- Lundbeck (Deerfield, IL)
- PV and GCP QA Quality Advisor...position is to work within and support the R&D Quality Assurance Division in assuring compliance of ... manage assigned global audit activities, in line with the GCP QA audit strategies and procedural framework....up on insourced or outsourced GCP and PV audits, in line with R&D Quality … 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
- 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
- Merck (Boise, ID)
- …to deliver objectives. + Take responsibility for any clinical audits, working closely with the Quality Assurance ( QA ) group and the Good Clinical Practice ... internal auditors in conjunction with CCQM, compliance, Regulatory, Pharmacovigilance ( PV ) and Medical Affairs. + Responsible and supports development...Quality and Compliance Council ( GCP QCC). **Extent of Travel** : up to 30%… more
- Orchard Therapeutics (Boston, MA)
- …Company strategic objectives while safeguarding patient safety, + Ensuring high- quality Standard Operating Procedures are described within a robust Pharmacovigilance ... team members are accountable for delivering activities in a timely, accurate, and high- quality manner through leadership by example. + Ensures a high profile for the… more