Quality & Regulatory Jobs in Pharma & Biotech

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

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

Engineer - Process Development (Commissioning, Qualification, and Validation) What you will do In this role, you will support the commissioning, qualification, and validation (CQV) of GMP equipment and processes that enable Final Drug Product (FDP) operations at the Amgen Ohio (AOH) site. You will apply strong engineering and scientific principles to ensure new and existing systems meet Amgen and regulatory requirements throughout the validation lifecycle. As a key contributor to AOH’s growth, you will play an essential role in technical transfer, equipment startup, process validation, and continuous improvement across automated device assembly, packaging, and FDP manufacturing operations. Your work...

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

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

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

MAIN PURPOSE OF THE ROLE Provide Process/Quality Engineering and Quality Systems support to distribution activities, helping to ensure delivery of highest quality product to the customer. MAIN RESPONSIBILITIES Support QMS Implementation and maintenance of applicable distribution sites. Activities include documentation updates, new releases of documents, QMS reviews for audit preparation, participation in internal and external agency audits Reduces and controls distribution process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. Execute qualification/validation activities to support distribution projects and internal process implementation driven by the business units....

Associate Specialist Quality The Associate Specialist Quality is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You’ll Work On Responsible for implementing and maintaining the effectiveness of the Quality System. Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation. Assist in determining quality attributes and requirements. may provide...

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior QA Specialist- Quality Assurance Validation & Tech Support – Facilities & Utilities Focus What you will...

Material Compliance Associate What you will do In this vital role you will be responsible to assist the Brand Marketers build and monitor their projects through the Material Approval and Compliance (MAC) review process. The MCA will quality check files submitted for review, collect “live” edits during compliance review/approval meetings, and edit submission documents within the electronic review system, Veeva. They will ensure all materials submitted adhere to Amgen MAC Standards and FDA requirements throughout the process. Responsibilities Quality check submissions for review to ensure alignment with internal standards Work with agencies and internal staff, including training on next...

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. Position Responsibilities Potency test raw materials, experimental samples, in-process lot material, and final product animal vaccines by ELISA, fill volume, or other methodologies for USDA release and subsequent sale in accordance with regulatory and internal requirements. Assist testing investigations, Change management, periodic reviews, MPS tools implementation Assist the...

The Regulatory Diagnostics Associate Director (RDAD) for Precision Diagnostics is responsible for implementation of strategic plans for development of diagnostics, including Companion Diagnostics (CDx), as they pertain to the Novartis innovative medicines portfolio, including its marketed products. The RD Associate Director works with oversight of senior members of the Regulatory Affairs Precision Diagnostics Team including the TA and Diagnostics Lead on strategies and submissions including companion diagnostics, in close collaboration with internal RA Disease Unit associates, associates of Digital, Data and Clinical Innovation (DDCI) at Novartis as well as Partner Companies that develop diagnostics and ensures adherence to regulatory requirements....

Responsibilities - Ensures adequacy of non-conformances and CAPA records, investigations, and corrective actions. - Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making. - Review equipment onboarding, calibration and preventative maintenance tickets and identify potential gaps for GMP compliance. - Review change requests/notices/approvals for compliance to change requirements outlined in applicable WIs/Procedures. - Develop and execute strategies to close gaps in an efficient, technical, and compliant manner. - Coordinate issue resolution using a risk-based approach. - Ensure manufacturing processes meet requirements of FDA and ISO. - Trend, analyze, and report on quality data...

Facilities Compliance Specialist 1 - US1 The Facilities Compliance Specialist works within the Facilities Compliance team and is supported with leveling up our quality maturity within the AMR facilities organization with primary focus in San Diego. Provide Compliance support for assigned Facilities Operations, Validation, and Engineering in the AMR region. Provide direct support and guidance for all Facilities compliance activities conducted within Manufacturing and related Operations. Support in process improvement and global/regional alignment Facilities compliance projects. Responsibilities Demonstrate strong competency and expertise in Facilities-related Compliance requirements and a proven ability to provide value-added support to fulfill business objectives Support...

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

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 This position will be part of the Regulatory Legal...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. As Quality Manager (QA) of CMO within External Manufacturing & Supply (EM&S), you will be responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs), and/or Business Partners (BPs) involved in the manufacture, testing, and transport of Sanofi products. EM&S QA interacts with functional units within the entire Sanofi organization, both within EM&S and with global to ensure compliance with internal and regulatory requirements for the disposition of...

This individual will be part of the Operations legal team and must possess deep substantive expertise in global trade areas core to the Medtronic Diabetes business. This role will work across geographies resulting in unique ability to 1) advise on complex legal regulatory questions, 2) identify common and conflicting legal issues and positions across the company, and 3) contribute to high-level policy decision-making. This individual will provide import and customs compliance advice to help mitigate risks and provide support to Global Trade Operations, global regional and business unit lawyers, and other relevant functions. Specific global trade areas of legal and...

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

A Senior Laboratory Technician, Quality Control/Senior QC Lab Tech is responsible for performing advanced laboratory procedures independently for the testing of veterinary biologicals according to strict government and company-imposed guidelines. Technicians may work with a variety of technical equipment while completing Quality Testing. At all times technicians must follow Good Manufacturing Practices and Standard Operating Procedures (SOPs) and adhere to all safety and company policies, perform duties assigned by department management. A Senior QC Lab Tech must possess thorough knowledge of the underlying principles used in testing procedures and understand the material being evaluated, i.e. virus, bacteria, cell line, etc....

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

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

Key Responsibilities Contributes directly to the completion of projects through the development of validation schedules, project plans, master plans, validation protocols and reports for systems that may be complex in nature to support clinical and commercial manufacturing. Works independently to resolve moderately complex to complex validation issues with very limited direct supervision. Conducts and serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations related to distribution and validation activities. Provides technical assessment and approval for engineering and process changes. Forecast external support requirements for continuous validation support, including implementation of new projects. Coordinates the activities of...

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. 2026 Quality & Compliance Intern- Patient Service (Pharm D) reports to the Associate Director of Quality & Compliance for US Patient Services. This role is responsible for assisting in the development of quality and compliance strategies, methodologies, and roadmaps to enhance process improvements. The objective is to ensure a superior experience for both internal and external stakeholders involved in patient services across all brands. Key responsibilities...

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

As an RDQA GQC Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical industry. You will support the RDQA GQC organization, working collaboratively and strategically with colleagues across R&D. The role of RDQA is to ensure the highest standards of quality and compliance in all we do. We are committed to safeguarding patient safety and upholding ethical conduct, serving as a cornerstone for trust and integrity. By continuously improving, and collaborating with partners, we promote a quality-focused culture that supports innovation...

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

As a QA & Compliance Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical and medical device industry. You will support the R&D Quality Assurance & Compliance team, which develops, implements, and continually improves the AbbVie Quality System in R&D. The team ensures that clinical research and operations consistently meet regulatory requirements, internal standards, and ethical guidelines, thereby protecting patient safety, upholding data integrity, and supporting the reliable development and approval of products. Key Responsibilities Supporting the Quality Assurance & Compliance...

The Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. This individual will support the Eyecare Therapeutic Area. Additional Responsibilities Include Prepares device regulatory product strategies....

As a QA & Compliance Intern at AbbVie, you will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical and medical device industry. You will support the R&D Quality Assurance & Compliance team, which develops, implements, and continually improves the AbbVie Quality System in R&D. The team ensures that clinical research and operations consistently meet regulatory requirements, internal standards, and ethical guidelines, thereby protecting patient safety, upholding data integrity, and supporting the reliable development and approval of products. Key Responsibilities Independently review complex clinical trial and...

The Sr. Director, Clinical Quality Assurance will act as a leader in the Quality organization and will be responsible for the quality oversight for Beam’s clinical trials and overall GCP (Good Clinical Practice). The position will be critical to the overall strategy and growth of the Quality organization for Beam as the company grows and evolves from Development to a Commercial organization in preparation for licensure. Reporting to the VP, Compliance, the position will be a key liaison with the Clinical Operations team, Clinical Development, Medical and Safety teams, programs teams, regulatory, and others back to the Quality organization. The...

In this cross-functional quality role, you will actively participate in design control activities, including research and diagnostic applications. You will ensure product and process conformance to applicable safety and quality system regulations and standards (e.g. FDA (820), ISO 13485, ISO 14971, IVDR). You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure the company's products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional project teams. Position Responsibilities - Provide Quality oversight to ensure Illumina’s products...

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 Quality Engineer is within our Cardiometabolic unit located at San Diego, CA. Responsibilities Analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. Apply quality principles, analyzes quality records, prepares reports and recommends improvements. Conduct inspection, verification and validation of components or materials used in...

Senior Manager Quality At Molecular Diagnostics, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. The position of Senior Manager Quality within our Molecular Diagnostics Business Unit located in Des Plaines, Illinois. This position provides leadership and guidance for the quality department with overall responsibility to maintain high quality levels on all products while achieving high efficiency. Responsible for Nonconformance/CAPA process management and oversight, including Material Review Board,...

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

Principal Supplier Quality Engineer Join us at Medtronic’s Boulder, Colorado facility - a dynamic hub for surgical innovations within our Medical Surgical portfolio. As a Principal Supplier Quality Engineer, you’ll play a pivotal role in advancing Medtronic’s mission to alleviate pain, restore health, and extend life for patients around the world. If you’re driven by challenge, energized by innovation, and passionate about making a real difference, this is your opportunity to be part of the next generation of life-changing medical technology. At Medtronic Boulder, your work will help shape the future of healthcare and positively impact patients’ lives every...

Quality Control Associate II Summary Perform analytical and microbiological testing; data review; and/or related activities that support QC operations. The Opportunity You adhere to all company policies, procedures, and Good Manufacturing Practices (GMP), while embodying the Genentech/Roche Core Competencies. You maintain accountability for all deliverables, ensuring they contribute to both departmental and organizational goals. Providing quality support and oversight for internal and external customers, and actively ensure the organization remains in a constant state of inspection readiness. You proactively identify and resolve technical problems and gaps in systems/procedures through training and ongoing efforts. Supporting and integrating Environmental Health, Safety, and...

