Quality & Regulatory Jobs in Pharma & Biotech

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 Leading a technical staff which perform activities related...

We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM). In this role you will play a key role in the lifecycle management of Medtronic products that get integrated with our strategic partners. You will be responsible for engaging with strategic partners in integration projects, preparing and submitting regulatory filings for the U.S. and EU market and managing global compliance. You will collaborate closely with engineering, marketing, clinical, quality as well as the regional and international teams working with integration partners to support the submission process and ensure regulatory requirements are...

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

Johnson & Johnson is recruiting for an Associate Director, Regulatory Advertising & Promotion within the Health Care Compliance Organization, based in Horsham, PA, New Brunswick, NJ, Raritan, NJ or Titusville, NJ. The Associate Director, Regulatory Advertising & Promotion will Provide direction and oversight of regulatory advertising & promotion compliance activities for assigned products. Conduct regulatory promotional labeling and marketing compliance reviews in the R&D and commercial arenas to help ensure that activities and communications are consistent with product labeling, are adequately supported and are in compliance with applicable laws, regulations and policies related to advertising & promotion of prescription products....

Job Summary We are seeking a Director, Quality Assurance, to join our Clinical Quality Assurance (CQA) organization. The person will provide leadership for the team responsible for providing quality oversight in collaborating with required functional areas in ensuring compliance with applicable Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), and Good Pharmacovigilance Practices (GVP) regulations. This position reports directly to the Vice President, Global Quality Systems and Compliance. Essential Functions Ensure the implementation and/or maintenance of global, phase-appropriate clinical Quality Management System (QMS) policies and procedures to ensure compliance to applicable regulations, including U.S. and EU. Provide quality oversight...

Director Supplier Quality The Opportunity Abbott Diabetes Care has an opportunity for a Director Supplier Quality. The Director leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies. What You’ll Work On Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially in the area...

Our company is expanding its global Bacillus Calmette Guerin (BCG) vaccine production by adding an end-to-end laboratory capability located in the Durham, NC campus. The new facility will be used to produce the bulk active ingredient, finished product, and laboratory testing for the BCG vaccine. The Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing for the BCG Product. The position will focus on environmental monitoring, aseptic process simulation and support testing readiness in preparation for commercial production. The selected candidate will participate in equipment validation, process validation, and GMP laboratory readiness. The...

Position This role will primarily support Manufacturing Operations and will serve as the primary Quality Assurance Representative for the Downstream (Blend, Fill and Lyophilization) Integrated Production Team (IPT). This team member will provide guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMPs. This position will serve as the Quality Point of Contact for any quality issues the Downstream IPT has. Additionally, this role will serve as the Quality Assurance Representative on Downstream Quality Systems Records. These records include Deviations, Change Controls, SOP updates, Batch Record updates and more. This...

Reporting to the Director of Medical Device and Combination Product Quality Assurance, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. This position will interact with cross functional teams working with all levels of employees. Activities will include developing, documenting, and maintenance of technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product current Good Manufacturing ruling (21CFR part 4), Device...

We are searching for the best talent for HR Leader, MedTech (MT) Quality and Compliance to be in Raritan or New Brunswick, NJ. The position is eligible to participate in J&J Flex, working days both in the office and remote each week. As a Business Unit Human Resources Leader MedTech Quality & Compliance you will provide strategic HR partnership to the Q&C teams in MT, contribute to shaping business strategy, and drive aligned outcomes in these focus areas Leverage internal and external insights to diagnose and design organizations optimized to achieve strategic goals Design and deploy data-driven talent strategies that...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Process Quality Technician to be in Palm Beach Gardens, FL. Purpose Under the guidance of the Manufacturing Engineering Leader, Quality Operations Leader or Operations Leader, the Process Quality Technician provides technical support to identify the causes for non-conformances and process failures and to implement corrections thus assuring process performance and compliance against QSR,...

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. T he Associate Director, Computer Systems Validation (CSV), Equipment Commissioning & Qualification (ECQ) supports the activities and personnel associated with design,...

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 Quality Control Associate I will participate in a variety of Quality Control functions, including but not limited to, raw material, in-process material, finished goods and stability testing, support process and method development, characterization and validation, and quality...

This is what you will do The Regulatory Affairs Director (RAD) , Regulatory Science & Execution will be accountable for the develop ment, implement ation and maintenance of regulatory strategies for assigned project(s)/ product (s) and regulatory jurisdiction ( s ) , with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will provide tactical and strategic input to and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio . This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and...

– We are seeking a highly organized and proactive Regulatory Operations Specialist for our Santa Clara, CA location to perform specialized level work assignments and/or analyses, evaluation, preparation and general support of global regulatory activities . As an individual contributor, the Regulatory Operations Specialist will play a crucial role in ensuring efficient and compliant business processes within the regulatory affairs department . T he function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment . The individual may execute tasks and exercise influence generally at the middle...

The Logistics, Compliance and Engineering (LCE) co-op will be a part of a cross functional team that concentrates on deviation management, change control, cold chain management, technology support, and operational efficiency projects in support of the North America Supply Chain Management (NASCM) organization. The LCE co-op will collaborate with Operations, Quality, Automation, and Validation to drive change in a collaborative manner. The candidate will gain some understanding of cGMPs and cGDPs and will be tasked with a problem(s) to solve while contributing to multiple projects and activities across the facility and North America transportation network as required. The individual must...

In this exciting role as a Senior Compliance/Audit Specialist, you will be responsible for ensuring compliance with regulatory requirements and internal policies at Medtronic’s North Haven, CT, manufacturing site. You will play a key role in maintaining quality and regulatory standards by facilitating and preparing for audits, assessing risks, and driving continuous improvement initiatives within the Quality Management System. Written in 1960, Medtronic's Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees around the world. The...

The Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations. Responsibilities Assist with proper integration and support of quality regulations drug, biologics, device and/or combination products. Assist project teams in planning, preparation, review and approval of...

POSITION SUMMARY The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. PRIMARY RESPONSIBILITIES Understands and interprets U.S. and international medical device and in vitro diagnostic device (IVD) regulatory requirements. Provides guidance on requirements to product development teams. Develops strategies for submissions...

POSITION SUMMARY At Natera, we revolutionize the world of medicine by developing genetics products that combine cutting-edge technology and science. On top of that we want to accelerate the breakthroughs in research to improve care by offering our unique genomic and clinical data. In order to achieve that we are looking for a Software Quality Engineer who has experience in testing data products to join the team. The ideal candidate for this position would want to help develop software that lasts -- extensible, testable and self-documenting. No biology background is required but this is an excellent opportunity for a strong...

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

The Compliance / Audit Program Manager will have responsibility for developing and executing global strategic internal audit and compliance improvement initiatives. This person should be a well-rounded individual who thrives in fast-paced, technically advanced, and collaborative settings. Responsibilities may include the following and other duties may be assigned. Plan, perform and implement process improvement initiatives (using Lean, DMAIC or Six Sigma processes to understand existing processes through to improvement). Organize, lead and facilitate cross-functional project teams. Develop metrics that provide data for process measurement, identifying indicators for future improvement opportunities. Collect data to identify root cause of problems. Take initiative...

