Director of Quality Assurance & Pharmacovigilance

We are conducting a confidential search for a Director of Quality Assurance & Pharmacovigilance to join a rapidly growing pharmaceutical manufacturer specializing in solid oral dose and small molecule products. This dual-function executive role combines oversight of site Quality Systems with leadership of Pharmacovigilance operations, including medical review of adverse events. The ideal candidate will bring 15+ years of experience in pharma QA/PV and must hold a PharmD, RPh, or MD credential to perform medical reviews in accordance with global safety regulations.

Reporting directly to executive leadership, the Senior Director will define the organization’s quality and drug safety strategies, lead cross-functional efforts in compliance and risk mitigation, and act as the point of contact for regulatory inspections and safety reporting requirements.

Key Responsibilities:

Provide strategic leadership for both Quality Assurance and Pharmacovigilance across the organization.

Lead development and continuous improvement of Quality Systems, including deviations, CAPAs, change control, and risk management.

Oversee pharmacovigilance operations including adverse event intake, evaluation, signal detection, and timely submission of safety reports.

Conduct or oversee medical review of individual case safety reports (ICSRs) and periodic safety update reports (PSURs), as required by global regulations.

Ensure full compliance with global GxP standards (including cGMP and GVP) and manage readiness for regulatory inspections.

Manage and maintain Quality and Safety Agreements, vendor qualifications, and external partner compliance.

Collaborate with Manufacturing, Regulatory, Medical Affairs, and R&D teams on product lifecycle, safety surveillance, and quality support.

Represent the company in health authority interactions, audits, and external safety communications.

Provide executive-level reporting of quality and safety KPIs, trends, and compliance risks.

Lead, mentor, and develop high-performing QA and PV teams, fostering a culture of accountability and continuous improvement.

Qualifications:

PharmD, RPh, or MD required — must be licensed and qualified to conduct medical reviews of pharmacovigilance data.

15+ years of combined Quality Assurance and Pharmacovigilance experience in the pharmaceutical industry, including solid oral dose and small molecule manufacturing.

5+ years of executive or senior leadership experience overseeing QA and PV teams.

Strong track record managing pharmacovigilance programs, including ICSR review, aggregate safety reporting, and signal management.

Deep understanding of global regulatory standards and frameworks: FDA, EMA, ICH, 21 CFR, and EudraVigilance.

Demonstrated success leading audits, inspections, and health authority communications.

Excellent communication, leadership, and organizational skills.

Experience working in a fast-paced, growth-oriented environment preferred.