Head, PV and Regulatory QA

About the role

You will direct the strategic development of the Global PVRQA function, supporting both the global R&D business and regional affiliates. Your focus is on three core pillars: Strategic Governance, Operational Excellence, and Regulatory Intelligence. Key Accountabilities: Strategic Leadership: Harmonize processes within Global PVRQA and across other GxP areas. Contribute to the larger strategic vision of Global R&D Quality and interact with the Leadership Team to ensure continuous alignment. Audit Strategy: Own the long-term, risk-based audit strategy aligned with GVP Module IV; deliver annual internal and external audit programs covering global systems, affiliates, and 3rd party vendors. Inspection & Regulatory Management: Lead the preparation, conduct, and response phases for PV health authority inspections and 3rd party audits. System Oversight: Monitor PV system health through oversight of deviation management, CAPA, change management, and performance reporting (KPIs). Cross-Functional Expertise: Provide GVP consultancy and cross-GxP expertise (GCP, GDP, GCLP) to ensure coordination across functional areas, including Commercial and Clinical Development. Operational Management: Oversight of PV IT systems, procedural quality assurance (SOPs), and third-party/vendor management. Resource Stewardship: Direct budget development and resource allocation by strategically assessing workload and coordinating consultant activities. Continuous Improvement: Monitor global regulatory trends and methodologies to implement improvement initiatives in response to the evolving landscape. Your Profile The successful candidate will be a high-calibre Quality Assurance professional with the executive presence to influence global cross-functional teams and the technical depth to safeguard our Pharmacovigilance system. Qualifications & Experience: Education: Undergraduate degree (BA/BS) in a Scientific or Life Sciences discipline; an advanced degree is preferred. Industry Tenure: 10+ years of pharmaceutical industry experience specifically within Quality Assurance. Leadership Track Record: Proven experience in a senior leadership capacity with deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines. Technical Mastery: Extensive understanding of end-to-end pharmacovigilance processes, including Deviation/CAPA management and the conduct of clinical research. Global Perspective: Experience working within global, cross-functional teams and managing complex regulatory interactions. Leadership Attributes: Strategic Acumen: The ability to quickly analyze complex circumstances and drive appropriate decisions and actions. Communication & Influence: Excellent communication, negotiation, and influencing skills across all levels of the business. Operational Rigor: Strong organizational skills with a focus on customer service and the ability to manage complex budgets and resourcing plans. About CSL Seqirus CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .