Associate Director, PV Case Ops & Quality Assurance

Regeneron; Kentucky; On-site; USD 130,000 - 180,000; Full time

Job summary

Regeneron is seeking an Associate Director to lead PV Case Operations, overseeing ICSR processing and quality across global programs. The role ensures readiness for inspections, drives continuous quality improvements, and maintains robust CAPA and KPI governance.

Collaboration with auditors and health authorities is expected. Located in Warren, NJ; Tarrytown, NY or Cambridge, MA with 4 days on site and up to 25% travel.

Qualifications

• Minimum Bachelor's Degree; Advanced Degree preferred.
• 10 years of Pharmacovigilance/Drug Safety/PV Quality experience.
• Familiar with FDA, EU and ICH PV guidelines and regulations.
• Experience supervising teams on complex projects and cross-functional work.

Responsibilities

• Oversee PV operations and ICSR processing across programs.
• Implement QA processes, quality review and source reconciliation.
• Develop tiered quality review frameworks and sampling strategies.
• Lead CAPA development, closure, and effectiveness checks.
• Interact with auditors and Health Authority inspectors during inspections.
• Monitor KPIs, vendor performance, and regulatory compliance.
• Provide mentorship and senior communication to stakeholders.

Skills

PV quality oversight

Team mentorship

Root cause analysis

KPI governance

Vendor performance

Education

Bachelor's degree

Advanced degree

Job description

Regeneron is seeking an Associate Director to lead PV Case Operations, overseeing ICSR processing and quality across global programs. The role ensures readiness for inspections, drives continuous quality improvements, and maintains robust CAPA and KPI governance.

Collaboration with auditors and health authorities is expected. Located in Warren, NJ; Tarrytown, NY or Cambridge, MA with 4 days on site and up to 25% travel.