Gilead Sciences PDM External Quality is currently seeking a leader at the Associate Director/Director level to lead a team of Quality Professionals to drive strategy development and implementation of standardized communication, training and rollout of Gilead’s Quality standards, requirements, systems and tools to the Gilead’s contract organization global network. The successful candidate must possess expertise in leading cross-functional business and quality process mapping, identifying improvements to existing business and quality processes and leading Operational Excellence (OpEx) initiatives that span multiple PDM External Quality teams. Being able to utilize the tools & training associated with business process management in a strategic...

Seeking an experienced leader to serve as Executive Director, Large Molecule Analytical Sciences (LMAS), Biological Critical Reagents (BCR). This position is accountable for building and running an efficient and high-performing organization that ensures reliable BCR supply to support on-time product release and new product introduction, while maintaining compliance with applicable regulations. The candidate will interface extensively with R&D to ensure high technical rigor for introduction of new BCRs during commercialization of pipeline biologics and vaccines. The role also requires extensive engagement with Manufacturing, QA, Regulatory Affairs, and Supply Chain. The ideal candidate should have extensive experience in BCR implementation, qualification...

Associate Director, Regulatory Submissions Archive Operations Location Rahway, NJ (Hybrid role - onsite 3 days per week required) Functional Area Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) The Associate Director of Regulatory Submissions Archive Operations serves as the Business System Owner (BSO) for the Veeva RIM Submissions Archive and is also responsible for managing the physical paper archives for GRACS. This dual role ensures seamless integration and governance of both digital and physical regulatory records, supporting audits, inspections, litigation, and business transactions. Specific responsibilities of this position include Digital Archive Ownership (Veeva RIM...

Job Title Quality Assurance Manager Our location in Temecula, CA, currently has an opportunity for a Manager, Quality Assurance THIS IS AN ONSITE DAILY ROLE. As the Manager, Quality Assurance, you will lead the team of Quality supervisors/engineers/technicians to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. You will directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements. What You'll Work On Implement a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with...

The Senior Director, Pharmacovigilance Compliance is a critical leadership role within Patient Safety, responsible for the global governance and continuous improvement of compliance controls across the AstraZeneca pharmacovigilance landscape. The role drives both strategic and operational compliance by implementing robust predictive and detective controls, fostering an enterprise-wide safety and compliance culture and s haping policy . Key elements include championing the use of analytics, innovating compliance frameworks, developing compliance policies and standards, and partnering with QPPV to ensure optimal compliance and readiness globally through prediction and early detection. Typical Accountabilities Accountable for the global pharmacovigilance compliance model, encompassing preventive, detective,...

ABOUT THE ROLE The Associate Director, GCP Audit & Compliance provides strategic quality oversight to clinical, medical, and pharmacovigilance suppliers across Takeda’s global network. You will lead the risk-based supplier audit program, drive compliance insights, and partner closely with stakeholders to ensure adherence to GCP, GCLP, and GVP standards. This role combines audit leadership, supplier oversight, and strategic risk management to enhance end-to-end clinical quality. HOW YOU CONTRIBUTE Lead strategic quality oversight activities for clinical, laboratory, medical, and PV suppliers. Develop, execute, and continuously improve the global risk-based supplier audit program. Conduct supplier audits end-to-end, including planning, execution, reporting, and...

POSITION OVERVIEW You will typically act as the Regional Regulatory Lead on the assigned products, compounds, indications or projects in Virology. With guidance, you will define the regulatory strategy, plans and objectives for the assigned products or projects. You will typically lead the Regulatory Submissions Teams associated with assigned products or projects and represent Global TA Regulatory to cross-functional sub-teams. You may serve as a Gilead contact to / for regulatory authorities. You will oversee and manage the work of less experienced colleagues supporting your work. You will coach and advise less experienced colleagues in completing their work and developing...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for a Director, Quality Control to be located in Gurabo, PR. The Director of Quality Control is a key member of the site leadership team, responsible for leading all aspects of all...

In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. To lead GRTs within Amgen’s GRAAS organization To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions To provide Regulatory leadership to cross-functional teams for high complexity...

In this key role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans Conduct the formal review and approval of authored documents, following applicable standard operating procedures With limited supervision,...

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm...

Summary In this cross functional quality role, you will actively participate in design control activities, including research and diagnostic applications. You will ensure product and process conformance to applicable safety and quality system regulations and standards (e.g. FDA (820), ISO 13485, ISO 14971, IVDR). You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure the company's products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional project teams. Key Responsibilities - Provides Quality oversight to ensure...

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...

We are seeking a highly skilled Risk Management Expert with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety, regulatory compliance, and effective risk mitigation throughout the product lifecycle. Develop and maintain comprehensive strategies for risk management activities, including Creating and managing risk management plans and reports, as well as conducting regular risk reviews. Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures. Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential...

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...

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

Ethicon LLC is recruiting for a Process Quality Leader position, located in San Lorenzo. 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 Under the direction of the Business Unit Leader, provides technical leadership towards the identification of the causes for non-conformances and process failures, and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Ethicon’s QSR, GMP, and ISO requirements for the entire Business...

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

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. Perform Computerized System Validation (CSV) Audit Trail Review for Systems...

The Associate Director, Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team. The individual will have excellent communication and collaboration skills and will work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance's or competitive intelligence. The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science...

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. Position Responsibilities Potency test raw materials, experimental samples, in-process lot material, and final product animal vaccines by bacterial titrations, bacterial proof of inactivation or bacterial identification or other methodologies for USDA release and subsequent sale in accordance with regulatory and internal requirements. Assist testing investigations Assist the area...

