- Amgen (Washington, DC)
- …support to the Senior Manager/ Associate Director in ensuring procedural compliance with GCP standards and other regulatory requirements across R&D. + Act ... transform the lives of patients while transforming your career. ** GCP Quality Compliance Manager** **What you will...experience OR + Bachelor's degree and 4 years of Quality/ Compliance /Process Management experience OR + Associate 's degree… more
- GRAIL (Durham, NC)
- …support Grail's partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director , Clinical Compliance will play a key ... 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
- 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
- Actalent (Frederick, MD)
- …who can oversee our clients Quality Assurance clinical operations. The Associate Director of QA will oversee quality for GCP , GLP, and PV operations, ... 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)
- …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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations + Analyze ... Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions + Collaborate with...new regulations and polices with emphasis Good Clinical Practices ( GCP ) and partner with business experts and stakeholders to… more
- Regeneron Pharmaceuticals (Warren, NJ)
- We are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the ... of study data of a clinical development program. The Associate Director leads in a matrix environment...compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical… more
- IQVIA (Durham, NC)
- …teams to improve patients' lives by bringing new drugs to the market faster. The Associate Clinical Lead Director is a member of the core project team ... **Job Overview:** Associate Clinical Lead Directors are an integral part...Functions:** + Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good… more
- Ascendis Pharma (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , PV Vendor Management Team reports to the Director , Head, ... of CAPAs as necessary + Work Closely with Ascendis GCP /PV Compliance team and Commercial organization as...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more