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Quality Assurance Manager
4 weeks ago
Main Responsibilities and Accountabilities:
Candidates for this role will be responsible for ensuring the timely completion of chemistry assays supporting product release and in-process manufacturing, as well as other ad-hoc testing. They will drive the use of risk-based and data-driven continuous improvement to deliver improvements in safety, quality, reliability, and productivity.
Key Responsibilities:
- Ensure the on-time completion of chemistry assays supporting product release and in-process manufacturing.
- Drive the use of risk-based and data-driven continuous improvement to deliver improvements in safety, quality, reliability, and productivity.
- Champion efforts to identify and implement best practices, driving harmonization within global CSL operations.
- Manage the selection, performance, and ongoing development of people, as well as develop succession, retention, and development plans for key talent.
- Accountable for resource allocation and operational budgets.
- Foster a culture of continuous improvement with a focus on operational efficiency and the elimination of non-value-added activities.
- Drive/support resolution of important/critical QC issues impacting quality, safety, production, compliance, and/or cost.
- Ensure Chemistry laboratory compliance with cGMPs.
- Comply with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Promote a safety-first culture.
Requirements:
- Bachelor's Degree in Sciences or equivalent discipline.
- 10 years of Laboratory Experience in Chemistry or related scientific discipline.
- 5-7 or more years managerial experience (preferably within Quality Control) in a pharmaceutical, biotechnology, or biological industry.
- Demonstrated understanding of cGMP, regulatory requirements, and relevant environmental, health, and safety requirements as applicable to secondary manufacturing.
- A team player with demonstrated initiative and proven problem-solving, communication, and negotiation skills.
- Excellent communication and interpersonal skills with proven ability to establish, enhance, and manage customer relationships.
Competencies:
- Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
- Indirect Influence
- Direct Influence
- Interpersonal Savvy
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.
We want CSL to reflect the world around us:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion.