Head of Quality & Pharmacovigilance Compliance
Global pharmaceutical product for Facial Angiofibroma associated with Tuberous Sclerosis Complex (TSC) seeking an experienced senior leader to serve as our Head of Quality & Pharmacovigilance Compliance, overseeing U.S. quality systems, enterprise compliance governance, and PV inspection readiness.
Head of Quality & Pharmacovigilance Compliance
Location: Hybrid or Remote (U.S.)
Full-time • Base Salary: $180K–$240K
What You’ll Lead
Enterprise-level oversight of U.S. compliance risk, governance, and inspection readiness.
Quality Assurance oversight across non‑PV areas, ensuring SOP and quality standard adherence.
Ownership of the U.S. Pharmacovigilance Quality System, including SOPs, deviations, CAPAs, and vendor oversight.
FDA inspection leadership, internal audits, and review of key safety deliverables (PADERs, DSURs).
Development and oversight of compliance training programs and company-wide compliance culture.
What You Bring
Bachelor’s degree in Business, Life Sciences, or related field (preferred).
7+ years of experience in pharma/biotech/life sciences with strong compliance and quality expertise.
Deep understanding of FDA/PhRMA requirements and PV quality expectations.
Experience in rare disease or specialty therapeutic areas is a plus.
Strong communication, leadership, and strategic execution skills.
To apply, please email your resume to xjiang@pasona.com