The Medtronic Grand Rapids site offers a Principal Quality Engineer level role in the Operations Quality group. This role is for an experienced engineer looking to make an impact on the site and positively affecting patient’s lives. This fast-paced role includes partnering with Operations, Manufacturing Engineering, Supplier Quality, Safety (and more) to drive improvements and risk reduction. The Grand Rapids site manufactures Cardiac Surgery devices sold across the globe. Come make a difference! Responsibilities may include the following and other duties may be assigned Collaborate with engineering and manufacturing functions to investigate and resolve quality or compliance issues discovered during...

The AstraZeneca Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets and capsules for over 60+ markets. The Mt Vernon site is complex, the largest AZ production site in the US with over 700+ employees. We are located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state. The Mt. Vernon site is both collaborative and Inclusive . We have several employee resource groups (ERGs) onsite that are...

The AstraZeneca Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets and capsules for over 60+ markets. The Mt Vernon site is complex, the largest AZ production site in the US with over 700+ employees. We are located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state. The Mt. Vernon site is both collaborative and Inclusive . We have several employee resource groups (ERGs) onsite that are...

Introduction to role Are you ready to lead the charge in strategic communication excellence? As part of the Clinical Regulatory Writing team, you'll be at the forefront of crafting pivotal clinical-regulatory documents that align with project strategies and regulatory requirements. Our mission is to support core therapeutic areas throughout all phases of clinical development, ensuring successful submissions and approvals. Join us in driving communication leadership and making a tangible impact on drug projects! Accountabilities Independently manage clinical regulatory writing activities across a portfolio of work. Author clinical-regulatory documents within a program, ensuring adherence to regulatory, technical, and quality standards. Provide...

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. S ummary of Job Responsibilities Quality Systems Ensure compliance with Good...

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

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

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

Position Specialist, Quality Assurance 2nd Shift Our Company constructed a new manufacturing facility to significantly expand its production capacity for a medicine for the treatment of certain forms of bladder cancer. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding commitment to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest,...

Position Specialist, Quality Assurance - 1st Shift Our Company constructed a new manufacturing facility to significantly expand its production capacity for a medicine for the treatment of certain forms of bladder cancer. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding commitment to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth,...

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

– We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management team in Sylmar CA. As an individual contributor , the function of a Regulatory Affairs Project 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...

Associate Quality Engineer This position works out of our Barceloneta location in the Vascular Division at Second Shift. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. What You’ll Do Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Learns to identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventive actions. Works with line support team (QC Supervisor, Mfg Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance is present,...

We are seeking an experienced Senior Development Quality Engineer to join our Structural Heart team at our Menlo Park, CA location. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects as well as support sustainability of commercially released product. This position may also support manufacturing processes to meet daily production schedules while enhancing productivity...

About the role This position supports site projects, technical transfers, and ongoing validation maintenance. Primarily responsible for compliance during the review of the design, authorship, and execution of commissioning, qualification and/or validation studies for the any or more of the following major disciplines Computerized systems validation (Honeywell, DeltaV, PLC based systems, DHS) Facilities, Utilities, and Equipment (FUE) qualification Electronic Batch Management (EBM) Cleaning validation QC Laboratory Data Integrity Assessment This position is responsible to maintain validation documentation aligned with Good Documentation Practices (GDP) and ensure compliance with industry standards (e.g. FDA, EU GMP, ISO, etc) Provides technical subject matter expert...

Responsibilities Under general supervision, this position assists with Maintaining quality expectations and regulations for a biological vaccine manufacturing site in accordance with GMP guidelines and site procedures Processing document change controls Management of the site’s Finished Product Samples Inventory including retention management and submission to the CVB Inspection, review and release of incoming raw materials for production, ensuring compliance with regulatory and site requirements for use Coordinating with site stakeholders and third-party vendors to maintain supply chain records, provide information for supplier audits, and manage incoming supplier change controls for site review. Reviewing documents against regulatory requirements for compliance 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 Johnson & Johnson is recruiting for a Senior Software Quality Engineer , located in Santa Clara, CA. Our team advances the MONARCH™ surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products. We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes and advance medical professionals’...

We anticipate the application window for this opening will close on - 11 Jul 2025 Position Sr. Quality Engineer for Medtronic, Inc., located in Jacksonville, FL. Provide quality manufacturing process solutions for Medtronic’s implantable and non-implantable medical devices. Partner with Manufacturing Engineering and Research & Development Engineering to assist in developing test methods, equipment acquisition for new product testing, design verification, process characterizations, Installation Qualifications, design reliability and process capability. Conduct statistical analyses and work with policy stakeholders regarding risk-based sampling methodologies. Coordinate projects for cost-saving initiatives, including eliminating duplicate inspections, and driving process improvements. Utilize Medical Device industry...

We anticipate the application window for this opening will close on - 11 Jul 2025 Position Sr. Quality Engineer for Medtronic, Inc. located in Menlo Park, CA. Responsible for products in the form of finished medical devices within the Ear, Nose, Throat (ENT) operating unit (OU) by supporting manufacturing operations, evaluating compliance of materials and processes with specifications, and customer requirements in compliance. Develop, modify, apply and maintain quality standards and protocols for processing materials into partially finished or finished materials product. Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products...

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 & Responsibilities The Analytical Quality & Integrated Services team...

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

The Opportunity We are seeking a Quality professional to join our GCP Quality function at Relay Tx. Under the direction of the Senior Director, you will partner with yourClinical Developmentcolleagues in supporting our clinical trials and overseeing external contract vendorswhile simultaneously contributing and influencing the continued builds of the Quality Management System as the team evolves along with our pipeline. At Relay Tx, we takeQualityseriously, but we don’t take ourselves too seriously. You’ll have fun in our collaborative and energetic environment where you’ll face new challenges every day. Your Role You will be the GCP Quality Lead to assigned studies/programs....

The Opportunity At Relay Therapeutics, quality is a core value—and we know that maintaining it takes both precision and creativity. We’re looking for a hands-on, proactive Manager, Quality Systems with expertise in vendor management to help elevate our Quality Management System (QMS). This is a high-impact role where you’ll ensure compliance, drive continuous improvement, and contribute directly to our mission of bringing life-changing therapies to patients. Experience with Veeva QualityDocs and eQMS platforms is a strong plus. Your Role Own and manage our GxP vendor qualification and approval process, including oversight of the Approved Vendor List. Coordinate audits from start...

Johnson & Johnson is recruiting for a Head of Quality and Compliance (Q&C) Leader for our Ottava platform. This role will report to Global VP of Q&C Robotics and Digital and located in Santa Clara, California. About MedTech 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...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Senior Manager, Supply Chain Quality to be located at Guaynabo, PR. Our journey to transform the MedTech Supply Chain Quality (SCQ) operating model continues, as we work to enable our vision of leading the way for the customers and patients who count on us. This position will ensure that we are better aligned to...

