Senior Quality Assurance Manager – Clinical QA

About the role

As a senior leader in the Australian office, you will drive the quality assurance strategy that underpins the clinical development of Ascentage Pharma’s pipeline. You will work closely with Clinical Operations and cross‑functional teams to ensure compliance with GxP standards and regulatory expectations.

Key responsibilities

• Lead and execute overall QA strategies for clinical development in Australia.
• Manage deviation and CAPA processes in partnership with Clinical Operations.
• Review, comment on, and revise SOPs, work instructions and other quality documents with global stakeholders.
• Provide GxP (GCP, GMP) guidance and SOP clarification to support study teams.
• Develop and implement risk‑management plans, perform trend analyses and drive mitigation actions.
• Design and maintain vendor qualification and review programs.
• Plan, conduct and report on on‑site study audits, ensuring timely communication of findings.
• Monitor emerging regulatory requirements and work with stakeholders to address compliance impacts.

Required profile

• Extensive experience in clinical quality assurance at a senior manager or AD level.
• Proven ability to lead QA strategy, deviation/CAPA management, and SOP governance.
• Strong knowledge of GxP regulations (GCP, GMP) and risk‑management methodologies.
• Experience with vendor qualification and on‑site audit execution.
• Effective collaboration with cross‑functional and global teams.

Required skills

• GCP compliance
• GMP compliance
• CAPA management
• Risk management
• Vendor qualification
• Audit planning and execution

What we offer

• Opportunity to shape QA strategy for a fast‑growing biopharma pipeline.
• Collaboration with global experts across multiple therapeutic areas.
• Competitive compensation and benefits package.