Quality & Regulatory Jobs in Pharma & Biotech

We are seeking meticulous and detail-oriented Quality Documentation Reviewer / Assembler III candidates to join our Dexter, MI manufacturing site. This unique role will begin with a focus on document control and quality assurance for approximately 12 months, supporting a critical compliance project. After the project concludes, you will transition into a hands-on production assembler role, contributing directly to the manufacturing of life-saving medical devices. As an Quality Documentation Reviewer / Assembler III, you will play a vital role in ensuring our products meet the highest standards of quality and safety—first through documentation review, and later through precision assembly work....

EMPLOYER AstraZeneca Pharmaceuticals LP Associate Regulatory Affairs Director LOCATION Gaithersburg, Maryland HOURS Full-Time; Mon-Fri (40 hours/week) DUTIES Provide strategic regulatory input to the development, commercialization and life cycle management of the assigned product(s). Serve as the regional regulatory leader. Provide ad hoc project input to support regional RAD or GRLs for specific project tasks. Play a key role influencing Regulatory authorities through regular contacts to improve Regulatory outcomes. Undertake leadership of cross- functional teams in major Regulatory Submissions (NDA, IND/CTA), Health Authority Interactions, Label discussions, and securing NDA/BLA Approvals. Act as a member of the Global Regulatory Strategy Team...

Johnson & Johnson Health Care

Janssen Supply Group, LLC, a member of Johnson & Johnson Innovative Medicine, is recruiting for a Sr. Specialist, External Quality (Small Molecules) . The preferred location for this position will be in Horsham, PA or Titusville, NJ . However, the role can also be located in Athens, GA or Tampa, FL. 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...

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

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

We are searching for the best talent for a Regulatory Law Paralegal to primarily support the Global Regulatory Legal Team (GRLT) in the Global Legal Organization (GLO), to be based in New Brunswick, NJ. Purpose The Regulatory Law Paralegal contributes to the achievement of key Johnson & Johnson GLO priorities by providing proactive and professional support to the GRLT and its business partners. You will be responsible for Work closely with regulatory lawyers and business partners to assist in the support and review of commercial and compliance programs and materials, which could include advertising and promotional copy review, social media,...

Medtronic, Warsaw, also known as Warsaw Orthopedics, manufactures Spinal Implants and Brain/ENT components. As a member of Supplier Quality Engineering at Medtronic, Warsaw, you will be responsible for management of external suppliers to Medtronic, Warsaw. You will lead oversight of supplied products, ensuring conformance to purchased material requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations. Together with our customers, we are moving spine and cranial surgery from an art to a science. Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put...

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

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

The Director Regulatory Affairs, US Advertising and Promotion is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan. He/she will contribute to strategic planning for the department (and departmental achievement of initiatives to meet goals and plan), manage assigned projects, and develop individual and team performance within the assigned franchise. He/she will also network and benchmark outside of AbbVie to provide for best practices and processes. Responsibilities Advise cross-functional teams on content and message consistency and best practices regarding planning and execution of marketing...

This Regulatory Affairs Manager will work on-site in Alameda, CA for our Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As the Regulatory Affairs Manager, you will combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by Abbott Diabetes Care, meet the required legislation in Canada and Latin America. Additionally, the Manager will have department/group/site level influence and is generally recognized...

The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and global submissions, and obtaining and maintaining approval for CRM products globally. Additionally, the Regulatory Affairs Specialist is responsible for assessing device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of three key businesses Cardiac Pacing Therapies, Defibrillation Solutions, and Cardiac Diagnostic Services. Together, we will transform the lives of people with cardiac arrhythmias and heart...

Careers That Change Lives In this exciting role as the Senior Principal Clinical Quality Specialist in the Cardiac Surgery O perating U nit , you will be responsible for providing experienced, comprehensive, and advanced expertise as the Operating Unit Quality Specialist . The Senior Principal Clinical Quality Specialist plays a critical role in ensuring the integrity, accuracy, and compliance of scientific data submitted to regulatory authorities. This position leads and conducts comprehensive audits, investigations, and quality reviews to assess adherence to regulatory requirements and internal standards. The specialist documents findings, recommends and tracks corrective and preventive actions, and may oversee...

GSK is currently looking for a Quality Technical and Validation Associate Director to join our team in Rockville, MD. The Quality Technical and Validation Associate Director provides leadership to a team Quality professionals and is responsible for ensuring the highest standards of GxP compliance in the validation and qualification activities, ensuring robust and compliant validation and change control efforts, providing GMP oversight on Continuous Process Verification process and GMP oversight on facilities and utilities (including maintenance, calibration and pest control programs).This role is pivotal in overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless introduction of...

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 and Johnson is seeking a Senior Investigation Quality Leader, located in Athens, GA. The Senior Investigation Quality Leader is responsible to ensure the generation and completion of robust investigation reports (i.e Nonconformance and Root Cause investigations). This includes,...

