Global Head, Patient-Facing QA (GCP/GVP) – Hybrid

CSL; Thatcham; Hybrid; GBP 120,000 - 180,000; Full time

Job summary

CSL Seqirus 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 (3 days on site) based in Maidenhead, UK, or King of Prussia, PA, with other locations open to discussion.

You will drive Quality by Design, risk-based quality management and data integrity across clinical development and pharmacovigilance, while maintaining expert depth in GCP and GVP and coordinating with

Qualifications

• At least 10 years of progressively responsible experience in pharma or regulated life sciences.
• Significant QA leadership in clinical quality or PV quality, including global teams in a complex matrix.
• Expert knowledge of GCP and GVP regulation and inspection expectations (ICH E6(R3) and EU GVP).
• A track record with health-authority inspections, serious breaches, investigations, CAPAs and inspection remediation.
• Hands-on experience of Quality by Design and risk-based quality management; data integrity and computerised systems.

Responsibilities

• Provide independent, risk-based QA oversight from trial design through close-out, and across the global pharmacovigilance system.
• Be the consistent quality voice in governance and a constructive challenger to the functions that own operational delivery.
• Set the strategy, operating model, governance, capabilities and global resource model for Clinical QA and PV QA, harmonising approaches without diluting specialist expertise.
• Embed Quality by Design, critical-to-quality factors and risk-based quality management, escalating risks to participant safety, patient safety and data integrity.
• Assure the quality systems behind clinical development and pharmacovigilance, including their integration with the enterprise QMS and Pharmacovigilance System Master File.
• Oversee clinical safety interfaces: SAE collection/reconciliation, SUSAR and expedited reporting, investigator safety reporting, data exchange agreements and signal escalation.
• Run a globally consistent framework for significant quality issues, serious breaches, and CAPAs with rigorous root-cause analysis.
• Lead GCP and GVP inspection readiness and health-authority inspections, providing senior leadership with an integrated view of quality risk and regulatory intelligence.

Skills

GCP & GVP knowledge

Quality leadership

Risk-based quality mgmt

Data integrity

CRO/vendor oversight

Education

Life sciences degree (life sciences, pharmacy, medicine, nursing)

Job description

CSL Seqirus 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 (3 days on site) based in Maidenhead, UK, or King of Prussia, PA, with other locations open to discussion.

You will drive Quality by Design, risk-based quality management and data integrity across clinical development and pharmacovigilance, while maintaining expert depth in GCP and GVP and coordinating with