Job Summary
A pharmaceutical company is seeking a Remote Senior Process Audit Lead Director.
Core Responsibilities Include:
- Developing a comprehensive audit strategy to assess compliance of processes
- Ensuring process audit standards are well calibrated against regulatory expectations
- Leading a team of experienced auditors capable of executing complex process audits
Must meet the following requirements for consideration:
- 15+ years of relevant experience
- BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
- Proven ability in enterprise leadership and execution of business practices
- Expert knowledge of ICH GCP, EMA Pharmacovigilance Directives and applicable global regulations
- Ability to identify risks, propose effective mitigations and escalate as needed
- Broad knowledge of pharmacovigilance processes and impact of PV/REG/Medical processes
