Executive Director, GxP Quality & Compliance
Confidential
Executive Director, GxP Quality & Compliance
About the Company
Esteemed life science company developing innovative medical products
Industry
Biotechnology
Type
Public Company
Founded
2014
Employees
1001-5000
Categories
- Health Care
- Medical
- Life Science
Business Classifications
- B2B
About the Role
The Company is seeking an Executive Director for GxP Quality and Compliance. This senior leadership role is pivotal in defining and executing the global compliance strategy across clinical development programs and commercial products. The successful candidate will be responsible for ensuring adherence to regulatory requirements, industry standards, and company policies governing GxP activities. Key responsibilities include providing executive leadership for the Quality Compliance function, serving as the executive lead for regulatory inspections, and directing the strategy and continuous improvement of the Quality Management System. The role also involves leading enterprise compliance risk management, partnering with various business functions to ensure consistent GxP compliance, and championing operational excellence initiatives. Applicants must have an advanced degree in life sciences, pharmacy, chemistry, or a related scientific discipline, with a preference for a PhD, MS, or equivalent. A minimum of 15 years' experience in GxP Quality and Compliance within the life sciences industry, with at least 8 years in an executive or senior leadership role, is required. The ideal candidate will have a proven track record in leading regulatory inspections, maintaining inspection readiness, and building and scaling enterprise compliance governance. Excellent leadership, communication, and strategic planning skills are essential, as is the ability to influence stakeholders at all levels. The role demands a professional with a deep understanding of global GxP requirements, including FDA regulations, ICH Guidelines, and EU GMP, and the flexibility to work in a fast-paced, dynamic environment.
Hiring Manager Title
Vice President, Global Quality
Functions
- Operations
$265k - $331k
...tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.The Opportunity:The Executive Director, GxP Quality & Compliance is a senior leadership role responsible for defining and executing the global compliance strategy across...SuggestedFull timeLocal area$265k - $331k
...Opportunity:We are seeking a skilled and experienced Executive Director (ED) of Global Patient Safety (GPS) Quality and Compliance to join our dynamic team. The ED GPS Quality... ...regulations and guidelines (i.e. ICH, GxP)Strong analytical and strategic thinking, problem...SuggestedFull timeContract workLocal area$300k - $350k
...communications and decision making.Summary:The Executive Director, Quality Assurance, External Manufacturing is... ...the external network, ensuring compliance, supply continuity, and effective... ...QA leadership for externally executed GxP activities, including manufacturing and...SuggestedContract workRelocationRelocation package2 days per week3 days per week$265k - $331k
...Opportunity We are seeking an accomplished and visionary Executive Director, Analytical Development & Quality Control (ADQC) to provide enterprise leadership for... ...product quality, process understanding, regulatory compliance, and successful technology transfer from early...SuggestedContract work$186k - $233k
...Opportunity:Lead the Global Quality Systems Monitoring & Excellence... ...ensure effective governance, compliance, and continuous improvement... ...planning, mock inspections, execution support, response coordination... ...ensuring compliance with global GxP regulations.Lead regulatory...SuggestedFull timeLocal area- Revolution Medicines is seeking a senior Quality Assurance leader to oversee the Global Quality Systems Monitoring & Excellence program,... ...candidates bring 10+ years in QA/QMS within biotech/pharma, strong GxP knowledge, and proven leadership in cross-functional, regulated...
$211k - $264k
...signaling pathway.The Opportunity:The Director, Good Laboratory Practice Quality Assurance (GLP QA) is responsible... ...Good Laboratory Practices (GLP) compliance at RevMed and external vendors... ...Ability to balance detail-oriented execution with strategic oversight.Experienced...Full timeLocal area$186k - $233k
...Opportunity: Lead the Global Quality Systems Monitoring &... ...ensure effective governance, compliance, and continuous improvement across... ...planning, mock inspections, execution support, response coordination... ...ensuring compliance with global GxP regulations. Lead regulatory...Full timeLocal area$164k - $205k
...with a pharmaceutical quality assurance and computer... ...Manager, IS Quality and Compliance within the Information... ...leadership for GxP computerized system compliance... ...reports to the Sr. Director, IS Quality, Risk & Compliance... ...are planned and executed in accordance with FDA...Full timeLocal area$265k - $331k
...RAS signaling pathway.The Opportunity:The Executive Director of GCP QA is a senior leadership role... ...for setting and executing the global GCP quality strategy across clinical development programs. This position ensures compliance with regulatory requirements, industry standards...Full timeContract workLocal area- ...are open to remote.As an Associate Director, Quality Assurance Compliance at Gilead you will have the following... ...inspection metrics dashboards) in a GxP‑compliant and inspection‑defensible... ...used in inspection preparation and execution are appropriately governed, validated...Full timeFor contractorsWork at officeLocal areaRemote work
- ...team. Position Overview : As the Executive Director of Dialysis Services , you will... ...efficiency of our dialysis services, ensuring compliance with regulatory standards and best... ...dialysis sites to ensure high-quality care in compliance with regulatory standards...Relocation package
University Health Careers
Belmont, CA1 day ago $164k - $205k
...Medicines is seeking a Senior Manager, GMP Quality who will play a key role within Quality... ...comprehensive review and approval of executed batch records, deviations, investigations... ...and serve as a resource for quality and compliance questions, issues, and planning across the...Full timeContract workLocal area- ...biopharmaceutical company based in Redwood City, CA is seeking a Manager for IT Business Systems Quality. This role entails managing Computer System Validation activities and ensuring compliance with GxP standards. The ideal candidate will have a Bachelor’s degree in a related field,...
