Quality & Regulatory Jobs in Pharma & Biotech

This is an exciting high-impact opportunity to independently lead Biostatistics efforts advancing Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics expertise to drive the strategy and execution of complex validation experiments for multiple high-priority projects. The ideal candidate will possess exceptional communication skills and a deep understanding of biostatistics in analytical validation. PRIMARY RESPONSIBILITIES Strategic Study Design and Analysis Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products. Cross-Functional Leadership Serve as the statistical lead on multiple high-priority project teams. Partner with...

This is an exciting high-impact opportunity to independently lead Biostatistics efforts advancing Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics expertise to drive the strategy and execution of complex validation experiments for multiple high-priority projects. The ideal candidate will possess exceptional communication skills and a deep understanding of biostatistics in analytical validation. PRIMARY RESPONSIBILITIES Strategic Study Design and Analysis Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products. Cross-Functional Leadership Serve as the statistical lead on multiple high-priority project teams. Partner with...

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

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...

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

As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. Your Role You will serve as CMC-regulatory lead for assigned projects. Develop and execute CMC global submission plans and timelines in accordance with project goals You will lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmaceutical Development leads/SMEs. You will be responsible for coordination of responses to CMC...

This Senior 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...

Quality Manager, Portfolio Expansion This position works out of our Columbus, OH location in the Nutrition Division . This position is responsible for supporting the expansion of Abbott Nutrition (AN’s) Third Party Manufacturer (TPM) portfolio through all stages of qualification. This requires collaboration with cross-functional personnel to lead and actively support activities through TPM selection, evaluation, approval, and first commercial run. The position also acts as the main AN Quality point of contact during the entire qualification process. This requires establishing a robust long-term working quality relationship with the TPM and ensuring that start-up project activities are carried...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of . Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings...

Corporate Facilities and Engineering Quality Manager What you will do In this vital role you will be responsible for ensuring compliance and operation excellence within the Global Facilities Operations organization. You will also use data analytics to drive process improvements and alignment opportunities. Activities include Coordinates, leads, participates and responds in internal and external audits from Quality and regulatory agencies in facility scope managed by integrated service providers. Assists with audit programs and activities, ensuring relevant data is correct and available, when necessary. Assesses state of compliance with appropriate integrated service provider quality leads and form action plans to...

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our...

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,...

We are searching for the best talent for a Quality Engineer II, Post Market Surveillance to be based in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company. 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 A hands-on Quality Engineer II responsible for executing and owning day-to-day Post Market Surveillance (PMS) activities with particular emphasis on responding to PMS data...

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 SECTION 1 JOB SUMMARY/ DESCRIPTION* As a Co-op/Intern in the Quality Engineering organization, you will have the chance to Use state of the art tools and take advantage of training courses offered on-site. Perform testing, experimentation, verification, and validation to support product design. Assist in developing laboratory testing, interpreting data results, and recommending next steps. Learn and perform various statistical analysis techniques. Create and...

We are searching for the best talent for an Innovation Excellence Quality Engineer 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 analysis...

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....

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

We are searching for the best talent for a Senior Quality Engineer, Post Market Surveillance to be located in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company. 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 role reports directly to the Manager, Post Market Surveillance and engages in all activities related to the Abiomed post market surveillance processes. Hands...

As US Regulatory Strategist in the Innovation Franchise Therapeutic Area - General Medicines GBU within our R&D team , you will serve as a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead (GRL). You will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy and drive the execution of aligned US or global regulatory strategies for projects under development, including Health Authority interactions. In this role, you will provide regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams, contribute to the development of 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. Organization Overview Verve

Join a Culture of Collaboration and Innovation. The Opportunity The Medtronic Mindset calls on leaders to act boldly, move with urgency, collaborate effectively, and deliver results—the right way. At Medtronic, our most impactful leaders are those who step into complexity, set clear direction, and elevate teams through strong communication, accountability, and purpose. We are seeking a hands-on Supplier Quality Engineering Manager to lead a critical turnaround at our Grand Rapids, MI manufacturing site. This role is designed for a proven people leader who brings energy, decisiveness, and a track record of driving results through others. The successful candidate will quickly...

The Associate Director, Audit Strategy and Vendor Quality supports the development and execution of risk-based audit strategies across Therapeutic Areas, R&D processes, and external vendors. This role focuses on operationalizing risk-based audit plans, delivering effective audit execution, supporting quality investigations and CAPA management, as well as proactively identifying and escalating quality risks. The Associate Director will lead and support maintaining and applying the vendor quality management framework such as vendor oversight plans, quality agreements, and governance metrics and supports inspection readiness and product submission activities through consistent, risk-based quality execution in partnership with RDQ Development Quality and business stakeholders. R&D...

Position Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm) Manager Manager, Quality Assurance Shop Floor The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. In the capacity of QA Shop Floor, the Senior Specialist shall serve as one of the Quality Representatives interacting with Manufacturing, Supply Chain, Quality Control and other supporting functions. The...

PRINCIPAL OBJECTIVE OF THE POSITION The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing, and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. The incumbent is tasked with qualifying new equipment, facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve...

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,...

Purpose AbbVie is dedicated to delivering innovative, safe, and effective medicines and products that address critical health issues and make a remarkable impact on people's lives. As a Global Trade Compliance organization, we are committed to driving and pioneering best-in-class trade compliance practices in a dynamic global environment. The Supervisor, GTC – Tariff Classification, is responsible for ensuring that AbbVie’s cross-border transactions are executed in compliance with import/export regulations worldwide. This Supervisor will play a vital role in the leveraging of technology solutions in the tariff classification area that enables import/export compliance and supports cost savings activities globally. The Supervisor,...

Purpose AbbVie is dedicated to delivering innovative, safe, and effective medicines and products that address critical health issues and make a remarkable impact on people's lives. As a Global Trade Compliance organization, we are committed to driving and pioneering best-in-class trade compliance practices in a dynamic global environment. The Supervisor, GTC – Tariff Classification, is responsible for ensuring that AbbVie’s cross-border transactions are executed in compliance with import/export regulations worldwide. This Supervisor will play a vital role in the leveraging of technology solutions in the tariff classification area that enables import/export compliance and supports cost savings activities globally. The Supervisor,...

