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Head, pv and regulatory qa

Maidenhead
Permanent
CSL Behring
Posted: 21h ago
Offer description

The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system. You are the independent quality authority ensuring that our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs remain compliant with global regulations, ICH guidelines, and company standards. Your role bridges strategic oversight with hands on operational leadership: you design the audit strategy and governance framework that keeps the system fit for purpose, but you also own the day-to-day quality assurance of how PV actually works across the business.

You will direct both the strategic evolution of the PVRQA function and its operational delivery. This means setting the long term compliance roadmap while simultaneously managing inspections, deviation management, and the practical quality controls that keep the system sound. You partner with senior leadership on strategic direction, but you're equally engaged in the details that matterensuring SOPs are fit for purpose, CAPA workflows are rigorous, and systems are inspection-ready.

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:

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