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$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- Job Summary:The Executive Director of Quality Control will be responsible for all aspects of quality control... ...Accountability may extend to other GxP regulated products within Revance (Rx... ...quality control operations to assure compliance with quality systems, data integrity...SuggestedContract workLocal areaFlexible hours
$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...Suggested
$211k - $264k
...service of patients.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 areaWorldwide$220k - $240k
...have fun, seriously.POSITION SUMMARYThe Director, GMP Quality Assurance is responsible for the... ...complex priorities, provides technical and compliance leadership, resolves quality issues,... ...and negotiate Quality Agreements with GxP vendors, intra-company sites, alliance...Contract workLocal 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- ...Senior Director, Quality As the Senior Director, Quality, you will serve as... ...Responsibilities: Quality Systems & Compliance: ·Own and continuously improve the company's GxP Quality Management System (QMS... ...oversight of externally executed GxP activities, including drug...
Sagimet Biosciences
San Mateo, CA5 days ago $210.38k - $272.25k
...DescriptionDirector, Global Supplier Quality Management ProgramPosition ImpactThe Director, Global Supplier Quality... ..., and enhances quality, compliance, supply continuity, and... ...stakeholders.Own and execute the plan and evolution... ...practices.Support SAP GxP Supplier process...Full timeFor contractorsLocal 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$55 per hour
...Quality Manager, Scientific Operations-TempSan Carlos, CAPOSITION... ...existing quality frameworks, compliance structures, and QA/QC systems... ...strengthening. This role reports to the Director of Scientific Operations.... ...).Deep understanding of GLP, GxP, ISO 9001/17025 quality...Work at officeNatera
San Carlos, CA5 days ago- ...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
- ...****@*****.*** Manager, GMP Quality The Opportunity:Seeking a Senior Manager... ...and serve as a resource for quality and compliance questions, issues, and planning across... ...internal and external stakeholders and execute quality systems as the QA SME on...
$164k - $205k
...service of patients.The Opportunity:Lead GxP internal audits and external audits including... .../external audit schedules.Assure GMP/GxP compliance with suppliers.Oversight of all aspects... ...and internal teams to draft and complete Quality Agreements.Perform Risk Assessments,...Full timeWork at officeLocal areaImmediate startWorldwideFlexible hours$164k - $205k
...Medicines is seeking a Senior Manager, Quality Validation who will play a key role within... ...activities are appropriately planned, executed, documented, and maintained throughout the... ..., planning, technical issues, and compliance risks, providing guidance consistent with...Full timeWork at officeLocal areaWorldwide- ...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,...
$145k - $165k
...This roleis responsible forensuring the company’s quality system is andmaintaincomplianceCalifornia FDB and US FDA QSR requirements... ...the organization on all matters affecting product quality and compliance. Specifically, this person mayinitiateaction to prevent non-conformities...Contract workInquis Medical, Inc.
Menlo Park, CA5 days ago$320k - $340k
...POSITION SUMMARYThe VP, Global GMP Quality position will be responsible... ...to ensure the seamless execution of GMP QA and QC functions, including... ...the highest standards of compliance with FDA, EMA, and other... ...and documentation to assure GxP compliance in the domestic and...Work experience placementLocal area$210.38k - $272.25k
...possible, together. Job Description Director, Product Quality Complaints Gilead Sciences, Inc.... ..., inspection-ready, and consistently executed across clinical and commercial... ...governance forums to assess process health, compliance, capacity, and opportunities for...Local areaWorldwideBiopharma Careers
Foster, CA1 day ago- ...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
$95.6k - $195k
...Joby Aviation Quality Control ManagerJoby Aviation is seeking a highly organized, passionate... ...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 Quality...Temporary workJoby Aviation
San Carlos, CA1 day ago$173.43k - $204.03k
...Senior Manager, Clinical Quality AssuranceRedwood City, California, United StatesFor more than 25 years, Corcept has been singularly... ...team and will perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies...Full time3 days per weekCorcept Therapeutics
Redwood City, CA1 day ago$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- ...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
$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$160.6k - $189k
...visit Corcept is seeking a Senior Manager/Associate Director, Quality Operations to provide strategic and operational... ..., helping ensure product quality, regulatory compliance, patient safety, and timely execution of Quality Operations deliverables in accordance with...Full timeContract work3 days per week$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$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$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
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