Purpose AbbVie is dedicated to delivering innovative, safe, and effective medicines and products that address critical health issues and make a remarkable impact on people's lives. As a Global Trade Compliance organization, we are committed to driving and pioneering best-in-class trade compliance practices in a dynamic global environment. The Supervisor, GTC – Tariff Classification, is responsible for ensuring that AbbVie’s cross-border transactions are executed in compliance with import/export regulations worldwide. This Supervisor will play a vital role in the leveraging of technology solutions in the tariff classification area that enables import/export compliance and supports cost savings activities globally. The Supervisor,...

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

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. Our location in Sylmar, CA , currently has an opportunity for a Staff Engineer, Customer Quality. WHAT YOU'LL DO The Staff Engineer, Customer Quality is responsible for understanding and representing the customer experience for...

The Senior Specialist Digital and Data Quality will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations. This includes involvement in all quality-related activities for computerized systems which are required by our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity. The position will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the...

PRINCIPAL OBJECTIVE OF THE POSITION The Associate Director, Quality Control Microbiology Laboratory Operations is accountable for the strategic leadership, governance, and GMP-compliant execution of microbiological quality control activities supporting commercial and clinical biologics manufacturing at the Devens site. The role ensures microbiology laboratory operations, systems, and personnel consistently meet regulatory requirements, internal Quality Management System (QMS) standards, and inspection readiness expectations to protect patient safety, product quality, and data integrity. Major Duties and Responsibilities Provide strategic and operational leadership for GMP Microbiology laboratory activities, including environmental and utility monitoring, sterility assurance, microbial testing, and microbiological release support. Establish and maintain...

Senior Technology Specialist, Veeva Quality Vault Location Lawrenceville, New Jersey At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology, and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. The primary focus of this role is the delivery of the Veeva Quality Vault portfolio and operational sprints. A secondary focus will...

Job Title External Quality Small Molecule Americas Lead Job Purpose This position is responsible is for the Quality oversight of assigned Contract Manufacturing Organisations (CMOs) in an External Manufacturing specific Region to ensure MAH’s product quality, compliance and reputation is protected. This role will be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CMO(s) and with internal stakeholders. These include Procurement, Technical, Supplier Relationship, Regulatory, Business Development, Production, Site Management and other related GSK functions. Key Responsibilities Lead Quality Agreement negotiations with CMOs and implement Quality Systems performance management,...

Job Summary The Asset Quality Lead (AQL) is responsible for driving GCP Quality by maintaining ‘quality’ line-of sight for assigned clinical trial programs/protocols. With this focus, the AQL role brings deep knowledge of GCP quality and risk management principles to asset and study teams. In partnership with the cross functional study team and functional lines in Clinical Development & Operations, the AQL will ensure program and study level quality oversight, drive quality risk management and inspection readiness activities and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS. The AQL is...

The Supplier Quality Engineer II will support Medtronic’s Brooklyn Park site by partnering closely with suppliers and internal stakeholders to ensure quality, compliance, and continuous improvement across the supply base. This role is responsible for supplier qualification, performance monitoring, and issue resolution, while driving corrective and preventive actions aligned with regulatory and quality system requirements. The ideal candidate brings strong technical judgment, a collaborative mindset, and a passion for delivering high‑quality products that ultimately improve patient outcomes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable...

As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. At Medtronic Neuromodulation (NM) and Pelvic Health (PH) our therapies use advanced stimulation, sensing, software, and digital technologies to restore function and relieve suffering for people living with movement disorders, epilepsy, chronic pain, and pelvic health disorders. Our newest generation of systems can listen...

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. Regulatory Publishing is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner with other Global...

Johnson & Johnson MedTech is recruiting for a Quality Engineer , located in San Angelo, Texas . 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 In collaboration with Operations and Engineering functions the Quality Engineer will be responsible for ensuring production of safe and effective products, while maintaining health authority and regulatory compliance. Key Responsibilities Partners with business stakeholders using Quality Engineering tools to support new product development and sustain...

About Orthopaedics 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 Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their...

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 An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Process Quality Technician. JOB SUMMARY Entry to developing individual contributor, who works under close supervision. Manages the tactical execution in the design and delivery of project and program management policies and practices. Applies project management skills, tools, and techniques...

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

As the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. Ready to get started? 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...

This position works out of our Des Plaines, IL location in the Abbott Molecular , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Specialist Quality Assurance (Supplier Quality) will support in the selection, approval, and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities. What You’ll Work On Assesses...

Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley. De acuerdo con las Buenas Prácticas de Fabricación (BPF) vigentes en Argentina, alineadas principalmente con la Disposición ANMAT 2819/2004 y su actualización Disposición ANMAT 3827/2018 – Guía de BPF, así como con...

Supplier Quality Engineer II – Pre-Market, Cranial & Spinal Technologies Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Cranial & Spinal Technologies (CST) operating unit advances surgical care for spine and cranial conditions through an integrated ecosystem of implants, navigation, robotics, imaging, and planning tools. Platforms like AiBLE enhance precision, efficiency, and outcomes for complex procedures worldwide. Check us out...

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 Manager Regulatory Affairs US Advertising & Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The Manager is responsible for 1-2 of the following therapeutic area, products or multiple driver indications for a product; develops and supervises regulatory professionals as needed. The Manager has department/group/site level influence and is generally recognized as an expert and resource within the department; supports the Director in efforts to influence the regulatory environment; shares knowledge and expertise with others in support of team activities; and analyzes broad scope implications of...

The Manager Regulatory Affairs US Advertising & Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The Manager is responsible for 1-2 of the following therapeutic area, products or multiple driver indications for a product; develops and supervises regulatory professionals as needed. The Manager has department/group/site level influence and is generally recognized as an expert and resource within the department; supports the Director in efforts to influence the regulatory environment; shares knowledge and expertise with others in support of team activities; and analyzes broad scope implications of...

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,...

The Manager Regulatory Affairs US Advertising & Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The Manager is responsible for 1-2 of the following therapeutic area, products or multiple driver indications for a product; develops and supervises regulatory professionals as needed. The Manager has department/group/site level influence and is generally recognized as an expert and resource within the department; supports the Director in efforts to influence the regulatory environment; shares knowledge and expertise with others in support of team activities; and analyzes broad scope implications of...