Job Title Validation Engineer Process Engineer - Des Plaines, IL The Validation Engineer will be primarily involved in preparing, drafting and execution of validation protocols. They ensure the assigned area of Validation are effectively managed and all elements follow the requirements specified by Abbott Molecular Diagnostics Division Quality System and in the relevant international standards. This individual will also participate in the development and improvement of engineering solutions for equipment, processes, parts and components. What You’ll Work On Equipment Validation Validate automated manufacturing equipment, ancillary equipment, facilities, and utilities. Draft Validation Change Requests and align on validation requirements with...

The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer activities to develop BCG and future testing capability at the Durham site. The successful candidate will report to the Associate Director, Laboratory Operations to lead start-up new laboratories for microbiological testing and environmental monitoring. Method transfer activities will include qualification of equipment, facility and utilities. Successful start-up of the laboratory will require candidates to work cross-functionally with existing company Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using principles of our company's Production Systems, Lean Laboratories, and...

Sr. Manager, Computerized Systems Validation and IT Compliance, Bristol-Myers Squibb Company, Bothell, WA. Lead development of the computerized systems validation strategy, including stage gate deliverables. Plan and manage assigned CSV (Computerized Systems Validation) projects; manage author, review and/or approve processes for applicable CSV lifecycle documentation. Ensure the validation of computerized systems used across GXP (Good x Practice) operations is conducted in compliance with applicable regulatory requirements and internal procedures. Partner with Business Owners, IT, and QA to ensure a compliant management of the computerized systems lifecycle. Act as subject matter expert for CSV and IT Quality during regulatory inspections. Conduct...

As an Associate Director of Regulatory Projects, you will be a forward-thinking leader, driving both the strategic and operational aspects of global regulatory projects. Acting as a key strategic partner, you will develop proactive regulatory plans, identify innovative pathways to success, and make decisive, progressive decisions that align with broader organizational goals. In this role, you will be hands-on in managing day-to-day project execution, while maintaining a clear focus on the bigger picture to ensure regulatory milestones are achieved. Here’s What You’ll Do Serve as a strategic partner by leading the development of forward-looking global regulatory plans for ongoing late-stage...

We are enhancing our US Oncology Office of Ethics and Compliance (OEC) team to deliver exceptional results and support our business growth. This is your opportunity to be part of AbbVie’s US Oncology Therapeutic Area (Oncology TA), which boasts multiple assets in commercialization and development, along with a mission-focused and inclusive culture. Your ideas and experience matter. We value driven individuals who thrive in a fast-paced environment, can lead initiatives from start to finish, see the promise before us, anticipate risks and opportunities, and are willing to learn and adapt to change. As the Associate Director, OEC, you will foster...

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

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

Position We are seeking a highly organized and detail-oriented individual to join our team as a Manager, Submissions Publisher. In this role, you will be responsible for overseeing the regulatory submissions publishing process, ensuring compliance with industry standards and timelines. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About you You have a thorough understanding of regulatory processes and...

BillionToOne is a next-generation molecular diagnostics company dedicated to developing powerful and accurate diagnostic tests that are accessible to all. Our innovative QCT molecular counting technology significantly enhances the resolution of disease detection using cell-free DNA by over a thousandfold. This groundbreaking technology is integral to our product offerings, including one of our flagship products, Unity Complete™ , the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from a single maternal blood sample. Leveraging the same molecular counting technology, we've expanded our impact into oncology in 2023 with a pioneering liquid biopsy...

Medtronic leads the health care industry to provide solutions that benefit the daily lives of people across the globe. Our organization contributes directly to this mission through our rich software system, which include Mobile applications combined with scaled infrastructure and advanced analytics. Become part of our team and you will be challenged to build these amazing software products, and in the process, make a real difference. The Medtronic Diabetes Operating Unit is on a mission to deliver the power of our Automated Insulin Delivery (AID) algorithm and its proven benefits and to give people with Diabetes a choice in the...

As a Quality Engineer II supporting manufacturing operations , you’ll work at the front lines of product quality and compliance. You will collaborate closely with production, engineering, and quality teams to support daily operations, drive process improvements, and ensure that all products meet Medtronic’s high standards and regulatory requirements. Your focus will be on ensuring consistent quality of manufactured products and resolving production challenges efficiently and effectively. Key Responsibilities Serve as the quality point of contact for manufacturing lines, providing guidance on quality issues and helping ensure day-to-day compliance. Monitor and analyze process and product performance data to identify trends,...

In this exciting role as a member of Medtronic Clinical and Regulatory Solutions (MCRS) Quality Audit team, the Principal Clinical Quality Specialist - Audit will be responsible for completing audits and ensuring that clinical personnel across the Medtronic are operating in accordance with external regulatory requirements, standards and Medtronic policies and procedures. The Principal Clinical Quality Specialist - Audit works without appreciable direction and exercises considerable latitude in determining objectives and solutions to a wide range of compliance problems. These solutions require regular use of ingenuity, influence management skills and creativity. This position applies extensive technical expertise and has full...

In this exciting role as a Principal Quality Engineer, you will have responsibility for supporting the CAPA process, change control, and internal/external audit support activities for the Medtronic Diabetes business. The Principal Quality Engineer is responsible for implementing, maintaining and improving the Quality Management System at the Diabetes sites. Specifically review and revise, as needed, QMS policies and procedures to ensure the work conducted conforms to established corporate and group processes and industry regulations/standards. This role is instrumental in contributing to defining the direction and plans for process improvement and ensuring the site is audit ready. This role will also...

In this key role you will, under the direction of a Regional Regulatory Lead, assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Key responsibilities include Assist US Regulatory Lead to support US regulatory activities (e.g. IND development and submission, meeting preparations) Provide and maintain IND/BLA documentation support (e.g. annual reports, amendments) in collaboration with US Regulatory Lead (and Regional Reg Leads, as appropriate) Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications Review US...

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we...

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, MSAT Validation & Digital that can be in either Raritan, NJ, Ghent, Belgium, or Sassenheim, Netherlands. Please note that this role is available across multiple countries and may be...

We are searching for the best talent for a Senior Regulatory Affairs Program Lead. The preferred location for this role is Cincinnati, OH however candidate may also be based within a commutable distance of Raritan, NJ. This role will work a Flex/Hybrid schedule with 3 days per week on-site; there is NO remote option. Purpose The Senior Regulatory Affairs Program Lead executes the Regulatory Affairs platform strategy. We support regional and country product registrations, monitor and assess impacts of product specific regulations for new products as well as lifecycle product registrations. You will be responsible for Provide independent...

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Supervisor, Quality Control - CAR-T! This position will be located in Raritan, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver tomorrow's breakthroughs and profoundly impact health for humanity....

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

The Senior Manager, Regulatory Labeling manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC and Rest of World (RoW) labeling. Provides labeling expertise to the Labeling Working Group and other relevant stakeholders, typically carrying out responsibilities with minimal guidance. Leads development of labeling strategies and is responsible for the management of marketed or pipeline products, across the product lifecycle. In this role, a typical day might include Managing the Regulatory labeling process throughout the product lifecycle. Leading the Labeling Working Group and manages development, review, approval, and maintenance of labeling for CCDS,...

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Under direction of the Associate Director, the Laboratory Operations Manager- West Point Stability is responsible for oversight of the building and activities supporting the West Point stability program, including sample receipt from manufacturing areas, sample dispensing, sample preparation for entry into the stability...

