Senior Manager, QA Site Compliance

at  CSL Behring

THE OPPORTUNITY:

We are looking for a Senior Manager, QA Site Compliance to provide leadership support to all compliance activities across the site including assessment of compliance with both regulatory and CSL/Seqirus requirements, KPI management, inspection readiness, and CAPA execution. You will ensure adherence to GMP/GxP standards and regulatory requirements, with a focus on compliance activities including external Health Authority Inspections. You will manage site self-inspection programs, coordinating quality management reviews, and escalating compliance issues.
You will perform gap assessments for other audits at sites within the CSL network according to procedure. You will be responsible in the evaluation of the site against the output of external regulatory or internal CSL audits, changes of market specific regulations, and the coordination and delivery of site-based gap assessments according to appropriate timelines. This will involve appropriate liaison with the global Compliance and Risk groups.

SKILLS & EXPERIENCE:

• Bachelor’s degree in science or engineering; advanced degree.
• 5-10 years’ experience engineering, manufacturing, or quality management in regulated industry
• Strong knowledge of GMP, quality, and risk management.
• Excellent leadership, organizational, and communication skills.
• Proven experience in managing regulatory inspections and audits.
• Experience with manufacturing processes and compliance requirements.