Quality & Regulatory Jobs in Pharma & Biotech

Are you looking for a patient-oriented, innovation-driven role that inspires you and promotes your career? Then take your future in your hands and become part of our team as a Senior Manager Clinical Program Quality You will oversee quality assurance for global clinical research across multiple business units, focusing on continuous inspection readiness. This role acts as a strategic quality advisor, partnering with clinical teams and stakeholders to guide risk-based decisions in research quality. How you will contribute Provide expert GCP compliance guidance, training, and recommendations to program teams and leadership. Develop, implement, and manage risk-based audit strategies and conduct...

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

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Supply Chain Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shift NIGHT shift available, Panama schedule ( 12-hour shift patterns with a 2-2-3 work cycle including weekends and holidays) 6pm to 6am Duties/Responsibilities Provide Quality on-the-floor oversight to Manufacturing/ QC/ Supply Chain Operations & responding to minor issues or escalating to senior members. Perform and document operational verification...

This internship position in Research & Development Quality (RDQ) offers education and exposure across various fields, including, Non-Clinical Quality, Product Development Quality, Clinical Quality, Pharmacovigilance Quality, Quality Risk Management, and Innovative Capabilities. We are seeking a self-motivated student eager to gain real-world experience in the pharmaceutical industry. The intern will work closely with professional mentors to hone their skills and build a professional network. Location New Brunswick, NJ and Princeton, NJ area. The starting hourly compensation for this assignment is within the range of $23.00 to $34.00/hr. Please note that the final individual compensation and any applicable benefits will be...

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

Purpose The Senior Specialist, Employee and Workplace Relations will support HR compliance related matters, to include the creation and management of employee separation agreements, affirmative action responsibilities, departmental analytics and other HR compliance-related matters that support our business needs. Key Responsibilities Responsible for the creation and management of separation agreements Support for affirmative action and related compliance activities and audits Support compliance-related initiatives to include restructurings and other projects as needed Liaison and vendor management with internal and external partners Identify opportunities and enhancements, conduct research and analysis, and consult across organizational levels in a timely, professional and accurate manner...

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

Purpose The Compliance Manager is responsible for the management and coordination of project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and AbbVie requirements. Participates in maintaining quality system documentation including but not limited to Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and participates in quality system management review. Oversees Global Product Surveillance CAPA program and is responsible for the site’s internal audits. Oversees internal, supplier and regulatory audits and preparation activities....

The Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and AbbVie policy compliance for the manufacturing plant. Responsible for implementing and maintaining the effectiveness of the Quality System. Support the ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her...

The Senior Validation Engineer for Facilities Utilities & Equipment (FUE) Qualification is responsible for leading, planning, executing, and maintaining qualification/validation activities at AbbVie’s manufacturing site. This role ensures that all systems are installed, commissioned, qualified, and maintained in compliance with regulatory requirements, internal quality standards, and industry best practices. The successful candidate will serve as the subject matter expert (SME) for equipment, facility and utility validation, lead cross-functional projects, and drive continuous improvement in validation strategies and lifecycle management. This position is fully onsite Monday-Friday. Open to considering non-local candidates; relocation required. Responsibilities Lead and execute qualification activities for facility...

Schedule 5am-5pm (2-2-3 rotation) Major Duties and Responsibilities Quality floor support of complex manufacturing activities Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs. Perform walkthroughs of GMP areas documenting observations and areas of concern. Perform training on routine facility Quality tasks for new team members. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines. May support review of quality master data. Authors...

SUMMARY The Specialist, Validation Engineer I supports the successful implementation of manufacturing, and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. T he incumbent is tasked with qualifying new equipment, facilities, utilities and maintaining equipment systems in a qualified / validated state a cco r ding t o established policies and pr o cedures. The i ndividual participates in proj e cts an d ongoing wor k activities of l ow to moderat e complexity. With minimum supervision and given general instructions, this individual carries out routine tasks and functions,...

To ensure Design Control activities are robust in ensuring the highest quality and reliability of products from concept through manufacturing. Ensures that development products have the appropriate characterization and validation data to demonstrate that business objectives have been met, prior to formal transfer to manufacturing. What You’ll Work On Recruits, coaches and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI regulations, etc.). Recommends and implements changes to the Quality System as the...

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,...

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 serve an extraordinary purpose. We make a difference...

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance. Essential Job Duties and Responsibilities This position provides strategic leadership and subject matter expertise within the External Quality (EQ) team as well as to key internal and external partners to ensure the department consistently delivers pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards. The following duties and responsibilities apply, based on the qualification status for each process Manages team providing support in execution of the transactional activities and quality system and process troubleshooting...

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

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

Senior Specialist Quality Assurance What you will do In this vital role, you will serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Supplier Quality Management (SQM) activities, with primary responsibility for Inspection Readiness and QMS Assessment & Improvement (A&I) programs. You will drive quality excellence across Amgen’s global external network and play a central role in ensuring successful regulatory outcomes. Key responsibilities include Own and lead the SQM/GSQ inspection readiness processes , ensuring best-in-class inspection execution and outcomes across global and virtual sites. Provide strategic and tactical leadership for inspection and audit preparation, inspection and...

Senior Director, Global Quality and Operational Excellence, Site Management & Monitoring Location Durham, NC Introduction to role Are you ready to lead the charge in transforming clinical operations? As the Senior Director of Global Quality and Operational Excellence for Site Management & Monitoring (SMM) at AstraZeneca, you'll be at the forefront of shaping our quality, capability, and learning vision. This pivotal role provides strategic direction and global oversight, ensuring our clinical trials are conducted with the highest standards of compliance and innovation. Reporting directly to the VP and Global Head of SMM, BioPharma R&D, you'll develop and execute plans that...

