Quality & Regulatory Jobs in Pharma & Biotech

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly,...

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 Ready to lead at the forefront of innovation? Learn more and apply today! The role will drive the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices. The incumbent is...

Introduction to role Are you ready to set the global agenda for cyber governance and regulatory adherence within a firm where trusted, protected technology accelerates life-changing medicines to patients? Can you translate complexity into crucial action that protects trust while enabling ambitious innovation and speed? As Executive Director for Global Cyber GRC, you will lead the enterprise approach to information security. You will coordinate technological risk and ensure our most critical data, platforms, and partners operate with resilience, regulatory confidence, and clear accountability. You will connect cyber risk to strategic decisions, equipping the company’s leadership team and Board with sharp,...

Software Quality Director Careers that Change Lives Transforming Patient Management with Smart Technology! The Software Quality Director will lead our software quality organization within CRDN supporting both current products in the markets, ensuring ongoing reliability, performance and customer satisfaction as well as new product development and release initiatives. This role is accountable for managing and developing a high-performing quality Engineering team, defining the long-term quality strategy, and ensuring the delivery of reliable, high-quality software across our product portfolio. The Software Quality Director will balance strategic vision with operational excellence- driving quality initiatives across the organization while overseeing day-to-day...

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...

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

The Senior Quality Engineer is responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations. Responsibilities Perform QA activities related to Combination Product and Medical Device Development Ensure compliance with company policies and procedures. Perform design control and risk management activities according to AbbVie's Quality System Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met Perform 3rd party supplier management...

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

POSITION SUMMARY Quality Engineer supports the quality system processes of the Natera CLIA laboratories and activities associated with clinical trials. The QE works with senior level QE’s and management to address GCP compliance, supplier issues, non conformances and corrective actions that impact the CLIA laboratory operations. PRIMARY RESPONSIBILITIES Support internal and external audits (GCP sponsor, CLIA/CAP, ISO 13485) Under limited supervision, collect and trend quality metrics for clinical trials per pre-defined parameters and/or upon request; provide partnered oversight (with QEII or higher) of CAPAs, deviations, and NCRs associated with clinical trials; Write/revise procedures and forms; submit to Document Control 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. Associate Director - Global Patient Safety About Lilly At Lilly,...

SENIOR REGULATORY AFFAIRS SPECIALIST Onsite Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release. Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product...

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

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 About Oncology 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. Our Oncology team is focused...

The Manager, Quality Assurance 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. Key Responsibilities Review and approve complex investigations/ CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems. Author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program....

This position will develop comprehensive internal and vendor quality oversight strategies for In Vitro Diagnostics (IVD), Companion Diagnostics (CDx), and Digital health assets within a regulated environment. The Director will serve as a key collaborator across external partners, internal R&D, Regulatory, Clinical, IT/Digital, and Quality organizations, ensuring fit-for-purpose, risk-based quality oversight aligned with a rapidly evolving global diagnostic and digital health regulatory landscape. This role is accountable for the development, implementation, and continuous improvement of QMS processes and oversight, including global audit strategy, vendor quality oversight, inspection readiness, and regulatory intelligence for IVD, CDx and Digital health programs. This position...

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...

Are you ready to steer US promotional regulatory strategy in a way that accelerates responsible growth and earns patient and prescriber trust? This role translates science into clear, compliant communication across healthcare professionals, consumers, and payers—so that what we say is as strong as the medicines we deliver. As Director of Promotional Regulatory Affairs, you will set the regulatory guardrails that enable confident brand execution and speed. You will partner closely with Medical, Legal, Commercial, and Corporate Affairs to shape claims early, guide labeling implications, and ensure promotional materials meet the highest standards across all channels—from print and broadcast to...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety...

Quality Compliance Senior Manager, GMP/GDP Inspections Global Process Owner (GPO) What you will do As part of the GxP Quality Management System (QMS) architecture, the GMP/GDP Inspections Global Process Owner (GPO) leads the design, governance, and continuous advancement of the end‑to‑end GMP/GDP inspection lifecycle , from inspection readiness and preparation through inspection execution, outcome management, and regulatory commitment tracking. This role is a critical leader within the Inspection Lifecycle Management organization , ensuring consistent, compliant, and inspection‑ready practices across the global network for Health Authority, Notified Body and Business Partner inspections of Amgen. This role is accountable for establishing...

Quality Technician - Microbiology This position works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine 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 the Quality Technician - Microbiology , you’ll undertake the role of as Technician Quality with minimal supervision. Execution of daily activities with minimal supervision. Perform microbiology...

Quality Engineer This position works out of our Barceloneta location in the Abbott Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. This is an exempt role First shift (Monday to Friday) . As the Quality Engineer, you’ll 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. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming...

Sr. Supplier Quality Engineer Location Scarborough, ME In this role, you will partner with suppliers and internal customers to identify and implement effective process control systems that support the development, qualification, and ongoing manufacturing of supplied materials. This position ensures supplied materials meet or exceed both internal standards and external regulatory requirements. Supplier Quality Leadership Partner with suppliers and internal stakeholders to support development, qualification, and manufacturing of supplied materials Identify, implement, and maintain effective supplier process controls Ensure compliance with internal quality standards and applicable external requirements Product Stewardship – Supplier Quality Lead Implement and sustain a Product Stewardship...

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 Sr. Quality Data Engineer is responsible for the full lifecycle development, implementation, production support, and performance tuning of the enterprise data warehouse, data platforms, analytics, and reporting environments. This role will also be responsible for supporting the...

Purpose Assumes ownership of the Office of Ethics & Compliance (OEC) Business Requirements management processes, including Jira (IT development task management system) and Compliance Demand Generation, in support of the OEC’s Global Strategic Solutions (GSS) program. Responsible for analyzing, refining, and translating stakeholder requirements into actionable opportunities for global analytics program improvement and AI enablement. Integrates GSS compliance programs with broader compliance initiatives and systems. The manager performs the following with moderate to significant supervision from the Compliance Director Responsibilities Assumes end-to-end ownership of Jira (IT development task management system) and the Demand Generation process, managing the intake, prioritization, and...

The Senior Manager of Quality System will report to the Director of Operations, Quality and Compliance within the Strategic Operations function of AbbVie Patient Services. This role is responsible for supporting the established Quality Management System, including Training, Document Management Systems, Quality Processes utilized across our patient support programs. In addition, this role will have BSO responsibilities of the Quality & Compliance Platform (GxP) housed by approved third party to ensure innovation, advancement of capabilities, reporting needs and alignment with functional program owners while ensuring SLC and Data Protection and Privacy enforcement. Responsibilities Be a champion of establishing the environment...

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 looking for experienced quality assurance associates to support our...

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

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. We prefer a candidate that is site-based (local to Foster City). You will be on site Tuesday, Wednesday, Thursday. For non-local talent,...

We're seeking a driven and talented Validation Engineer to support manufacturing operations through close collaboration with cross‑functional partners. This role is critical in defining, implementing, and maintaining validation activities that ensure robust, compliant manufacturing processes and systems. The ideal candidate brings experience in quality engineering, process development, or process engineering, and can quickly develop while working independently within a fast‑paced, team‑oriented environment. As a Validation Engineer, you will play a key role in driving overall quality performance and compliance by leading validation deliverables and activities across manufacturing systems and processes. Responsibilities Represent the Consumable Validation group as the validation subject...

The Director, Clinical Quality & Development Operations (CQDO) Inspection Excellence is a key contributor in Global Clinical Operations (GCO’s) audit and inspection management program, focusing on GCP health authority inspection planning, logistics, pre and post inspection support, ensuring all activities are conducted in compliance with health authority regulations (e.g. FDA, EMA, etc.). In addition, the Director will also contribute to regulatory intelligence activities, partner with local R&D functions and study teams to create a quality culture within Vertex and help reach a sustained state of inspection readiness. Key Duties and Responsibilities Lead inspection readiness and inspection preparation activities for GCO,...

As a Post Market Quality Engineer II where you'll play a pivotal role in driving quality excellence and continuous improvement. Reporting to the Post-Market Quality Director, you will be working with the post market team on analysis of complaints and quality data, Health Risk Assessments, conduct Product hold, field action activities, and manage quality improvement projects. Based in Colorado, this position offers the opportunity to work in a dynamic, innovative-driven environment where your analytical skills will directly impact product quality and patient safety. Responsibilities may include the following and other duties may be assigned. Maturing Post Market trending – the...

At Medtronic, quality is at the heart of everything we do—it’s how we fulfill our Mission to alleviate pain, restore health, and extend life. As a Quality Engineer II at our Nathan Lane Manufacturing site, you will be at the forefront of driving excellence in our products and processes. You’ll leverage your experience to ensure our life-changing therapies meet the highest standards of quality, compliance, and reliability. This role requires you to be onsite Monday through Friday, providing you the opportunity to collaborate closely with cross-functional teams in a fast-paced, hands-on environment. If you’re ready to take on a meaningful...

Our Vascular business develops innovative, minimally invasive, and cost-effective products for the treatment of coronary and peripheral vascular disease. Quality Engineer I is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You’ll Work On Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Assist in the implementation of assurances,...

As a Quality Inspector III at our Billerica site, you will be essential in making sure our cutting-edge cardiac ablation devices meet the highest quality and safety standards. You will meticulously examine components and assemblies, ensuring they meet precise specifications and function correctly. Leveraging your expertise and the appropriate tools, you will assess whether products conform to our stringent quality criteria or require modifications. By adhering to established protocols and instructions, you'll contribute to operational efficiency and guarantee the safety and reliability of our products for patients. Your sharp attention to detail and unwavering dedication to quality will reinforce our...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized...

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 Process Quality Technician. Purpose Under the direction of the Process Quality Leader, the PQT is responsible for providing support to Process Quality Leader, Manufacturing Manager and Technical teams on activities related to identify causes for non-conformances and process failures, process improvement, and quality improvement activities. Updates supervisor of work status or problems with recommendations...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized...

What You Will Achieve As a Senior Manager, Document Quality Reviewer , you will manage projects and conduct document quality review (DQR) on the clinical components of documents authored by Vaccine Clinical Research (VCR) across VCR global sites. DQR includes clinical data checking/consistency checking, clinical editing, checking for uniformity and compliance with Pfizer and clinical guidelines. Day-to-day goals and priorities are guided by Vaccine Clinical Research objectives and priorities. How You Will Achieve It Independently performs DQR of clinical components of assigned documents (e.g., protocols, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses, etc.). Formally documents quality review...

The Associate Director, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. Responsibilities include developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading cross-functional process improvement efforts to help achieve business performance goals for regulatory compliance and productivity. Responsibilities Provides project management leadership in support of GRPTs; develops schedules and wave plans to ensure regulatory...

This role is critical to turning strategy into action, helping drive business goals, regulatory compliance, and continuous improvement. We’re looking for a motivated, detail-oriented professional to join our team and lead the preparation and approval of key quality documents, including Annual/Periodic Quality Reviews, Quality Agreements, and technical reports and memos. In this role, you will serve as the site lead for center of excellence teams and partner cross-functionally with Quality Control, Product Quality Assurance, PDST, Validation, and Compliance to drive document alignment and approvals. You will also work directly with third-party clients, suppliers, and other network sites to ensure timely...

The Associate Director, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. Responsibilities include developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading cross-functional process improvement efforts to help achieve business performance goals for regulatory compliance and productivity. Responsibilities Provides project management leadership in support of GRPTs; develops schedules and wave plans to ensure regulatory...

The Associate Director, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. Responsibilities include developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading cross-functional process improvement efforts to help achieve business performance goals for regulatory compliance and productivity. Responsibilities Provides project management leadership in support of GRPTs; develops schedules and wave plans to ensure regulatory...

The Associate Director, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. Responsibilities include developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading cross-functional process improvement efforts to help achieve business performance goals for regulatory compliance and productivity. Responsibilities Provides project management leadership in support of GRPTs; develops schedules and wave plans to ensure regulatory...

The Associate Director, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. Responsibilities include developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading cross-functional process improvement efforts to help achieve business performance goals for regulatory compliance and productivity. Responsibilities Provides project management leadership in support of GRPTs; develops schedules and wave plans to ensure regulatory...

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 Senior Clinical Quality Specialist is part of the clinical affairs team, which is responsible for planning, executing, managing, and closing projects associated with the company clinical study plans. The Senior Clinical Quality Specialist will partner with the...

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...

Principal Objective of the Position Provide GxP subject matter expertise to support an effective and knowledgeable GxP Data Integrity Governance tower within the Global Quality GxP Data Integrity organization, with a focus on remediation activities being performed at the sites and functions. Accountable for helping establish and maintain an end-to-end (PDS and R&D) Data Integrity Governance program to ensure that regulatory and BMS requirements are addressed thoroughly and effectively in a timely manner. Additionally, may support oversight for the management of electronic records and/or electronic signatures in compliance with worldwide health authority regulations. Key Responsibilities and Major Duties In conjunction...