The Senior Specialist, Quality Assurance Lot Disposition (QALD) is a full-time position at the Bristol Myers Squibb (BMS) Bothell, WA Cell Therapy manufacturing site. The primary focus for this role is to ensure final drug products and incoming raw materials are released to market following all internal procedures and cGMP requirements. This position reports directly to the Senior Manager of Quality Assurance – Lot Disposition. Work Shift 4 x 10hrs / Day. Weekend and holiday work is required. Sat-Mon and Wed 8am -6pm Duties / Responsibilities Conduct routine lot disposition activities for finished drug products and incoming raw materials by...

Quality Professional The Specialist Quality Assurance within Abbott Diagnostics Division will analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. What You’ll Work On Design/Change Control - Responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity. Risk Management – Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc. Design Verification/Validation – Understands and applies basic Design Verification/Validation methods...

Director, Technology-Global Regulatory Operations What you will do In this vital role you will lead the end-to-end digital strategy, delivery, and operational excellence of Global Regulatory Affairs and Safety (GRAAS) systems. This role will provide strategic oversight of the capabilities provided by platforms such as Veeva Vault RIM, Lorenz DocuBridge, and TrialScope, while driving transformational initiatives that improve regulatory operations, data quality, and compliance across all regions and product lifecycles. The successful candidate will operate at the intersection of technology, compliance, and business process—partnering with senior regulatory leaders, technology partners and external vendors to ensure global systems deliver business...

Join the Medtronic Cardiac Ablation Solutions (CAS) regulatory affairs team of innovators who bring their worldview, unique backgrounds, and individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, and we believe that this drives healthcare forward and sets us apart as a global leader in medical technology and solutions. Cardiac Ablation Solutions is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care, cardiac mapping, and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives...

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

Purpose This position leads and maintains compliant Documentation Quality Systems (QS) according to AbbVie policies, procedures, and applicable government regulations by managing the documentation review board to process and update complaint plant procedures, Process Control Records, Specifications, Test Methods, and other GMP documentation. It also provides leadership to a team for the creation and/or update of material codes in the SAP inventory system and the electronic batch record recipes in POMs system. The Quality Systems and Third-Party Contractor (TPC) role also is the main QA point of contact with TPC to manage regulatory compliance and business continuity requests in a...

This role will support manufacturing operations and will be primarily responsible for the review and labeling of raw material and review of printed material documentation. This Quality Assurance colleague will ensure documentation for these two areas are complete and compliant. Additionally, this role will serve to update and maintain Master Data within SAP, review occasional production batch records. The ideal candidate will have ability to maintain detailed focus while reviewing paper documents for significant portions of their workday. The Quality Assurance Senior Technician will also work closely with other members of Quality Assurance as well as internal and external customers...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Senior Validation Engineer will lead validation efforts to support the Radiopharmaceutical facility and GMP operations in Indianapolis. This role is responsible for the development, execution, and management of commissioning, qualification, and validation (CQV) documents and protocols for...

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

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

WHAT YOU’LL DO We are recruiting for a Regulatory Operations Specialist I I, to join our team in the Plymouth, MN location. In this ro le, you will be re sponsible for specialized level work assignments and/or analyses, evaluation, preparation, and management of global regulatory product releases and ge neral support of global regulatory activities. Responsibilities Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives . Responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs) and tender...

Careers That Change Lives In this exciting role as a Senior Quality Systems Manager, you will have responsibility for QMS Data Analytics, Data Reporting and managing multiple Digital based improvement initiatives within the Quality Transformation organization that will systematically evaluate and transform the capability of the Quality Management System (QMS) to better meet the needs of its stakeholders, both internal and external. Quality Data steward, supporting Data analysis and reporting methodologies Leading a team of Data analysts to support specific analysis where needed to perform advanced data analysis, dashboarding, and reporting in support of quality improvement goals ...

Vertex is seeking an experienced Regulatory Affairs Advertising & Promotion Director to provide strategic and tactical regulatory direction for the review and approval of product, pipeline, and disease state communications for its pain assets in the US. This role is critical in ensuring that all promotional and nonpromotional communications meet regulatory requirements and support Vertex’s business objectives. The Director will collaborate cross-functionally to develop viable communications and implement processes that drive compliance and business success. Key Duties and Responsibilities Serve as a regulatory expert on US statute, regulations, and relevant guidance governing product promotion and related communications, including pipeline and...

The CQAD is the first point of contact on quality and compliance matters for the Oncology Site Management and Monitoring (SMM) function. They are responsible for developing, tracking and analyzing quality metrics at country level. They provide direction and advice on how to apply GCP principles to SMM Oncology personnel so that their work can be conducted while meeting high quality standards. The CQAD utilizes regulatory guidance, globais standards and SOPs to provide compliance advice to SMM Oncology. When appropriate, the CQAD recommends and communicates improvement opportunities to the Business Process & System Owners (BPOs). CQADs supports SMM Oncology management...

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society. THIS POSITION IS FOR 3rd SHIFT M-F 10pm - 630am. Accountabilities Support specific Quality Operations processes within assigned area External Audit Readiness - support the preparation activities for internal and external inspections, including...

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 all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System,...