Position Overview - Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing Controls and Device Supplier Management objectives and build QMS capabilities that touch every aspect of our business processes, systems, and data. The Associate Director will collaborate and interact with cross-function teams to identify opportunities for improvement and tackle challenges, balancing effective operations with transformative initiatives. The Associate Director, Quality System & Compliance will support to integrate the Device Supplier Management activities across MDCP programs and product...

This position of Quality Engineer is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. What You'll Do Identify, review, and implement effective process control systems to support the development, qualification, and on going manufacturing of products to meet or exceed internal and external requirements Perform Risk Assessments, as required, across functions, including FMEA, change management, and issue investigation / resolution Lead in the review and/or implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements Assist in the review,...

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...

This position has responsibility to establish and maintain quality assurance programs to drive alignment of policies, processes and develop appropriate quality plan objectives to ensure the global Core Diagnostics division has a suitably effective Quality System that conforms to all established regulatory requirements and standards. This includes ensuring appropriate clarity of quality roles and responsibilities across Core Diagnostics manufacturing sites and Business Units, ensuring alignment, appropriate quality agreements and clear approaches to strategic compliance are understood and communicated as necessary across Core Diagnostics Global QA Functions as well as its various Business Units. The incumbent is the designated Core Diagnostics...

The Analytical Research & Development (AR&D) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories Division is seeking applicants for a Validation Specialist position available at either the Rahway, New Jersey or West Point, PA research facilities. The Analytical Instrument Validation Specialist will work as part of the integrated Validation and Compliance team and drive a culture of quality and operational excellence across the global AR&D network. The Analytical Instrument Validation Specialist role oversees and supports the validation of computerized analytical instrumentation within the GMP environment for multiple US-based sites in Pennsylvania and New Jersey. The key...

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

Director, Devices & Combination Products Complaints QA We are seeking a highly motivated and experienced Director of Combination Products Complaints QA to join our team. This role is responsible for leading and supporting the complaints management processes for combination products with a focus on auto-injectors, pre-filled syringes and other innovative drug delivery systems. The ideal candidate will have a strong background and deep expertise in complaint management systems, regulatory reporting and post-market surveillance for combination products. The ideal candidate should also have a proven track record of establishing and managing compliant, scalable complaint processes across pharma, biotech or medical device...

SENIOR ENGINEER - COMPLIANCE SYSTEM OWNER (INSPECTION) What you will do Let’s do this. Let’s change the world! In this vital role you will serve as the Compliance System Owner for inspection lines, leading complex compliance strategies and technical resolution activities. As a senior technical leader, you’ll drive system lifecycle management, regulatory readiness, and performance optimization to ensure high-impact, sustainable outcomes in a GMP-regulated environment. You’ll apply advanced engineering and compliance expertise, coordinate multi-functional initiatives, and serve as the primary subject matter expert (SME) for compliance systems—ensuring alignment with evolving industry standards and internal quality objectives. Responsibilities include but are...

We have an opportunity for the role of Regulatory Specialist within our Core division based out of Lake Forest, IL. Regulatory Specialists will be responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control. Provides regulatory direction on team activities. Applies basic regulatory understanding to support product and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation, labeling, and field support. Applies regulatory and technical knowledge to a focused area of work assignments. Understands, implements, and maintains the quality policy....

The Senior Director, Regulatory Digital Strategy is accountable for the development and implementation of a robust digital strategy which aligns to and meets the needs of the Regulatory business. In this role, you will partner extensively with senior Regulatory business leaders to ensure understanding of business priorities and needs. You will also collaborate with other key internal collaborator groups (e.g., IT, Regulatory Systems, Process Excellence, Change Management, Finance) and drive collaboration with key external industry partners/peers/agencies to ensure the success of a comprehensive Regulatory Digital Strategy encompassing people, process, and technology. To ensure success in this space, you will work...

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. AstraZeneca’s pipeline of industry-leading innovative medicines is consistently growing, and we are investing in our capabilities to become leaders in the delivery of next-generation cell and gene therapies. At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about...

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

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. KEY RESPONSIBILITIES The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position will ensure “right first time” global approvals of CMC regulatory (Biologics) submissions,...

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

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

The Quality Validation Engineer II ensures the quality of processes and product outputs. You will define activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and reporting on deviations and defects. By maintaining high standards, you will support Takeda's mission to deliver quality products. You will report to the Quality Validation Manager. About the role The Quality Validation Engineer II position is in the Validation Quality organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility. You will work as part of cross-functional teams providing quality oversight and approval of change control and validation deliverables to ensure...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - GI² TAU within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory Lead (GRL) on Global...

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, North America Regulatory Leader (Oncology) to be in Raritan, NJ; Titusville, NJ; or Spring House, PA. Purpose The Director, North American Regulatory Leader, is responsible for the development, implementation...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, Innovation, Expertise. This critical role Covers all Lifecycle phases of pre-authorization to regulatory submission, submission to pre-approval inspection (PAI), PAI...

As the Senior Regulatory CMC Device Lead, you will play a pivotal role in providing Regulatory CMC expertise to support the development and implementation of global regulatory strategies for combination products and medical devices. Your focus will be on single-entity combination product development, such as prefilled syringes, autoinjectors, and in vitro diagnostics. This position is critical to ensure the clinical and commercial success of key assets, making it highly visible within the organization and across the company. You will collaborate with cross-functional teams, lead regulatory submissions, and contribute to the development of processes that advance business objectives. In this role,...

As the Senior Regulatory CMC Device Lead, you will play a pivotal role in providing Regulatory CMC expertise to support the development and implementation of global regulatory strategies for combination products and medical devices. Your focus will be on single-entity combination product development, such as prefilled syringes, autoinjectors, and in vitro diagnostics. This position is critical to ensure the clinical and commercial success of key assets, making it highly visible within the organization and across the company. You will collaborate with cross-functional teams, lead regulatory submissions, and contribute to the development of processes that advance business objectives. In this role,...

Purpose Purpose This individual will be responsible for leading and supporting Quality Risk Management (QRM) activities for AbbVie products such as Combination, Pharmaceutical and medical devices. Support the strategic direction to ensure business objectives are met to support and sustain the Quality System in compliance to Quality Risk Management regulations, guidance’s and standards Responsibilities Drive Quality Assurance activities to develop, implement and sustain required QRM regulations and standards to comply to global requirements. Assure proper integration for AbbVie products such as device, combination, drug and biologics regulations Areas of direct responsibility include development and maintenance of QA procedures for risk...

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

The Director, Regulatory Affairs - CMC (CGT) is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of AstraZeneca's C ell and Gene T herapies (CGT). This position may be based in Santa Monica, CA or Gaithersburg, M D and reports to the Senior Director, CMC Regulatory Affairs (CGT) . Essential Functions and Responsibilities Provide strategic guidance during all stages of product development and l ead the development and implementation of global CMC regulatory strategies for the pipeline of AZ cell and gene products . Interpret global regulations and guidance to identify...

The Senior Director, Technical Quality establishes, maintains and improves quality system programs, policies, procedures, compliance and best practices across the Division. Specifically, this position provides Abbott Diabetes Care (ADC) Division Quality leadership for Design Control, Design Transfer to Manufacturing, on market risk assessments and product portfolio risk management. The position ensures support of new product development programs, change to on market products, assessment of risk for all on market products, ensuring design changes are transferred into manufacturing appropriately, including transfer into complaint investigations. The scope of this role applies to all ADC sites. This role directs the following functional areas;...

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

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

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

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

And as the world evolves, so do we. For over 125 years, we have tackled some of the most sophisticated challenges in healthcare. At Roche, Technical Regulatory plays a crucial role in developing new medicines and making them accessible worldwide. We provide strategy, expertise, and mentorship to offer top-tier technical regulatory support for the chemistry, manufacturing, and controls (CMC) components of clinical trial licensure applications, new market applications, and post-approval changes. We collaborate with health authorities and industry groups globally and are integral to our internal development and marketed product teams. As a Senior Technical Regulatory Program Director you...

About the role As the GMS Global Customs & Trade Compliance Excellence Management, you will be focused on delivering a unique customer experience through a self-driving, compliant, and regionally unique distribution network, aligned with Takeda’s commitment to the Patient, People, and Planet. You will be a subject matter expert (SME), providing best practices to plants on transportation, customs, and trade compliance processes—including LLP, SAP GTS, SAP LES, and self-filing tools—while supporting the Global Business Process Owner for Transportation Operations and Customs & Trade Compliance. You will ensure the efficient and compliant transport of intermediates and finished goods between Takeda sites...

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. Shift Day Shift, 6am - 6pm, rotating schedule including holidays and weekends, onsite This is a key role on the Shop...

The Clinical Supplies Quality organization, within our Research & Development (R&D) Division, is responsible for assuring the reliable availability, quality and regulatory compliance of clinical supplies in support of the clinical development programs for the R&D portfolio to enable the execution of all clinical trials (including more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced trials, 200+ IIS clinical trials and 200+ External Collaborations across 60+ countries) in accordance with worldwide regulations, company policies and standard operating procedures. The Clinical Trial Regulatory Release auditor will have responsibility for releasing supplies to support our global clinical trials, ensuring regulatory...

The Clinical Supplies Quality organization, within our Research & Development (R&D) Division, is responsible for assuring the reliable availability, quality and regulatory compliance of clinical supplies in support of the clinical development programs for the R&D portfolio to enable the execution of all clinical trials (including more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced trials, 200+ IIS clinical trials and 200+ External Collaborations across 60+ countries) in accordance with worldwide regulations, company policies and standard operating procedures. The Clinical Trial Regulatory Release auditor will have responsibility for releasing supplies to support our global clinical trials, ensuring regulatory...

– We are seeking a Regulatory Operations Specialist I for our St. Paul, MN Structural Heart team to perform specialized level work assignments and/or analyses, evaluation, preparation and general support of global regulatory activities . What You’ll Work On - Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives . Creates, reviews and approves engineering changes. Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines. Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those...

The Opportunity The position of Design QA Specialist in Des Plaines IL, will conduct quality-related activities to deliver consistent, high-quality documents, services, products and processes, which adds value to the business. What You'll Do Contributes to defining and timely achievement of overall project goals. Scope typically limited to one specific QA function. Provides compliant solutions to a variety of problems of moderate scope and complexity. Interacts constructively with employees, managers and cross-functional peers. May lead a project with a limited scope, but usually a contributor on broader projects. Provides guidance to other Professionals and Technicians. Quality System Compliance -Maintains awareness...

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help get the nutrients they need to live their healthiest life. The Quality Manager, Portfolio Expansion role is responsible for supporting the expansion of Abbott Nutrition's Third-Party Manufacturer (TPM) portfolio through all stages of qualification. This requires collaboration with cross-functional personnel to lead and actively support activities through TPM selection, evaluation, approval, and first...

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

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

Are you passionate about science and experience within regulatory affairs and drug development ? We are now recruiting a Director, Clinical Regulatory Writing (CReW Program Lead). In this role you will provide expert leadership to the delivery of the CVRM product pipeline through partnering with senior leaders to define and lead the global communications strategy. You will be a leader for clinical regulatory writing activities within the disease area for cross functional teams and external vendor partners. This opportunity is available at our Gaithersburg, MD (USA) location . We expect employees to be on-site for a minimum of three days...

About the role Join Takeda as U.S. Ethics & Compliance Transparency Operations Manager, where you will enable the organization to take decisions which are ethical and following our priorities of Patient, Trust, Reputation, and Business (PTRB). You will be the primary contact for data collection and vendor onboarding, as well as, assist in development of business processes, data taxonomy, and data collection designs and methods. As part of the Global Ethics & Compliance team, you will report to the Ethics & Compliance Transparency Operations, Lead and you will collaborate across all E&C teams and partner with and partner with stakeholders...

The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations....

The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations....

Independently leads and collaborates with Clinical Operations (ClinOps) to drive strategic initiatives related to clinical process compliance, continuous improvement, and inspection readiness. Plays a pivotal role in shaping and implementing process enhancements, including study-specific training programs and management of NBI consent document templates. Oversees the facilitation of training and the creation and revision of controlled documents to ensure operational excellence. Serves as a key ClinOps liaison, adept at identifying procedural gaps and championing innovative solutions to enhance efficiency and effectiveness across clinical processes. _ Your Contributions (include, but are not limited to) Guides study teams on audit/inspection activities, offering insights...

In this exciting role as the Senior Quality Engineer, you will be responsible for optimizing patient care by timely resolutions of post-market quality and product safety issues. The position ensures adequate engineering evaluation of field reported complaints including trends in patient impact, device failures, root cause investigation, and on-going risk assessment driven by data analytics and signal detection for neurovascular product sustenance and improvements. This individual will support all Neurovascular products and expected to apply his/her knowledge of Design Control, Risk Management principles and quality engineering techniques, statistics, and data analytics to monitor post market product safety and ensure conformance...

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

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 We are searching for the best talent for an Associate Director, North America Regulatory Leader to be located in Spring House, PA; Raritan, NJ; or Titusville, NJ. Purpose The Associate Director, Regulatory Lead in Global Regulatory Affairs will be...

The Good Clinical Practice (GCP) Compliance Manager (Americas Hub) is accountable for the compliance oversight and control of regulated Global Clinical Operations (GCO) activities focusing on Americas Hub & Country level delivery including country trial level conduct as per country assignment. This role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections as per country assignment and GCO self-strategy delivery. The GCP Compliance Manager (Americas Hub) is the single point of contact for Americas Hub & Country team members, providing day-to-day support and ongoing quality oversight. This role promotes a product quality...

Careers That Change Lives In this exciting role as a Post Market Quality Senior Engineering Manager, you will lead the Aortic Post Market Product Assurance and Quality Sustaining team based in Santa Rosa, CA for all commercial Aortic products for our Structural Heart and Aortic business. Manages a team of Reliability Engineers that are responsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product Manage a team responsible for all Design Assurance activities supporting changes to commercial products. Coach team members through technical problem solving including CAPA investigations and triaging issues. Provide technical knowledge and...