Employer Biosense Webster, Inc. Staff Quality Engineer - Quality LCM Job Code A011.5768 Job Location Irvine, CA Job Type Full-Time Rate of Pay $125,000 - $150,000 Job Duties Plan and coordinate quality assurance projects and activities throughout lifecycle of BWI's products, primarily electrophysiology catheters, cables, and systems. Serve as subject matter expert on Quality LCM (Life Cycle Management) matters. Use Quality Engineering tools/processes in the development and implementation of practices for effective and efficient development, transfer, and maintenance of products, including manufacturing transfers, project management, shelf life evaluations, and compliance. Collaborate with QE-NPD, R&D, PMNPD, Operations/Supply Chain, BWI-Israel and...

Analyst, Quality Control (P-23_E4) Entry to developing individual contributor, who works under close supervision. Assists staff in various processes in the Quality Control function. Supports day-to-day laboratory activities such as sample management, supply ordering and receipt, and general housekeeping. Assists with analysis, qualification/validation activities, and lab investigations. Supports data review and metrics reporting. Executes continuous improvement projects with supervision. May execute testing under supervision. Assists laboratory staff with sample receipt, management of reagents and supplies, and general housekeeping. Tests samples of finished goods under general supervision. Applies developing knowledge of Quality Control standards to review results of quality analysis...

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

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....

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...

Quality Engineer I This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Quality Engineer I , you will assure new or modified products conform to requirements and establish compliance with the quality system. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. You will support new...

The Quality Assurance Engineer II position works out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This position is responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medica device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. Lead/support design planning efforts to include heading CFTs; establishing deliverables and tracking completion...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week at our Jacksonville Florida facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This This position has the responsibility and authority to support the development and implementation of the overall objectives and long-range regulatory strategies that impact both the introduction of new products and the market status of existing products. The Principal Regulatory Affairs Specialist will exercise a leadership role and serve as a mentor...

This is a seasoned individual contributor role responsible for developing, implementing, and maintaining rigorous quality standards and protocols during the sustaining and post-market phases of the product lifecycle. The Specialist serves as a key technical expert, working with limited supervision, who must demonstrate substantial expertise in risk management (e.g., assessing product risk and supporting field actions). This role involves providing design-quality oversight for product changes (including design change analysis and DHF maintenance), and using advanced inspection, testing, and statistical analysis methods to ensure product precision, accuracy, and compliance with all required standards and documentation. A successful candidate will drive process...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This position will support international registrations for the Acute Care & Monitoring Operating Unit products. Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling,...

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 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 Lilly is actively growing its manufacturing footprint globally to meet...

Associate Director – Global Compliance Platform (C3) What you will do In this vital role you will be responsible for the strategic oversight, governance, and optimization of Amgen’s global compliance platform (C3). This role ensures the platform effectively supports the execution of Amgen’s global healthcare compliance framework and enables compliant business operations across regions. The Associate Director leads platform strategy, drives process improvement and system optimization, and partners closely with Technology, Compliance, and business stakeholders to ensure the platform evolves to meet changing regulatory and operational needs. Serving as the business product owner for the C3 platform, this role...

US Regulatory Lead What you will do US Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules. The Local Regulatory Representative (Manager) is assigned to one or more Amgen products, and plans and executes the Regulatory strategies for that product(s) in their country(ies). The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen. Assist in aligning local regulatory requirements with Amgen’s corporate standards. Provide local input to and execute regulatory strategies. Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements. Provide...

Director, Global Regulatory Lead – Obesity & Related Conditions What you will do The Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions—a rapidly evolving therapeutic area requiring sophisticated scientific, clinical, and regulatory assessment. The GRL is accountable for developing and executing global regulatory strategies, shaping cross-functional decision-making, and leading global interactions with Health Authorities and external partners. This role ensures regulatory strategies fully reflect the unique scientific, mechanistic, and clinical complexities of metabolic disorders. Key Responsibilities Regulatory Strategy & Scientific Leadership Develop and lead global regulatory strategy for obesity...

United States Regulatory Manager – Obesity and Related Conditions What you will do Amgen is seeking a United States Regulatory Lead (USRL) Manager supporting products in the Obesity and Related Conditions Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. In this product-facing role, you will develop and execute U.S./regional regulatory strategy and tactics under general supervision, represent the region on global teams, and lead U.S. regulatory execution to enable clinical trials and maintain commercial licenses in compliance with local laws, regulations, and Amgen...

Director, Global Regulatory Lead – Obesity & Related Conditions (Chronic Weight) What you will do The Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions—a rapidly evolving therapeutic area requiring sophisticated scientific, clinical, and regulatory assessment. The GRL is accountable for developing and executing global regulatory strategies, shaping cross-functional decision-making, and leading global interactions with Health Authorities and external partners. This role ensures regulatory strategies fully reflect the unique scientific, mechanistic, and clinical complexities of metabolic disorders. Key Responsibilities Regulatory Strategy & Scientific Leadership Develop and lead global regulatory strategy...

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. We have an exciting opportunity within US Medical Affairs for a Senior Manager in our Patient Access and Quality of Care (PAQ)...

About the Role This application is for a 6-month student role from July - December 2026. Resume review begins in January 2026. The Global Trade Compliance team’s mission is to enable Biogen’s purpose and commitment to patients, shareholders and communities by managing risks, creating values, driving excellence in execution and critical capabilities. We do this by ensuring that all our products (finished drugs, drug substances, clinical samples, etc.) move across multiple countries in compliance with international trade regulations and without delays. Global Trade Compliance also pays a key role across Biogen’s end to end business planning by completing due diligence...

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. With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on...

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

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 Collect Environmental Monitoring (Viable Air, Viable Surface, Non-Viable Air Samples) and Critical...

Compliance Specialist uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within Engineering & Maintenance operations. Engineering & Maintenance Compliance Team is responsible for managing change controls, CAPAs and deviation intake and closure across GMP activities in the following areas - Metrology, Engineering, Facilities, Utilities, Validation, Automation and Capital Projects. The responsibilities of the team primarily extend to owning deviations relating to facilities, equipment and utilities and their associated systems. The Senior Compliance Specialist is responsible for developing programs and metrics to ensure all aspects of engineering and maintenance are compliant. About Sanofi We...

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

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

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...

Sarepta is searching for an experienced professional to lead and support critical activities related to Sarepta’s Regulatory Information Management System (RIMS), which is used to develop regulatory submissions for dispatch to health authorities globally. The Senior Manager, RIM will have responsibility for assuring that RIMS is used in an effective manner across the organization in adherence to applicable internal procedures and guidelines, that users have the knowledge, skills, and training to use RIMS effectively for their needs, and that RIMS is monitored from a data perspective. The Opportunity to Make a Difference Engage with stakeholders to define and improve internal...

