- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** GCP Quality Compliance Manager** **What you will do** Let's do this! Let's ... In this vital role you will provide critical support to the Process Quality function by assisting in the implementation, monitoring, and continuous improvement of… more
- BeOne Medicines (Emeryville, CA)
- …and Experience: + BA/BS degree required; advanced degree preferred. + GCP Quality Assurance auditor's registration/certification preferred. + Minimum of ... Perform on-site or remote audits (routine, for-cause/directed); Evaluate compliance with GCP regulations, internal quality standards, and relevant guidelines;… more
- Gilead Sciences, Inc. (Foster City, CA)
- …evolving global clinical regulations and guidance. + Support the development of GCP Audit material/insights for quality forums and management reviews. _Training ... aspirations. Join Gilead and help create possible, together. **Job Description** Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Head, Global Development Quality Standards & Continuous Improvement (GDQSCI) will lead and support the GDQSCI sub-function, ensuring effective oversight of ... responsibilities and team management. As a member of the Global Development Quality Governance & Oversight (GDQGO) Leadership Team, this role involves overseeing the… more
- Actalent (Frederick, MD)
- … Quality Assurance clinical operations. The Associate Director of QA will oversee quality for GCP , GLP, and PV operations, a fast-paced cell therapy ... Practice (GVP) vendors and systems. * Prepares and negotiates Quality Agreements with vendors. * Manages study, GCP... Quality Agreements with vendors. * Manages study, GCP , GLP, and GVP deviations, quality issues,… more
- Lilly (IN)
- …within the global Avid Quality Assurance (QA) function, ensuring the GCP Quality Management System (QMS) is well-defined, effectively executed, and aligned ... efforts in GCP investigations and critical events. Escalate specified events, significant GCP quality related issues to appropriate levels of quality … more
- GRAIL (Durham, NC)
- …20916, ISO 14155, IVDD/IVDR), US [21 CFR Part 812 and Part 11]. + Experience managing GCP quality processes such as managing Quality Events and CAPAs; and ... and CDx project teams, ensuring adherence to ICH E6 ( GCP ), relevant diagnostic regulations, and internal quality ...E6 ( GCP ), relevant diagnostic regulations, and internal quality standards. + Support and, where necessary, lead risk… more
- Sanofi Group (Swiftwater, PA)
- …+ Supports the coaching of less experienced and / or newly hired GCP Quality Auditor(s). **COMPLEXITY & PROBLEM SOLVING** **Major Challenges/Problems:** + ... within the required timelines. May provide advice and consultation on GCP and Quality issues during audit activities. + Manages appropriateness of responses, the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs ... **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality...and GCP /GVP regulations including FDA, EU, MHRA, PMDA and ICH.… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs ... **Job Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of...and GCP /GVP regulations including FDA, EU, MHRA, PMDA and ICH.… more