Project Manager Quality and Compliance This position works out of our Sturgis, MI location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. For over 70 years, Abbott’s Sturgis, Mich. , has been impacting its community while producing products that provide essential nutrition to millions...

Purpose The Quality Engineer IV performs as QA specialist in the area of quality assurance oversight of operations, production, process and equipment systems and computer validation as well site specific projects related to process improvement and optimization. Responsibilities Provide Quality Assurance oversight and assessment of operational activities in Production, Compliance, Validations, and Technical Services projects. Serve as the QA representative on Validation and Technical Services projects. Liaison to process and equipment validations for QA/QC laboratories, BT, Manufacturing, and Engineering. Ensure process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits...

This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. We are seeking a high caliber Software Quality Engineer I. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. Work requires the application of theoretical engineering principles, evaluation, ingenuity and creative/analytical techniques typically acquired...

The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our West Point campus, internal manufacturing facilities, external contract manufacturers and suppliers we create a global manufacturing network dedicated to deliver a compliant, reliable supply to customers and Patients on time, every time, across the globe. The West Point Quality organization is a team of leaders who will exemplify and cultivate the Company's core leadership behaviors and ways of working, fostering a culture of collaboration, innovation, and accountability across...

Primary responsibilities are routine laboratory dissolution, assay/degradate, content uniformity, and identity testing and documentation in a GMP laboratory. Additional responsibilities include entering data into Labware, participating in investigation meetings and some drafting of investigations, participating in root cause analysis, simple troubleshooting instrumentation issues, and participation in the daily tier process. Testing equipment utilized include but are not limited to UV, HPLC, FTIR, dissolution baths, & Karl Fisher, pH meter, conductivity meter, & NIR. This is an entry level position with high expectations in a fast-paced laboratory. It requires a good knowledge of GMP documentation and a good team mindset. Education...

Johnson & Johnson is currently seeking a Quality Inspection Engineer Co-Op to join our Quality Engineering Team located in Danvers, MA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at . Requirements Data...

Summary Lead and manage Computer System Validation (CSV)/Computer System Assurance (CSA) and qualification efforts for systems used across multiple functional business organizations supporting regulated processes. Engage with project team for CSV projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures. Collaborate with IT Delivery teams, business users and internal business functions staff to ensure that CSV activities are planned and executed in accordance with internal procedures. Work with one-up manager and peers to propose effective and efficient quality strategies for IT implementation across multiple business functions. Refine and standardize SDLC and CSV processes for...

Responsible for the development, implementation, execution and continuous improvement of the Neurocrine compliance and ethics program. _ Your Contributions Provides expert level compliance guidance consistent with applicable laws, regulations and Neurocrine policies Leads effort to conduct monitoring and auditing, training, and assists with transparency data collection and reporting Proactively monitors, interprets laws or regulations impacting the business, and recommends and gains approval for new/changes to company guidelines for compliance issues Manages reviews of alleged compliance violations and escalates to executive leadership as needed Leads general case management Case intake and assignment, check-ins with other investigators, manage case files, and ensures...

The Director, International Regulatory Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. Designs and delivers optimized global regulatory strategies, plans and dossiers that align with AbbVie’s overall business strategy. 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. Leads the international regulatory strategy for the assigned marketed and development compounds.Interface with International Marketing, Global Legal and Office of Ethics and Compliance with regard to advertising and promotion strategies and tactics intended for use globally....

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

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

The Transparency roles have primary responsibility for operationalizing and managing Genentech’s Aggregate Spend and Transparency operations, ensuring applicable reports and regulatory obligations are met in a complete, timely and accurate manner. These roles play a critical internal customer-facing leadership role in advancing the goal of driving seamless, consistent, and meaningful patient and other customer experiences by enabling effective navigation of and adherence to relevant and delegated regulatory requirements. The general purpose of these roles are to operationalize and manage Genentech’s compliance with internal policies, procedures and external laws specific to state and federal reporting, tracking and registration obligations for pharmaceutical...

Position Specialist, Quality Assurance 2nd Shift Our Company constructed a new manufacturing facility to significantly expand its production capacity for a medicine for the treatment of certain forms of bladder cancer. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding commitment to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest,...

The AstraZeneca Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets and capsules for over 60+ markets. The Mt Vernon site is complex, the largest AZ production site in the US with over 700+ employees. We are located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state. The Mt. Vernon site is both collaborative and Inclusive . We have several employee resource groups (ERGs) onsite that are...

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

At 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...

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

Careers That Change Lives We are currently looking for a Senior Quality Engineer to join our growing team. This role will be part of a cross functional group within the Spine and Biologics Portfolio, Cranial and Spinal Technologies (CST) operating unit. CST is focused on developing Spinal medical devices catered to specific needs, uses and/ or preferences. The CST operating unit provides a comprehensive portfolio of proven powerful technologies setting the highest standards of integrity and reliability in Cranial and Spinal care. This position will work a hybrid schedule with 3 days onsite at our Memphis, Tennessee location. In this...

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 Quality Incoming Inspector. Purpose Under direction of the Quality Incoming Supervisor, responsible for the sampling, inspection and approval of Packaging Components. Responsible for testing of Packaging Components and some Raw Materials....

Our location in Santa Clara, CA currently has an on-site opportunity for a Senior Regulatory Affairs Manager - Transcatheter Mitral and Tricuspid Valve Repair . This new team member is responsible for the management and leadership of Regulatory Affairs activities for the Transcatheter Mitral and Tricuspid Heart Valve Repair Franchise. This individual will lead and coordinate global Regulatory Affairs activities including regulatory strategies, submissions and product launches. The Senior Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. The person in this role will manage a team of 3 to 6 Regulatory...

This position works out of our Santa Clara, CA location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Quality Technician , you’ll support manufacturing in the Structure Heart Division of Abbott, reporting to the Manager of Quality. Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions Responsible for performing in-process and final components, subassembly and product inspection. Measure component dimensions per requirements or inspection plans. Records inspection and...

Quality Technician, Environmental Monitoring , 2nd Shift This position works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As the Quality Technician, Environmental Monitoring 2nd Shift , you’ll undertake the role of as Technician Quality with minimal supervision. Execution of daily activities...

As part of the medical device business, our Vascular division has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure and endovascular disease. Our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people. We currently have an opportunity for Supplier Quality Auditor , based on-site in Temecula, CA. In this role, the incumbent Performs on-site quality assessments of new suppliers, as required, and...

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

Brief Description of Position The Medical Writing & Disclosure (MW&D) department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers. The Director, Disclosure Quality & Compliance is responsible for independently leading/executing projects that contribute to successfully achieving disclosure quality goals while ensuring compliance with US and global laws, regulations, and policy, leading teams through changing processes, and negotiating with stakeholders across the organization. The responsibilities of the Director, Disclosure Quality & Compliance are...

Working at Abbott At Abbott, you can do work that matters, grow, 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 bachelor’s...

We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in St. Paul, MN. As an individual contributor, the function of a Regulatory Affairs Specialist I is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for international registration assessments. What You’ll Work On · Analyzes the input of cumulative product changes to current product submissions. · Shares knowledge with...

