The Senior Manager, North America Regulatory Liaison will serve...

Johnson & Johnson is currently recruiting for a Quality Operations Manager! This position will be located in Cornelia, GA. Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals. Implement and lead the quality operations organization for the Ethicon Cornelia, Georgia site by Planning, coordinating, and directing quality assurance programs designed to ensure continuous production of products...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find...

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 Principal Associate QA-FUME is responsible for providing oversight to...