Position Overview The Technical Business Analyst serves as a vital link between Digital Technology teams and business stakeholders, ensuring that business needs are accurately translated into effective technical solutions. This role involves guiding moderately complex technology initiatives, with a strong emphasis on delivering impactful business outcomes and exceptional user experiences. The ideal candidate will have the capability to contribute to and drive mid-scale digital programs from concept to execution. Working closely with business partners, the Technical Business Analyst is responsible for gathering, analyzing, and clearly communicating requirements to ensure that digital solutions align with strategic goals and meet the expectations...

Job Title Manager, Quality This position works on site out of our Plano, TX site supporting the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. The Quality System Manager is responsible for developing, maintaining, and continuously improving the company’s Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulatory requirements. This role serves as the quality system owner and...

Director Quality Assurance Responsibilities The Director Quality Assurance is r esponsible for ensuring the quality of licensed and clinical products manufactured at the facility. Oversees teams focused on quality oversight of day-to-day site operations, raw material release and drug substance lot disposition. Responsible for ensuring the quality of licensed and clinical products manufactured at the facility. Provides leadership and guidance to other functional areas in areas of regulatory compliance, quality practices, and quality systems. Communicates company goals, safety practices, and deadlines to the team. Motivates team members, provides guidance and leadership, assesses performance, and helps with the development of direct...

Specialist II Quality Control Must be available to work - Wednesday through Saturday, 2PM to Midnight Responsibilities Good organizational skills, basic first-line management skills for daily operation, Situational Leadership, decision making skills Responsible oversight for the testing of raw materials, in process samples, and finished product testing according to standard operating procedures. In-direct supervision of lower level personnel. Investigate and resolve problems. Clear and concise communication to Management. Coordination of tasks to meet assigned schedule Audit support, including presenting information to regulatory agencies, and performing laboratory tours. Coordination of projects and project management. Develops solutions to complex problems requiring ingenuity...

Associate Quality Control Must be available to work 2nd Shift - Wednesday to Saturday, 2PM to Midnight Job Responsibilities Responsible for performing laboratory testing. Assist with/ complete routine tests on products and materials and help generate laboratory results, under supervision. Maintain lab from housekeeping and stocking perspective. Perform appropriate tasks in the laboratory (e.g. sample prep, recording of results) to meet needs and demands of the work plan. Set up and take down testing and other laboratory equipment and clean up the testing sites. Identify and highlight equipment and testing issues. Support with the availability of proper equipment and supplies...

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...

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and...

Johnson & Johnson is hiring for a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business 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 MedTech, Neurovascular, is recruiting a Regulatory Affairs Specialist II, to join our team. This position is remote anywhere within the continental United States. 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...

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...

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....

Associate Vice President, Quality What you will do In this vital role as Associate Vice President, Quality you will report to the Vice President Research and Development Quality (RDQ) Organization (a team of 30-40 staff will be built to serve Amgen’s Research Development Organization). The Associate Vice President, Quality will lead and provide proactive end to end quality strategies globally for therapeutic areas Oncology, Inflammation, Cardiovascular, Neuroscience and others. This role will drive the transformation of clinical quality oversight in compliance with ICH E6R3 and enable embedded quality oversight into clinical development teams. Incorporate quality by design principles to...

USE YOUR POWER FOR PURPOSE Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. WHAT YOU WILL ACHIEVE In this role, you will Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications. Conduct rigorous sampling and statistical process control procedures to identify deviations from standards. Approve investigations and change control activities to maintain compliance...

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...

Our Global Workplace and Enterprise Services (GWES) team delivers a safe, reliable, and compliant environment that supports research and production while protecting colleagues, communities, and the environment. The Senior Specialist, GWES EHS Compliance and Operations is a field‑facing, execution‑focused role responsible for day‑to‑day Environmental, Health, and Safety (EHS) compliance across assigned GWES operating areas in the SE Pennsylvania region. This role ensures reliable, compliant operations by simplifying regulatory and permit requirements, EHS standards, and site procedures into practical, site‑level processes; maintaining inspection and audit readiness; and closing commitments from permits, audits, incidents, and process safety reviews. The incumbent will lead...

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

The Quality Assurance Specialist participates the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Quality Specialist 3 ensures safety, quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures smooth and safe operations of the storage facility through stakeholder and vendor engagement. PRIMARY RESPONSIBILITIES Oversight and Ownership of a Quality System (e.g. Change Control Lead including system and board lead) Collecting and trending quality metrics Assistance and leadership in CCRS, CAPAs, Deviations, SCAR, Complaints, and NCRs and filing...

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

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. What You’ll Work On Performs visual, dimensional and functional inspection and testing according to documented policies and procedures. Records inspection and test data as prescribed by written instructions and procedures. Operates all associated test and measurement equipment as instructed and as documented in procedures. Recommends changes to policies and procedures. May prepare and submit change requests....

We anticipate the application window for this opening will close on - 2 Jul 2026 Position Sr. Design Quality Engineer for Covidien, LP (a Medtronic company), Perform Quality engineering activities in support of new product development. Work cross-functionally to review requirements and identify and assess product risks, and mitigation strategies, as well as review protocols and reports to support product validation. Support Systems NPD Quality team in performing engineering analysis to ensure design quality, analyzing system, and sub-system risk, technical writing, resolving high-profile quality issues, and product improvements for robust design. Utilize Medical device design controls, product risk files,...

Lead AbbVie's global Regulatory Policy & Intelligence function, overseeing Senior Director and Director-level leaders. Set strategic direction, drive organizational awareness and alignment, and ensure proactive, compliant engagement with evolving regulatory environments governing medicinal products and medical devices. Serve as executive sponsor and internal/external ambassador to influence worldwide regulatory and policy standards. Set vision and strategy for AbbVie's Regulatory Policy & Intelligence portfolio, ensuring alignment with business goals and compliance obligations. Lead, coach, and develop a high-performing team of Senior Directors and Directors, fostering cross-functional collaboration and talent development. Oversee monitoring and analysis of global regulatory landscapes, anticipating trends and guiding...

The Compliance Analyst will be responsible for the management and successful completion of key operational responsibilities and activities. Specifically, they will provide support for department operations, project compliance, supplier on-boarding and evaluations, supplier vendor master updates, and continuous process improvements. They are expected to have a solid understanding of market research compliance requirements and processes. Key Duties and Responsibilities PO/POCN Review/Processing Own the IMABI PO/POCN process - review, processing, and proactive monitoring - identify and remove blockers, escalate per governance, and operate with minimal managerial oversight Supplier Evaluations Own the end‑to‑end IT.28 supplier evaluation and ongoing monitoring for market research...