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 an Associate Director, CMC Regulatory Affairs for Biologics, at Gilead you will be responsible for defining regulatory strategy for one or...

About the role The Head of Regulatory Legal is responsible for developing and leading the global legal strategy supporting Global Quality (GSQ), Research & Development (R&D), Regulatory Affairs, and Plasma Derived Therapies (PDT) across the enterprise. This role provides high-level legal counsel on regulatory matters (FDA, EMA, and other global agencies), manufacturing, supply chain, and the product development lifecycle from research through clinical trials. As a trusted advisor to senior leadership, the Head of Regulatory Legal leads a team of legal professionals, ensures compliance with all relevant laws and regulations, mitigates legal and regulatory risks, and collaborates across business units....

Under general supervision, participate in new and sustaining product/process teams to support design verification tests, process validations, quality processes. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will work on complex problems and projects. Will show leadership by innovating compliant approaches and solutions to problems. Will receive technical guidance on sophisticated problems, but independently develops...

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - CAR-T in Raritan, NJ! This shift is going to be scheduled 400pm - 200am through Sunday - Wednesday. 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...

The Senior Manager, Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC), works with internal stakeholders and external partners to deliver products to patients. This individual prepares CMC regulatory strategies that enable first pass approvals. The Senior Manager develops and manages the content strategy for regulatory submissions, which include INDs, CTAs, amendments, new marketing applications, and supplements or variations. They build and maintain relationships within the Regulatory Affairs functional areas, as well as Operations and Research & Development (R&D) organizations. The Senior Manager represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams, where they negotiate,...

The Senior Manager, Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC), works with internal stakeholders and external partners to deliver products to patients. This individual prepares CMC regulatory strategies that enable first pass approvals. The Senior Manager develops and manages the content strategy for regulatory submissions, which include INDs, CTAs, amendments, new marketing applications, and supplements or variations. They build and maintain relationships within the Regulatory Affairs functional areas, as well as Operations and Research & Development (R&D) organizations. The Senior Manager represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams, where they negotiate,...

The Manager, Regulatory Affairs Submission Management is responsible for providing expert support and continuous improvement for all publishing systems used by the RA Submission Management team. Responsible for providing functional leadership in system upgrades, process enhancements, and large scale platform initiatives, while also fostering collaboration across global Submission Management teams. This role is responsible for ensuring robust and efficient operations, driving innovation, and advocating for timely delivery of technology solutions. Responsibilities Serve as the primary point of contact and subject matter expert for publishing related systems, providing day-to-day support and guidance. Partner with BTS to lead and execute system upgrades...

The Manager, Regulatory Affairs Submission Management is responsible for providing expert support and continuous improvement for all publishing systems used by the RA Submission Management team. Responsible for providing functional leadership in system upgrades, process enhancements, and large scale platform initiatives, while also fostering collaboration across global Submission Management teams. This role is responsible for ensuring robust and efficient operations, driving innovation, and advocating for timely delivery of technology solutions. Responsibilities Serve as the primary point of contact and subject matter expert for publishing related systems, providing day-to-day support and guidance. Partner with BTS to lead and execute system upgrades...

The Senior Manager, Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC), works with internal stakeholders and external partners to deliver products to patients. This individual prepares CMC regulatory strategies that enable first pass approvals. The Senior Manager develops and manages the content strategy for regulatory submissions, which include INDs, CTAs, amendments, new marketing applications, and supplements or variations. They build and maintain relationships within the Regulatory Affairs functional areas, as well as Operations and Research & Development (R&D) organizations. The Senior Manager represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams, where they negotiate,...

The Senior Manager, Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC), works with internal stakeholders and external partners to deliver products to patients. This individual prepares CMC regulatory strategies that enable first pass approvals. The Senior Manager develops and manages the content strategy for regulatory submissions, which include INDs, CTAs, amendments, new marketing applications, and supplements or variations. They build and maintain relationships within the Regulatory Affairs functional areas, as well as Operations and Research & Development (R&D) organizations. The Senior Manager represents CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams, where they negotiate,...

The Associate Director of Regulatory Strategic Writing (RSW) is responsible for providing leadership and direction for clinical and regulatory writing projects for one large or multiple compounds within a therapeutic area within budget, with quality, and in accordance with timelines. Responsibilities Directly leads multiple individual contributors located in geographically disbursed locations with oversight of both internal and external staff. Assists in the selection of freelance consultants or other vendors. Participates in continual improvement across Strategic Medical Writing best practices, processes, and performance. Leads execution of cross-functional initiatives. Effectively utilizes project management tools/techniques to drive multiple projects; responsible for overall project...

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. Open to our Newton, MA or Mounds View, MN offices. Join Medtronic as a Software Reliability Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll...

Position Overview The VP Global Patient Safety & Global Safety Therapeutic Area Head - Oncology will be responsible and accountable for the definition and execution of the worldwide pharmacovigilance strategy for all investigational and marketed products in their Gilead Therapeutic Area. The VP will lead broadly in a cross-functional and multi-cultural environment and leverage extensive scientific and pharmacovigilance experience to represent Global Patient Safety in discussions with senior leadership, Executive Management and regulatory authorities and lead benefit/risk efforts for the specific therapeutic area across the company. Key Responsibilities Strategic Thinking Set the overall safety strategy for a specific therapeutic area...

Essential functions include, but are not limited to Requires knowledge and experience in the Quality Control discipline and solves a range of straightforward problems. Analyzes possible solutions using standard procedures. Builds knowledge of the company, processes, testing and customers. Receives a moderate level of guidance and direction and also proactively seeks advice/information from others when addressing serious business issues that may impact other functions. Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group while contributing and adding value to the achievement of team goals. Demonstrates a deep understanding of customer needs, requirements, and expectations. Continuously...

The Forensics & Compliance internship program is a full-time summer work experience focused on providing college students with practical compliance and forensics experience. It allows them to develop leadership, technical, and communication skills as well as broaden their understanding of the concepts learned in school and "get a taste of the real world" before they are fully committed to it. Internship participants will be better able to apply concepts learned in the classroom and to ask more poignant questions of their professors to further their goals and education. Forensics & Compliance internship applicants must demonstrate strong communication, organization, and critical...

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of Quality Control, CAR-T Manufacturing! This position will be located in Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone...

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 Director, Global Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote work options may be considered...

