- Gilead Sciences, Inc. (Foster City, CA)
- …for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions. ... as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …innovation for quality objectives. + Contribute to GDQ/GDQGO policies and ensure compliance with regulations and best practices. + Integrate quality risk management ... in processes where applicable. + Collaborate with other department leaders for effective quality oversight. + Represent senior management at quality forums and during regulatory inspections. **This Role May Be for You If You:** + Have strategic leadership and… more
- Amgen (Washington, DC)
- …hands-on support to the Senior Manager/Associate Director in ensuring procedural compliance with GCP standards and other regulatory requirements across R&D. ... 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 change the… more
- Amgen (Washington, DC)
- …Suppliers for Amgen sponsored clinical trials + Monitoring and evaluating Supplier compliance and data quality + Tracking corrective actions in relation to ... external partners, including study teams, functional leads, procurement, quality, compliance , and suppliers + Support business functions with evaluation, selection,… more
- GRAIL (Durham, NC)
- …partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director , Clinical Compliance will play a key leadership role in ... System, leveraging lessons from inspections, audits, and emerging clinical compliance trends, in both GCP and CDx...and emerging clinical compliance trends, in both GCP and CDx domains. + Contribute to, implement, and… more
- Actalent (Frederick, MD)
- …motivated professional who can oversee our clients Quality Assurance clinical operations. The Associate Director of QA will oversee quality for GCP , GLP, and PV ... Description Quality Assurance Director with extensive experience in biopharmaceutical quality assurance...Leads Quality Assurance (QA) oversight for assigned studies, ensuring compliance with Good Clinical Practice ( GCP ) and… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ensuring the ... and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs and … more
- Lilly (IN)
- …For more information, visit www.avidrp.com . **Job Overview:** The Associate Director , Clinical Operations Quality Assurance is an integral role within the ... global Avid Quality Assurance (QA) function, ensuring the GCP Quality Management System (QMS) is well-defined, effectively executed, and aligned with quality risk… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- As a Senior Director of IT, Quality Assurance and Compliance , you will lead a team of those managing 20 to 30 members The focus is to provide leadership, ... are in compliance and audit-ready. * Ensure compliance with all GxP regulations, including GMP, GCP , and GLP, SOX, and other compliance requirements,… more
- Takeda Pharmaceuticals (Boston, MA)
- …on quality compliance activities. + Provide guidance and support to GCP , PV Health Authority inspections including logistics. + Present insights to the health ... and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs and … more