Join AstraZeneca as a Lead Quality Advisor, Site Quality (Development Quality). At AstraZeneca, quality is how we deliver on our mission to transform patients’ lives. We’re seeking a Lead Quality Advisor to provide GMP leadership across our development value chain—from internal Drug Substance and Drug Product to Pack & Label and clinical trial supply. In this high‑influence role, you will Build and translate robust, risk‑based cGMP standards into practice across Development Provide QA oversight of manufacturing documentation, deviations, risk assessments, and SOPs Release internal Drug Substance, Drug Product, and IMP for clinical trials (DevQ release) Lead/host regulatory inspections and contribute...

SENIOR REGULATORY OPERATIONS SPECIALIST – (Lafayette, CO, or Mounds View, MN) Join a diverse team of innovators who bring their world view, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. The Senior Regulatory Operations Specialist position is part of the Acute Care & Monitoring (ACM) Regulatory Affairs Team supporting regulatory compliance processes. Primary responsibilities include leading process improvement and...

Use Your Power for Purpose The Senior Validation Specialist 1 will support a diverse variety of qualification activities for manufacturing processes and equipment within a biopharmaceutical manufacturing facility, including shipping validation, equipment qualification, steaming and depyrogenation qualification. What You Will Achieve This role will also provide technical support for continuous improvement projects, driving the projects to completion to support the ongoing activities within a manufacturing environment. As a Senior Validation Specialist 1, you will act as a subject matter expert / program owner within the team, ensuring that the program remains compliant with corporate, regulatory, and industry standards and regulations....

Join us at Medtronic, where we are partnering across the industry to tackle systemic healthcare challenges with bold leadership. If you seek a challenging, energizing, and rewarding career that changes lives, we invite you to join our team. Become part of the next generation of life-changing medical technology, impacting patients worldwide. The Senior Software Engineering Program Manager drives the evolution of Medtronic’s product development processes to set new industry-leading standards serving as a domain expert in Software Design Control. Lead our team by coaching internal customers across our diverse product portfolio, to elevate Software Design Control capabilities throughout the organization....

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 Deviation Mentor plays a critical role within the Quality Assurance...

Associate, Quality Control Analytical, Cell Therapy Role Overview The Associate, QC Analytical, supports cGMP lot release and stability testing for cell therapy products by preparing samples and reagents, completing test methods, operating instruments per SOPs, and maintaining accurate documentation. The role focuses on learning and performing routine activities with high quality and data integrity, assisting with lab maintenance and inventory, and supporting QC operations to meet timelines. Role Responsibilities Routine analytical testing Complete assays under supervision (e.g., automated cell counting, viability, ELISA, PCR, flow cytometry, basic cell culture handling) following approved methods and cGMP/GDP expectations. Sample and reagent preparation Prepare...

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity JOB LOCATION Lexington, MA POSITION Senior Manager, Device Quality Engineering POSITION DESCRIPTION Takeda Development Center

Reporting to the Director, Material Compliance Operations- Material Review, the Associate Director of Global Material Review Compliance is accountable for implementation of processes, standards and compliance monitoring and supplemental medical compliance training supporting the scientific development and review of medical content of pharmaceutical promotional and non-promotional materials for marketed and investigational products/devices. This position plays a crucial role in ensuring presentations of medical, scientific information, and documentation meet various standards for pharmaceutical promotion and scientific exchange. This role is responsible for fostering positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups from Global Headquarters, Affiliates 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. This is an opportunity you don’t want to miss! Lilly is...

The Executive Director, Privacy Law and Compliance is responsible for leading the organization’s global privacy strategy, governance, and compliance programs under the NextGen Privacy Program framework in partnership with Business Insights and Technology (BI&T). This role sits in the newly formed AI, Data and Privacy Law and Compliance department and ensures adherence to international data protection laws and internal standards while enabling responsible data use across all business units. The position requires strategic vision, operational excellence, and strong leadership to manage privacy risks, foster a culture of compliance and trust, and drive technology-enabled solutions for scalability. Key Responsibilities Strategic Leadership...

The Senior Director, AI Governance, Law, and Compliance is responsible for defining, implementing, and leading the organization’s global AI governance strategy in partnership with Business Insights and Technology (BI&T). This role sits in the newly formed AI, Data and Privacy Law and Compliance department and ensures that AI technologies—including generative AI and high-risk systems—are developed and deployed in compliance with evolving international laws, ethical standards, and technical safeguards. The position drives enterprise-wide accountability for responsible AI, harmonizing regulatory requirements (EU AI Act, U.S. OMB M-24-10, OECD Principles, ISO/IEC 42001) and fostering innovation while minimizing legal, operational, and reputational risks. Key...

About This Role As a Senior Manager, Regulatory CMC Lead, you will provide regulatory CMC expertise to support assigned projects and products, contribute to global CMC regulatory strategy, and where appropriate, lead regulatory submissions and related strategic activities. You will be part of a dynamic team, collaborating closely with the CMC Global Regulatory Lead and key stakeholders to compile and prepare submissions/documentation for biologics projects. Your role will involve managing routine and non-routine regional Health Authority interactions, serving as the primary global contact for regulatory CMC activities. In late-stage development programs, you will be the contact for assigned regions, ensuring...

JOB SUMMARY Global Regulatory Sciences (GRS) serves as a strategic leader and catalyst, enabling high‑quality, efficient, and innovative, label‑focused global development that changes patient lives throughout the product lifecycle. This position reports to a Sr. Vice President, GRS. Member of the GRS Leadership Team and RU Leadership Teams Partners with other Global Regulatory Leaders and RU Heads to assure consistent professional and appropriate regulatory support and cross TA portfolio oversight Works with all relevant GRS contacts and other internal contacts Works with external contacts including Regulatory authorities (FDA, EU, MHLW, etc.), professional scientific and regulatory groups, trade associations, and consultants....