Lead AbbVie's global Regulatory Policy & Intelligence function, overseeing Senior Director and Director-level leaders. Set strategic direction, drive organizational awareness and alignment, and ensure proactive, compliant engagement with evolving regulatory environments governing medicinal products and medical devices. Serve as executive sponsor and internal/external ambassador to influence worldwide regulatory and policy standards. Set vision and strategy for AbbVie's Regulatory Policy & Intelligence portfolio, ensuring alignment with business goals and compliance obligations. Lead, coach, and develop a high-performing team of Senior Directors and Directors, fostering cross-functional collaboration and talent development. Oversee monitoring and analysis of global regulatory landscapes, anticipating trends and guiding...

This role is responsible for working collaboratively with QA Labs Business Owners, Manufacturing Sites and the broader BTS organization to conceive, design, engineer, and implement data, software, and technology solutions that solve significant scientific or business problems for Quality Labs processes. A successful candidate will develop deep understanding of lab processes to investigate, identify, and implement state-of-the-art technology platforms that drive productivity and efficiency gains in Product Release Testing , Stability Study Operations, and Lab Inventory Management for all AbbVie QC labs. Responsibilities Conceive, design, engineer, and implement data, software, or technology solutions by studying system flows, data usage, and...

The Senior Engineer (2nd Shift) in our Company's Research Labs (Pharm Ops Engineering) provides engineering and compliance support for the FLEx (Formulation, Laboratory & Experimentation) Center in Rahway, NJ. This role supports non‑sterile process equipment and utilities used in the manufacture of oral solid dosage (OSD) products across clinical, developmental, and commercial programs. The position operates with minimal supervision and serves as a key technical and compliance resource during second‑shift operations. Education Bachelor’s degree in engineering with a minimum of 5 years of experience supporting pharmaceutical manufacturing operations for oral solid dosage (OSD) formats Required Experience and Skills Demonstrated commissioning...

Specialist, Metrology and Validation, Pharmaceutical Analysis & Digital Technologies The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our company Research Laboratories Division is seeking applicants for a Metrology and Validation Specialist position available at the Rahway, New Jersey research facility. The Metrology and Validation Specialist will work as part of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The role oversees and supports the onboarding, qualification, validation, and routine maintenance of analytical equipment and instrumentation...

The Pharmaceutical Analysis & Digital Technologies (PADT) department of our Research Laboratories Division is seeking applicants for a senior specialist position in the GxP compliance and documentation team to support the global analytical organization. The position will be based at the Rahway, NJ research facility. The Compliance Senior Specialist will work as part of the integrated Compliance team and be pivotal in driving a culture of quality and operational excellence across a global analytical network. The key responsibilities of this role include Management and oversight of Good Manufacturing Practices (GMP) documentation, training, and standard operating procedures (SOPs) for the global...

The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our company Research Laboratories Division is seeking applicants for a Validation Specialist position available at either the Rahway, New Jersey research facilities. The Analytical Instrument Validation Specialist will work as part of the integrated Validation and Compliance team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The Analytical Instrument Validation Specialist role oversees and/or supports the validation of novel computerized analytical instrumentation within the GMP environment for multiple sites (Pennsylvania, New Jersey, and Schachen,...

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

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

This is an add position with a special focus on developing clinical strategies and clinical study support worldwide. This individual will also perform other regulatory duties. PRINCIPAL REGULATORY AFFAIRS SPECIALIST – Global Clinical Trial s (High-Risk Devices) Pelvic Health Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomes—helping improve confidence, independence, and quality of...

Supplier Quality Engineer II - Software Careers That Change Lives In this exciting role as a Supplier Quality Engineer II - Software you will have responsibility for review and approval of software elements and software of unknown provenance (SOUP) items developed outside of Medtronic; partnering with sourcing teams for the selection, evaluation, approval and ongoing performance monitoring of software suppliers; and working with software development and New Product Development teams to qualify and release software product to support CRM and CDS products and devices. CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well...

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

At Medtronic, 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. Facility Overview The Lilly Medicine Foundry is a new center for...

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are currently seeking a Quality Director to join the Quality Team in Wilson, North Carolina. While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Quality Complaint Lead to be located in Gurabo, PR. The Quality Complaint Lead executes assigned responsibilities in line with established Company and Corporate Standard Operating Procedures, J&J Policies, and applicable...

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

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shift Day shift, Panama schedule (12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays) 6 am to 6 pm Duties/Responsibilities Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations. Able to interpret problems and effectively prepare surrounding communication...

SR ASSOCIATE QUALITY ASSURANCE - PQA What you will do In this vital role you will be the Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems...

Key Responsibilities Serve as a Lead Quality Engineer for medical device combination product development programs, with a strong focus on design controls, risk management, and lifecycle quality oversight . Partner closely with Device Engineering on new combination product development, supporting design verification, design validation, and technology transfer activities. Ensure compliance with applicable regulatory requirements and standards , including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971 , and Gilead Quality System requirements. Plan, implement, and track approved quality improvement initiatives , ensuring timely execution of action items and deliverables. Interface...

The Manager, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for cross-functional teams of low- to medium-complexity 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 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 QC Manager, Raw Materials will be responsible for developing, leading, and managing the Raw Materials QC program at the Beam Therapeutics Manufacturing facility in Durham, NC. This role will develop and maintain documentation regarding testing requirements and strategies, serve as a subject matter expert (SME) for raw materials issues, providing technical expertise aligned with current GMPs and current industry practices. This person will have knowledge and experience with USP methods, and the ability to apply as required, and as well as maintaining compliance to USP, ICH and FDA guidance documents. Interface with Manufacturing, Supply Chain, and Quality Assurance leadership...

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 Indianapolis Device Manufacturing (IDM) is responsible for the development,...

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. This role provides strategic, tactical and operational regulatory CMC leadership across...

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. This role provides strategic, tactical and operational regulatory CMC leadership across...

About the role This Quality Compliance Specialist is responsible for managing external regulatory inspections and responding to regulatory observations while leading GMP compliance projects. How you will contribute Manage external regulatory inspections, lead local inspection readiness efforts, oversee inspection and support rooms, escorting regulatory agents, and serve as a subject matter expect during inspections. Draft responses to regulatory inspection reports, collaborating with multiple departments under short deadlines to ensure accurate and appropriate responses. Editing skills are important. Promote on-time completion of corrective action commitments made to regulatory authorities. Coordinate efforts associated with GMP re-certification and product licensing. Lead projects to...

To define and shape the Quality strategy for global Contract Manufacturing Organizations (CMO) and associated Contract Test Labs (CTLs) management for the Cell Therapy External Manufacturing (ExM) network and to ensure a high level of cGMP compliance and the safety, efficacy, and quality of externally manufactured commercial products. This includes but is not limited to the following areas 1) CAR T (Cell Banks, Plasmids, Vector, and Drug Product) manufacturing/ testing and evolving Gene Editing technologies for both clinical and commercial products. 2) Areas managed by BMS companies, e.g., 2Seventy Bio (testing) and Orbital Therapeutics (in vivo). 3) Patient Operations as...

In this exciting role as the Senior Quality Systems Specialist, you will use data analysis skills and CAPA experience to support the quality function completing audits at the Mystic, CT facility. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 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. Responsibilities may include the following and other duties may be...

Join our collaborative team at our manufacturing site in Plymouth, MN to put our patients first through ensuring compliance in everything we do. In this role as a Senior Quality Systems Specialist, you will ensure compliance with Medtronic policies, FDA regulations, ISO 13485, and other requirements. You also will provide guidance and mentorship on CAPA processes and tools, such as root cause analysis, and participate in both internal and external audits and inspections. Additionally, you will support the Quality Management System by performing continuous improvement activities and ensuring that processes are compliant to regulations as well as meeting the needs...

Senior Specialist Regulatory Affairs Our location in Columbus, OH, currently has an opportunity for a Senior Specialist Regulatory Affairs . Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions. WHAT YOU’LL DO As the Senior Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, renewal, amendments, or periodic experience reports. Interacts with country affiliates to compile and prepare...

The Associate Director, Asset Quality Lead – Hematology, Oncology, Cell Therapy, ICV and Neuroscience will mainly be responsible for developing the Quality Performance Narrative at the ASSET & Trial level to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. Qualifications & Experience Education and Experience B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related...

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 a cutting-edge facility for the...

This position works out of our Lake Forest, IL location in the Core Lab , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Professional Quality (Commodities) will conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes. What You’ll Work On Develops and executes local quality strategies aligned with divisional and business objectives. Translates strategic priorities into executable long‑range programs, projects,...

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

The Principal Quality Engineer – DevOps is responsible for ensuring that AbbVie's IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role provides leadership in defining, implementing, and optimizing quality systems through digital enablement and AI-driven solutions, and involves direct collaboration with cross-functional teams, Business stakeholders, and the Business Technology Services (BTS) Quality organization. This techno-functional expert transforms traditional quality assurance by implementing automation frameworks and DevOps best practices that enhance efficiency, reduce cycle times, and ensure regulatory compliance while optimizing CI/CD pipelines The Principal Quality Engineer – DevOps will provide oversight of quality...

The Senior Manager, IT Quality is responsible for elevating AbbVie’s IT operations and software quality practices by ensuring full compliance with regulatory requirements and corporate standards, while providing advanced strategic leadership across process improvement, risk management, and validation strategies. This role leads the development and implementation of quality systems and processes by leveraging digital enablement, data-driven methodologies, and emerging technologies including automation, AI, and advanced analytics. Collaborating directly with cross functional teams, the Senior Manager provides audit and inspection support, Corrective Action and Preventive Action execution in the Business Technology Solutions Quality area, and adoption of vendor documentation, strengthening operations...

Are you a quality-driven professional who thrives in a fast-paced environment, tackles complex issues head-on, and pivots seamlessly when priorities shift? We’re looking for a highly motivated, experienced Quality Assurance professional to lead and manage critical quality event processes, including complaints, nonconformances, CAPAs, and deviations. The Senior Quality Assurance Specialist oversees the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Senior Quality Assurance Specialist ensures product safety, product quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures...

Are you a quality-driven professional who thrives in a fast-paced environment, tackles complex issues head-on, and pivots seamlessly when priorities shift? We’re looking for a highly motivated, experienced Quality Assurance professional to lead and manage critical quality event processes, including complaints, nonconformances, CAPAs, and deviations. The Senior Quality Assurance Specialist oversees the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Senior Quality Assurance Specialist ensures product safety, product quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures...

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...

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

As the Regulatory Affairs Manager, you will be responsible for establishing strategy for worldwide product approval submission activities, directly responsible for execution of submission activities focused on US/EU and for ensuring regulatory compliance for Acute Care and Monitoring products. The Regulatory Affairs manager is expected to accomplish results through hands on and delegation of responsibility to individual contributors. This role will require collaboration with business partners to develop regulatory strategies to support the business goals and translate the strategies into work plans for the Regulatory Affairs teams to implement the newly created ACM OU is committed to excellence in innovation...

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

REGULATORY AFFAIRS SPECIALIST Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life. Check us out on LinkedIn Medtronic Brain Modulation and Pain Interventions Pelvic Health Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these...

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

About Orthopaedics 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 Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their...

About Orthopaedics 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 Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their...

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....

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...

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

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

Associate Quality Control What you will do In this vital role you will support the QC General and Immunoassay team by performing general testing methods for BLE (Breakloose and Extrusion), Moisture Determination by Karl Fisher and Solid Phase Extractions with UV Spectrometer. In addition the role will support ELISA methodologies testing for HCP (Host Cell Protein) and ProA (Protein A) Impurities and qPCR. Responsibilities Responsible for one or more of the following activities in QC analytical testing, sample and data management and equipment maintenance. Perform routine laboratory procedures such as sample analysis, standard and solution preparation. Responsible for documenting,...

Lead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives. Lead global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions. Develop global CMC regulatory strategies to enable life-cycle product/process development strategy while maintaining global licensure and right to operate of Gilead’s operations. Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development. Lead the integration and implementation of CMC Team Leaders...

