Upvote
Downvote
Compliance QA Director - Inspections (Onsite Role)
Share Job
- Suggest Revision
$150
- SUMMARY/JOB PURPOSE:The Compliance QA Director for Inspections is accountable for providing the strategy and direction and is responsible for leading and managing the Inspection Readiness program for GxP-regulated areas, including systems managed by external vendors.
- The Compliance QA Director will serve as the QA Partner (Primary Point of Contact) and be the voice of Quality for Exelixis business stakeholders.
- Partners with stakeholders, including Pharmaceutical Operations and Supply Chain, R&D (Biologics and CMC), Product Development, Clinical Operations, Regulatory Affairs, Global Patient Safety, Non-clinical Development, etc., regarding inspection preparedness, compliance assessments, including identifying and mitigating compliance gaps, and provides compliance guidance related to GxP processes.
- Responsible for inspection record archival and maintenance in eQMS.SUPERVISORY RESPONSIBILITIES:None. Indirectly leads cross-functional teams, as required.
- Knowledge/Skills:Applies a wide range of knowledge of the biotechnology/pharmaceutical sector to perform complex work and demonstrates influence beyond QA.Makes decisions on complex issues using strategic and critical thinking skills.
Active Job
Updated 10 days agoSimilar Job
Relevance
Active