Remote Senior Process Audit Lead Director

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Fri, Oct 30, 2020

Job Category: Information Technology

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors, Masters

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