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 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...

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

In this exciting role as a Quality System Manager - Change Control, you will have responsibility for leading the QMS change control process for the Medtronic Diabetes business. 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...

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

Materials Operations is a regulatory compliant service operation that is responsible for the safe and secure, Receipt, Storage, Shipping and Transport of Sanofi materials and products. Materials Operations is also responsible for supply chain security compliance, hazardous materials, import/export, inventory management & control, warehouse operations and other value-added logistics. Operations compliance engineers main functions are leading deviation investigations and managing CAPA implementation, partnering with direct APU staff for enhancing and improving the APU instruction set, overseeing and supporting APU training program, and identifying and managing continuous improvement initiatives. Senior Operations Compliance Engineer uses expert knowledge of compliance and GXP processes...

The Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations, and materials management for the internal programs at Vertex Manufacturing Center (VMC), Boston, MA. The position will be a part of the QA operation floor support team. This role will review & support activities related to product disposition, including batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation. The Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs. The position will support multiple production functions (from Quality operations to Quality...

Strategy & Capability Building Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. Own continuous improvement of the operating model and capability roadmap for the CMC RA function. Creating and implementing functional business strategies Improving performance and operational excellence Centralizing key activities to support each team’s global product, pipeline, and people’s ambitions Operations & Cross-Functional Leadership Design, build, and lead a high-performing organization to drive strategic initiatives, centralize activities, and foster cross-functional support of CMC RA’s processes, systems, data, and tools. Define and track Key Performance Indicators for CMC RA. Collaborate with...

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 The Manufacturing Quality Operations Senior Associate provides Quality Assurance (QA) support to all modalities manufactured on site including clinical, commercial, and contract manufacturing operations providing QA Operations Floor oversight. The role ensures adherence to regulatory expectations,...

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. Role Summary The Associate Director Quality Compliance supports strategic and operational...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Associate Quality Assurance Engineer will provide support to Operations for a variety of functions such as material receipt, production, process validation, facility qualification, and test method validation to determine the acceptability of material and the process in...

Quality Assurance Manager (Bogdanoff) As a Quality Assurance Manager for Complaint Investigations, they will be responsible for sustaining the complaint investigation operation, while developing a team and leading projects to advance the lab for future expectations with regards to compliance, capabilities, and workforce output. This role oversees engineers and leads for direct and indirect labor to sustain complaint investigations, and complaint returns. This role is responsible for establishing an operation that performs consistently to maintain requirements for investigation timeliness, and develop processes for new or updated products, while ensuring ongoing compliance and audit readiness per Abbott's Quality Policies and...

Personalized healthcare is the future. Bio-wearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Diabetes is a growing problem worldwide, and at Abbott Diabetes Care (ADC) we are helping people with diabetes lead healthier, happier lives. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, and we‘re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. ADC is responsible for the development and launch of new digital products based on the FreeStyle Libre platform, the world’s #1 continuous glucose monitoring (CGM)...

Quality Engineer II This position works out of our St Paul, MN location for our Electrophysiology medical device business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As a Quality Engineer, you’ll play a key role in ensuring product excellence by investigating software/hardware-related customer complaints. Your work will directly impact product reliability and customer satisfaction. You’ll collaborate closely within a small to medium-sized team and across departments to uncover root causes and drive improvements. What You’ll...

In this exciting role as an Audit Compliance Manager, you will have responsibility for leading the compliance audit program for the Medtronic Diabetes business. The Audit Compliance Manager is responsible for managing the compliance audit program, for internal, external and supplier audits at the Diabetes sites. This position is an exciting opportunity to work with Medtronic's Diabetes business. This role is instrumental in contributing to defining the direction and plans for process improvement and ensuring the site is audit ready. The individual in this role must be comfortable coaching all employees on audit readiness and working professionally with others to...

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

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. When it comes to research and development, our goal is to...

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

Use Your Power for Purpose This position will oversee the Quality Control Laboratory in Rochester, MI. The Rochester Quality Control Laboratory performs Assay, Viscosity, Breakloose & Extrusion, Sterility, Gas chromatography, pH, LOD, Bacterial Endotoxin, Karl Fischer, and multiple other analytical technologies used to determine quality attributes for Rochester manufactured Drug Products. The selected candidate will lead the laboratory to meet defined quality standards and QO objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the laboratory and department. Provides guidance and...

POSITION SUMMARY Robotics and Digital Surgery, a division of Johnson & Johnson Medtech Surgery Group, seeks a Head of Quality and Compliance for the Monarch platform. The role oversees Design & Development, Manufacturing/Operations, Quality & Compliance, and Post Market Surveillance, reporting to the Global VP of Q&C Robotics and Digital Surgery at the Santa Clara campus in California. This role is responsible for overseeing Quality and Compliance, with a focus on product design, manufacturability, and reliability throughout Product Development, Operations, Distribution, and Commercial processes. The position involves collaboration with teams including quality associates, engineers, and managers, who carry out product...

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

As a CAPA Quality Systems Specialist , you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters. As a CAPA Quality Systems Specialist, you will Lead and support Quality System processes , such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control. Serve as a subject matter expert (SME) for one or more Quality System elements in compliance with FDA...

