- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a timely manner.Support CAPA completion for all outsourced audits with Development and Medical QA , PV QA , QMS and stakeholders.Collaborate with QMS Team and ... diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP /Document Audits supports end-to-end audit activities per audit program...applicable QA function to ensure no overdue CAPAs.Conduct document audits… more
- 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)
- …representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits Work collaboratively with Vendor ... PV Vendor processing ICSRs for Ascendis Products. Performs Quality Checks of processed ICSRs and provides feedback to...Pharmacovigilance 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 + 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