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 and Johnson is seeking for an Investigation Quality Leader, located in Athens, GA. The Investigation Quality Leader is responsible to ensure the generation and completion of robust investigation reports (i.e Nonconformance and Root Cause investigations). This includes, but...

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

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

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, External Quality (Small Molecules)! This position can be performed in Titusville, NJ, Horsham, PA, Athens, GA or Toronto, Ontario CA. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) North America- Requisition #R-016448 Canada- Requisition #R-017597 Remember, whether you apply to one...

Primary Responsibilities Support the company-Durham site and Quality organization by performing tasks associated with the site’s goals and initiatives as they relate to batch release and Quality requirements and standards. This involves the items as listed below, but is not limited to the following Product release of batches for a company-Durham Facility. Completion of tasks required to release batches such as DOM/SLED Review, QN and CR review, testing review, market restrictions review, and CBER submissions. Create batch specific documentation such as Health Authority monitoring reports or release-specific shipping documents, and prepare packaging or distribution requested batch certificates. Interface with technical,...

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...

The candidate will be responsible for leading a team of Systems & Hardware Quality Engineers in the definition, development, and support of complex medical device systems used in a variety of surgical procedures. This role reports to the Director of Systems and Hardware Quality and will help with strategy, vision, development, and execution of the Quality and Reliability Engineering team. This role will sit at our North Haven, CT site. Functional Excellence Lead cross-functional teams to make appropriate, timely decisions and recommendations that result in the successful completion of major organizational objectives. Drive functional strategy to advance Quality...

Senior Manager Quality Assurance (Quality Systems/Technical Services QA) What you will do In this vital role you will lead a team of Quality professionals supporting Inspection and Packaging operations at our Juncos, Puerto Rico site. You will provide technical quality leadership and oversight of Quality Management Systems, partnering closely with cross-functional teams to build, enhance, and sustain compliant commercial operations. As we continue to grow and expand through efficient and effective technology transfers, you will play a critical role in ensuring product quality meets both Amgen and regulatory standards. This position requires a regular onsite presence to drive results,...

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

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

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

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, Innovation, Expertise. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A2 Shift (6pm to...

Purpose Execute Compliance area activities related to compliance projects, inspections (external, internal, customers), and regulatory submission documentation. Responsibilities Responsible for conducting a comprehensive internal audit program and ensures that the Internal Audit system is effectively implemented. The incumbent must work closely with the QA Director in the handling of external regulatory inspections and on the resolution of regulatory compliance issues. Assists in the development, implementation and continuous improvement of the Internal Audit System and utilizes audits and consultations as a training vehicle to increase awareness of Compliance expectations. Monitors and maintains plant compliance with Operations and regulatory/applicable standards requirements. Participates...

Conducts independent quality control reviews of regulatory, scientific, and clinical documents with applicable checklists by checking against sources to ensure that the results presented are accurate and delivers documented quality control review comments to the author through resolution. Ensures quality control review documentation is completed from all areas and provided/uploaded to the applicable master file(s) per the established business processes and procedures. Interacts daily with ClinPharm writers and/or ClinPharm writing managers and interfaces/communicates with applicable cross-functional areas. Communicates and provides deliverables to ClinPharm writers, ClinPharm writing managers, and others as applicable. Accountable for receiving and meeting the main objectives/deliverables of...

We are searching for the best talent for a Staff Quality Systems Engineer to be located in Santa Clara or San Jose, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Purpose This role requires a Quality Engineer with diverse experience. Not only will this individual be responsible for helping govern the overall Quality Management System and the maintenance and continuous improvement of Quality Management System elements this individual will work with...

The Sr. Director, HRBP for Global Regulatory Strategy and Worldwide Patient Safety in Drug Development, plays a pivotal role in providing strategic partnerships to senior leaders for these functions. This role is at the forefront of driving transformative people strategies, workforce planning, and architecting cutting-edge organizational designs. You will be the catalyst for talent innovation, fostering team synergy, and spearheading dynamic change management initiatives. Given the global presence of the client group across multiple BMS locations and geographies, close alignment with the People Org and function leadership is essential to ensure the seamless execution of a forward-thinking workforce and talent...

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 Oversee quality activities, including change control systems and product change control oversight, in collaboration with Regulatory Affairs and APR program management. Support non-manufacturing functions, strategic quality planning, and manage performance metrics and quality goals. Review and...

Key Responsibilities Lead strategy and execution of complex sterile product qualification activities. Expertise in contamination control, cleaning validation and isolator systems. Adopt best practices for continuous qualification of sterile production facilities. Provides relevant CMC support for sterile products pre- and post-approval filings. Interface with Senior Leadership Team to provide a unified set of goals and objectives for the Validation team. Assist with onboarding of new technologies and provide oversight for new qualification programs. Work with Quality to adopt an effective quality management system and achieve the quality objectives. Provide leadership for Validation team and ensure growth and development of staff...

At Medtronic's Pyramid site in Memphis, TN, we are seeking a dedicated Quality Engineer II to join our team. In this role, you will be instrumental in developing and maintaining quality standards for our medical products. You will work closely with engineering and manufacturing teams to ensure that our products meet stringent quality standards. Your responsibilities will include designing inspection methods, conducting quality assurance tests, and performing statistical analyses to uphold product reliability and compliance. If you're ready to leverage your skills in quality engineering to enhance healthcare solutions, we encourage you to apply and become part of our mission...

Regulatory Affairs Specialist II The position of Regulatory Specialist II is within our Toxicology business based in Lake Forest, IL or Pomona, CA . In this role, you will work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for domestic and/ or international product registrations for new and modified products, regulatory assessment of product changes, review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files. What You’ll Work On Provides extended regulatory support for diagnostic product and commercial diagnostic products Assists in...

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. Prior experience working with software development teams, diabetes management devices (e.g. insulin dosing algorithms), and artificial intelligence/machine learning technologies is preferred. This role will also be...

Johnson & Johnson is recruiting for a Sr. Quality Engineer , located in Santa Clara, California . This is a fully onsite position. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Our...

Job Functions Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log. Serve as the primary Quality representative in the PDM meeting. Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones. Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner. Review and approve the strategy for...

Senior Quality Manager, Design Transfer The Senior Quality Manager, Design Transfer position will have responsibility for the design transfer of all Diabetes Care Blood Glucose Monitoring Systems (strips, meters & accessories), FreeStyle Libre portfolio of products, medical device combination products, new medical sensors, Lingo which will deliver products to over 15MM customers globally over the next 5 years with a revenue of over $10Bn. In addition, this position will also be accountable of transfer of all designs (new product introductions, product changes to on market products, test method validations, complaint investigation techniques) into all manufacturing sites, including contract manufacturers....

Your skills could be critical in helping our teams accelerate progress. Sanofi is an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities Advice and guidance based on integrated safety review Provide expertise on translational safety science for early development projects to ensure translation of non-clinical and emerging preclinical data into potential clinical risk Support...

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide. Medtronic's Endoscopy Operating Unit (OU) is seeking a strategic and accomplished Sr. Director of Quality Assurance and Regulatory Affairs (QA/RA) to lead and evolve the global quality and regulatory function. This individual will be responsible for overseeing all aspects of quality compliance, regulatory strategy, product approvals, and post-market surveillance...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Operations Compliance Engineer Senior is responsible for the daily activities at the Northborough facility, in partnership with his/her team and peers, to achieve business objectives aligned with site priorities. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives....

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

The Regulatory Affairs Manager will work on-site at our Plymouth, MN location for our Electrophysiology division. As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. This new team member will develop and supervise regulatory professionals as well as share knowledge and expertise with others in support of team activities. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. This Regulatory Affairs Manager may analyze broad scope implications...

As the Associate Director, Cleaning Validation and Contamination Control Expert, you will be the primary accountable for setting up technical expectation for the site contamination control and cleaning validation strategies that are agile and adequate. You will be accountable for establishing improved cleaning validation and contamination control strategy, maintain them and provide support to site investigations through complex issues and challenges related to microbial contamination. You will work in a highly cross-functional matrix environment and will work closely with cleaning validation and contamination control counterparts in quality and engineering organizations. This role will provide YOU the opportunity to lead key...

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure. Preference for software-based regulatory experience or familiarity with software regulations and requirements. The Principal Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostics products and External Pacemaker to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval....

We are currently looking for a Principal Quality Engineer to join our growing team supporting the Cranial and Spinal Technologies (CST) portfolio. The CST operating unit provides a comprehensive portfolio of proven powerful technologies setting the highest standards of integrity and reliability in Cranial and Spinal care. This position will work a hybrid schedule with 3 days onsite at our Memphis, Tennessee location. Travel expectation less than 20% Careers That Change Lives In this exciting role, you will have primary responsibility for leading quality assurance strategies and execution for new and commercialized devices. This is a dynamic opportunity where you...

Employer Auris Health, Inc. Senior Regulatory Affairs Specialist, Program Lead Job Code A011.485 Job Location New Brunswick, NJ Job Type Full-Time Rate of Pay $135,000 - $160,000 Job Duties Author regulatory submissions and support product development stages to help the organization achieve US and international regulatory (NPD) approval goals. Support health authority communications and contribute to strategy development. Manage, prepare, and submit regulatory submissions required for device approvals and registrations in the US and globally. Oversee SME resources preparation of submission deliverables to meet regulatory requirements or other project objectives. Correspond and collaborate with international J&J colleagues on international...

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 This is a hybrid role available in United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. We are searching for the best talent for Staff Quality Systems Engineer to be located in Irvine, CA or Plymouth, MN....

