Senior Director, Quality Control Operations
vor 1 Tag
CSL is seeking a highly experienced Senior Director, Quality Control Operations to lead our global quality control organization. This role will be responsible for ensuring the quality of our products and processes, and for developing and implementing quality control strategies to meet regulatory requirements.
Key Responsibilities- Lead global quality control processes and procedures to ensure compliance with regulatory requirements and corporate standards.
- Provide quality control oversight and approval of cGMP QC documents, including change controls, deviations, CAPAs, procedures, and validation protocols.
- Develop and implement robust measurement and reporting tools to enable accurate and timely reporting.
- Collaborate with partners to enable compliant, timely, and successful quality control testing.
- Partner with all functions to proactively identify and mitigate quality control issues and concerns.
- Oversee the operations of all quality control activities globally for testing activities.
- Lead and/or review key global laboratory deviation evaluation and resolution activities as required.
- Continuously improve quality control processes to reduce cost and improve quality.
- Collaborate with business partners to identify improvement opportunities across the organization.
- Optimize in-process and final quality control/inspection efficiency.
- Work with operations leaders and team members to define implementation strategies for continuous improvement.
- Develop appropriate tools and methods to sustain improvements across the organization.
- Provide quality control team leadership and guidance to a global quality control site heads to effectively execute on quality control strategies and programs.
- Set objectives and provide clear direction for execution.
- Responsible for organizational design and staffing decisions, including recruiting, retaining, training, and developing the quality control team.
- Lead proactive risk assessments to identify and mitigate quality control issues.
- Represent CSL during audits and inspections, as needed.
- Ensure inspection readiness across the QC network.
- Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
- Advanced degree (Master's) in a life sciences field; PhD preferred.
- Minimum of 12 years' experience in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality management.
- Minimum 10 years of managerial experience.
- Experience working in a highly regulated GMP environment as it applies to laboratory and stability functions.
- Experience in preparing and complying with required regulatory guidelines, including inspection readiness and follow-up.
- Experience with testing methods and processes, including raw materials testing, stability testing, and sample management.
- LEAN experience, preferred.
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.
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