Senior C&Q Principal — GMP Qualification Leader

CSL; Melbourne; On-site; AUD 180,000 - 240,000; Full time

Job summary

CSL is seeking a Senior Principal for Qualification & Commissioning to oversee all C&Q activities across new and modified facilities, equipment and systems. You will lead master plans, establish GMP-compliant strategies and drive lifecycle management across CSL sites in Australia.

You will mentor teams, coordinate with project managers and engineers, and ensure readiness for regulatory inspections while aligning with global policies and quality systems.

Qualifications

• Tertiary qualification in Science or Engineering.
• 5+ years’ experience in pharmaceutical manufacturing; C&Q focus.
• Strong knowledge of cGMP and validation principles.
• Experience supporting regulatory audits/inspections (TGA, FDA).

Responsibilities

• Lead and manage all Qualification & Commissioning activities across facilities, equipment and systems from master plan to execution and handover.
• Develop and maintain C&Q Master Plans, SOPs, protocols, reports and documentation.
• Embed C&Q requirements into system design, testing, deployment and lifecycle management.
• Oversee project delivery, design reviews, testing, and post‑deployment support to meet schedules.
• Provide leadership, coaching and SME support to project teams and site personnel.
• Ensure regulatory compliance and readiness for inspections across CSL sites.

Skills

Leadership

Regulatory knowledge

Strategic thinking

Cross-functional collaboration

Education

Science or Engineering degree

Job description

CSL is seeking a Senior Principal for Qualification & Commissioning to oversee all C&Q activities across new and modified facilities, equipment and systems. You will lead master plans, establish GMP-compliant strategies and drive lifecycle management across CSL sites in Australia.

You will mentor teams, coordinate with project managers and engineers, and ensure readiness for regulatory inspections while aligning with global policies and quality systems.