Director, Central Quality Audit, Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of the Pharmacovigilance (PV) Audit Program by developing, implementing, and maintaining the global PV audit strategy.

• Manage Audit Operations by overseeing the scheduling, planning, execution, reporting, and follow-up processes for PV audits.

• Identify and communicate risks by pinpointing high-risk compliance issues, escalating findings, and offering actionable recommendations to senior leadership.

• Provide support for Regulatory Inspections by preparing for and assisting with PV-related health authority inspections.

• Define and track metrics by establishing PV audit KPIs, ensuring that compliance risks and trends are visible to leadership.

• Take ownership of systems by managing audit-related modules within the electronic Quality Management System (eQMS).

• Lead and develop a team of 3–5 auditors to enhance their skills and performance.

⛳️ Requirements

• A minimum of 5 years of experience in people leadership, encompassing team development and performance management.

• Active certification as a Qualified Lead Auditor.

• A Master’s degree with 5+ years in pharmacovigilance or the pharmaceutical industry; or a Bachelor’s degree with 10+ years of relevant experience.

• At least 5 years of experience in driving global programs to address quality compliance issues directly.

• Familiarity with Pharmaceutical QMS requirements and regulatory obligations, including but not limited to cGMP, GDP, GPvP, GCP, and GLP.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Paid time off.

• 401(k) plan offering both employee and company contribution opportunities.

• Life insurance.

• Disability insurance.

• Accident insurance.

• Tuition reimbursement.