$151k - $176k
...and decision making.Summary:Vaxcyte is seeking a Manager, Quality Assurance, Compliance who is responsible for providing day-to-day operational... ...functions and with external partners.Reports to: Associate Director, QA, ComplianceLocation: San Carlos, CA;...- ...Therapeutics, Inc., is seeking a Sr. Director/Director of Quality Assurance to lead our... ...CDMO/CRO partners, who execute the majority of our GMP manufacturing... ...a single, inspection-ready compliance picture. This role partners... ...Develop and deliver GxP yearly training for...Contract work
Attovia Therapeutics
San Carlos, CA23 days ago $210.38k - $272.25k
...Job DescriptionJob Summary: The Product Quality Lead (PQL) supports one or more assigned... ...PQL will define the product Quality and Compliance strategy for the assigned products by leveraging... ...product development to facilitate the execution of the strategies that enable the...Full timeFor contractorsLocal area- ...together.Job DescriptionAssociate Director, Global Supplier... ...Associate Director, Global Supplier Quality serves as the global program... ...reliability, and regulatory compliance across business and quality systems... ...visibility, and compliance execution.Governance and Stakeholder...Full timeContract workFor contractorsLocal area
$186k - $233k
...Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a... ...providing leadership and compliance support for RevMed... ...Participate in clinical study execution teams (CSETs) to enable risk... ...Enable other assigned GCP or GXP related tasks, as...Full timeLocal area$281.01k - $363.66k
...help create possible, together. Job Description Executive Director, Head of Product Quality , Foster City, CA or North Carolina Gilead... ...quality programs, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other...Full timeContract workFor contractorsLocal areaWorldwide$160.6k - $189k
...Corcept is seeking a Senior Manager/Associate Director, Quality Operations to provide strategic and operational Quality... ..., helping ensure product quality, regulatory compliance, patient safety, and timely execution of Quality Operations deliverables in accordance with...Full timeContract work3 days per weekCorcept Therapeutics
Redwood City, CA1 day ago$173.43k - $204.03k
...City, California. To learn more, visit The Senior Manager of Clinical Quality Assurance (CQA) is a key member of the CQA team and will perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies sponsored by...Full time3 days per week$265k - $331k
...pathway.The Opportunity:The Executive Director, Clinical Supply Chain provides... ....Collaborate with PDM, Quality, and Regulatory to ensure compliant... ...issues as they arise.Compliance & QualityEnsure all clinical... ...supply activities comply with GxP, ICH, FDA, EMA, and global regulatory...Full timeLocal area- ...Executive Director or Vice President, Global Privacy About the Company Esteemed life science company developing innovative medical products... ...15 years of experience in privacy, data protection, legal, compliance, or risk management. This role is pivotal in ensuring that...Worldwide
$95.6k - $195k
...individual to help lead designated Marina Quality Control teams. Reporting to the Senior... ...Manager will lead a team to ensure the smooth execution of quality processes and inspections to ensure the safety, reliability, and compliance of aircraft systems and components. The...Temporary work$229k - $268k
...:This role is pivotal in ensuring compliance with global regulatory guidelines... ...and talented individual to join our Quality Assurance team as a Senior Director. This role carries dual... ...influencing cross-functional and executive stakeholders in a fast-paced commercial...Contract work$265k - $331k
...professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.The Opportunity:As an Executive Director and Head of Research Computational Biology within our Biology Function, the individual will oversee the scientific and...Full timeLocal area$315k - $362k
...into a cohesive and forward-looking approach.Develop and oversee execution of advanced and creative patent prosecution strategies,... ...and direct outside counsel globally to efficiently deliver high-quality, strategically aligned work product.Required Skills, Experience...Full timeWork at officeLocal areaWorldwideFlexible hours$157.59k - $203.94k
...for generations to come. As a Senior Manager, Quality Assurance at Gilead you will report to the Associate Director, Quality Assurance within the PDM External Quality... ..., management of Quality Agreement templates in compliance with applicable laws and regulatory...Full timeContract workFor contractorsLocal area$310k - $360k
...incorporated cities and towns. Governed by a 21-member Board of Directors and supported by eight active committees, C/CAG serves in... ...San Mateo Countywide Water Pollution Prevention Program. The Executive Director serves as the Chief Executive Officer of C/CAG, providing...ICMA Services
Redwood City, CA2 days ago
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