- 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. (Parsippany, NJ)
- …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
- TEKsystems (Trafford, PA)
- …communication and change control standards. * Maintain client satisfaction while ensuring quality and governance of GCP solutions. Practice & Product Line ... experience you've been searching for? We're looking for a GCP Practice Architect 2 to join our team. A...is a leadership-level role focused on Google Cloud Platform ( GCP ) delivery and practice development. The role oversees consulting… 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
- Danaher Corporation (Austin, TX)
- …of the job include: + Bachelor's degree in science with 14+ years of clinical quality / GCP experience within the device industry OR + Master's degree in science ... with 12+ years of clinical quality / GCP experience within the device industry + Knowledge of US requirements and regulations related to Good Clinical Practice… 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
- Lilly (Indianapolis, IN)
- …field or equivalent work experience + 2+ years experience within a GCP quality organization **Other Information/Additional Preferences:** + Experience in a ... development and implementation of the strategy for Good Clinical Practice ( GCP ) quality systems and activities to support business goals and objectives. This… 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
- 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 ... of my knowledge. **Job Description** **OBJECTIVES:** + Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ + Partner with… more