Job Title Quality Manager Our location in Temecula, CA, currently has an opportunity for a Quality Manager (Development) in our Vascular Division. This is an onsite role. This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. WHAT YOU’LL DO...

Job Title Quality Systems Specialist We currently have an opening for a Quality Systems Specialist for the Vascular division. This role is located at our St. Paul, MN location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. MAIN RESPONSIBILITIES The Quality Systems Specialist will directly support tasks around current integration projects. Will analyze quality standards for components, materials or services. Applies measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. Apply quality principles, analyzes quality records, prepares reports and recommends improvements....

POSITION SUMMARY The Sr. Quality Specialist leads robustness of investigations and approvals, ensuring timely triage, thorough root-cause analysis, and effective corrective/preventive actions. This skilled and competent Quality Approver role will support monitoring progress, provide feedback to investigation owners, resolve stakeholder conflicts, and escalate issues to senior management when required. Investigation Quality System Investigation Process Execute quality reviewer/approver duties, review evidence, and approve closure of investigation records. Conduct investigation record quality reviews for documentation completeness, robust root-cause analysis, and compliance with procedures. Provide coaching and actionable feedback to issue owners on best practices, system usage, and investigation execution. Facilitate the progression...

Job Title Quality Engineer Our location in Temecula, CA, currently has an opportunity for a Quality Engineer in our Vascular Division. This is a fully onsite role. The Quality Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. 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. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters...

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. The Software Compliance Engineer participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. This person will monitor design controls...

Regulatory Policy and Intelligence Senior Manager What you will do The Global Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgen’s goals and priorities, by engaging externally with regulators, industry trade associations, and patient advocates, along with internal subject matter experts across Amgen. In this vital role you will support the development, articulation, and implementation of Amgen's positions on regulatory policies that impact Amgen's business and will report to the Amgen’s U.S. Lead for Global Regulatory Policy and Intelligence. Key Responsibilities Promotes internal awareness of key regulatory policy activities, including International Council for Harmonization (ICH) activities;...

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

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

Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. As a Senior Quality Engineer, you will be responsible for supporting manufacturing operations at the Irvine Toledo site by leading activities such as NCMRs, DHR review, CAPA execution, Inspection Optimization, and NPI support. This role ensures quality compliance and drives continuous improvement across manufacturing...

As the Director, US Advertising and Promotion, Global Regulatory Affairs within our GRA Advertising and Promo Team, you will be responsible for decisions, providing strategic direction and oversight for the day-to-day activities for assigned products. Ready to get started? Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. Job Summary In this role, the candidate will serve as the resident expert in GRA US Advertising and Promotion (A&P) group on promotion, labeling, product defense, and development strategies for assigned product(s). The...

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

The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager, this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level.The Validation Engineer responsibilities may include the review of commissioning and validation documentation completed by others, leading, authoring or reviewing investigations and implementation of preventive and corrective action, review and authoring of plant standard operating procedures, review and approval of critical planned maintenance routines,...

The Manager, Medical Device External Quality is part of AbbVie’s External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by third parties. In this capacity, the Manager, Medical Device External Quality, champions best practices related to sustaining product quality, equipment qualification, and manufacturing process validations. As such, the Manager, Medical Device External Quality works closely with AbbVie’s Contract Manufacturing Organizations (CMOs), relevant third-party suppliers (e.g., custom...

Job Profile Summary The Quality Engineering Service Manager for Worldwide TechServ will be responsible for managing all Compliance and Quality aspects across multiple global service and depot centers. This role ensures adherence to regulatory requirements, internal standards, and continuous improvement initiatives within a highly complex and evolving environment. - Support Quality & Compliance Strategies for Worldwide Tech Serv operations across multiple regions. -Act as the primary Quality point of contact for Worldwide Tech Serv leadership. -Ensure compliance of service centers and depot centers globally with global regulatory standards and internal policies. Provide direct oversight for regions USA, EMEA, China,...

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 wellness. Learn...

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...

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

About the role As a Quality Control Analyst II, you will perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeial standards. You will author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies and design and coordinate analytical method onboarding activities, including execution planning, training, and documentation. How you will contribute Lead and manage the qualification of critical materials, ensuring fitness for use in analytical testing. Oversee change control management processes, including risk assessment, documentation, and implementation. Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality...

About the role As a Quality Control Analyst II for QC Compliance is to provide technical expertise and support for the Operational Support functions of the QC Laboratory through ownership and participation in Quality Record management activities. How you will contribute Author and revise GMP documents and Quality Control records (e.g. Test Methods, SOPs, change controls, etc.) Train staff in general Quality Control activities and updates Train staff in Deviation and Laboratory Investigation processes and techniques Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks Identify and implement improvement initiatives to improve yield, reliability, and/or...

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

Specialist IT SOX and SAP GRC Compliance What you will do In this vital role, you will support the integrity, accuracy, and compliance of key reports and SAP GRC controls relied upon for SOX processes, helping ensure strong financial and IT control environments across the organization. Key Responsibilities Serve as a key contributor to the SOX Key Reports program, supporting reports relied upon for SOX controls. Perform detailed technical analysis of report logic, including code, queries, scripts, and data transformations, to understand how reports are generated. Validate report completeness and accuracy by reconciling report outputs to source systems and...

Target Validation Sr Director What you will do In this vital role as Senior Director, Global Research – Target Discovery you will have the opportunity to shape and lead Amgen’s Target Validation Unit within Research Biology. This research based Senior Director role will be responsible for building, leading and developing a multidisciplinary team that implements the most cutting-edge experimental and computational science and technologies to address and solve complex biological problems related to target discovery for multiple therapeutic areas. Responsibilities Lead and develop a multidisciplinary organization of ~25 scientists within Research Biology Integrate diverse experimental disciplines and workflows to...

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Senior Director - U.S. Ethics & Compliance Advisor (HIV), you will a ct as the key point of ethics and...

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to Training and career development, with onboarding programs for new employees...

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

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

This position will work on pre-market and post-market changes for the Pelvic Health Operating Unit. SENIOR REGULATORY AFFAIRS SPECIALIST Pelvic Health Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomes—helping improve confidence, independence, and quality of life. Check us out on LinkedIn Medtronic Pelvic Health Onsite At Medtronic, we bring bold ideas forward with...

The Cardiac Rhythm Management operating group is a division within Medtronic focused on developing and manufacturing medical devices and solutions for the management of cardiac arrhythmias and heart failure. This group’s product portfolio includes implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. CRM’s mission is to improve patient outcomes and quality of life by providing innovative therapies for the detection, prevention, and treatment of abnormal heart rhythms. The group collaborates closely with healthcare professionals and leverages advanced technology and data-driven insights to drive improvements in cardiac care. At Medtronic, we bring bold ideas forward...

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Senior Software Quality Engineer and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and...

If you have experience in regulatory compliance and enjoy working with cutting-edge medical technologies, we’d love to hear from you. Join us as a Senior Regulatory Affairs Specialist. Our products include different technologies (active and non-active, hardware and software) and are sold in more than 30 countries. The Senior Regulatory Affairs Specialist will be part of the US Regulatory team, reporting to Regulatory Affairs Manager, supporting a wide range of activities with frequent interactions with corporate teams in US and globally. Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document...

As a Senior Quality Engineering Manager in the Cardiac Surgery Post Market Quality organization, you will lead quality strategy and execution for a complex, global commercial portfolio. You will be accountable for ensuring patient safety, product performance, and regulatory compliance for released products, while leading a high‑performing team responsible for post‑market surveillance and risk management. This role requires deep technical expertise in risk management, design controls, and root cause investigation, along with proven leadership capability to drive change, strengthen quality culture, and deliver results in a fast‑paced environment. At Medtronic, we bring bold ideas forward with speed and decisiveness to...

This position will ensure excellence in Marketing Company GMP & GDP Quality activities to maintain the local License to Operate (LTO), driving compliance, quality performance, and continuous improvement across the US market and aligned cluster. Key Responsibilities Governance and Leadership Serve as back-up to the Cluster Lead as the GMP/GDP contact for the region. Maintain an effective governance structure that provides transparent oversight of quality activities and risk management. Act as a core member of the Marketing Company Quality Regional Leadership Team, contributing to strategy, prioritization, and resource planning. Lead, manage, and develop team members in a multi-layered organization; set...

We anticipate the application window for this opening will close on - 25 Jun 2026 Position Lead the quality engineering team, ensuring that products and processes meet regulatory standards and Medtronic’s quality expectations. Oversee quality initiatives, support compliance, and drive continuous improvement across engineering and manufacturing operations. Manage and mentor a team of quality engineers, providing guidance, training, and performance feedback. Oversee the development, implementation, and maintenance of quality systems and processes in accordance regulatory requirements including Good Manufacturing Practices (GMP) standards, 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, EU Medical Device Regulation (MDR), and State...

The Third-Party Quality team delivers strategic leadership and comprehensive oversight for Third Party Quality compliance across the MA Bio Campus. Our focus is on ensuring excellence in quality standardsand regulatory adherence in all external partnerships. The Third-Party Management Specialist is responsible for overseeing Third Party Quality for the MA BioCampus. This role is crucial in maintaining high-quality standards and ensuring compliance in our Relationships with external partners. About Sanofi We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition,...

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 & Position Overview Clinical Supply and Delivery (CSD) provide the...

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

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

Within Oncology Regulatory Affairs, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and optimally as possible. As an industry leading Oncology Regulatory function, we’re growing fast, and we’re as passionate about and committed to the development of our people as we are our business – providing an open and encouraging space to explore, learn, grow and develop across all roles and levels. At AstraZeneca, we share and are motivated by the same...

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

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 Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant. The Senior Quality Engineer will provide Quality support for projects related to core production, new software/computer systems, new products/technologies/Automation systems. As part of the project team, the Senior Quality Engineer will ensure all activities including Qualification/Validation Strategy, Deviation Investigation and Resolution, Risk Management activities, etc. meet applicable Quality and Regulatory requirements. Additionally, the Senior Quality Engineer supports on-going production including by working with operations/quality teams for deviation resolution, auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation...

GenerateBiomedicines is seeking a dynamic and experienced Associate Director, Quality Systems and GxP Compliance to lead our Quality Systems and Compliance operations across the organization. This role will oversee core quality management functions—including training, documentation, change control, deviations, CAPAs, audits, complaints, and supplier management—ensuring GxP compliance and inspection readiness. Reporting to the Vice President, Quality this individual will manage and develop the Quality Systems while collaborating with site stakeholders to uphold GB’s commitment to regulatory excellence and operational efficiency. This is a unique opportunity to shape and strengthen Quality systems in a fast-paced biotech environment, supporting innovative therapies from...

Regulatory Affairs Director Oncology R&D Gaithersburg, MD Hybrid Work- on average 3 days a week from office The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialisation, and life cycle management of the assigned cell and gene therapy (CGT) product(s). You'll s erve as the global regulatory lead ( GRL ) on early - stage projects or be responsible for specific indications or jurisdictions of larger programs . You'll have the opportunity to contribute significantly to product and clinical strategy and support cross-functional alignment for governance and health authority interactions . Th e RAD also...

Location Durham, NC 3 Days in office/week The role is responsible for supporting quality partnering across BioPharmaceuticals R&D, providing data-driven insights to inspection readiness, regulatory compliance, and empowering study teams to deliver clinical studies. The Associate Director, Clinical Quality is responsible for facilitating the delivery of Quality Management activities related to Clinical Operations within R&D working with partners across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities. They are also accountable for identifying and sharing industry trends in quality for the new business area(s), in their scope, through benchmarking with industry peers, and collectively...

We are searching for the best talent for a Senior Quality System Engineer, Field Actions to be based in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the company. 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 exciting opportunity will allow the individual to not only collaborate across the Abiomed business for day-to-day operations, but also will regularly communicate and...

We are searching for the best talent for Senior Counsel, Regulatory Law, MedTech. The Johnson & Johnson Global Legal Organization (“GLO”) is recruiting for a Senior Counsel, Regulatory Law, MedTech to support Johnson & Johnson MedTech. This position will be based in Santa Clara, CA. This Senior Counsel position is for an attorney within the Global Regulatory Legal Team of the GLO. The responsibilities of this Senior Counsel involve providing strategic legal counsel on a wide range of regulatory and compliance issues to support the development and commercialization of innovative MedTech products, services, and solutions, including digital health and robotics....

Johnson & Johnson Vision Care, a member of Johnson & Johnson Family of Companies, is currently seeking a Sr. Software Quality Engineer, to join our outstanding team located in Jacksonville, FL! In this role the Sr. Software Quality Engineer applies tools and practices for the effective and efficient development, transfer, and maintenance of manufacturing processes throughout the product lifecycle. The Sr. Software Quality Engineer conducts assignments encompassing complete projects or portions of major projects. By determining methods and techniques to be used, will coordinate phases of work internally and externally. Key Responsibilities Support Computer Software Validation (CSV) project planning activities...

About the role The Project Management Lead (Manager level) oversees and drives cross‑functional execution of GLEC strategic initiatives, process transformation efforts, and enterprise‑wide programs. In this management role, they provide leadership, structure, and governance to ensure disciplined project delivery, effective risk management, and the achievement of measurable business outcomes. How you will contribute Own PMO execution for assigned programs. Enable and support more complex initiatives Set up and manage program governance structures, plans, RAID logs, charters, and status routines. Build integrated workplans, stakeholder maps, resourcing strategies, and decision frameworks. Manage cross-functional dependencies with DD&T, Finance, Procurement, and Legal and E&C...

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

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,...

Key Responsibilities Provide leadership to the global inflammation regulatory organization to advance Gilead’s portfolio across the full product lifecycle, from Phase I through Phase IV, in alignment with corporate objectives. Leverage in-depth regulatory knowledge and inflammation expertise to deliver strategic and technical guidance, including innovative and precedent‑informed regulatory approaches to global registration. Dissect and distill complex regulatory issues to provide clear strategic direction and support interactions with health authorities, including preparation of high‑quality regulatory content. Hire, develop, and retain diverse top talent; set clear and aspirational goals; and coach direct reports on performance, development, and career progression. Foster a culture...

The Vice President, Cell Therapy Global Quality is accountable for development, deployment and execution of the Quality strategy for the Cell Therapy Development and Cell Therapy Operations organizations. The role is responsible for building, leading and optimizing the Quality organization throughout the global cell therapy network, including responsibility for Patient Operations Quality Internal Manufacturing Quality External Manufacturing and Supply Chain Quality Global Product Quality, consisting of Development Quality, Product Lifecycle and CMC Quality Analytical Science and Technology Quality Systems & Compliance The role leads the Quality organization in the development, commercialization, supply, and lifecycle management of cell therapy products to...

We are seeking a seasoned IT Validation/Quality Assurance professional with life sciences expertise to join our team as Associate Director, IT Validation. Reporting to the Director, IT Compliance and Processes, in this role, you will lead CSV/CSA activities and ensure that GxP computerized systems across R&D and Technical Operations are implemented, validated, and maintained in compliance with FDA, EMA, ICH, GAMP and other Health Authority requirements, good data integrity and data quality standards and industry guidelines/best practices. You will provide validation oversight as well as hands-on development of the computer system validation/computer software assurance lifecycle and associated deliverables from design...

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...

Nourish the world and your career as part of the Nutrition team at Abbott. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna®– to help get the nutrients they need to live their healthiest life. Our Global Supplier Quality Assurance (GSQA) group in Columbus, OH currently has an opportunity for a Project Leader, Ingredient Supplier QA. The primary function of the GSQA group is to...

Sr. Specialist Quality Assurance Participates as a member of the Non-Product Software Quality Assurance (SWQA) team for Abbott Diabetes Care. Ensures systems / applications produced in support of the Quality System or consumer products are developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software or systems /applications in support of the Quality System. Coordinate activities with other engineering disciplines, departments, and contractors. What You’ll Work On Completes software quality tasks in accordance with current Quality System...

Supplier Quality Engineer This position works out of our Pomona, CA location in the Toxicology Business Unite , 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 Supplier Quality Engineer is part of the product development core team responsible for quality engineering deliverables including specification development, risk management, process and test method characterization and control plan development. What You’ll Work On Plans and perform...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of . Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings...

Sr. Specialist Quality Assurance Participates as a member of the Non-Product Software Quality Assurance (SWQA) team for Abbott Diabetes Care. Ensures systems / applications produced in support of the Quality System or consumer products are developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software or systems /applications in support of the Quality System. Coordinate activities with other engineering disciplines, departments, and contractors. What You’ll Work On Completes software quality tasks in accordance with current Quality System...

We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN or Plano, TX. This position performs three 1-year rotations that include 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. Additionally, during certain rotational periods the position may be responsible for regulatory operations activities such as logistics management of global product release, and maintaining tools needed for managing global regulatory...

About the role Computerized Systems Validation Engineer I is responsible for supporting the engineering operations within the organization. This role involves applying theoretical knowledge to practical scenarios, ensuring quality, safety, and performance standards are met in production processes. The role supports Takeda's mission by ensuring reliable and efficient engineering operations. How you will contribute Support site projects, technical transfers, and ongoing validation maintenance. Primarily responsible for the design, authorship, and execution of commissioning, qualification and/or validation studies for any of the following major disciplines Assist in testing equipment Ensure standards of quality, cost, safety, reliability, and performance are met in...

Senior Director, Global Regulatory Strategy - Early Development & Business Development Location Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week . Our head office is purposely designed with collaboration in mind, providing...

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

This is a full time on-site position with M-F business hours About This Role The Sr. Associate I is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. This individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The Sr. Associate I provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and Corporate policies, cGMP, safety,...

Senior Manager QA What you will do At Amgen, our mission to serve patients drives everything we do. At our Ohio site, we are building a culture where quality is not just a function—it’s a mindset. We’re seeking a Senior Manager, Quality Assurance who is passionate about leadership, thrives in a dynamic environment, and is ready to make a tangible impact on product quality and patient safety. This is more than a role, it’s an opportunity to lead from the front, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide. Responsibilities Lead, coach and develop...

In support of the Chief Quality Officer, define and shape the Quality strategy for the Global Business Unit (GBU) Manufacturing Quality Network which includes the biologics & pharma operating units, internally and externally, to ensure a high level of cGMP compliance and the safety, efficacy, and quality of all bio and pharma manufactured commercial products. Responsible for direction of the quality operations teams supporting manufacturing, laboratory operations, and releasing or certifying of all BMS’ products produced, including internal and external manufacturing. This role will ensure consistency and alignment in the overall GBU Network Strategy and operational performance. The role will...

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,...