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 the Analyst 1, Lab Quality Control role to be in Athens, GA. Benefits you will enjoy starting your first day Competitive pay based on experience, night shift differential, plus an annual...

Reporting to the Vice President, Corporate Quality, this role provides strategic and tactical direction for the GPS divisional audit program for product development, clinical supplies, manufacturing, and product distribution across all modalities including CMOs, CLOs, material suppliers and service providers, inclusive of IT systems and services. Leads inspectional readiness activities across the network inclusive of biologics, small molecule and cell therapy as well as distributors and local markets inclusive of global regulatory agencies worldwide. Serves as consultancy to sites/functions with regulatory inspections including Pre-inspection readiness. Key Responsibilities · Responsible for development of risk-based process for assessment of sites, suppliers and...

PREREQUISITES Bachelor’s degree in life sciences with a minimum of 5 years of clinical lab operations, quality and/or compliance; experience in pharma, biotech, CRO, or medical device preferred. MS in relevant life sciences field preferred. Previous lab supervisor experience preferred. Strong knowledge in CLIA/CAP lab requirements and/or ISO13485 Quality Management System Regulation (QMSR). Knowledge of global quality standards and regulations (GCP, GLP, GDP, and ICH GCP), and ALCOA+ principles. Knowledge in various diagnostics technologies and platforms (e.g., PCR, NGS, IHC/pathology, Flow Cytometry, Mass Spectrometry, Imaging, etc.). Experience in diagnostic lab operations, biomarker assay verification/validation, material qualification, and monitoring of quality...

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

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, North America Regulatory Leader. This position is a hybrid role and can be located in Spring House, PA; Raritan, NJ; or Titusville, NJ. Remote work options may...

Use Your Power for Purpose The Principal Validation Engineer under Andover Site Technical Services (STS) is the principal owner of the Pfizer (PGS) Andover site validation program and master plan. The incumbent is responsible for delivering overall site validation program effectiveness and compliance in partnership with validation program owners across Andover site functions and the Pfizer network. What You Will Achieve In this role, you will Principal owner of overall Andover site validation philosophy and master plan in partnership with local owners of validation programs, associated technical disciplines, and relevant Pfizer global/network/site quality system principals applicable to biologics drug substance/drug...

This position will involve much interaction with Internal J&J customers (Operating Companies and Business Units) and external Transportation providers at all levels of their respective organizations. Key Responsibilities Support major RTO projects through data analysis (i.e. Operating Company initiatives, reports, databases, etc.). Provide recommendations to project teams based on analysis Maintain databases used by RTO and RTO suppliers for various transactions. Updates to metrics while working to improve and enhance processes with all available data. Lead cost and service improvement initiatives as related to transportation and logistics processes. Complete all assigned training on time. Qualifications Education Candidate must be currently...

At Johnson & Johnson, we use technology and the power of teamwork to discover new ways to prevent and overcome the world’s the most significant healthcare challenges. Our teams leverage data, real-world insights, and creative minds to make life-changing healthcare products and technologies. We're disrupting outdated healthcare ecosystems and infusing them with transformative ideas to help people thrive throughout every stage of their lives. With a reach of more than a billion people every day, there’s no limit to the impact you can make here. Are you ready to reimagine healthcare? About MedTech Fueled by innovation at the intersection of...

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...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At JP Morgan 2024, Dave Ricks announced Lilly Catalyze360, our external...

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

& SPECIFIC OBJECTIVES The Quality Management System (QMS) Lead role will involve establishing the QMS structure at Close collaboration with high performance talent from our Company’s global team and the biotechnology industry to develop and execute multiple Quality Management Systems and processes will be key, and the successful candidate will inspire his/her team to build the future of our Company’s antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide. Providing training and guidance on the interpretation and implementation of our Company policies and regulatory requirements...

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

The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets. This role will also work on expanding indications of existing products, as well as work on sustaining/post-market regulatory activities for Class II robotic devices. Devices that are part of the Robotics Surgical Technology Business are inclusive of hardware and software components. The senior principal specialist will work directly with new product development and sustaining teams to develop the global regulatory strategy and support regulatory activities throughout the product lifecycle. The senior principal specialist has...

Medtronic – Milwaukee, WI manufactures spinal implants and Brain/ENT instrument components. As a member of Supplier Quality Engineering, you will be responsible for management of external suppliers to Medtronic, Milwaukee. You will lead oversight of supplied products, ensuring conformance to purchased material requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations. Responsibilities may include the following and other duties may be assigned. Ensure that suppliers deliver quality parts, materials, and services. Lead cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance...

We are searching for the best talent for a Performance Evaluation Compliance Engineer located in Raritan, NJ. Purpose Our Performance Evaluation Engineer will make vital contributions to the New Product Development and Lifecycle Management pipeline and transform patient care through innovation. They are responsible for working with our project teams to develop and execute clinically relevant predictive bench-top models to advance the standard of care in medical devices. You will be responsible for In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position Overall main point of contact for any...