Executive Director, Global Regulatory Strategy, Policy and Intelligence Location Gaithersburg, MD (US) Overview AstraZeneca is seeking an Executive Director to lead enterprise regulatory strategy on intelligence and external policy across all therapeutic areas. This leader will accelerate patient access, enable innovative development pathways, and elevate regulatory excellence globally by advancing data-driven, AI-enabled regulatory intelligence, shaping emerging frameworks for novel modalities and evidence, and partnering across R&D to deliver differentiated outcomes for patients and the business. What you’ll do Leadership and Strategy Set a clear vision for Global Regulatory Strategy, Policy and Intelligence, leveraging digital, data, and AI...

The Clinical Quality Associate Director helps set strategic direction across R&D. They provide comprehensive Quality Management support services. They embed quality and compliance “Right From Me” and ensure ongoing proactive inspection readiness. The Associate Director, Clinical Quality is accountable for developing and delivering digital solutions that reduce manual quality efforts. They also maintain these solutions and deploy innovative tools to track inspection readiness and clinical quality across the organization. The role develops and enhances best practices for quality and compliance; contributes to vendor oversight to uphold quality agreements and performance across R&D; maintains strong internal and vendor networks to promote...

The Senior Manager, RA Global Regulatory Strategy US and Canada is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. Assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. Responsibilities Responsible for a product(s) or products...

Company AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. Our impact spans immunology, oncology, neuroscience, eye care, and the Allergan Aesthetics portfolio. Locations Irvine, CA; Lake County, IL; Ludwigshafen, Germany preferred Job Purpose The Quality Toxins Office (QTO) provides compliance strategy, design, implementation, and continuous improvement to support global toxin quality strategy across Therapeutics and Aesthetics. The QTO assures robust global compliance programs to assure quality oversight, controls, compliance, and defining quality standards across AbbVie’s toxin enterprise. The Associate Director, Quality Toxins Office...

Purpose The primary responsibility for the Validation Specialist I is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists Responsibilities Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility Executes...

Performs quality laboratory testing required for the manufacturing process, utilities, raw materials, in process samples and final product following specifications in both the microbiological and analytical laboratories. Performs microbiological and analytical testing such as bio burden, endotoxin, TOC, pH and conductivity to water samples used in the product manufacturing process and to the final product. Performs in process product testing such as bio burden, and endotoxin and analytical testing (HPLC, Gel Electrophoresis, DNA), among others. Performs other microbiological lab testing such as growth promotion and identification of microorganisms. Provides support in method transfer, equipment/instrument qualification and process validation. Understand Regulations...

Responsibilities In this role, an individual supports site manufacturing operations and quality by managing the approved supplier list including supplier qualification, performance, and maintenance. They help maintain and implement the company's Quality System, ensuring all activities and procedures align with company standards and regulatory requirements. The person also assists Incoming and Manufacturing QA in investigating plant events, performing product impact analyses, and managing product/material holds when needed. They collaborate effectively with other local and global QA and Technical departments, participate as the Supplier QA in Global Supplier Center of Excellence (CoE) meetings, and approve standard operating procedures and change management...

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

Purpose As a Senior Analyst on the Compliance HR Operations team, you will are operating globally within HR Shared Services. The position partners across the HR Operations landscape, works closely with cross-functional stakeholders enterprise-wide, and engages externally with auditors to help ensure consistent and timely execution of HR processes, data governance, and internal controls. This is a hands-on, execution-focused role with emphasis on HR and Payroll associated audits, compliance initiatives, internal controls, and operational improvements. This role will serve as a key contributor to this team. They will be a professional who brings a strong foundation in HR Compliance, Shared...

Purpose The Quality Control Planner is responsible for the oversight of QC Laboratory Planning and Scheduling within the Plant QC Group. Additional responsibilities may include short-term forecasting for enablement of efficient and effective laboratory scheduling, maintenance of laboratory planning and scheduling applications, evaluation and presentation of laboratory KPI's, and cross site harmonization of planning/scheduling processes. Responsibilities Maintains/manages laboratory planning/scheduling application, ensuring accurate configuration for laboratory workflows and timely prioritization of laboratory samples. Monitors, maintains, evaluates, and reports out laboratory KPI's. Collaborates with Laboratory Management to identify and implement process changes that enable continuous improvement. Participates in cross-site harmonization of laboratory...

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

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

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

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

Manager, Rare Disease Compliance What you will do In this vital role you will will serve as a strategic partner to the Rare Disease Business Unit (RDBU), working closely with RDBU leadership to uphold Amgen’s reputation and advance ethical, patient-centric compliance solutions. As part of Amgen’s Worldwide Compliance & Business Ethics (WC&BE) organization, this role supports a strong culture of compliance, integrity, and ethical decision-making through data-driven insights and proactive engagement. Reporting to the Senior Director, Rare Disease Compliance, the Compliance Manager will leverage advanced analytical capabilities (including statistical analysis, data mining, and predictive modeling) to assess compliance, translate...

Senior Manager, Quality Engineering - Minnetonka MN This position works out of our Minnetonka , MN location in the Electrophysiology business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Senior Manager Quality Engineering , you’ll provide leadership and guidance for the quality engineering department supporting commercial products and new product development. This role is responsible for developing goals, objectives, procedures, policies, and systems that are in line with company goals and objectives, mission and...

