- BeiGene (San Mateo, CA)
- **General Description:** The Director , GCP Inspection Management , is responsible for: + Supervising activities related to inspection readiness, ... + Act as R&D Quality Delegate for the Executive Director , R&D Quality, as needed + Support development of...+ Promote continuous improvement + Provide support with the GCP Inspection Management Team for… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …together. **Job Description** You will act as a primary point-of-contact for R&D Quality inspection management and act as an inspection readiness ambassador, ... maintenance of a comprehensive and connected framework for continually improving inspection management , supporting R&D personnel with the readiness, preparation,… more
- Taiho Oncology (Princeton, NJ)
- …or CRO any quality issues + Ability to conduct any level of PAI GCP Inspection Readiness; experience with Regulatory Inspections required; solid understanding of ... Value Proposition: New and exciting opportunity to join Taiho's GCP Quality Assurance Team as a Director ... QA roles with all Clinical Trials Teams, the GCP Audit Program, regulatory inspection readiness, conduct… more
- Takeda Pharmaceuticals (Boston, MA)
- …activities and potential observations and mitigation activities. And timely escalates to management . + Lead the inspection response activities, ensuring the ... to the best of my knowledge. **Job Description** **Job Title** : Associate Director , Clinical Quality Compliance **Location** : Cambridge, MA **About the role:** As… more
- Pfizer (Groton, CT)
- …and asset teams for asset and study quality risk management , quality issues management and general GCP guidance. **ROLE RESPONSIBILITIES** Level 1 GCP ... and study level information is appropriately incorporated within the GCP QMS. + They will be the initial escalation...within Pfizer Oncology Quality governance processes / meetings. + Inspection Readiness and Preparation, CAPA management -… more
- Bristol Myers Squibb (Princeton, NJ)
- …health, etc.) + Oversee the development and maintenance of an effective inspection management framework supporting clinical trials. + Provide leadership and ... oversight plans, including internal and external audit strategies and inspection readiness/ management strategies. + Oversee the planning,...oversight for GCP Inspections ensuring effective readiness, preparation, management ,… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Senior Director , Risk Management and Central Monitoring Position is a ... making at site, study, country, portfolio level. The Senior Director , Risk Management and Central Monitoring, is...enabling them to lead execution of the Risk Based Management Framework, enhancement of quality, compliance and inspection… more
- Kelly Services (Alameda, CA)
- …Bay Area** Type: Direct Hire Shift: M-F 8a-5p Salary: 200K-250K + DOE The Senior Director will lead QA compliance across GCP , PV, and GLP functions, ensuring ... data integrity through risk-based audits and Quality Risk Management (QRM). Key responsibilities include tracking metrics, driving continuous improvement, and… more
- BeiGene (San Mateo, CA)
- …study protocol, SOPs, ICH/ GCP and all other relevant regulations. + Ensures inspection readiness for studies in region at any point in time throughout the study ... **General Description:** _Study management responsibilities:_ + Accountable for regional study or...Accountable for regional study or portfolio delivery with appropriate inspection readiness quality, within agreed timelines and budget +… more
- BeiGene (San Mateo, CA)
- The Associate Director (AD) Clinical Study Management leads both indirect and direct reports, external partners, consultants, vendors and external budget to ... of contracts and/or work order changes prior to submission to senior management for approval. The AD CSM establishes and maintains effective communication and… more