Senior Director, Product Quality Lead – Post-Marketing, Pharmacovigilance

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

📋 Description

• Direct and enhance our global Pharmacovigilance (PV) Quality function.

• Offer strategic guidance and operational Quality leadership in pharmacovigilance initiatives.

• Collaborate closely with teams in Pharmacovigilance, Regulatory Affairs, Manufacturing, and Commercial sectors.

• Develop risk-based PV QA frameworks and mentor a team dedicated to patient safety practices.

• Create product-specific quality strategies and ensure readiness for inspections.

• Facilitate quick responses to product quality issues.

⛳️ Requirements

• Bachelor’s or advanced degree in Life Sciences, Pharmacy, Nursing, or a related field.

• Over 12 years of experience in the pharmaceutical or biopharmaceutical industry, with substantial experience in post-marketing PV QA.

• A minimum of 5 years of experience in Quality Assurance (GVP and GMP).

• Demonstrated experience in leading and assisting with regulatory inspections (FDA, EMA, MHRA, etc.) and executing Corrective and Preventive Actions (CAPAs).

• Comprehensive understanding of ICH guidelines, GVP Modules, FDA 21 CFR, EU PV regulations, and EU Volume 4.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible paid time off.

• Medical, dental, and vision insurance.

• Life/disability insurance.

• Mental health benefits provided through the Employee Assistance Program.

• Additional voluntary benefits, including supplemental life insurance and legal services.