Global Head of Patient-Facing QA & Safety

Csl; Maidenhead; On-site; GBP 120,000 - 180,000; Full time

Job summary

CSL Seqirus seeks a Head of Patient-Facing Quality Assurance to lead an integrated QA team covering GCP and GVP, reporting to the Head of Global R&D Quality. The role leads PV and clinical QA, sets strategy, and ensures patient safety and data integrity worldwide.

You will steer quality governance, risk-based management and inspection readiness, coordinating with CROs and partners to maintain compliant, high-quality processes across trials and safety systems.

Qualifications

• At least 10 years of pharma/regulated life sciences experience.
• Degree in life sciences, pharmacy, medicine, nursing or related field.
• Advanced degree or certification in Quality, GCP, GVP or auditing is an advantage.
• Significant QA leadership in clinical quality or PV quality with global teams.
• Experience with health-authority inspections, serious breaches, investigations and CAPAs.

Responsibilities

• Set strategy, governance, capabilities and global resource model for Clinical QA and PV QA.
• Embed Quality by Design and risk-based quality management, escalate risks to safety and data integrity.
• Assure quality systems behind clinical development and pharmacovigilance, integrate with enterprise QMS.
• Oversee the clinical safety interfaces: SAE collection, SUSAR, expedited reporting and safety data exchange.
• Lead a globally consistent framework for significant quality issues, CAPAs and inspections.
• Prepare for GCP and GVP inspections and health-authority readiness, provide integrated quality risk view.

Skills

QA leadership

GCP knowledge

GVP knowledge

Regulatory inspections

Quality by Design

Risk-based QA

CRO oversight

Education

Life sciences degree

Quality/GCP/GVP certification

Job description

CSL Seqirus seeks a Head of Patient-Facing Quality Assurance to lead an integrated QA team covering GCP and GVP, reporting to the Head of Global R&D Quality. The role leads PV and clinical QA, sets strategy, and ensures patient safety and data integrity worldwide.

You will steer quality governance, risk-based management and inspection readiness, coordinating with CROs and partners to maintain compliant, high-quality processes across trials and safety systems.