Johnson & Johnson is hiring for a Sr. Quality Engineer, Design Assurance – Shockwave (Reducer) to join our team located in New Brighton, MN. Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the innovative Shockwave Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. To support the growing Shockwave Reducer business, we are establishing a facility in New Brighton, MN focused...

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

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

This Regulatory Affairs Specialist will work out of our Alameda, CA location in the Diabetes Care Division. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment are followed. With limited supervision you will execute tasks and partner across business functions. The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data, and ensuring that the information is reliable and effectively presented to substantiate claims. You may also have opportunities to participate in...

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

The Supplier Quality Specialist works out of our Princeton, NJ location in the Abbott Point of Care Diagnostics business. Our Point of Care Diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology. This role supports 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 improvement activities. What You’ll Work On Ensures that the division’s approved supplier list is maintained and accurate. Assesses potential new suppliers and service providers for quality and quality system capabilities through the execution of...

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

As the Executive Director, Strategy & Program Excellence for the Compliance & Ethics (C&E) department, you will report directly to the SVP, Chief Compliance & Ethics Officer (CCEO) at Bristol Myers Squibb. You will serve as a senior strategic advisor and program leader, driving the ongoing assessment, innovation, and continual enhancement of BMS's healthcare compliance program. You will be a member of the Compliance & Ethics Leadership Team (CELT), partnering closely with all verticals of the C&E organization — both locally and globally — as well as key enterprise stakeholders across Legal, Finance, Internal Audit, Corporate Communications, and beyond. The...

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. Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. This critical role Influences the development of external regulations, guidance, policy, and other initiatives that are external and relevant to Sanofi. Obtains Quality Intelligence through regulatory surveillance, benchmarking and participating in Trade and Industry Associations. Serves to clarify the existing regulatory framework to inform our internal compliance...

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...

Head of Clinical, Regulatory, Quality & Therapeutic Area Unit (TAU) Data, Digital & Technology (DDT) Location Cambridge, MA (Hybrid) Level Vice President I Job code DD_TGM_J_DDA_P Reports to Head, R&D and Global Medical Data, Digital & Technology (DD&T) Role on Leadership Team Member, R&D and Global Medical DD&T LT Role Overview Takeda is recruiting an accomplished executive to serve as Vice President and Head of Clinical, Regulatory, Quality & Therapeutic Area Unit (TAU) Data, Digital & Technology (DDT). This strategic leadership position requires partnering closely with Clinical Development, Regulatory Affairs, R&D Quality and Therapeutic Area Units to advance business-facing technology...

Expected Areas of Competence Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement. Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders Develop registration strategy for a product, and translate that into operational...

The Senior Director, Global Logistics, Warehousing and Trade Compliance is responsible for defining and executing the global strategy, operational leadership, and compliant storage and movement of materials supporting R&D, Clinical, and Commercial programs across Beam. This role provides end‑to‑end leadership across global logistics operations, warehousing networks, and trade compliance, ensuring reliable supply, regulatory adherence, and scalable infrastructure to support pipeline growth and commercialization. This position reports to the Vice President, Supply Chain and serves as a key member of the Supply Chain Leadership team, partnering closely with Technical Operations, Quality, R&D, Finance, Legal, Procurement, Clinical Patient Supply and Commercial Patient...

POSITION SUMMARY Manage a team dedicated to executing Natera’s billing strategy. This highly important function will lead our efforts to collect payments for our services from third-party payers and assist the Sales Team. The Supervisor is responsible for coaching, developing, motivating, and leading the quality specialist team. PRIMARY RESPONSIBILITIES Effectively develops, monitors, coaches, and manages staff, ensuring the development of employees through orientation, training, establishing objectives, communication of rules, and constructive discipline. Promotes a positive working environment through role modeling, team development, respect, fairness, and consistency. Assists withfeedbackfor hiring, discipline, and performance evaluations. Responsible for monitoring ,...

The Quality System Documentation Specialist is responsible for performing activities that directly support execution of site processes. The incumbent will support quality systems, with a focus on documentation and training process support. We are seeking a highly motivated individual to join us and assist with document processing and other duties related to the processing and archival of documentation. The successful candidate is proficient in communication (written and verbal), can multi-task, is a time-line focused and flexible in their work schedule. You will be expected to provide support for both the Santa Monica, CA and Tarzana, CA sites as needed. Essential...

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. Eli Lilly RTP is a new state of the art Parenteral,...

The Director in Global Clinical Supply (GCS) Compliance is a technical leader responsible for governing and advancing GCS’s global GxP Quality Systems to ensure the organization executes clinical supply operations in a compliant, inspection‑ready, and risk‑based manner. GCS supports Phase I–IV trials across 60+ countries in alignment with local and regional regulations for GxP (GMP, GDP, and GCP) and Environmental Health & Safety. This role provides global‑level oversight and strategic direction across key GCS compliance processes—including deviations, CAPA, change control, documentation, training, audits/inspections, analytics, risk management, and safety—while recognizing that individual depth may vary by area. Directors are expected to...

Staff Quality Engineer for TRB & Change Control SME for JJV. Primary Focus Position Overview This role combines Technical Review Board leadership with Global Change Control governance in Johnson and Johnson Vision (JJV &JJSV). The position is responsible for leading TRB discussions, ensuring compliant and efficient change management, and driving continuous improvement across quality systems. Exceptional communication skills, the ability to facilitate challenging conversations, and a strong leadership presence are required for this role. In-depth knowledge of medical device Quality Management Systems (QMS), Risk Management, and Change Management processes is expected, along with the confidence to challenge assumptions and guide...

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

REGULATORY AFFAIRS SPECIALIST Onsite Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA, European, and Canadian submissions for product changes to ensure timely approval for market release. Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls....

The Brooklyn Center facility also known as Medtronic Electronics Components Center (MECC) supports the production of components used in devices for a variety of Medtronic Operating Units (OUs). The Senior Quality Engineer serves as the Quality decision‑making partner on cross‑functional development and sustaining engineering teams at the MECC site. This role leads risk‑based quality planning across design, manufacturing, and supplier interfaces, providing strategic quality guidance throughout the product lifecycle. The Senior Quality Engineer is accountable for ensuring quality readiness prior to MECC Decision Points (MDPs) and market release, proactively identifying and mitigating risks to ensure compliance and product integrity. It...

Supplier Quality Engineer II – Pre-Market, Cranial & Spinal Technologies Onsite – Memphis, Tennessee In this role as a Supplier Quality Engineer II, you will support Pre-Market Supplier Quality Engineering activities for the CST Operating Unit. The Supplier Quality team primarily supports NPI (New Product Introduction) projects and supplier management activities and processes. Cranial and Spinal Technologies (CST) is redefining cranial and spinal procedures to reduce variability and improve outcomes with the goal of restoring long-term quality of life for more patients. CST is the market leader in spinal implants, robotics, and navigation. The scope of this position will...

Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In this dynamic role as a Senior Quality System Specialist, you will play a key role in overseeing the development, implementation, and maintenance of quality systems, programs, processes, and procedures that ensure compliance with company policies and regulatory standards. You will work both independently and collaboratively across teams and functions to uphold the highest standards of...

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

Join Medtronic as a Sr. Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to support design and development of cardiac surgery products. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare. Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to...

About BioLife Plasma Services BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Limited, is an industry leader in the collection of high-quality plasma, which is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma can’t be made synthetically, many people rely on plasma donors to live healthier, happier lives. BioLife operates 250+ state-of-the-art plasma donation centers across the United States. Our employees are dedicated to enhancing patients' quality of life and ensuring that the donation process is safe, straightforward, and rewarding for donors who wish to make a positive impact....

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...

Regulatory Affairs Manager Our location in Lake County/Abbott Park, IL, currently has an opportunity for a Regulatory Affairs Manager . WHAT YOU’LL DO The Latin America Manager of the Regulatory Affairs Innovation oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports for pediatric nutritional products distributed in Latin America. Interacts with Affiliate Regulatory, Division Regulatory, international manufacturing plants, and other Divisional functional areas. Serves as regulatory liaison throughout product lifecycle. Participates in some of the following Innovation product plan development and implementation, regulatory submission strategy, risk management....

This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As the Quality Engineer II you will be responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. You will lead/support design planning efforts to include heading CFTs; establishing...

Ready to redefine what's possible in molecular diagnostics? Join a team of brilliant, passionate innovators determined to transform healthcare. At BillionToOne, we've built a category-defining, publicly traded company on Nasdaq where transparency fuels trust, collaboration drives breakthroughs, and every contribution moves the needle on our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we build products that are 10x better than anything that exists today. With over 700 employees, half a million patients helped, and one of the most successful IPOs in medical diagnostics history behind us, we're just getting started. Our scientists,...

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. This position works out of our Westford, MA location in the AVD Vascular division. Supplier Quality Engineer is r esponsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner. What You’ll Work On Supplier Audits Develop and execute to a supplier audit schedule per current requirements. Develop audit plans and associated supplier communications. Approve and monitor Supplier CAPA plans and activities to closure...

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 ROLE We are seeking a high caliber Software Quality Engineer supporting the design and development of company products ( mainly mobile apps) , software reliability , developing and maintaining processes and...

The Cardiovascular portfolio delivers innovative therapies and technologies to diagnose, treat, and manage cardiovascular disease. It spans solutions for coronary and peripheral artery disease, structural heart and aortic conditions, cardiac rhythm management, and hemodynamic monitoring. The portfolio focuses on improving clinical outcomes, enabling less invasive care, and supporting physicians and health systems with integrated, evidence‑based solutions that enhance patient care and procedural efficiency. 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...

The Principal Radio Regulatory Affairs Specialist is responsible for managing global RF/Wireless regulatory compliance activities for RF enabled devices within the Acute Care and Monitoring (ACM) Operating Unit. The Principal Radio Regulatory Affairs Specialist is dedicated to the Acute Care and Monitoring (ACM) Operating Unit. In this role, the specialist supports both New Product Development (NPD) programs and lifecycle maintenance activities across the RF enabled device portfolio. The specialist collaborates closely with Regulatory Affairs colleagues, cross functional partners at all levels, external test laboratories and certification bodies, and International Regulatory Affairs teams to ensure ongoing compliance with global RF, wireless,...

Are you ready to shape how we communicate life-changing science to patients and healthcare professionals—safely, compliantly, and with impact? This role leads the US advertising and promotional compliance strategy for assigned products, ensuring our external communications are scientifically rigorous, fair-balanced, and fully aligned with FDA requirements. You will partner closely with cross-functional colleagues in medical, legal, regulatory, commercial, and regulatory operations to drive high-quality promotional and scientific materials from concept to submission. Can you anticipate regulatory risk and translate complex guidance into clear, actionable direction for teams? Your work will enable timely launches, confident market presence, and consistent, ethical engagement...

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 Trade Operations Compliance Assurance Senior Analyst to be based in New Brunswick, 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 Purpose The Trade Operations Compliance Assurance Senior Analyst will support hands‑on operational ownership and tactical oversight of North America Post Entry Review Process, ISF Filings, Customs Bond management and Power of Attorney accuracy record retention, including Southern Border. This role...

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity, and innovation. Abiomed is recruiting for an Entry‑Level Supplier Quality Engineer — Electronics to be located in Danvers, MA. About MedTech...

We are searching for the best talent for a Design Quality Engineer II, Lifecycle to be based in Danvers, MA. Purpose This person will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products! Activities will include risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support statistical analysis and more! This role’s emphasis will be in support of Abiomed’s existing single-use heart pumps. You will be responsible for Support and lead Design Assurance engineering activities in support of Abiomed’s Life Cycle processes including design controls,...

Johnson & Johnson is currently recruiting for an Innovative Medicine Transformation IT Compliance Senior Manager (Transcend Program) and the role will be based in Titusville, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn...

We are searching for the best talent for a Senior Design Quality Engineer I to be based 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 Purpose This person will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products! Activities will include risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support statistical...

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

(This position is part of our Corporate Legal Compliance team). Plays a key role in strengthening and enhancing the Company’s compliance monitoring and analytics capabilities by leading data-driven monitoring initiatives and translating risk into practical, measurable monitoring processes and reporting mechanisms. _ Your Contributions (include, but are not limited to) Independently scope, design, and implement data-driven compliance monitoring initiatives in alignment with Compliance leadership priorities. Translate compliance requirements into measurable monitoring frameworks, dashboards, and key risk indicators (KRIs). Develop, maintain, and enhance compliance dashboards and reports to support leadership oversight. Identify opportunities to strengthen monitoring and analytical processes. Conduct risk-based...

Your skills could be critical in helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with other key functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines. You'll be asked to solve problems creatively and strategically, and introduce innovative concepts to more effectively manage ad/promo projects. This is a subject matter expert role wiht no direct reports, though there will be mentoring, training and team leadership opportunities. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s...

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. Ensures that Sanofi Quality and Compliance Standards, and applicable regulatory authorities’ requirements are met and that all Sanofi sites, Operational Units, affiliates, and third parties achieve, maintain and improve the adequate level of compliance, through independent auditing and follow-up. Job Family Group Quality - Audit Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. About Sanofi...

