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Associate Director, Quality Assurance Bulk
1 month ago
CSL Behring is seeking a highly skilled and experienced Associate Director, Quality Assurance Bulk to join our team. As a key member of our Quality Leadership Team, you will be responsible for providing quality oversight of the activities within the manufacturing Bulk & Recombinant Value Stream at the CSL Broadmeadows site.
Key Responsibilities:- Assure the appropriate quality of systems and processes within the value stream, adherence to any applicable CSL standards.
- Oversee the review and approval of related records, support and approval of quality risk assessments, non-conformances, investigations, CAPAs, and change controls.
- Monitor and continuous improvement of quality performance metrics.
- Lead and manage quality investigations, deviation management and other Quality and Production activities.
- Partner with the team to support/review/approval of trends, product technical complaints, investigations, corrective and preventative actions, and change control.
- Perform QA review and approval of operational, processing and records to ensure regulatory compliance with Australian, EMEA and USA regulatory requirements.
- 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.
- 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: Technical aspects / manufacturing, Quality and compliance, Batch disposition, 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.
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.
We want CSL to reflect the world around us. As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.