Position We are seeking an experienced Senior Director, Regulatory Affairs, to lead our regulatory strategy and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to guide product development and market entry strategies while maintaining a steadfast commitment to regulatory integrity and transparency. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical...

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. Purpose The purpose of the Senior Director – GPS Safety Data...

Responsibilities may include the following and other duties may be assigned. Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families Accountable for and owns the Risk Management Files for assigned product families within the Robotic Surgical Technologies business. Maintains Risk Management Files for assigned product families Conducts product Risk Analysis (PHA, RAC, SSRCI/System & Use FMEAs) in compliance with ISO14971 Evaluates product Risk Management Files against field data to ensure accuracy and correctness of predicted risks; validating pre-market Benefit Risk Analysis and updating the Risk Management Files...

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

Johnson & Johnson is currently recruiting for Associate Director, Centralized Compliance Services ! This position can be located in Raritan, NJ, Horsham, PA or Beerse, Belgium. 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-044264 Beerse Belgium-Requisition# R-045004 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as...

We are seeking a highly motivated and digitally fluent Quality Metrics & Digital Insights Specialist to join the PT Quality (PTQ) organization. In this impactful role, you will partner across global sites and functions to design and deliver data-driven solutions, dashboards, and advanced analytics that power decision-making and promote a culture of continuous improvement across the Pharma Technical (PT) network. You will help translate complex quality and operational data into meaningful insights that inform strategy, support regulatory compliance, enable proactive risk mitigation, and unlock business value. Working at the intersection of Quality, Data Science, and Digital Innovation, you will be...

Responsibilities Provide ongoing software quality engineering support throughout the software development life cycle Provide support to development, engineering and manufacturing functions for validation planning and transfer activities Assist teams in determining verification and validation needs and requirements Provide support for software development projects in the manufacturing areas by review/approval of software deliverables Software Development Plans, Verification Plans, Validation Plans User Requirements, Functional/Software Requirements Configuration Specifications, Software Architectural and Design Documents, Peer Reviews Risk Management Documents Test Protocols, Requirement Traceability Matrices, Summary Reports Provide review and approval of software related change orders Ensure successful transfer of software from development into manufacturing...

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

The Sr. Regulatory Affairs Manager hired in this role will work out of the Lake Forest, IL location 4-5 days a week in the office. This role will require some travel up to 25% to Abbott locations potentially in and outside of the US. This is part of the Infectious Diseases Division at Abbott Rapid Diagnostics. This role reports to the leader that also leads Global New Product Introductions and US Regulatory. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests...

About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. Please note that this position can be...

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Executive Director — Biologics Quality Control (Grade 34) KEY RESPONSIBILITIES The Executive Director, Site Quality Head is responsible for leading all Quality functions at the pharmaceutical manufacturing site, ensuring compliance with global regulatory standards, driving...

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 Systems & Compliance Data Analytics Lead role provides critical...

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. Sr. Principal Infrastructure Architect – Manufacturing & Quality Systems At Lilly,...

We are seeking a Regulatory Affairs Manager to join Abbott’s Heart Failure Division on-site in Pleasanton, CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the...

Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. Intern will be joining the Regulatory Affairs U.S. Advertising and Promotion (USAP) Standards Team. The Standards Team leads USAP through department-wide initiatives, influences process improvements and fosters the review of compliant promotional and R&D communications. Key responsibilities may include Learning the FDA Regulations on Drug Advertising & Promotion Understanding the detailed USAP activities Creating reports, including metrics, department highlights and communications Attending meetings Creating presentation materials...

Purpose The Associate Director, Global Quality and Compliance Excellence uses advanced subject matter expertise of global quality standards, cGMP, and external agency regulations to lead preparedness for regulatory inspections and audits at AbbVie sites across the global network. Drives the development and maintenance of a quality culture by closely collaborating with AbbVie Manufacturing Site leadership, Quality Lab leadership, global functional groups, and Third Party Manufacturers to conduct mock audits, coach site leadership on opportunities identified, maintain roles and responsibilities, identify potential project gaps, and obtain an in-depth understanding of the quality, compliance, and resource needs at each site. Responsible for...

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

The Strategic Global Labeling Manager in Regulatory Affairs is responsible for developing and delivering patient-centered global product labeling for the safe and effective use of AbbVie products. The key responsibilities include leading cross-functional teams to develop comprehensive label strategies and create accurate labeling for development and marketed products, ensuring compliance with company procedures and applicable regulations. Responsibilities Develop and maintain target labeling and prescribing information, including company core data sheets, and US and EU labeling documents, through the product lifecycle. Make recommendations to proactively optimize labeling language, including effective use of target labeling as applicable, for assigned products. Product portfolio...

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality assurance background to join our Quality Assurance (QA) team. The successful candidate will contribute to the advancement of our product pipeline by performing QA batch record review, label review and verifications, document archival of records, and other assigned tasks. You will also be expected to independently organize and manage timelines for batch record reviews. You will be expected to provide support for both the Santa Monica, CA and Tarzana, CA sites as needed. Responsibilities include, but are not limited to Reviews routine manufacturing batch documentation and quality control...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at...

Johnson & Johnson is currently recruiting for a Senior Manager External Quality! This position can be located at any J&J Internal Medicine site in the US, with a preference for New Jersey or Pennsylvania. In this position you will be responsible for providing quality leadership and oversight of external manufacturers in the North America region, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards. Key Responsibilities Ensure effective and compliant execution of quality systems at external manufacturing sites Participate in the selection, qualification, and ongoing monitoring of external partners Provide leadership in the...

