Senior Director, Pharmacovigilance Quality Assurance
Core
Leads the strategy, governance, and execution of the global pharmacovigilance quality framework to ensure scalable, inspection-ready operations supporting regulatory submissions and patient safety.
Role type
Senior Director, Pharmacovigilance Quality Assurance
Builds
Global PV Quality Management System, inspection readiness, and vendor oversight for clinical and future commercial programs
Domain
Biopharmaceuticals / Pharmacovigilance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Enterprise strategy definition, regulatory expectations knowledge, inspection readiness, risk-based quality framework design, vendor governance, cross-functional partnership, organizational leadership, KPI establishment, deviation/CAPA management, health authority interaction
Preferred skills
None stated
Technologies
None stated
Responsibilities
Define and own the global PVQA strategy aligned with the development and commercialization roadmap; Serve as the subject matter expert on PV quality advising senior leaders on regulatory expectations, compliance risks, inspection trends, and emerging best practices; Build, lead, and develop a high-performing PVQA organization including capability building, mentorship, succession planning, and talent development; Represent PVQA in regulatory authority interactions, external audits, health authority inspections, and executive-level quality discussions; Partner cross-functionally to embed a culture of quality, accountability, and continuous improvement across PV and related functions; Own the end-to-end PV Quality Management System ensuring scalability, compliance, and operational efficiency across preclinical, clinical, and future commercial stages; Establish and monitor enterprise PV quality metrics and KPIs translating trends into actionable improvements and executive-level reporting; Oversee deviations, quality issues, CAPAs, effectiveness checks, and quality events ensuring timely resolution, robust root cause analysis, and systemic improvement; Establish a risk-based PV quality framework to proactively identify, assess, escalate, and mitigate risks across programs, vendors, systems, and regulatory submissions; Lead global PV audit and inspection strategy including internal audits, vendor audits, health authority inspections, and continuous inspection readiness; Serve as the senior inspection lead ensuring consistent messaging, rapid issue resolution, compliant responses, and effective CAPA execution; Oversee Pharmacovigilance System Master File governance and ensure alignment with applicable regulatory expectations; Provide quality oversight for PV vendors and partners through defined governance, KPIs, audits, performance reviews, and issue escalation pathways
Seniority
Senior Director, strategy & organizational leadership
