- Gilead Sciences, Inc. (Parsippany, NJ)
- …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)
- The Associate Director , Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible ... for the effective management of GCP , GVP and GLP inspections. The GDQIM IML will...guidelines including the management of significant/complex quality issues and compliance activities. * Extensive experience with participating in, 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
- 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
- AbbVie (North Chicago, IL)
- …. Job Description Drives vision, strategic oversight, and operational delivery of GCP compliance and quality principles related to clinical trial execution. ... Ensures clinical studies are successfully implemented through a strong foundation of GCP Compliance , governing quality system documentation, and quality control… more
- St. Luke's University Health Network (Allentown, PA)
- …serve, regardless of a patient's ability to pay for health care. The Director , Research Finance and Compliance provides strategic and operational leadership for ... the financial management, regulatory compliance , and long-term sustainability of SLUHN Clinical Trials and...the Code of Federal Regulations (CFR), Good Clinical Practices ( GCP ), Fair Market Value (FMV), sponsor-specific requirements, and all… 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
- 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
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director Global Clinical Compliance builds, collaborates and manages key relations to better support and understand the ... GMP and GDP compliance matters. This role reports to the Senior Director , Global Clinical Operations Compliance Lead. **Essential Functions of the Job:** +… more