Responsibilities:
The role holder is responsible for completing the site master file and self-inspection program, ensuring site compliance with GMP/GxP standards and regulatory requirements, and managing local quality reviews, KPIs, and contributing to global quality reviews. They provide impartial quality oversight and work closely with the FLQA organization.
Additionally, they organize and facilitate external regulatory, CSL corporate, and customer audits, oversee preparation and readiness for regulatory inspections and third-party audits, and manage inspection results, corrective actions, and timely responses to authorities. They also perform gap assessments, evaluate site compliance with audit outputs and regulatory changes, coordinate site-based gap assessments, and liaise with global Compliance and Risk groups.
The role holder is responsible for facilitation of the site Change control review panel and the site Deviation Review Board meetings, as assigned.
The role holder is responsible for preparation, facilitation and governance of the site Quality Plan.
Qualifications:
• Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred
• 7+ years' experience in quality/GMP in the pharmaceutical/biotech industry including 1-3 years' leadership/team management experience
• Experience within a global matrix organization
• Demonstrated success in project management and business/QA systems
• Knowledge of appropriate regulatory requirements including GMP/GQP
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