About the role As a Quality Associate II at the Takeda Round Lake aseptic pharmaceutical manufacturing facility, you will work to perform review and approval of released raw material documentation. You will focus on product quality and compliance through Documentation review (Batch records, electronic batch records, etc.), Investigation/Change control approvals and Quality oversight of manufacturing processes. How you will contribute Responsible for raw material and bulk container receipts, release, and investigation if any issues are found. Follow-up with appropriate Takeda facilities for documentation correction in timely manner. Manufacturing support activities including batch record documentation, issuance of Batch record, approval of...

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. As Executive Director, Global Regulatory Affairs CMC Early Development you will p rovide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development, maximizing global regulatory success and minimizing time to...

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned...

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

Sr Supplier Quality Engineer Cranial & Spinal Technologies Onsite We are seeking a committed professional to join our team. This position is onsite in Fort Worth, TX to support collaboration with local teams and global suppliers. We value what makes you unique. Together, we can change healthcare worldwide. In this exciting role as a Senior Supplier Quality Engineer, you will have responsibility for supplier quality activities for the CST O perating Unit (O U ) . The Supplier Quality team primarily supports NPI (New Product Introduction) projects and supplier management activities and processes for the OU. Cranial and Spinal...

Join Medtronic as a Sr. Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to support design and development of cardiac surgery products. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare. Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to...

This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This position is responsible for activities related to design control, qualification, specification, and corrective and preventive action (CAPA) of medical devices, including software as a medical device (SaMD), digital platforms, and globally deployed web‑based systems supporting regulated products. The role will have a particular emphasis on governance, design control,...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. This is an on‑site role within the Cardiac Rhythm Management division, supporting the Operations Quality Engineering team based in Minnetonka, Minnesota . In Abbott’s Cardiac Rhytem Management (CRM) business, we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough...

In GBS we dare to change the way we work—being brave, resilient, and focused on simplifying how we deliver value. Through our global scale and diverse services, we drive outcomes with innovation and expertise. This requires a team that sees no boundaries, collaborates across functions, challenges the norm, and feels empowered, motivated, and engaged. The Senior Director, Compliance and Legal Services will lead the global build-out and maturation of a cohesive service portfolio spanning Compliance, Privacy, Legal Operations, and eDiscovery within GBS. Reporting to the Head of GBS Operations & Enabling Functions Services, this role supports strategy build, is the...

Our team is involved in developing regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in the development stage of drug products. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? The Regulatory Strategist provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within...

Purpose Ensure GxP compliance to AbbVie policies/processes/procedures, global regulatory requirements, and industry guidelines. Remain current with major compliance trends and their application within the biopharmaceutical industry. Evaluate organizational compliance needs and opportunities to improve efficiency and productivity. Serve as a business compliance liaison for Development Sciences (Dev Sci) scientific personnel involved in pipeline research and product development. Collaborate with cross-functional teams, including personnel from Dev Sci, Legal Operations, Office of Ethics and Compliance, Corporate Affairs, Outsourcing, Pharmacovigilance & Patient Safety, Global Scientific Publications, external partners and vendors, and other R&D groups, to ensure compliance with relevant policies, regulations, and industry...

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

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

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

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

This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for supporting day to day sustaining activities in a manufacturing environment. The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results. This position will have direct interaction with Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. The position may also have quality oversight for more than one manufacturing area. The position will be responsible to support change management activities, Nonconformances, equipment lifecycle, meeting facilitation and...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Senior Quality Program Manager – Quality Core Team Member (QCTM) and be at the forefront of transforming lives through advanced medical technology. In this highly visible role, you will serve as the Quality Core Team Member for...

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

This position works out of our Austin, TX location in the Abbott Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This role manages the Quality System for third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance. The role is responsible for keeping all the QS elements consistent and effective for its purpose. Ensures implementation of TPM related Quality Assurance policies...

PURPOSE OF THE ROLE The Senior Manager, Quality Engineering provides enterprise‑level leadership across Quality Engineering and Compliance functions, ensuring the effectiveness, sustainability, and business integration of the Quality Management System (QMS). The role is accountable not only for regulatory compliance and product quality, but also for driving measurable business outcomes —including cost optimization, throughput improvement, and operational risk reduction—through data‑driven quality strategies . This role serves as a key quality leader influencing decisions across manufacturing, engineering, supply chain, and capital delivery functions, while advising executive leadership on quality performance, trends, and risk. KEY RESPONSIBILITIES Enterprise Quality Leadership & Governance Provide...

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

The Reliability Engineer is responsible for ensuring medical devices meet lifetime, safety, and performance expectations through rigorous testing, data analysis, and cross-functional collaboration. This role focuses on identifying early-life failures, improving product robustness, and supporting design and manufacturing teams with data-driven reliability insights. Responsibilities Execute reliability engineering activities across the product lifecycle, including Design for Reliability (DfR) in R&D and post‑market support. Perform early‑life testing using engineering methodologies to identify components at risk of premature failure. Conduct reliability tests such as environmental, thermal, shock, vibration, and lifecycle testing; develop test methods as needed to evaluate component and system durability. Apply...

The Senior Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs. They independently perform routine audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution of audit findings, and notify relevant management of...

Role is heavily focused to support the key site digital/software/automation transformation and related validation activities. The first two years will focus on validation of digital tools (MES systems, software, etc) and may require continued administrative support of this system. Responsible to perform adequate and comprehensive qualification and validation of equipment, processes, products, and facilities at the Redwood City site to support the site goals and targets. Responsible for assuring the design, installation, implementation, data integrity and validation of computer systems meet all applicable industry standards and regulatory requirements to support the site goals and targets. System or business owner and...

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly,...

Position Quality Assurance Senior Specialist, Site Support Location Devens, Ma Support Devens site through review and approval of investigations and change controls. Provide Quality oversight and support for Technology Transfer, Automation, Cell Bank Disposition, Validation, Manufacturing Science and Technology, Master Data and Site Engineering programs. Assure the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for and hosting of regulatory and customer audits. Key Responsibilities Provides quality support to Devens Site through quality review and approval of deviations or change controls. Supports technical transfer sub-teams and the review and...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

The QA Manager, PDMA is responsible for providing leadership and oversight of Quality Compliance matters in support of quality system requirements associated with sample distribution, Supplier Controls, Risk Management, Agency inspections/internal audits, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business from receipt through shipment of final product are in compliance with corporate, governmental, and local regulations. The QA Manager, PDMA position manages a team of QA Specialists and is responsible for coordinating with applicable US Commercial areas, third party vendors, and internal cross function stakeholders to ensure...

