Director, Central Quality Audit, Pharmacovigilance
$142,400–$213,600 year
RemoteUnited States
Job Summary
Develop and maintain the global Pharmacovigilance audit strategy, ensuring alignment with regulatory expectations and industry best practices. Oversee scheduling, planning, execution, and reporting for PV audits, including internal reviews and service provider assessments. Identify high-risk compliance issues, escalate findings, and provide actionable recommendations to senior leadership. Prepare for and support health authority inspections, manage post-inspection follow-up, and define KPIs to track compliance trends. Lead a team of 3–5 auditors through coaching, mentorship, and performance management while collaborating with PV Operations, Quality, and Regulatory teams. Manage audit-related modules within the electronic Quality Management System, including configuration and documentation support.
Required Qualifications
- Minimum 5 years of people leadership experience, including team development and performance management
- Qualified Lead Auditor with active certification
- Master's degree and 5+ years in pharmacovigilance or pharmaceutical industry; or Bachelor's degree and 10+ years relevant experience
- Minimum of 5 years' experience driving Global programs to resolve quality compliance issues (directly)
- Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP
- Ability to travel globally up to 15%
Desired Qualifications
- Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
- Prior Veeva and TrackWise Digital experience a plus
- Prior health authority experience a plus
- IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt)
- Extensive experience in the Medica Device and Pharmaceutical industry
- Understanding of product quality improvement using tools such as Six Sigma, DFR
- Demonstrated ability to analyze and resolve problems
- Exceptional conflict-resolution skills
- Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner
- Demonstrated ability to lead programs / projects
- Ability to prioritize and drive multiple programs
- Ability to energize others by building a connection with the team through personal involvement and trust, providing feedback and coaching to develop others, and accountability of actions
- Strong oral and written communication skills in English
- Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
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