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 Quality Control Technician I to be in Jacksonville, FL. Purpose Entry support individual contributor, who supports staff in various processes in the Quality Control function. Executes day-to-day laboratory activities such as sample management, supply ordering and receipt, and general housekeeping, under direct supervision. Supports data review and metrics reporting. Implements risk mitigations and process...

Drives development and execution of plans that build and manage an infrastructure to effectively support the company's needs in logistics, distribution, import/export, and trade compliance across a complex supply chain spanning multiple continents, which includes contract manufacturers, distribution centers, and warehouses for pharmaceutical products. Supports effort to ensures that Commercial and Clinical shipments of raw materials, intermediates, drug substance, drug products, and clinical trial materials are delivered securely, reliably and cost-effectively while meeting relevant compliance requirements. _ Your Contributions Leads, plans and controls the flow of materials, products, services and related systems information from point of origin to point of...

The Associate Director, Quality Control is responsible for overseeing and managing the quality control operations to ensure compliance with GMP and regulatory standards. This role involves driving continuous improvement initiatives, and will develop, execute, and periodically evaluate QC practice and processes to ensure that QC operations are efficient, timely, and safeguard data integrity. The role will author, review and/or approve QC documents such as test methods, SOPs, validation protocol/reports, reference standard qualification protocols/reports, stability protocols/ reports, quality records and investigations (deviations, change controls, CAPAs), regulatory filings, specifications/justification of specifications, and APQR. In addition, this role will develop and validate new...

We are currently looking for a Senior Program Manager - Quality and Regulatory to join our Program Management Office (PMO) within our Ear, Nose, and Throat (ENT) Operating Unit (OU). In this exciting role as a Senior Program Manage r, you will engage with multiple Product Development teams within the ENT OU. You will manage projects that are strategic to the business and work cross functionally with various functional managers while driving program execution. Also, this role will engage with the OU leaders through steering meetings, monthly leadership meetings and daily project execution. The ideal candidate can work a hybrid...

Senior Regulatory Writer, Remote “This position can be based remotely anywhere in the U.S. Please note that this role would not provide relocation as a result. The expectation of working hours and travel will be defined by the Hiring Manager. This position will require minimal travel” Purpose To write, review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide documentation related consultancy to other line functions. To coach/mentor and/or train less experienced writers. #LI-Remote Key Responsibilities 1. To author, review and manage high quality clinical and...

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

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

The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell & Gene Therapies. This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Senior Director, CMC-CGT Regulatory Affairs. Responsibilities Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams. You will partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / BLA/ Master Files, amendments, annual reports) and...

Objective / Purpose A dvance the objectives and vision of the Head of Regulatory Ensure project management support and facilitation of the Regulatory Leadership Team meetings and offsites including the coordination of the preparation of the meetings and tracking of required actions until completion Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that Regulatory is on track to meet or exceed its performance targets . Provides insight into evaluating overall Regulatory performance over time and for future planning Accountabilities Responsible for overseeing and consolidating input for the decision support resource(s), including tracking resource utilization ,...

Responsible for supporting regulatory strategy execution for development programs. Works closely with the Director of Regulatory Affairs to prepare regulatory submissions (strategy, authoring, timeline planning, etc.) and to maintain department regulatory processes. Coordinates, prepares, and contributes to the development of document packages for regulatory submissions including IND/CTA, NDA/BLA. DSUR/Annual Reports, clinical protocols, clinical study reports, application amendments and postapproval activities. Ensures submission compliance with local and regional regulatory requirements, company policies, and internal quality and compliance standards. Provide regulatory representation on cross-functional teams as directed. Collaboratively develop regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs....

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 Engagement Compliance, Manager to be in Spring House, PA. Purpose IHEA organization is seeking to hire a solution oriented, innovative and engaging member in their Patient Engagement Strategy team who will...

Johnson & Johnson is currently recruiting for a Senior Manager, Quality Control, Stability Operations. This position will be located in Titusville, NJ. At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Associate Director, Quality Assurance, GoSolo Site Deployment will play a pivotal role in helping to design and execute the future...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Manager, Quality System Innovation, GoSolo Site Deployment will play a pivotal role in helping to design and execute the...

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Primary Responsibilities Employee must show ability to perform routine assignments and develops competence by performing structured work assignments Ability to use existing procedures to perform routine testing Requires knowledge and exposure to fundamental laboratory instrumentation, theories, principles, and concepts Receives instruction, guidance, and direction from others and also...

Location Upper Gwynedd, Pennsylvania ( preferred ); Rahway, New Jersey Employee Status Regular Full Time A part of the Ethics and Compliance Organization (ECO), the Compliance Program Oversight team (the “Team”) designs and helps implement our company’s global compliance program, including compliance standards and processes (collectively, the “Program”). The Program is designed to mitigate enterprise risk and to empower employees and business partners to act with integrity while fulfilling our company’s mission of helping to improve and save lives. Reporting to a Director of the Team, the Associate Director supports the implementation and maintenance of the Program. 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. The purpose of the Sr Director, GPS Medical role is to...

Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination Products will lead a team responsible for device regulatory activities associated with Sanofi’s combination product and medical device portfolio in the Specialty Care R&D and commercial product ranges. The team is comprised of direct reports and matrix team members. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. The incumbent will work closely with key stakeholders including clinical, medical affairs, R&D, Manufacturing & Supply (device development, manufacturing,...

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

Our location in Lake Forest, IL currently has an opportunity for the Director of Regulatory Affairs. The function of a Director of Regulatory Affairs is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has division-level influence and is generally considered a key opinion leader and an expert resource both within Abbott and externally. The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, and provide executive management with regulatory...

Sr. Hardware Design Quality Engineer Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Senior Design Quality Engineer is within our Infectious Disease Developed Markets business unit located in San Diego, California. In this role you will actively participate in product development and transfer activities, ensuring product and process conformance to FDA and ISO 13485 standards. This position will review validation methods and protocols, test methods, statistical...

About the Role Assist in the development of lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities. How you will Contribute Assist in the development of lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities. Work under minimum supervision. Assist with the installation and validation of sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of microbiology and chemistry principles. Complete all testing,...

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

POSITION SUMMARY Sr. Software Quality Engineer is responsible for complete end-to-end verification of Natera software systems and services using both manual and automated test strategies. PRIMARY RESPONSIBILITIES Perform software verification, define and execute test cases and scenarios required for software quality assurance and regulatory compliance. Perform system analysis, assess risk, and develop strong test strategies by analyzing product design and technical specifications, and by collaborating with product managers and developers. Participate in building and maintaining test automation framework using automation tools and libraries. Perform debugging and root cause analysis of product issues or defects. Evangelize new testing methodologies, best...

Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. The unit focuses on providing innovative solutions for ENT conditions, including surgical and therapeutic products designed to improve patient outcomes in ear, nose, and throat health. We are currently offering an excellent opportunity to join the ENT Quality team as a Senior Software Quality Engineer. This position is based onsite in Jacksonville, FL. In this role, you will serve as an individual contributor with responsibilities in our technical functions to advance existing technology or introduce new technologies and therapies. You will be tasked with formulating, delivering,...

Description The Associate Director position’s core responsibilities are to oversee our Company's compliance related to customs country of origin. In the origin space, responsibilities are to oversee our company’s customs country of origin program and lead efforts related to global customs origin reviews. CIT is primarily responsible for determining trade compliance requirements and processes, as well as executing select trade compliance functions that are best performed on a global and/or cross-divisional level. Among other centralized trade compliance activities, CIT implemented and continues to manage and monitor compliance with the Trade Agreements Act (TAA). CIT is also responsible for the management...

Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to all collaborators and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives globally. Accountabilities Lead and/or contribute to the planning, preparation, and...

Purpose The Senior Quality Engineer is responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetic Devices, etc. Responsibilities Perform QA activities related to Combination Product and Medical Device Design Transfer and Change Management Ensure compliance with company policies and procedures. Perform design control and risk management activities according...

The Director will provide strategic support and compliance oversight for business initiatives within the US Allergan Aesthetics business with a focus on Plastics and Regenerative Medicine (PRM), Body Contouring and digital/social media. Responsibilities Partners with US AA Leadership for PRM, Body Contouring and digital marketing to provide moderate to complex OEC and functional policy interpretation and provide guidance on the requirements. Active contributing member of the PRM Leadership Team, bringing compliance insights, governance and strategic solutions to support business goals and improve compliance. Conducts compliance risk assessments, trend analysis and provides recommendations for novel, creative and compliant business activities to...

The Compliance Engineer will be involved in projects that require obtaining agency approvals for both new and existing products. This role requires experience in securing certifications from agencies such as the FCC, CE, EMC/RED, IC, and safety organizations. Familiarity with relevant standards and directives from UL, CSA, FCC, IEC, and EN is essential. Additionally, experience with environmental regulations such as RoHS, WEEE, REACH, and Proposition 65 is a valuable asset. The Compliance Engineer will create and execute a compliance test plan addressing EMC, EMI, safety, environmental, and other product compliance requirements. Key Responsibilities Read, interpret, and communicate changes in technical...

This position onsite in our Temecula CA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. The Associate Design Quality Engineer provides Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Also provides Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. What You’ll Work On Learns to identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May...

About the Role The Quality Operations, Analyst II is responsible for ensuring the quality of processes and product outputs by adhering to established policies and procedures. This role involves auditing, monitoring, and determining the quality of processes or outputs against defined internal and regulatory standards, contributing to Takeda's mission of delivering high-quality products. How you will contribute Leads ongoing, daily departmental operations. May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner Interview/hire, evaluate, train and develop direct reports Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective...

