Manager, Quality Assurance Compliance

2 months ago

Melbourne, Australia CSL Full time

**The Opportunity**:
Join the CSL Behring Quality Assurance (QA) Compliance team on a full-time ongoing basis. CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by the Lifeblood Australia. Part of the CSL family, when you join the over 1200 employees at Broadmeadows, you join an integrated global network of research and manufacturing facilities delivering on our 100-year-old promise to save lives using the latest technology.

Reporting to the Associate Director, QA Site Compliance Lead, Quality Management, and working on site at Broadmeadows you will manage self-inspections (internal audits) and regulatory inspection readiness programmes. You will oversee regulatory response preparations and associated follow-on activities.

**The Role**:
As the Manager QA Compliance, you will:

- Lead quality initiatives and taskforces as they arise from different sources and issues;
- Initiate and manage impact assessments of new regulatory requirements;
- Manage all Corrective and Preventive Actions (CAPA) resulting from the Regulatory Alert impact assessments and provide reports as part of the Quality Management Review Process;
- Mentor and develop team members to provide support across the site to ensure compliance with regulatory requirement and global policies;
- Participate in continuous improvement activities including global harmonisation projects.

**Your skills and experience**:
To be considered for this role you have:

- A degree in science or engineering or pharmaceutical science;
- 5+ years’ experience in the pharmaceutical manufacturing industry in a cGxP environment;
- Experience with cGxP regulatory requirements including industry guidance documents such as those required by TGA or FDA;
- Experience leading a technical team in a regulated environment and providing technical support;
- Experience preparing written technical documents and presenting complex information;
- Experience in a role requiring conceptual and analytical thinking to reconcile ambiguities.

**How to Apply**:

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