Senior Specialist Pharmaceutical Quality Systems Summary The Pharmaceutical Quality Systems Senior Specialist supports Quality Control (QC) cell and gene therapy (CGT) laboratory operations by ensuring the reliability and readiness of laboratory infrastructure. The role emphasizes equipment lifecycle management, cross-functional coordination, and compliant, efficient operations. As part of L aboratory M anagement and S tability ( LMS ) team , the role supports shared core responsibilities such as stability program coordination , sample flow oversight, inventory management, a nd the management of OOT/OOS, deviations, CAPAs, and continuous improvement initiatives. Key Responsibilities Laboratory Infrastructure Manage laboratory infrastructure, utilities, and maintenance programs to...

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate...

The Quality Engineer II will play a critical role in driving quality systems improvements and ensuring compliance with regulatory requirements. This position is responsible for leading CAPAs, managing quality improvement projects and collaborating across departments to enhance product quality and process effectiveness. The ideal candidate will possess strong leadership skills, technical expertise, and a passion for delivering exceptional results. This role is 100% onsite at our Rice Creek, MN site a nd travel between the Twin City campuses as needed. Responsibilities may include the following and other duties may be assigned Manage CAPA lifecycle, including root cause analysis, corrective action...

The Senior Quality Engineer will play a critical role in driving quality systems improvements and ensuring compliance with regulatory requirements. This position is responsible for leading CAPAs, managing quality improvement projects and collaborating across departments to enhance product quality and process effectiveness. The ideal candidate will possess strong leadership skills, technical expertise, and a passion for delivering exceptional results. This role is 100% onsite at our Rice Creek, MN site and travel between the Twin City campuses as needed. Responsibilities may include the following and other duties may be assigned Manage CAPA lifecycle, including root cause analysis, corrective action implementation,...

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 Contract Compliance Analyst III will facilitate contract implementation and revenue pull-through activities, both proactive and reactive, with internal and external parties. This position will ensure the public and private payer reimbursement. The role is also fundamental in...

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 Lead Quality Assurance Engineer, Supplier Quality will provide supplier related QA technical and compliance support for commercial, clinical, and future products. This role ensures all suppliers and the materials provided are in compliance with product specifications and...

Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Senior Director, Regulatory Affairs-Biosurgery to be in Raritan, NJ with a minimum of 25% domestic and international travel! About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare...

Quality Project Leader, Packaging Supplier Quality Our location in Columbus, OH, currently has an opportunity for a Quality Project Leader, Packaging Supplier Quality . Primary Function The primary function of 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...

We are presently hiring for a Regulatory Affairs Specialist to work on-site at our Santa Clara, CA location. This new team member performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry. What You’ll Work On Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Acts as core team member providing review and analysis of applicable regulatory...

Sr. Technician Quality Microbiology Our location in Lake County, IL, currently has an opportunity for a Senior Quality Technician. The role involves coordinating and performing Microbiology testing and Good Manufacturing Practices (GMP) to support efficient production testing. This position is essential for maintaining high-quality standards and supporting continuous improvement within the organization. What You’ll Work On Perform product testing including Bioburden, Sterility, and Enumeration testing. Ensure that Microbiology testing is scheduled for department according to production due dates. Manage electronic quality information management system and media growth promotion testing. Provide support during audits by providing data and represent the...

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...

Purpose Describe the primary goals, objectives or functions or outputs of this position. Support manufacturing operations in the resolution of events and documentation discrepancies. Provide guidance for product/process impact analysis, investigations and risk based evaluations in support to plant events.
Responsible for implementing and maintaining the effectiveness of the Quality System. Responsibilities List up to 10 main responsibilities for the job. Include information about the accountability and scope. Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with AbbVie policies and applicable regulations for the Quality areas under his /her responsibility. Ensures...

Responsible for quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include infusion pumps, enteral and sub-cutaneous tubing, pump carrying accessories, and other drug administration system accessories. Products may be produced by AbbVie plants or by third-party manufacturers, in licensing relationships, or co-marketing relationships. Develops the appropriate Regulatory, Quality and Product Development strategies for NPI products in concert with Regulatory Affairs, marketing, Product Development and other cross-functional stakeholders....

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

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

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

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

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 Software Design Quality Engineer II role to be located at Danvers, MA. The ideal candidate for the Software Design Quality Engineer II position will support various New Product Development and sustaining activities as well as play a role in product risk management, cybersecurity, change controls, and design controls. The engineer should have the ability...

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

As a Quality Systems Specialist, you will play a vital role in maintaining and enhancing the Quality Management System (QMS) to ensure compliance with regulatory requirements and internal standards. Your expertise will support audit activities, CAPA documentation, and reporting processes, contributing to the overall success of the organization's quality initiatives. Responsibilities may include the following and other duties may be assigned. Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provide expertise and...

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

Quality Associate Director What you will do Let’s do this! Let’s change the world! In this vital role, you will serve as Amgen’s operations enterprise leader for the Supplier Quality Management (SQM) Quality Management System (QMS) processes. Reporting to the Business Performance & Quality Management System Leader, you will drive the global SQM strategy, lead digital transformation through DQMS and AI-enabled capabilities, and ensure consistent, compliant, and inspection-ready SQM execution across Amgen’s global operations and affiliate network. You will also shape and govern end-to-end SQM processes ensuring Amgen remains aligned with regulatory expectations and positioned for Quality 2032 ambitions. As...

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

Quality Assurance Senior Associate, Drug Substance Plant What you will do Let’s do this! Let’s change the world! In this role as Senior Associate QA, you will be responsible for providing quality oversight to Drug Substance manufacturing facilities at Amgen Thousand Oaks, working within a shift system. Under general supervision, you will support and ensure compliance for Manufacturing, Facilities, and Engineering staff in their processes, procedures, and use of quality systems. You will engage directly with a diverse range of partners, establishing effective working relationships with production operators, line leads, shift supervisors, warehouse staff, facilities, maintenance, and engineering teams. This...

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

2nd shift Quality Engineer II This position works out of our Menlo Park, CA location in the Structural Heart division. Structural Heart Business Mission why we exist 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. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business...

