Head, PV and Regulatory QA

Join Our Team as the Head of Pharmacovigilance and Regulatory Quality Assurance!

Are you ready to take the lead in ensuring the highest standards of quality and compliance in our pharmacovigilance system? As the Head of Pharmacovigilance and Regulatory Quality Assurance, you will be the independent quality authority, overseeing our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs. This is your chance to bridge strategic oversight with hands-on operational leadership!

Your role will involve designing the audit strategy and governance framework that keeps our system fit for purpose, while also managing the day-to-day quality assurance of how PV operates across the business. You will play a pivotal role in both the strategic evolution of the PVRQA function and its operational delivery.

The Role

In this dynamic position, you will direct the strategic development of the Global PVRQA function, supporting both our global R&D business and regional affiliates. Your focus will be 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, contributing to the larger strategic vision of Global R&D Quality.
• Audit Strategy: Own the long-term, risk-based audit strategy aligned with GVP Module IV, delivering annual internal and external audit programs.
• Inspection & Regulatory Management: Lead the preparation, conduct, and response phases for PV health authority inspections and third-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 to ensure coordination across functional areas, including Commercial and Clinical Development.
• Operational Management: Oversee 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

We are looking for a high-caliber Quality Assurance professional who possesses 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.

If you are passionate about quality assurance and ready to make a significant impact in the world of pharmacovigilance, we want to hear from you!