Own the Pharmacovigilance (PV) Audit Program: Develop, implement, and maintain the global PV audit strategy, ensuring alignment with regulatory expectations (e.g., EMA, FDA, MHRA, PMDA) and industry best practices
Manage Audit Operations: Oversee scheduling, planning, execution, reporting, and follow-up for PV audits, including internal audits and audits of service providers and affiliates
Risk Identification and Communication: Identify high-risk compliance issues, escalate findings, and provide actionable recommendations to senior leadership
Regulatory Inspection Support: Prepare for and support PV-related health authority inspections, including back-room management and post-inspection follow-up
Metrics and Reporting: Define and track PV audit KPIs, ensuring visibility of compliance risks and trends to leadership
System Ownership: Manage audit-related modules within the electronic Quality Management System (eQMS), including support of configuration, UAT, and documentation
Team Leadership: Lead and develop a team of 3–5 auditors, providing coaching, mentorship, and performance management
Cross-Functional Collaboration: Partner with PV Operations, Quality, and Regulatory teams to ensure audit outcomes drive continuous improvement
Strategic Influence: Contribute to policy development and influence PV compliance strategy across the organization

Requirements

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
Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485

Benefits

medical, dental, vision
paid time off
401(k) plan with employee and company contribution opportunities
life insurance
disability insurance
accident insurance
tuition reimbursement

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

PharmacovigilanceAudit Program DevelopmentRisk IdentificationMetrics and ReportingQuality Management System (QMS)Configuration ManagementUser Acceptance Testing (UAT)Compliance Strategy DevelopmentPolicy Development

Soft Skills

Team LeadershipCoachingMentorshipPerformance ManagementCross-Functional CollaborationStrategic InfluenceCommunicationProblem Solving

Certifications

Qualified Lead Auditor