PV Case Ops Associate Director: Quality & Compliance

Regeneron; New Jersey; On-site; USD 157,000 - 257,000; Full time

Job summary

Regeneron is seeking an Associate Director to lead PV Case Operations in Warren, NJ. You will oversee global ICSR processing, quality reviews, and CAPA programs, ensuring regulatory compliance and inspection readiness. This role emphasizes data-driven governance, vendor oversight, and collaboration with auditors and Health Authorities.

You will manage a team, drive continuous improvement, and communicate findings to senior management while maintaining adherence to timelines and safety standards.

Qualifications

• Minimum Bachelor's degree; advanced degree preferred.
• 10 years of Pharmacovigilance/Drug Safety experience.
• Well informed on FDA, EU and ICH guidelines governing PV activities.
• Experience managing teams on complex projects; cross-functional work.
• Ability to drive projects to timely completion and compliance.

Responsibilities

• Oversee PV case processing across global development programs and marketed products.
• Oversee ICSR quality review, including narrative quality and source reconciliation.
• Establish tiered quality review frameworks and sampling strategies.
• Drive continuous improvement in ICSR quality and CAPA ownership.
• Support audits and Health Authority inspections; respond to findings.
• Lead root cause analysis for quality deviations and compliance failures.
• Develop and track CAPAs to closure with effectiveness checks.
• Monitor KPIs, vendor performance, and governance meetings.
• Ensure regulatory compliance with PV regulations and Regeneron SOPs.

Skills

Team leadership

Quality oversight

Regulatory compliance

Education

Bachelor's degree

Advanced degree preferred

Job description

Regeneron is seeking an Associate Director to lead PV Case Operations in Warren, NJ. You will oversee global ICSR processing, quality reviews, and CAPA programs, ensuring regulatory compliance and inspection readiness. This role emphasizes data-driven governance, vendor oversight, and collaboration with auditors and Health Authorities.

You will manage a team, drive continuous improvement, and communicate findings to senior management while maintaining adherence to timelines and safety standards.