- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director… more
- Taiho Oncology (Princeton, NJ)
- …collaborative, and global cross-functional environment. Position Summary: The Director , Quality Assurance , (Pharmacovigilance [ PV ]) reports into the Sr. ... Director , Quality Assurance , PV and is responsible for partnering with the Sr. Director of QA, PV and PV colleagues to assure their strategy… more
- Ascendis Pharma (Palo Alto, CA)
- …representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits + Work collaboratively with Vendor ... (GPS) organization. Under the direction of the Head, Global PV Operations, the Director , ICSR Management Team... Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to… more
- Ascendis Pharma (Princeton, NJ)
- …representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits + Work collaboratively with Vendor ... employees to grow and develop their skills. The Associate Director , ICSR Management Team reports to the Director...+ Responsible for operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …quality capabilities, enhance process improvements and transparency. This is a quality assurance role, helping maintain global compliance, reinforcing audit ... of GVP audit activities and deliverables across affiliates, partners, vendors and internal PV processes. + Lead internal R&D quality audits for assigned R&D… more
- Honeywell (Atlanta, GA)
- …requirements. + Implement best practices in project controls, risk management, and quality assurance . + Manage budgets, cost forecasts, and resource allocation ... delivered on time, on budget, and to the highest quality and safety standards. The Senior Director ...C&I energy projects (DER, energy efficiency, renewables, storage, solar PV , etc.). + Strong financial acumen with experience managing… more
- Takeda Pharmaceuticals (Boston, MA)
- …issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance , Medical Affairs, Marketing, Manufacturing, and Legal. + ... risk management. + Knowledge and understanding of national and international PV and regulatory guidelines. **Travel Requirements:** Local and international travel… more
