- Ardelyx (Waltham, MA)
- …of responsibilities based on needs analysis. Responsibilities: Develop, implement, and maintain QA GCP /GLP/ PV systems, risk management processes, and ... Other responsibilities include the provision of regulatory compliance and QA guidance to clinical and drug safety teams, review...with 8+ years of experience in GCP /GLP Quality and PV Quality related… more
- Ascendis Pharma (Palo Alto, CA)
- …appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits + Contribute to the maintenance ... Head of Vendor Management by contributing to the Vendor Quality Agreements + Accountable for maintaining oversight over Source...of CAPAs as necessary + Work Closely with Ascendis GCP / PV Compliance team and Commercial organization as… more
- Ascendis Pharma (Palo Alto, CA)
- …representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits + Work collaboratively with Vendor ... Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to...System Master File (PSMF) + Through coordination with Ascendis GCP and PV Compliance team will provide… more
- Ascendis Pharma (Palo Alto, CA)
- …appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits. . Functions as a patient ... Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products in the Ascendis...of products in development. . Through coordination with Ascendis GCP and PV Compliance team will provide… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …+ **Data Integrity:** Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes. + **Team Leadership:** Lead, ... Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a… more
