Head of Patient-Facing Quality Assurance

You will provide independent, risk-based QA oversight from trial design through close-out, and across the global pharmacovigilance system. You will be the consistent quality voice in governance and a constructive challenger to the functions that own operational delivery.

• Setting the strategy, operating model, governance, capabilities and global resource model for Clinical QA and PV QA, harmonising approaches without diluting specialist expertise
• Embedding Quality by Design, critical-to-quality factors and risk-based quality management, and making sure risks to participant safety, patient safety and data integrity are escalated in time
• Assuring the quality systems behind clinical development and pharmacovigilance, including their integration with the enterprise QMS and accurate representation in the Pharmacovigilance System Master File
• Overseeing the clinical safety interfaces: SAE collection and reconciliation, SUSAR and expedited reporting, investigator safety reporting, safety data exchange agreements and signal escalation
• Running a globally consistent framework for significant quality issues, serious breaches, critical deviations and CAPAs, backed by rigorous root-cause analysis and reportability assessment
• Leading GCP and GVP inspection readiness and health-authority inspections, owning the patient-facing audit plan, and giving senior leadership an integrated view of quality risk, trends and regulatory intelligence

Bringing clinical and pharmacovigilance quality under one leader is a deliberate choice. Some of the most consequential risks sit at the interfaces between them: serious adverse event reconciliation, expedited reporting, and the safety information that reaches investigators and regulators. A single function can see these clearly and act on them. The role is also a chance to shape how quality is done, not just police it. With ICH E6(R3) moving the industry toward Quality by Design and risk-based quality management, you will set the strategy, operating model and standards for how the company protects participants and patients. You will keep the specialist depth that GCP and GVP each need while making the approach consistent worldwide.