Johnson & Johnson is hiring for a Sr Design 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...

We are hiring for a Regulatory Affairs Specialist to work on-site at our Santa Clara, CA location. As an individual contributor, this new team member will combine knowledge of scientific, regulatory and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. The individual may share knowledge and expertise with others in support of team activities as well as identify data needed, obtain this data and ensure that they are effectively presented for the registration of products worldwide. What You’ll Work On Prepares robust regulatory applications (either for FDA or for international...

We are presently hiring for a Regulatory Affairs Specialist II to work on-site at our Cardiac Rhythm Management (CRM) location in Sylmar, CA. This new team member performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry. What You’ll Work On Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Acts as core team member providing review...

This position works out of our Barceloneta, Puerto Rico location in the Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. The Supervisor Quality Control is responsible for the performance of the quality technicians and meeting daily production / operational / department demands. He/she will work with line supervisor, manufacturing engineer, quality engineer, and other team members, to address all opportunities found in the manufacturing lines and will the primary quality representative for the quarantine area. The individual performing this role will have to ensure proper management of resources while ensure quality and...

Position Overview We are seeking a strategic leader to establish and lead our new Regulatory Intelligence organization. The Sr. Director, Head of Regulatory Intelligence will set the strategic direction for the team, oversee the integration of regulatory insights into organizational decision-making, and represent the organization at the highest levels. This role is pivotal in shaping our regulatory intelligence strategy, setting key initiatives, and delivering actionable insights on emerging regulatory guidance and health authority enforcement trends. Key Responsibilities Set strategic direction and priorities for the Regulatory Intelligence team to ensure alignment with organizational goals. Represent the organization at the executive level,...

Job summary Support and drive continuous improvement of the quality management system across MedTech entities under moderate supervision. Develop and track quality-systems metrics and implement quality programs aligned with enterprise and segment standardization initiatives. Provide coaching and training on quality-systems topics to ensure consistent execution across assigned entities. Duties & Responsibilities General / Compliance Communicate business issues/opportunities upward and ensure personal and company compliance with applicable laws, regulations, and corporate policies. Perform other assigned duties as needed. Quality Systems (Core) Help design, develop, implement, and maintain quality systems in conformance with applicable standards and regulations. Support change management and standardization...

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

Director, Global Customs & Trade Compliance Location New Brunswick, NJ We are seeking a Director of Global Customs & Trade Compliance to lead our customs strategy and ensure adherence to international trade regulations. This leadership position is responsible for driving global alignment, optimizing duty savings, and managing compliance across all our operations. You'll work closely with regional teams to develop and implement effective trade strategies that support our global supply chain. Responsibilities Strategic Leadership Influence and execute the strategic direction for global customs compliance. Process Optimization Partner with Regional Compliance Leads to standardize and optimize global trade activities, policies, and...

The Manufacturing Process & Technical Quality Associate Director is accountable for end-to-end technical quality oversight of cell and genetic program throughout clinical development, commercialization, product launch and post approval lifecycle management activities. This includes establishing relevant product quality standards for current or novel technologies, ensuring internal and cross-functional alignment with industry and regulatory expectations, and identifying product quality risks and mitigations throughout development for the assigned programs. The role will closely partner with operational stakeholders to participate in Cell & Genetic therapies projects and associated governance to meet business, regulatory and operational requirements. Key Duties and Responsibilities Lead and/or participate...

The Senior Analyst, Regulatory Affairs Information Management is responsible for monitoring the activity in Cosmos (the Regulatory Information Management system) for assigned portfolio products and ensuring the completeness and accuracy of RIM data in the Cosmos system. Works with submission teams and provides appropriate guidance for managing the lifecycle of product submissions, applications and authorizations in Cosmos as described in functional area procedures. Responsibilities Determines system properties appropriate for the classification type/submission type of object desired by the business in Cosmos, Elevates non-compliant records appropriately to the business user or regulatory admin for resolution using AbbVie change management expectations. Demonstrates...

Are you a highly skilled professional, interested in Quality Excellence, driven by a passion for innovation and a desire to make a tangible impact? We have a thrilling opportunity for a Senior Quality Excellence Lead to join our Global Quality team. At Roche, our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. The Opportunity As a Senior Quality Excellence Lead, you will play a pivotal role in driving excellence, efficiency and effectiveness across our global quality landscape, from managing the...

At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. At For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world — and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a...

Step into a pivotal role where you’ll be at the heart of our advanced manufacturing environment, safeguarding both product quality and patient safety. As a leader in the Environment and Microbial disciplines, you’ll ensure our operations not only meet—but exceed—regulatory standards. You’ll have the opportunity to perform specialized microbial testing and orchestrate the dynamic activities of the microbial laboratory. This is your chance to make a direct impact, driving excellence and innovation across our manufacturing processes, while collaborating with a passionate team dedicated to improving lives. Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting...

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 Senior Director, Patient Safety & Quality is the accountable affiliate...

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

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

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 Technician, Quality Control to be in San Angelo , TX . Purpose Responsible for conducting complex test and analysis to assure that product comply with established specifications. What you will be responsible for Carries out routine calculations and prepares documentation that shows the results for test performed. Responsible for ensuring personal and...

About the Role Takeda is seeking an experienced Associate Director, Head of IMP Quality to lead quality operations for investigational medicinal products (IMPs) from clinical development through to commercialization. This role provides strategic, industry-leading oversight of Takeda’s quality processes, ensuring compliance with global regulations, cGMP standards, and corporate policies. As the head of a highly skilled team, you will define quality standards, oversee audits, manage deviations, and lead process improvement initiatives. You will play a key role in supporting Takeda’s mission to deliver high-quality, safe, and effective therapies to patients worldwide. How You Will Contribute Provide strategic leadership and oversight...

