Job Details:
Sr. Manager R&D Audits and Inspections
My client is a highly regarded pharmaceutical company. Focusing on developing products to meet medical needs.
This position will be providing support to the R&D Audits & Inspections function in leading the preparation for, and hosting of Regulatory Authority PV Inspections and external audits. Verifying compliance with PV regulations. Inspection will be focused in GVP.
Required
- 5+ years in the pharmaceutical industry
- Knowledge of GVP required, GVP auditing experience preferred.
- Inspection experience with FDA, MHRA is preferred.
- Bachelor's degree in a related field
Essential Functions
- Partners with PV system stakeholders in R&D, Tech Ops and Commercial to monitor trends in regulatory inspection activities to proactively identify potential areas of risk, and develop proposals against risks.
- Work with local site teams to ensure logistical support during inspections and audits.
- Prepare subject matter experts to present their functions during audits and aid in creating storyboards.
- Work with business to develop appropriate corrective action / preventative action against observations from inspections and audits.
- Track corrective action / preventative action details from inspections and audits to completion.
- Develop monitoring programs to ensure regulatory requirements for PV/Post-Authorization requirements are complied with and risks are minimized through coordination of internal/external audits.
- Upon notification of a regulatory inspection or internal audit initiates and supports the inspection team to prepare and submit pre-inspection document requests, logistics, and execution. Preforms inspection host responsibilities when required.
- Contribute to the development and execution of Global PV/Post-Authorization audit strategy, and implementation within the Quality Management System.
- Coordinate and implement strategic audit plans for pharmacovigilance and post-authorization commitment activities that include service providers, vendors, business partner, and internal audits.
- Evaluate corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement; ensure adequate and timely closure of CAPAs generated from audits.
Qualified candidates send resumes in word format to: chrisl@libertyjobs.com
Your resume will be kept confidential. I will not forward it until I speak with you about the position and its details.
Chris Lyons
Liberty Personnel Services, Inc.
410 Feheley Drive | King of Prussia, PA 19406
Keywords: (Pharmaceuticals, GVP, Audit, Inspection, QA, Compliance, R&D, Remote)