The Senior Director, Quality Assurance leads the site’s independent Quality Assurance organization, accountable for an effective, risk‑based PQS, final batch disposition, inspection performance, and a culture of continuous improvement and data integrity. Partners with the Site and global Quality leaders to assure supply and compliance. FOCUS AREAS Quality Leadership & Strategy Demonstrate ownership of a site Pharmaceutical Quality System (PQS) aligned to our Quality Manual, including policy/standards oversight, CAPA/change control governance, data integrity, risk-based approaches and periodic management reviews . Able to run an independent QA function , with authority for final batch disposition , QA oversight of manufacturing/testing, and...

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

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Senior Manager, QA for QC is responsible for quality oversight of the Quality Control (QC) Analytical and Quality Control Microbiology laboratory operations at the RayzeBio facility in Indianapolis in accordance with RayzeBio policies, standards, procedures and global...

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Senior Specialist, External Manufacturing Quality Assurance is responsible for quality oversight of the Contract Manufacturing Organization (CMO) operations for Radiopharmaceutical products in accordance with business agreements, regulatory standards, and RayzeBio procedures. The scope includes clinical and commercial...

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

This role will support the Global Privacy Office in developing, executing, and enhancing AbbVie’s privacy compliance monitoring and analytics program, including the maturity of monitoring initiatives of privacy controls across the enterprise and the execution and adoption of privacy analytics tools and systems to manage and mitigate risk. This role sits in North Chicago with a hybrid in office schedule . Key Responsibilities Responsible for informing, executing and adjusting the annual, Privacy Global and Local monitoring plans leveraging data analytics and performing data analysis to inform our on-going understanding of potential Privacy risks, and providing guidance for monitoring the compliance...

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

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

Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Careers That Change Lives In this exciting role as the Senior Quality Systems Program Manager , you will lead strategic initiatives to improve the Neuromodulation and Pelvic Health Quality Management System (QMS), focusing on enhancing customer experience through innovative solutions. Additionally,...

Our Purpose Within the CRDN Design Assurance Laboratory at Medtronic’s Mounds View site, we focus on providing Quality support across all aspects of PDP from pre-market product development to post-market product surveillance. We participate in the design process to ensure the performance and safety of the complex electromechanical devices we develop are assured and maintained throughout the product lifecycle. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment...

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

Job Title Compliance Manager This position works out of our Sylmar, CA location. This is an onsite role . Sets strategy for internal, clinical, and external audits (Regulatory Agencies, Corporate, Certification bodies, and major clients) ensuring sites are audit ready at all times. The incumbent manages a team of auditors across the sites and acts as a change leader, responsible for management of major global improvement activities to improve quality systems, audit readiness, and compliance. Represents the division within Abbott through Corporate based advocacy forums as well as external Regulatory Intelligence Forums such as the Notified Body Audit Coordination...

Quality Compliance Senior Manager What you will do In this vital role you will be responsible for driving Global Quality Compliance Audits and assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers, to assess compliance with all applicable regulations and to identify top compliance risks. Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies. Implements risk assessments. Ensure...

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...

Global Patient Safety, Oncology TA Intern Overview Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. The Global Patient Safety, Oncology Therapeutic Area (TA) Intern will spend your summer engaged with energetic colleagues and inspirational leaders, gaining world-class experience within one of the most dynamic organizations in the pharmaceutical industry. The intern will support the enhancement of clinical safety insights by leveraging reverse translatability to improve non-clinical capabilities (e.g. complex in vitro models (CIVM) or...

Global Patient Safety, Specialty TA Intern Overview Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. Global Patient Safety, Specialty TA Intern Overview Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. As a Global Patient Safety, Specialty Therapeutic Area (TA) Intern at AbbVie, you will spend your summer engaged...

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 Associate Director – Global Quality Management Review Lead will...

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 Design Quality Engineer role to be located at Danvers, MA. The ideal candidate for the Design Quality Engineer position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. This engineer should excel in an environment that embraces teamwork,...

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We have an opening for a Sr. Quality Engineer at our Minnetonka, MN site within our Electrophysiology division. This position will provide Process/Quality Engineering support to manufacturing for commercially released product, helping to ensure delivery of highest quality product to the customer. What You’ll Work On Reduces and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing...

AbbVie’s diversified portfolio provides a unique mix of pharmaceutical products and direct-to-consumer aesthetic products and devices. This allows for distinct opportunities for AbbVie professionals to learn and operate in both spaces, gaining an understanding of the different industries and associated business models. The Global Compliance Audit Associate Director has the primary function to lead/manage global sales and marketing, corporate functions, and other healthcare compliance audits. The role will assist the Director with annual risk assessments and be expected to form relationships with a broad spectrum of stakeholders to understand business risks for US/International locations and recommend a thoughtful audit approach....

About GenerateBiomedicines GenerateBiomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform...

About the role The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's mission to provide better health and a brighter future. This role is located in Cambridge, MA and it is Hybrid (not remote). R elocation Benefit is available to support your transition. How will you contribute Ensure compliance to Regulatory Intelligence Procedures by executing the...

