Job Description

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.

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