- BeiGene (Emeryville, 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
- BeiGene (Emeryville, CA)
- …quality guidance, expertise and leadership to the regional Clinical Operations Americas GCP compliance team. The Director GCP Compliance collaborates ... with ICH GCP and any local regulations. + Leads the development of a GCP inspection readiness programme at a regional level in alignment with global … more
- Vera Therapeutics (Brisbane, CA)
- …Quality Assurance and will be responsible for developing and maintaining GMP, GLP and GCP Quality Management Systems in accordance with FDA, ICH, EMA regulations ... Title: Associate Director , Quality Assurance Location: Brisbane, CA About Us:...global quality matters. Responsibilities: * Develop and maintain Quality Management Systems in compliance with quality standards and guidelines… more
- BeiGene (Emeryville, CA)
- …Data Management , Biostats, GPS, RBQM, etc. + Support the inspection readiness activities and participate in managing regulatory health authority inspections as ... **General Description:** The Associate Director of R&D Quality Systems, Strategy, and Excellence...drive cultural change and system modernization, ensuring that quality management systems (QMS) evolve across R&D to meet industry… more
- BeiGene (Emeryville, 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
- 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 ... to assigned R&D programs. + Collaborates with the Audit, Inspection and CAPA Management Team within R&D...requirements. **This position will be filled at the Associate Director or Senior Manager level, based on experience of… more