The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes multidivisional initiatives. The Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Responsibilities Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and...

The Senior Quality Engineer, Risk Management has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending,...

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...

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. What You’ll Work On Preparation of regulatory submissions for Electrophysiology devices to achieve departmental and organizational objectives. Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities. Acts as...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We're working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In this dynamic role as a Quality Systems Specialist, you will play a key role in supporting the development, implementation, and maintenance of quality systems, programs, processes, and procedures that ensure compliance with company policies and regulatory standards. You will work both independently and collaboratively across teams and functions to uphold the highest standards of quality and...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Quality Technician III supporting the Cardiac Ablation Solutions organization, you will have responsibility for the inspection and testing of returned products as part of the complaint handling process. The Technician will be capable of supporting...

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

Biosense Webster a member of Johnson & Johnson's Family of Companies, is recruiting for an Senior Quality Engineer-NPD! This position will be located in Irvine, CA. 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 Senior Quality Engineer – plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities...

This is a full time, on-site position at our RTP facility with standard M-F business hours and occasional off-hours support About This Role As a Sr. Associate II in Quality Assurance, you will play a pivotal role in overseeing the quality strategy for our assigned internal programs and manufacturing operations at the RTP PHARMA site. You will ensure the coordination of key tactical and operational aspects, supporting batch record review, disposition, investigations, change controls, and handling post-release activities . Your expertise will drive the review and approval of critical documents, including batch reports and technology transfer documents, ensuring compliance with...

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

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. Eli Lilly and Company seeks a Quality Control Associate (R1-R3) to...

The Manager, Quality Assurance is responsible for supporting and maintaining compliance with the Quality Management System (QMS) and applicable regulatory requirements. This role ensures that manufacturing, testing, and release activities for cell therapy products are conducted in accordance with cGMP standards and company procedures. The position provides day-to-day oversight of Quality Assurance activities, supports cross-functional teams, and contributes to risk assessment and continuous improvement initiatives. This role supports operations across the Santa Monica, CA and Tarzana, CA sites and reports to the Director of Quality Site Head. Key Responsibilities Support management of the Quality Assurance team, including training, scheduling, and...

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

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. The candidate will audit/inspect/release all incoming company Animal Health pharmaceuticals, third party pharmaceuticals, medical devices, third party biologic and diluents...

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...

The Senior Quality Engineer, Risk Management has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending,...

Regulatory Affairs Strategy Lead POSITION SUMMARY Plays a key role in supporting the development of regulatory strategy on behalf of the regulatory affairs team across Natera’s products and services. Combines strong technical knowledge and understanding of regulatory requirements within at least one regional expertise, e.g. US FDA, CAP/CLIA/NYS, EU, or Japan to support the approval and registration of Natera’s products and services. Represents the RA team to internal and external stakeholders through written and verbal communication within at least one product line. May represent RA in different core teams and change control initiatives. Maintains product registrations, change assessments and post-market...

GENERAL POSITION SUMMARY The Senior Manager, RDQ Compliance is responsible for leading quality assurance and compliance activities in support of Compliance and Issues Management. This role requires expertise in overseeing investigations, root cause analysis, CAPA development, and effectiveness checks, as well as the ability to educate and guide stakeholders in performing effective root cause investigations. The ideal candidate will have experience in linking issues and risks, conducting data analysis, performing spot checks, and leveraging data trending to identify patterns and drive continuous improvement. This individual will work closely with Quality Leads, Study Team members, and other stakeholders while exemplifying Vertex...

The External Manufacturing Director – Quality Control (ExM-QC) will lead the strategic and technical oversight of Quality Control (QC) activities to ensure the highest standards of product quality and compliance for Vertex’s biologics and combination device product across development, PPQ, launch, and commercial lifecycle. This role is pivotal in driving QC excellence, fostering collaboration with internal and external stakeholders, and ensuring adherence to cGMP regulations. Reporting directly to the head of ExM-QC small molecule and biologics, the Director will play a critical role in shaping QC strategies, managing external partnerships, overseeing investigations and supporting regulatory submissions. Key Duties and Responsibilities...

Laboratory Supervisor Quality Control This position works out of our Gretna, LA location in the Toxicology , 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 Laboratory Supervisor Quality Control will oversee a small team and assist in preparing calibrators and controls, performing annual verifications, overseeing proficiency testing, assisting in method development and QC review, and other duties for which the individual is qualified...

ROLE SUMMARY Our Global Cybersecurity Governance, Risk, and Compliance team provides comprehensive blueprints for cybersecurity excellence by embedding governance, risk management, and compliance into every layer. The team is responsible for ensuring risk-based decision-making is used and that security, privacy, and regulatory compliance is integrated seamlessly with Pfizer’s organization. We are seeking an experienced Senior Director, Security & Compliance to lead the Security and Compliance Business Partners function within the Cybersecurity GRC organization. This role partners closely with R&D, PGS Manufacturing, Commercial, Digital, Enabling Services and corporate functions to ensure cybersecurity, data protection, and regulatory compliance requirements are understood, implemented,...

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. Join Lilly’s Technological Revolution A Gateway to Innovation and Global Impact...

The Senior Quality Engineer – Combination Products External Quality is responsible for the quality of assigned suppliers/contract manufacturers to ensure business objective are me with regards to on time delivery of product while assuring compliance to AbbVie requirements, applicable external regulations, and standards. Products include injection molded components, and critical device components used to manufacture AbbVie On Body Injection Delivery Systems. Responsibilities Support supplier quality development projects and continuous improvement activities. Investigate/coordinate supplier quality issues resolution with the appropriate department, including the dispositioning of non-conforming product, event, deviation, and market complaints. Initiate and follow up on Supplier Corrective Action...

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...

Johnson & Johnson Med Tech is recruiting for a Vice President of Global Regulatory Affairs, Heart Recovery located in Danvers, Massachusetts! 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 Are you passionate about improving and growing the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of...

Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. The Reg ulatory Affairs Specialist ( RAS) develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to the market. The RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required . Primary responsibilities include developing global regulatory strategies; preparing US,...

Digital & Data Quality (DDQ) GMP AI Compliance Director We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and contribute to our mission of using the power of leading-edge science to save and improve lives around the world. Responsibilities Keep abreast of emerging regulatory trends pertaining to AI use in GMP/GDP operations. Define and implement standards for GMP/GDP use of AI-based tools and applications, including data management, quality risk management, vendor assessment, human-in-the-loop role,...