THE OPPORTUNITY

CSL Behring is seeking a Senior Associate, Quality Assurance Compliance to join our Quality team at Broadmeadows on a fixed-term contract (approximately 13 months). Reporting to the Manager, QA Compliance , you’ll play a key role in maintaining audit readiness and supporting compliance across the site. You’ll work closely with a small, collaborative team and engage with multiple departments across the business.

YOUR SKILLS AND EXPERIENCE

• Bachelor’s degree in Science, Engineering, or a related discipline.
• 3–5 years’ experience in pharmaceutical manufacturing or a highly regulated industry.
• Experience conducting audits or supporting regulatory inspections.
• Familiarity with GMP and regulatory frameworks (e.g., FDA, TGA, EMA).
• Preferred familiarity in electronic quality systems such as TrackWise, Veeva, or similar.

• Support the Self-Inspection Program , including scheduling, conducting audits, and managing CAPAs.
• Prepare for and participate in Regulatory Authority and Internal Audits , including TGA and FDA inspections.
• Ensure audit findings are addressed and closed out in alignment with regulatory expectations.
• Maintain and update documentation in electronic quality systems (e.g., TrackWise, Veeva).
• Collaborate with cross-functional teams to ensure compliance with global regulatory standards.
• Support the Quality Management System and contribute to continuous improvement initiatives.