- 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
- Pfizer (South San Francisco, CA)
- …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
- Gilead Sciences, Inc. (Foster City, CA)
- …Inflammation risk areas and provide these insights to the Quality Audit and Inspection Management programs in order to prioritize oversight activities and ... in in licensing and collaboration activities as applicable. + Lead/oversee management of internal inspection readiness activities throughout program life… 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
- 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:_ + As part of the regional...Accountable for regional study or portfolio delivery with appropriate inspection readiness quality, within agreed timelines and budget +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …that specializes in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations. The Associate Director , will ... to ensure quality, proactively identify risk, mitigate non-compliance and support inspection readiness activities. The position will partner closely with Research &… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... leadership over the DP Supply Planning, CMO operation and Distribution management . Ensures organization effectively manages vendor relationships and activities and… more
- BeiGene (San Mateo, CA)
- …and the need for process improvements. + Assisting R&D Quality Inspection Management Teams and cross-functional compliance functions, in developing/adjusting ... **General Description:** The Associate Director R&D Quality Excellence, Analytics, and Innovation is...maintaining a proactive, risk-based, and phase appropriate approach to GCP , GVP and GLP Quality Assurance. This role serves… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and resources to assigned groups, including - data, reporting, training, audit, inspection , risk assessment and deviation/ CAPA management support. You may ... vendors or relevant to assigned R&D programs. + Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance… more