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

Reporting to the Executive Director, RIIM , this role will be accountable to ensure a holistic Regulatory centric D ata M anagement ( R DM) capability and related data centric submissions within GRACS , are implemented and maintained . This role has broad accountabilities for the following Regulatory Data Management ( RDM) Strategy & Regulatory Data Standards Governance Regulatory Compliance and Risk Management for Regulatory Data Direct and Indirect (e.g., partnering with CMC, Labeling, etc ) e xecution activities that support Data-based Submissions ( e.g. XEVMPD, IDMP, PQCMC, SPL etc . ) Internal & External Stakeholder Engagement and Change Management...

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

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...

POSITION SUMMARY Software Quality EngineerIII, Production Bioinformatics Pipelinesis responsible for complete end-to-end verification of Natera software systems and services using both manual and automated test strategies. PRIMARY RESPONSIBILITIES Perform software verification, define and execute test cases and scenarios required for software quality assurance and regulatory compliance. Perform system analysis, assess risk, and develop strong test strategies by analyzing product design and technical specifications, and by collaborating with product managers and developers. Participate in building and maintaining a data-driven test automation framework using automation tools and libraries. Perform debugging and root cause analysis of product issues or defects. Evangelizenew testing methodologies,...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Supplier Development Quality Engineer II position drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You'll Work On Upholds Division approval requirements to supplier...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Supplier Development Quality Engineer II position drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You'll Work On Upholds Division approval requirements to supplier...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Supplier Development Quality Engineer II position drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. What You'll Work On Upholds Division approval requirements to supplier...

Are you ready to make a significant impact in the pharmaceutical industry? As a Quality Systems Specialist II, you will play an essential role in supporting quality system activities that are vital to our site processes. Your focus will be on documentation and training process support, ensuring that our operations align with best practices and deliver excellence every time. Join us in this dynamic role where you'll collaborate with subject matter experts, improve processes, and contribute to the continuous improvement of our quality systems. Accountabilities In this role, you will be responsible for managing documentation issuance, including procedures, test methods,...

The Quality Systems Manager serves as a senior technical expert in the principles and application of quality assurance and compliance within a regulated environment. This role leads and supports cross-functional quality initiatives, drives continuous improvement, and ensures robust compliance across Quality Systems. The Quality Systems Manager may also lead and mentor a team to execute department and business objectives. Key Duties and Responsibilities Collaborate with internal stakeholders and external partners to resolve quality issues and deliver compliant, risk-based solutions. Identify and lead initiatives to close compliance gaps and strengthen cross-functional Quality Systems. Act as a subject matter expert and Quality...

The Manager of Quality Control will be responsible for supporting the oversight of QC external contract labs. The position will manage GMP release and stability activities in support of clinical and commercial programs, while ensuring compliance with SOP’s, policies and industry guidances. In addition, this role may support transferring/validating GMP analytical methods, establishment of internal Quality Control systems, processes and procedures in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations. This role will interact with internal cross-functional teams and Vertex network of external CMOs/contract labs to ensure that all GMP analytical methods for lot release and...

Shire Human Genetic Therapies, Inc. is seeking a Sr. Cleaning Validation Engineer II with the following duties manage validation programs and projects. Develop validation strategies to test equipment and processes in compliance with domestic and international GMP regulations. Create and maintain validation life cycle documentation, including IQ/OQ/PQ protocols and reports, risk assessments, and traceability matrix. Provide technical assessments for Corrective and preventive actions (CAPA’s), deviation, and change control management. Troubleshoot cleaning and steam sterilization issues to ensure smooth manufacturing operation. Collaborate with stakeholders to establish project timelines and scopes. Review and approve validation deliverables including project plans, protocols, reports, risk...

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...

OBJECTIVES Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ Partner with teams across CPMQ to proactively assess the needs for functional processes and system enhancements Lead the development of internal functional processes and training and ensure alignment with global processes and regulatory requirements and expectations. Drive the implementation and change management of processes and systems across CPMQ Create mechanism to monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans Engage with CPMQ teams to foster a culture of learning and continuous improvement Lead CPMQ...

Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate...

Director of Validation, Cell Therapy Technical Operations reports to the Senior Director, Cell Therapy Technical Operations within the Cell Therapy Development and Operations (CTDO) organization. This Technical Leadership role will provide Technical oversight to drug product and vector sites, covering process validation for commercial cell therapy products manufactured globally via internal and external manufacturing sites. This role will serve as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy the standards to site MS&T at internal and external sites. The validation lead is accountable for developing...

The Director, Regulatory Strategy will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects within the Vertex cell and gene therapy portfolio. This position will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring effective integration of broad regulatory ideas/tactics supporting program strategy. This role's assignments may be global or regional depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy. Key Duties and Responsibilities Leads the development of regulatory strategy for assigned projects/regions...