Job Title QC Inspector I We are seeking a QC Inspector I to work at our Temecula, CA location in our Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. WHAT YOU’LL DO Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Audits materials or the work of others through the examination, inspection, measurement, or test of raw materials, components, sub assemblies, final assemblies and documentation....

Staff Quality Auditor This role for the Staff Quality Auditor will serve as experts for the compliance team with respect to observation tracking, auditing, regulations and standards and the Division quality system. This role will conduct internal quality audits to assess compliance to the requirements of the quality system, as well as FDA, ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What You'll Work On Plan, perform, support and document...

This role is responsible for overseeing and improving upon established compliance and quality system processes associated with patient support programs (area of focus will be patient engagement & contact centers). This person should be familiar with quality management system processes (CAPA, Training, Audits, Metrics and Monitoring) as well as change management, process mapping and continuous improvement tools. This role will support the implementation of Patient Services Q&C Roadmap. This role is also responsible to maintain a culture of excellence to ensure a superior experience for partners and patients that will deliver desired outcomes and enable timely, informed decisions. RESPONSIBILITES Assist...

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. Organization Overview At Lilly, we serve an extraordinary purpose. We make...

About This Role As the Senior Director, Global Regulatory CMC - Drug-Device Combination Products, you will serve as the enterprise regulatory leader for our global device and combination product portfolio. Operating within the Product Delivery Solutions team, you will have end-to-end accountability for defining and executing CMC regulatory strategy across development, licensure, commercialization, and lifecycle management. Your role is crucial in shaping the long-term regulatory posture for device-enabled therapies, ensuring patient supply continuity, and influencing global regulatory policy. Reporting to the VP, Head of Product Delivery Solutions, you will be a core member of both the Product Delivery Solutions Leadership...

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

The Information Security Governance, Risk & Compliance (GRC) Director is responsible for leading and maturing the company’s global security governance framework, enterprise cyber risk management program, and compliance activities across IT, OT, cloud, and regulated medical device environments. This leader ensures alignment with cybersecurity expectations, Quality System requirements, and industry best practices. The Director partners closely with IT, R&D, Operations, Legal/Privacy, Quality & Regulatory (QARA), and Internal Audit to strengthen the company’s security posture, reduce enterprise risk, and ensure readiness for audits, inspections, and regulatory submissions. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has...

Career Category Regulatory Let’s do this! Let’s change the world! Amgen is seeking a Global Regulatory leader with expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. The Global Regulatory Leader (GRL) is a product facing role that leads the Global Regulatory Team in the Regulatory Affairs organization. The purpose of this role is To lead one or more Global Regulatory Teams within Amgen’s Global Regulatory Affairs department To develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of...

In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements. To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions To assist the Global Regulatory Lead to manage GRT interactions Key responsibilities include Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings) Provide and maintain CTA/MA documentation support (e.g. initial filings,...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for a Senior Manager Source Quality to be located in Guaynabo, PR, Cornelia, GA, San Angelo, TX and/or Raritan, NJ. 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...

KEY RESPONSIBILITIES The Senior Director Quality Control is vital for the success of Clinical Biologics QC, providing strategic leadership and overseeing daily operations. Responsibilities include leading the cGMP QC team that manages the release testing and stability program supporting Gilead’s Clinical biologics drug substances and drug products. The role is accountable for refining clinical QC processes across Gilead’s biologics internal and external manufacturing and testing network, ensuring compliance with global cGMP and Gilead’s Quality Management System. This individual collaborates with cross-functional teams, fosters a culture of continuous improvement, and offers mentorship to the QC team for timely project completion and...

About the role This position supports the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. How you will contribute Lead the execution of CD/PQ/CV/PV/RV activities. Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts. Supervise and manage contractors or consultants as needed. Participate in change control review board. Track and trend...

Johnson & Johnson is hiring for a Manager of Supplier Quality – 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...

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

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, GCP Compliance in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to...

Our location in Sylmar, CA, Pleasanton , CA or Minnetonka , MN currently has an on-site opportunity for a Staff Auditor, Quality Systems professional. This new team member will be a leader and mentor responsible for implementing internal audits required for compliance with global regulatory standards and collaborating with Abbott Medical Device Business Units for external inspection preparation and support. What You’ll Work On Internal audit planning, developing audit schedules and plans, performing and documenting audits and managing related following up activities including related KPI and metrics reporting. Support the development, training, and supervision of auditors to improve their ability...

Job Title Manager, Design Quality Assurance This position works out of our St. Paul, MN (New Brighton) location in the Abbott Vascular division. The Design Quality Assurance Manager has the broad objective of assuring the quality of design from development through manufacture and distribution for assigned products of the division. The successful incumbent will assure product designs provide necessary safety, efficacy, regulatory compliance and customer satisfaction while balancing the need for speed to market for new innovations as well as cost effectiveness. The ability to appropriately identify, assess and mitigate risks in the design of products can result in...

Job Title Manager, Site Quality Assurance This position works out of our St. Paul, MN (New Brighton) location in the Abbott Vascular division. As the Site Quality Assurance Manager , you’ll have the chance to ensure that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system. The Site Quality Manager will work with their group to Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product. What You’ll Do Reduce costs by employing Quality/Reliability...

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

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

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply....

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply....

Principal Objective of the Position Provide Quality oversight during Clinical Supply Operations drug product and packaging and labeling manufacturing activities, and other GMP support areas. Provide Quality on the floor in-Process support during manufacturing operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines. Performs QA manufacturing floor support activities within the Clinical Supply Operations areas to ensure compliance with all principle of current Good Manufacturing Practices (cGMP). Support material and component release for clinical drug product manufacturing. Key Responsibilities and Major Duties Performs QA Manufacturing Support Program activities and upholds the program’s principles and initiatives....

Key Responsibilities Perform independent review and approval of initial Commissioning, Qualification, and Validation (CQV) lifecycle documents and subsequent changes. Review and approval of periodic reviews, re-qualification, decommissioning and retirement and plans, protocols, and summary reports. Review and approval of Standard Operating Procedures, Work Instructions, Deviations, CAPAs and Change Controls related to facilities, utilities, equipment, instruments, and systems. Provide instruction and guidance on CQV quality issues during regulatory agency inspections, deviations, and CAPA discussions. Support the Contract Service Providers program. Provide reports to management related to timely deviation completions, CAPA implementations or other issues related to CQV and CSV activities. Support...

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

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

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

The Manager, QA-CSV (Quality Assurance - Computer System Validation) Auditing is a key position in the Global Development Quality Assurance (GDQA) group and will provide guidance and leadership for the CSV Auditing group. This individual will build strategic partnerships and implement risk-based quality auditing activities across GDQA. We feel the Manager, CSV Auditing, should apply their expertise in GxP, CSV and international regulations to the auditing process to independently address a variety of CSV compliance issues. We believe the person in this role will have in-depth knowledge of the FDA and EU regulations and ICH guidance documents along with any...

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

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

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

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...

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 is currently seeking a Quality Systems Manager to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina. This role will support the construction, operational start-up and end state of the DS site operations...

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

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

Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed in alignment with our incredibly high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Line Oversight Program at West Point is an entry level 2 year program with 8 month rotations focused on providing hands-on experience in pharmaceutical quality assurance supporting our Company’s largest and most complex...

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

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Prefer candidates who can work in Jacksonville, FL. Responsibilities may include the following and other duties may be assigned. Contributes to the development and maintenance of Quality programs, systems, processes, and procedures that ensure compliance with global policies, local regulations and...

Project Leader Third Party Manufacturing - Quality Abbott 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. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer Fast paced work environment where your safety is our priority Production areas that are clean, well-lit...

Senior Quality Assurance Specialist The position of Senior Quality Assurance Specialist is within our Toxicology Business Unit. The position will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, launch process, NPI, complaints, nonconformances, CAPA and/or supplier control. What You’ll Work On Responsible for implementing and maintaining an effective Quality System. Leading and/or contributing to system, product and process improvement projects. Independently lead groups and projects to resolve complex issues, analyze complex problems and identify their impact, establish probabilities, draw conclusions reflecting broad business needs and ensure compliance. Cross-functionally lead...

This position, Sr. Quality Engineer, works out of our Lake Forest, IL and Willis Tower, IL location in the CMI 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 is 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 a Quality leader, your main responsibility will include ensuring the quality standards and procedures are upheld in all site and operational processes. Role expectations will include leading a team...

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

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. Organizational Overview Verve Therapeutics, a wholly owned subsidiary of Eli Lilly...

Director of Corporate Compliance We are seeking aDirector, CorporateComplianceto manage the day-to-day execution of Truveta’s enterprise complianceprogram.This role sits within the Legal Department and reports to the General Counsel. This Opportunity TheDirector, CorporateCompliancewillbe responsible forthe operational design, implementation, and continuous improvement of Truveta’scorporatecomplianceand ethicsactivities. The role partners closely withvariousteamsacross the organizationto ensure Truveta meets regulatory obligations while supporting responsible, mission-driven use of health data and analytics. This is a hands-on role requiring strong execution skills, sound judgment, and the ability to translate regulatory requirements into scalable, practical processes. Director, Corporate Complianceresponsibilities include...

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

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

As the Director of Regulatory Affairs, you are a critical leader and the ultimate regulatory authority within the Acute Care & Monitoring (ACM) operating unit for the product portfolio within your scope. Your day is focused on setting strategic direction, managing a portfolio of high-impact devices, and delivering excellence through a world-class team. A significant part of your day is dedicated to mentorship and talent development, ensuring your team has the resources and guidance they need to excel. You will work closely with other leaders to align regulatory strategy with enterprise-wide goals, such as market expansion, product innovation, and M&A...

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’...

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 Lead Quality Assurance Engineer will provide support to various operational teams for a variety of functions. Based on the scope of the assigned area, activities may include process validation, facility validation, test method validation, risk management, change...

Clinical Regulatory Writing Manager (Associate Director) Location Boston, MA - Hybrid Introduction to role Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. Accountabilities As a Clinical Regulatory Writing Manager...

About the Role This application is for a 6-month student role from July - December 2026 . Resume review begins in January 2026 . Biogen’s Decision & Quality Analytics Innovation (DQAI) team is part of the R esearch D evelopment & M edical (RDM) organization. The vision of the DQAI team is to drive data-driven insights from trusted data , and our team mission is to maximize the quality, efficiency and application of analytics across RDM Portfolio and Quality Management Systems through improved data and metrics management, optimization opportunities, identification of compliance risk, and enhanced business analytics application. Specifically,...

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

We are seeking an experienced IT Quality Assurance Leader to drive compliance across global IT organizations. In this role, you will ensure adherence to regulatory standards and corporate policies while enabling operational excellence and minimizing business impact. What You’ll Work On Lead and coordinate IT Quality Assurance activities across global teams. Maintain compliance with corporate and divisional policies, procedures, and industry regulations. Oversee internal quality audits and supplier quality assurance programs. Manage quality event investigations and documentation (IT CAPA). Ensure adherence to Abbott’s software lifecycle processes and quality systems. Develop and implement metrics to assess quality processes and systems. Coordinate...

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

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...