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 Assurance Investigations at the Cell Therapy Facility (CTF) in Devens, MA will be responsible for providing quality...

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

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

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. At Medtronic, we must work with a sense of purpose and ownership, knowing there is a human life on the other side of every decision. We bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work....

The Regional Distribution Quality Specialist is responsible for ensuring the quality of distribution operations across the Americas, focusing on warehousing, order fulfillment, product returns, and value-added services such as labeling, boxing and recharging. This role will provide quality support and oversight to ensure compliance with internal and external regulations, standards, and guidelines, specifically ISO 13485, and 21 CFR 820, across multiple 3PL distribution centers in the Americas in support of Medtronic Minimed. 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...

The Opportunity We are seeking a motivated and experienced Quality Assurance Specialist to join the Synthetic Molecule Analytical Chemistry (SMAC) department in Genentech Research and Early Development on the South San Francisco campus. The specialist will be a member of the SMAC Equipment and GMP Operations Group. This role will be responsible for Qualification of GMP equipment and associated compliance documentation, writing qualification protocols, working with QA to obtain protocol approval, and executing validation activities. Manage equipment lifecycle activities and documentation such as system risk assessments, decommissioning, and periodic review; serving as department SME for data migration and archival; initiating,...

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. The Compliance Engineer organization supports the Engineering and Maintenance (EM) department by performing investigations and supporting the completion of CAPAs and change controls at the Sanofi, Framingham manufacturing facilities. Responsible for managing a compliance EM department supporting and coordinating Compliance efforts for the EM Department consisting of Engineers and specialists. Supports manufacturing facilities and manages staff performance against department’s operational goals. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to...

About the Role This position will provide guidance in validation strategy to the site and global projects. The position will have engineering validation signatory responsibility for approval of cleaning cycle development and cleaning validation protocols and final report documents. This position is responsible for assessing and validating cleaning processes. Primary tasks include development of protocols, coordination of validation activities, execution, preparing final reports and assembly of final validation packages; generation of project plans. Responsibilities will consist of both initial validation efforts as well as revalidation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final...

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

JOB SUMMARY Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global development that changes patient lives throughout the product life cycle. The Vice President, Internal Medicine Regulatory Strategy, serves as a senior regulatory leader who has global mindset and expertise of drug development and product lifecycle processes in support of Pfizer’s Internal Medicine portfolio including metabolic disease, cardiovascular risk, diabetes and cachexia. The goal of position is to provide, maintain and direct regulatory resources in the provision of regulatory guidance to projects and products to optimize input to development and commercial decision-making...

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

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

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...

This is an onsite role located in 1420, Harbor Bay Parkway, Alameda, CA. This is not a remote role/opportunity. The IT Process Architect - Global Quality and Regulatory plays a pivotal role in shaping and optimizing enterprise-wide business processes to support strategic transformation and operational excellence. This role partners with cross-functional teams to design scalable, service-oriented process frameworks that align with business goals, improve efficiency, and enable innovation. The Process Architect ensures that business capabilities, value streams, and workflows are clearly defined, integrated, and continuously improved to drive measurable outcomes across the organization. Core Job Responsibilities Process Architecture & Optimization...

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 Experienced Analyst, Quality Control to be located in Malvern, PA. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products?...

The Manager, Quality Systems is responsible for supporting the ownership and oversight of Devens Cell Therapy quality systems, such as CAPA, Investigations per established local and global standards. This position supports the overall compliance and performance of Devens Cell Therapy Quality Systems Management as it applies to the site level, including periodic assessments of process performance and continuous improvement opportunities Duties/Responsibilities Review and approve complex site quality system deliverables and risk assessments associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems. Ensure quality system deliverables are robust and adequately address requirements and risks, by...

We are seeking a dynamic and experienced Associate Director to join the Global Supplier Quality team within External Quality Operations. This leadership role will provide strategic direction and operational oversight for biologics-related material categories (e.g., single-use systems, resins, filters, media, excipients). The Associate Director will serve as a key quality leader, driving supplier performance, risk mitigation, and lifecycle management across a global network. This role requires strong technical expertise, external relationship management, and the ability to influence cross-functional teams and senior stakeholders. Job Responsibilities Provide strategic quality leadership for biologics material suppliers across internal and external manufacturing networks Lead supplier...

Objective / Purpose The Head of Research Quality holds the highest leadership role within the Research Quality organization and serves as a key member of the R&D Quality leadership team. This executive is fully accountable for defining and executing the global strategic vision for Research Quality, overseeing a global team of experienced subject-matter experts dedicated to ensuring integrity, compliance, and ethical excellence in non-clinical research activities, studies, and processes supporting Takeda’s R&D pipeline. Through strategic leadership, impactful stakeholder engagement, and championing an enterprise-wide quality culture, the Head of Research Quality drives organizational success and reinforces Takeda’s commitment to industry-leading standards....

OBJECTIVES/PURPOSE Drive the design, implementation, and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures. Lead and develop a global organization, fostering talent, accountability, and high performance to advance quality, ensure regulatory readiness, and drive innovation and operational excellence and execute Takeda’s global Quality strategy for medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, geographies, and therapeutic modalities spanning Takeda’s development pipeline and lifecycle management of marketed products. Drive inspection-ready and escalable, compliant, and...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...