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

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

Job Purpose Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. Key Responsibilities Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned...

As part of GSK’s ambition to “Supercharge our data capability”, the Onyx Research Data Platform organization represents a major investment by GSK R&D and Digital & Tech, designed to deliver a step-change in our ability to leverage data, knowledge, and prediction to find new medicines. We are a full-stack shop consisting of product and portfolio leadership, data engineering, infrastructure and DevOps, data / metadata / knowledge platforms, and AI/ML and analysis platforms, all geared toward Building a next-generation, metadata- and automation-driven data experience for GSK’s scientists, engineers, and decision-makers, increasing productivity and reducing time spent on “data mechanics” Providing best-in-class...

About the role Plan and Develop improvement and compliance projects relating to the QC Microbiology department. Responsible for basic project management and documentation authoring (e.g. change controls, protocols, reports, and regulatory submissions). Provide technical knowledge and support investigation teams for QC Microbiology related systems and test methods. Self-led individual that works under only very general management. You will report to the Head of Quality Control Labs How you will contribute Lead projects across all shifts for the QC Microbiology department, including indirect management of assigned personnel when supporting these activities. Communicate with departments and influence decision-making to support QC Microbiology...

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities This role reports into the Assoc. Director of Compliance and will report to a cluster lead for the EMEA / AP or US region....

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The senior specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities This role reports into the Assoc. Director of Compliance and will report to a cluster lead for the EMEA / AP or US...

Specialist, Quality Systems and Compliance (P2)- Night Shift Our company is expanding its global recombinant human papillomavirus (HPV) vaccine production network by investing $650 million and adding a 225,000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the HPV vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps. Approximately 614,000 people are diagnosed with certain HPV-related cancers each year. Our company's manufactures the two HPV vaccines that are predominantly utilized to eradicate these cancers globally. In recent years, countries around...

Executes the Clinical Quality and Evidence Generation strategy through strong data analytic support, employing experience in Quality Improvement and biostatistics to support business objectives of the Clinical Quality program, development of evidentiary claims using real world evidence, and data visualizations and reports to surface insights to decision makers to improve population health through our products. Responsibilities Creates effective communication methods with XFN stakeholders to share and interpret data by building reports and dashboards to surface insights and support decision making. Participates in QI projects from initiation to completion, analyzing results and developing narratives about the effectiveness of the project to...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Sr Logistics Compliance Specialist will lead and direct efforts as it relates to international and domestic product movements, dangerous goods / hazmat regulatory adherence, and audit-ready process management. The incumbent will be responsible for identifying, developing, implementing,...

Ethics & Compliance (E&C) is a catalyst for our Values driven culture and shares accountability with business leaders to ensure business practices meeting applicable laws, regulations, industry codes and internal policies. It focuses on what the organization needs by ensuring Ethical behavior plays a fundamental role in risk mitigation; Being a data-led forward-thinking leader in risk identification and mitigation; and Building a modern function supporting achievement of Takeda’s Vision. In this role as Head of Ethics & Compliance (E&C) for our Global Oncology Business Unit (OBU), you will respond to the rapidly to changing environment and business needs, it is...

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

Johnson & Johnson is hiring for a Principal Regulatory Affairs Specialist (Remote) – Shockwave Medical to join our team located in Santa Clara, CA or Remote US . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for...

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

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

Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise. In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our...

The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC 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 CMC on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. Responsibilities Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new...

This role offers an exciting and challenging opportunity that will be key to Gilead's success as we advance new combination products, such as vial kits and pre-filled syringes, to market. You will be a key Quality leader responsible for managing compliance for combination products compliance at Gilead La Verne site. We are looking for an experienced Quality professional to ensure that our QMS provides comprehensive support of these combination products. Roles/Responsibilities Monitor medical device standards for quality management system (QMS) updates to ensure adherence to global regulations Monitor device/combination product enforcement trends in the industry and develop recommendations and action...

Senior Project Leader, Packaging Supplier Quality Our location in Columbus OH currently has an opportunity for a Senior Project Leader, Packaging Supplier Quality. The primary function of the Supplier Quality Assurance (SQA) is to assure a high-quality supply of materials through evaluation and development of Abbott Nutrition suppliers worldwide. Packaging SQA is responsible for working and communicating with packaging suppliers as part of an ongoing supplier management process. Packaging SQA supports the following areas (1) Supplier qualification, (2) Supplier development & monitoring, (3) Supplier corrective & preventative actions, (4) Continuous improvement of department & supplier performance, and (5)...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Quality Control Technician will perform QC testing by strictly adhering to Sanofi policies, procedures, and current Good Manufacturing Practices (cGMP) to support investigational activities throughout the product lifecycle, as well as product release testing. The incumbent will ensure assays are completed in a timely and compliant manner. Additional responsibilities...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. How you will contribute This role is within in the R&D GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as...

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,...

Manager Quality Assurance What you will do Let’s do this! Let’s change the world! In this vital role you will lead our B7 QA team supporting EPO manufacturing with responsibilities of ensuring the quality and compliance of the medicine we manufacture. Responsibilities Manage and develop a team of QA professionals, providing guidance, coaching, and performance evaluation Establish and maintain quality standards, policies, and procedures in accordance with regulatory (FDA), local, and corporate requirements Supervise and audit the process, material, and product testing against established specifications and acceptance criteria Conduct root cause analysis and implement corrective and preventive actions for quality...

Associate Director, External Quality Introduction to role Are you ready to make a significant impact in the world of pharmaceuticals? As the Associate Director of External Quality, you will be at the forefront of ensuring the highest standards in Quality Assurance distribution processes and Quality management enablement across the region. Your role will involve executing and continuously improving our quality management system, being responsible for quality performance, handling issues, and supporting GMP/GDP capability development in distribution processes and at distributors. Join us in shaping the future of life-changing medicines! Accountabilities Support implementation of AZ Global Standard for GMP and GDP...

Be trusted and empowered to be the best you can be! Here at AstraZeneca , we thrive in our inclusive and ambitious environment. We draw on our knowledge to take smart risks and uncover creative ways to better deliver for our patients and our business. Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and own the regulatory strategy for the development, manufacturing and testing of all of our medicines. With our expertise we interpret, anticipate and craft global Health Authority expectations to build CMC and Device Regulatory Strategies. We are seeking a Director, CMC RA...

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...

The Associate Director, Quality Assurance CMO Management is responsible for supporting the day-to-day Quality Operations of Contract Manufacturing Organizations (CMOs) for Cell & Genetic Programs through the management of quality management system (QMS) events. The role will assure Quality oversight for technical and operational CDMO activities from clinical throughout product commercialization activities, post-approval process monitoring, and deviation management. The role is also responsible for the development and maintenance of relationships with the internal and external partners, to drive compliance, monitor performance, and support continuous improvement activities. The role will closely partner with operational stakeholders and participate in associated governance for...