This opportunity is an exciting and challenging role that will be key to Gilead's success as we work towards bringing new combination products, such as pre-filled syringes and autoinjectors, to market. As the Sr Quality Engineer I , you will be a key Quality person supporting these new product lines in the commercial stage, starting with collaborating with the design and development team on Design Transfer. We are looking for a Quality professional to ensure that we have end-to-end Quality support of our combination products. Roles and Responsibilities Develop key relationships and interface extensively with internal stakeholders and contract manufacturers...

Director, Global Patient Safety Physician, US About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AZ, we’re proud to have an exceptional workplace culture that encourages innovation and collaboration. Here, employees are empowered to express diverse perspectives – and made to feel valued, energized and rewarded for their ideas and creativity. AZ is a place where passionate people can immerse themselves in their work and make significant contributions...

About the Role This application is for a 6-month student role from July - December 202 6 . Resume review begins in January 202 6 . The RTP Pharma site supports two sterile filling lines in the Parenteral Fill (PF) facility, a small-scale filling line, Antisense Oligonucleotide (ASO) Manufacturing Areas , and an Oral Solid Dose (OSD) Manufacturing Area. As a Co-Op in Quality Engineering, the successful candidate will help ensure that Quality systems supporting facility, equipment, automation, and utilities remain in compliance with Biogen and industry cGMP standards. These activities would include support of facility and equipment controls...

About the Role This application is for a 12-week internship role from June - August 202 6 . Resume review begins in January 202 6 . The Q uality C ontrol (QC) Raw Materials team is responsible for ensuring that all materials needed within manufacturing are inspected, sampled, tested, and released to meet manufacturing timelines . This team works closely with Materials Management and Planning to meet these commitments . As an intern within this team, you can expect to learn how materials are introduced into the facility and how the quality control team ensures that these materials meet...

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...

Position The Quality Assurance Manager supports CMC operations by ensuring compliance with global regulatory requirements while fostering a collaborative, cross-functional environment. This role provides day-to-day support and execution of quality systems and GMP quality assurance activities across internal and external operations. About You You are a hands-on GMP professional with experience developing, implementing, and maintaining the electronic quality management systems (eQMS) and processes. You value consistency, efficiency, and regulatory rigor while taking pride in building scalable, compliant quality systems through strong attention to detail and effective stakeholder partnership. You are comfortable balancing operational execution with continuous improvement in a fast-paced,...

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

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

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

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...

About Synchron Synchron is a neurotechnology company with a mission to deliver the first commercially scalable brain-computer interface (BCI) for millions of people with paralysis to reconnect with the world. Our minimally invasive BCI system is designed to enable users to control digital devices directly through thought, restoring access and control over the digital world. Our team is working at the intersection of healthcare and technology to translate breakthrough research into real-world care. Join us in shaping a more connected and accessible future. Location San Diego, CA, United States (on-site) About the Job We are seeking an experienced Senior...

Instrument Quality Technician Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. Instrument Quality Technician Location South Portland, ME Business Unit Infectious Disease Developed Markets About the Role Join our team as an Instrument Quality Technician and play a key role in serving as an advanced technician supporting the Global Instruments Quality organization. If you're looking for a dynamic role where your contributions will drive the development and manufacture of...

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

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

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

POSITION SUMMARY The Senior Director, Next Gen CAR-T Quality Leader is a strategic Quality leadership role responsible for shaping, executing, and overseeing the end-to-end Quality strategy for Johnson & Johnson’s next-generation CAR-T manufacturing and QC testing platform. This leader will guide the design, implementation, and commercialization of highly automated, robotics-enabled manufacturing and QC testing systems to support a transformative new cell therapy product. The role serves as the primary platform Quality responsible leader, accountable for end-to-end Quality oversight from clinical development through full commercial launch of two global manufacturing locations (US and Europe), representing a combined investment of $2.2B. The...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at We are searching for the best talent for Sr. Supplier Quality Development Engineer (2 openings) , located in Santa Clara, CA. At Johnson & Johnson Robotics & Digital Solutions, we’re building the future of surgery. Our OTTAVA™ robotic platform unites advanced engineering, digital technologies, and precision manufacturing to deliver next-generation solutions that transform patient care. We are seeking a Sr. Supplier Quality...

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. To ensure we receive high quality data from the investigational sites around the globe, our Clinical Research systems have to be compliant with regulatory requirements and follow our SDLC policy. Clinical Systems Quality Manager will be responsible to ensure our clinical systems are developed, validated and implemented while following high quality standards. Under the guidance of Head BEO and in collaboration...

About the Role This application is for a 12-week internship role from June - August 202 6 . Resume review begins in January 202 6 . The QC Microbiology team is responsible for ensuring the safety of our products by checking for microbial contamination . The team samples surface and air sites in manufacturing areas , performs facility water testing and tests in-process and final drug product samples . We e nsure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines (FDA, EMA, etc.) for microbiological quality . Data generated from the lab is a nalyze d to detect...

About the Role This application is for a 6-month student role from July - December 202 6 . Resume review begins in January 202 6 . The QC Microbiology team is responsible for ensuring the safety of our products by checking for microbial contamination . The team samples surface and air sites in manufacturing areas , performs facility water testing and tests in-process and final drug product samples . We e nsure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines (FDA, EMA, etc.) for microbiological quality . Data generated from the lab is a nalyze d to detect...

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...

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

We are seeking an experienced, Quality Engineer II - Risk Management who will work closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation. Perform risk assessments and evaluations for products that conform to established standards and agency regulations. What You’ll Work On Perform risk evaluations associated with post market data, give guidance to risk evaluations for product development. Perform Health Hazard and Regulatory Risk Evaluations. Works cross functionally with development/manufacturing/quality/regulatory/clinical to establish product risk documentation Demonstrates compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies,...

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

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. We are seeking an experienced, high caliber Quality Engineer II for our Sylmar, CA Operations Quality Engineering team. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support...