Global Head of Patient-Facing Quality Assurance

CSL; Maidenhead; Hybrid; GBP 120,000 - 160,000; Full time

Job summary

CSL is seeking a Head of Patient-Facing Quality Assurance to lead an integrated QA organisation spanning GCP and GVP, reporting to the Head of Global R&D Quality. The role is hybrid with 3 days on site in Maidenhead, UK, and other global locations open to discussion.

You will implement Quality by Design and risk-based quality management, ensuring participant safety, data integrity and regulatory readiness across trials and PV activities. Travel and cross-border collaboration are expected.

Qualifications

• At least 10 years in pharma/regulated life sciences with QA leadership across clinical quality or PV quality.
• Experience leading global teams in a complex matrix and across GCP and GVP.
• Expert knowledge of GCP, GVP, ICH E6(R3) and EU GVP framework.

Responsibilities

• Set strategy, operating model and governance for Clinical QA and PV QA; harmonise approaches while maintaining specialist depth.
• Embed Quality by Design, risk-based quality management, and escalation of risks to participant safety and data integrity.
• Assure quality systems behind clinical development and pharmacovigilance, including integration with the enterprise QMS and accurate representation in the Pharmacovigilance System Master File.
• Oversee clinical safety interfaces: SAE collection and reconciliation, SUSAR and expedited reporting, investigator safety reporting, safety data exchange agreements and signal escalation.
• Run globally consistent framework for significant quality issues, breaches and CAPAs with root-cause analysis and reportability assessment.
• Lead GCP and GVP inspection readiness and health-authority inspections, managing the patient-facing audit plan and providing integrated leadership insight into quality risk.

Education

Life sciences/related degree

Job description

CSL is seeking a Head of Patient-Facing Quality Assurance to lead an integrated QA organisation spanning GCP and GVP, reporting to the Head of Global R&D Quality. The role is hybrid with 3 days on site in Maidenhead, UK, and other global locations open to discussion.

You will implement Quality by Design and risk-based quality management, ensuring participant safety, data integrity and regulatory readiness across trials and PV activities. Travel and cross-border collaboration are expected.