Head of Quality and Pharmacovigilance Compliance
Head of Quality & Pharmacovigilance Compliance Location: United States (Remote / Hybrid) Travel: ~10% Compensation: Base salary $180,000 – $240,000, +bonus
About the Company
Global commercial pharmacovigilance product, Tuberous Sclerosis Complex (TSC) U.S. affiliate, the company operates with a lean internal structure, leveraging best‑in‑class external vendors and consultants while maintaining strong internal governance and regulatory oversight. Seeks Head of Quality & Pharmacovigilance Compliance serves as the company’s senior U.S. authority for Pharmacovigilance (PV), Quality, and Compliance. This role provides enterprise‑level oversight and governance to ensure regulatory compliance, inspection readiness, and effective risk management across U.S. regulatory domains. This is a strategic leadership role, accountable for system ownership, risk visibility, and inspection readiness, while day‑to‑day execution is performed by functional teams and external partners. Key Responsibilities 1. Enterprise Compliance Oversight & Risk Visibility Serve as the accountable owner of the U.S. compliance framework across PV and Quality domains. Maintain a consolidated, enterprise‑level view of compliance status, risks, and mitigation activities. Identify, document, monitor, and escalate material compliance risks. Advise the CEO and executive leadership on compliance risk exposure, trends, and inspection readiness. Prepare and present regular compliance and risk updates to executive management. Review and formally approve compliance‑related documentation for accuracy, completeness, and regulatory alignment. Provide readiness confirmation for documents requiring executive signature (legal responsibility remains with officers). 2. Quality Management System Oversight (Non‑PV) Oversee adherence to Quality Assurance SOPs and processes outside of Pharmacovigilance. Act as the internal Quality authority, partnering with external QA consultants. Review audit findings, quality metrics, and compliance reports. Require and track corrective actions, confirming ownership and timelines with functional leaders. Escalate unresolved quality or compliance issues as appropriate. Ensure consistent application of quality governance, documentation, and reporting standards across functions. 3. Pharmacovigilance Quality System Ownership & Inspection Readiness Serve as the formal owner of the U.S. post‑marketing Pharmacovigilance Quality System, including: PV SOP governance Deviations and CAPAs Training oversight Documentation and record readiness Drive adherence to PV SOPs through oversight and monitoring of internal teams and external PV vendors. Oversee PV vendor performance related to adverse event intake, case processing, complaints, and regulatory submissions. Review key safety deliverables (e.g., PADERs, DSURs) to ensure quality and regulatory compliance. Lead and coordinate FDA inspections, regulatory interactions, and PV‑related audits. Maintain continuous inspection readiness through periodic reviews of PV processes, records, training, and vendor performance. 4. Training & Compliance Culture Oversee the design and effectiveness of role‑based Quality and Pharmacovigilance compliance training. Promote a strong compliance and quality culture across the organization. Serve as a key escalation point for compliance questions, concerns, and potential issues. Required Qualifications (Must‑Have) 6+ years of experience in Pharmacovigilance, PV Quality, or Quality / Compliance roles within the pharmaceutical or life sciences industry. Direct experience with U.S. post‑marketing Pharmacovigilance. Proven experience owning or governing a Pharmacovigilance Quality System, including SOPs, deviations, CAPAs, training, and vendor oversight. Experience supporting or leading FDA inspections or PV‑related audits. Strong understanding of PV regulatory requirements and inspection expectations. Demonstrated ability to operate effectively in a lean organization with extensive vendor reliance. Ability to communicate complex regulatory topics clearly to executive and non‑specialist audiences.
Preferred Qualifications
Exposure to broader Quality or Compliance areas beyond PV (e.g., GxP, DSCSA, Medical Information / OPDP). Experience coordinating and governing external vendors or consultants. Prior experience in small or mid‑sized pharma / biotech organizations. Interest in expanding scope from PV‑focused leadership to enterprise‑wide Quality & Compliance oversight.
Why Join Us
First U.S. product launch with high visibility and impact True system ownership and executive influence Clear separation between governance and execution Opportunity to shape the Quality and PV compliance function from an enterprise perspective To apply, please email your resume to [email protected] Apply tot his job Apply To this Job