Associate Director, QA Bulk

CSL are hiring a senior quality professional join our Quality team on a full-time permanent basis. Reporting to the Site Quality Head and as part of the Quality Leadership Team, the Associate Director - QA Bulk and Recombinant Value Stream provides quality oversight of the activities within the manufacturing Bulk & Recombinant Value Stream at the CSL Broadmeadows site.

You will assure the appropriate quality of systems and processes within the value stream, adherence to any applicable CSL standards.

You will oversee the review and approval of related records, support and approval of quality risk assessments, non-conformances, investigations, CAPAs, and change controls, and monitoring and continuous improvement of quality performance metrics.

Your Responsibilities

Reporting to the Senior Director, Site Quality Head you will:

- Oversee all quality related activities for the Bulk & Recombinant value stream
- Lead and manage quality investigations, deviation management and other Quality and Production activities, including a priority of supporting peers and other CSL Departments via coaching, training, and developing others
- Manage all batch documentation review per unit operations and issue final batch disposition recommendation
- Partner with the team to support/review/approval of trends, product technical complaints, investigations, corrective and preventative actions, and change control
- Provide oversight and approval for any quality related activities related to site/department shutdowns
- Perform QA review and approval of operational, processing and records to ensure regulatory compliance with Australian, EMEA and USA regulatory requirements, as defined in relevant CSL procedures
- Oversee the management of change controls for the Bulk & Recombinant Value Stream to ensure that impacts are appropriate identified and actioned in a timely manner
- Deliver training as required for example Veeva Deviation Management, Documentation Management and additional systems as applicable
- Foster a culture of continuous improvement through self-development, training and mentoring while focusing on operational efficiency and the elimination of ‘non-value added’ activities

Your Experience
- A minimum of a Bachelor Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience
- Ten (10) years or more working in a similar role
- Significant experience in:
1. Technical aspects / manufacturing
2. Quality and compliance
3. Batch disposition
4. Health authority expectations and inspections
- Leadership and influencing skills
- 5 years or more experience working within a global matrix organization
- Involvement in cross-functional, multicultural, and international teams

Please include your resume and cover letter addressing the key selection criteria in one document by 11th October 2024.

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**: