GVP Pharmacovigilance Audits – Senior GVP Audit/Project Manager Needed
Our client needs a full-time Senior GVP Audit/Project Manager to handle their GVP Pharmacovigilance Audits. This person will plan and perform domestic and international GVP audits to assess the company’s compliance to local and international government regulations. They will also assess internal SOPs as they relate to GVP Quality Assurance and regulatory compliance. This position is located in Brisbane, CA.
- Minimum of 12 years in Pharmaceutical, Biotechnology or Medical Device Industry. Positions in Pharmacovigilance Assurance/Regulatory Compliance or equivalent.
- Experience in international compliance auditing
- Experience in developing, writing and implementing SOPs
- Domestic and International travel (30%)
- Auditor certification a plus
- Lead GVP Pharmacovigilance Audits
- Maintain audit schedule
- Identify audit team members
- Conduct pre-audit meetings with other departments
- Identify audit observations and prepare summaries
- Ensure timely and adequate closeout of audit corrective and preventive actions
- Provide training and oversight to GVP team members, fostering their expertise
- Identify and escalate issues, risks roadblocks that may impact product quality, safety or efficacy, regulatory compliance or business continuity
- Track GVP audit trends
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