The Director Global GxP Regulatory Intelligence provides strategic leadership and quality oversight of the Global GxP Regulatory Intelligence, Regulatory Surveillance, and Compliance / Market Intelligence across all modalities (small molecule, biologics and devices/combo devices) as well as cross-GxP areas (GMP, GCP, GDP, GVP, GLP). This role is recognized as a leader in the organization and an expert in the principles and application of quality and regulatory compliance. This position within the Quality Organization is vital to the advancement of excellence in navigating the changing regulatory landscape as well as understanding the requirements as Vertex moves into new global markets. The...

We are seeking an experienced, high caliber Sr. Quality Inspector to perform quality control inspection activities. What you’ll work on Performs visual, dimensional, and functional inspection and testing according to documented policies and procedures. Records inspection and test data as prescribed by written instructions and procedures. Operates all associated test and measurement equipment as instructed and as documented in procedures. Recommends changes to policies and procedures. Documents non-conformances in Non-Conforming Material Review system. Participates in GR&R studies as directed by engineers or technicians. Collects data for First Article inspections. Performs testing and inspection in accordance with special test requests. May...

The Patient Safety Aggregate Reports and Risk Management (ARRM) Manager will be responsible for the preparation of aggregate safety reports, including PSURs, PADERs, and DSURs, for assigned Vertex products, marketed or in development. The Patient Safety ARRM Manager will collaborate closely with Global Patient Safety Physicians on product safety teams and supporting risk management activities, including signal detection and tracking, Regulatory Authority requests, and maintenance of risk management plans (RMPs). Key Duties and Responsibilities Contributes to ARRM activities for Vertex products, marketed or in any phase of development Prepares aggregate safety reports, including establishment of timelines, content and project management,...

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

Senior Specialist, Quality What you will do Let’s do this! Let’s change the world! At Amgen, we are deeply committed to our mission to serve patients—and our core values, including “Ensure Quality,” are at the heart of everything we do. As part of our continued focus on innovation and excellence, we are advancing our QC Digital Optimization Initiative as part of the broader End-to-End Quality Transformation. We are looking for a highly skilled Sr. Specialist in Quality Control (QC) with strong data analytics expertise to join our Global QC Network Team. This role offers an exciting opportunity to be a...

This position works out of our Abbott Park, IL location for our AQR Abbott Quality and Regulatory division. The Compliance Auditor leads and performs audits, assessments, and regulatory readiness activities across the corporation. Participate in cross-divisional activities to integrate information from compliance audits and assessments and regulatory trends that may impact Abbott Divisions. What You’ll Work On Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Produce audit/assessments reports according to management expectations and following the standard set in the internal Style Guide. Ensure proactive determination of regulatory, compliance, quality issues and manage to integrate them into audits,...

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

About 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...

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

This position works out of our Sylmar CA or Austin TX facily. What You’ll Work On Abbott is currently seeking an experienced professional to provide Provides direct oversight for moderately complex elements of Abbott’s compliance program at the franchise, business unit, regional, divisional, or corporate level. Responsible for directing the development and administration of OEC education and training, and development and implementation of divisional monitoring plan. Identifies compliance risk areas and recommends action plans to ECO or direct management. Responsible for direct compliance support of key business activities for the applicable business unit. Responsible for direct compliance support to e.g....

About the role As the Head of Compliance and Systems you will ensure compliance with all applicable provisions of the Takeda Quality Management System, and the regulations and standards applicable to Thousand Oaks operations. You will conduct gap analyses, implementing Quality Management System procedures across several departments, and managing compliance. You will interface with regulators during inspections, oversees Quality Council meetings, and manages the Product Complaint Management process. You will drive Risk management, Data Integrity, and fostering a strong Quality Culture at the site. You will report into the Site Quality Head. How you will contribute Conduct gap analyses and...

The Medical Director, Patient Safety Physician is responsible for the Clinical Safety strategy for assigned AstraZeneca-MedImmune drug projects and products throughout all stages of development and/or when on the market. This includes the implementation and communication of the strategy at the project team/governance level. You will ensure the continued safety assessment, evaluation, and risk management of AZ products or product groups in various stages of clinical development and/or the post-marketing setting. Your role will involve continuous efficient evaluation of adverse events and all other safety information to predict and manage the safety profile of compounds in clinical development and marketed...

The Associate Director of Regulatory Affairs – Soft Tissue Fillers supports regulatory objectives for the company’s soft tissue fillers devices for new products introduction (NPI) including coordination, management of global submissions to support new registrations. As Global regulatory lead (GRL), directs and supports development of the regulatory strategy related to NPI activities for device regulatory activities in a variety of countries including but not limited to US, EU, Japan and China. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact new products introduction. Supports Aesthetics business at Regulatory Authority/Notified Body meetings...

About the role The Associate Director, Clinical and Safety Quality 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. How will you contribute Ensure compliance to Regulatory Intelligence Procedures by executing the regulatory intelligence process in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and...

Sr. Specialist Quality Assurance Engineer The Sr. Specialist Quality Assurance Engineer will lead complaint investigation activities related to blood glucose meters, sensors, and applications. This is a 5 days/week onsite opportunity based out of Alameda, CA. What You’ll Work On Ensure complaint investigations are conducted in compliance with internal procedures, regulatory standards (e.g., FDA, ISO 13485), and within required timelines. Drive and support continuous improvement initiatives aimed at enhancing investigation quality, reducing turnaround times, and increasing operational efficiency. Monitor investigation workflows, team performance, and key metrics to identify bottlenecks and implement corrective actions where needed. Collaborate with cross-functional teams,...

Senior Validation Specialist Introduction to role Are you ready to lead and innovate in the world of GxP compliance? As a Senior Validation Specialist, you will provide GLP and GCP compliance support to the Integrated Bioanalysis (iBA) Department. You will spearhead the GxP system validation program and manage the life cycle of systems including instruments, equipment, and software within our Regulatory Bioanalysis Lab. Accountabilities Lead instrument/system validation programs. Schedule and coordinate cross-functional activities among internal stakeholders and external vendors to support instrument/equipment/system validation. Manage the life cycle of validated instruments/equipment and systems by working with internal stakeholders from conception, understanding...

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

This S enior Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This Senior Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment. You will be responsible for managing a team overseeing the Diabetes Care product...

DePuy Synthes, a member of the Johnson & Johnson Family of Companies, is currently hiring for a Senior Quality Engineer . The role can be located in Raynham, MA. The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. The Senior Quality Engineer will be a critical member of the Supply Chain Quality...

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

AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board. Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture. The scope of compliance audits may include, but is not limited to, the following...

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-QA Quality Systems and Regulatory Compliance role is part of...

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

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 Validation Engineer II will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The Validation Engineer II will be responsible for the drafting and executing commissioning, qualification, and validation (CQV) documents and protocols which support the...

For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development—we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day. Join a diverse team of innovators who bring their worldview, their unique backgrounds and...

GSK is currently looking for a Validation Engineer to join our team in Upper Merion, PA. In this role, you will be responsible for equipment/facility validation projects in a hands-on role including writing validation protocols, scheduling and executing testing, gathering and analyzing data and writing validation summary reports. This person will participate as a supporting member representing validation on project teams. Validation Engineers will lead specific validation projects. KEY RESPONSIBILITIES Design required validation studies and write protocols for the facility and equipment. Coordinate resources required to complete validation studies in a timely manner. Execute validation studies per required schedules in...