Senior Specialist - Regulatory Affairs -Transfusion Our location in Lake Bluff, IL, currently has an opportunity for a Senior Specialist - Regulatory Affairs . As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for on-market regulatory affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit...

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

In this vital role, you will support establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. The lead will also specifically develop and implement regulatory strategies and processes for in vitro diagnostics (IVDs)/companion diagnostics (CDx’s). Key responsibilities Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning and decision-making Developing clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of both therapeutic and diagnostic products by regulatory health authorities Providing regulatory leadership and input to internal teams involved with IVD/CDx development planning, including Diagnostic Development teams and joint project...

About the Role As the Quality Systems Analyst II, you will participate in the daily Quality System department activities for Thousand Oaks including Change Control, Deviations, CAPA, and Quality Documentation. This is an on site position and you will report to the Quality Systems Manager. How you will contribute Support Change Control, Deviation, CAPA and continuous improvement initiatives. Review quality related documentation and approval of Deviations/CAPA and Change Control including evaluating the impact to the process and product as applicable. Complete and approve nonconformance investigations and change control requests in accordance with Quality system requirements. Revise SOPs and forms to...

About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis, and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit Acadia.com and...

Purpose Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market. Responsible for assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetics Devices, etc. Responsibilities Primary driver for the quality and compliance aspects of Design transfer and on-market change management. Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and...

The Opportunity The Therapeutic Data Manager Lead will contribute to the company's Clinical Data Management organizational and Therapeutic Area Data strategies, lead and deliver on complex projects, and interact with external partners. Responsible for global and broad organizational high impact deliverables. Responsibilities will include Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies and projects. Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones. Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements...

This position works out of our Tipp City, OH location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. Tipp City, Ohio, is one of Abbott’s newest nutrition manufacturing facilities with technology that enhances production efficiency and product quality. Join us and you’ll be part of...

Your skills could be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports. In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice...

Purpose To provide Quality oversight and approval for Quality Engineers on qualification/validation activities and documentation. Responsibilities Provide interpretation and guidance regarding qualification and validation requirements in GLP-, GCP- and GMP-regulated areas of an R&D organization. Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision. Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.). Support CAPA activities related to validation and qualification Provide guidance, direction, and support to peers. Provide assurance that applicable national and international regulatory requirements are adhered to...

Purpose Primarily responsible for quality assignments related to batch records, quality approvals, exception reports, metrics, and other documentation. Responsibilities Review/approve/release batch record packets and associated documentation Provide quality approvals of materials in the materials management system as defined by procedures Write/review/approve exception documents and corrective actions/preventive actions (CAPA) and ensure they meet timeliness requirements Review/approve clinical documentation and specifications, as applicable Write/review/approve policies/processes/procedures and related documents Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, R&D GxP Compliance Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality...

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. AstraZeneca’s pipeline of industry-leading innovative medicines is consistently growing, and we are investing in our capabilities to become leaders in the delivery of next-generation cell and gene therapies. 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...

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

We are seeking a strategic and experienced Senior Manager, Quality Systems to lead our global internal audit and compliance programs across multiple divisions and global sites. This role is pivotal in ensuring consistent adherence to external laws, regulations, guidance, and standards (LRGs Local and Reginal Governments Standards), while driving continuous improvement in quality systems, regulatory compliance, and operational excellence. You will lead a team of professionals responsible for internal audits, investigations, audit execution, and quality system enhancements. This role is pivotal in mitigating risk, supporting external audits, and fostering a culture of compliance and performance across Abbott’s global operations. This...

We are seeking a skilled privacy professional to help drive our privacy strategy, implement our global privacy program, ensure compliance with global data protection laws, enable innovation in an evolving and highly regulated digital landscape, and foster a culture of responsible data stewardship across the organization. The Deputy Chief Privacy Officer reports to the Chief Privacy Officer and will manage a team of professionals located globally. The Global Privacy Office is comprised of two teams. One team is responsible for counseling internal stakeholders on privacy matters, as well as engaging with external organizations, data subjects, and regulators. The other team...

We are seeking a Principal Regulatory Affairs Specialist to join Abbott’s Electrophysiology Division on-site in Plymouth, MN or St. Paul, MN. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. The individual may execute tasks and play a consultative role by partnering across business functions....

About the Role The primary responsibility is to serve the operations support group by ensuring compliance with procedures and regulatory requirements on the floor. You are responsible for investigations and escalation on the floor promptly to continue un-interrupted production. You are responsible for sample management (sterility, stability, etc.) and preparing shipments of those samples. Additional responsibilities incudes and are not limited to Triage, Deviation/CAPA initiation and investigation, raw material investigations, QOTSF, online batch documentation review, and serve as a Subject Matter Expert for processes. How you will Contribute Sample Management Manage sterility, stability, and retention samples, ensuring proper storage and...