Director of Quality Control
6 days ago
Adaptimmune is a leading cell therapy company with a strong commitment to quality and excellence. We are seeking a highly skilled and experienced Director of Quality Control to join our team.
Job SummaryThe Director of Quality Control will be responsible for leading the Quality Control analytical testing organization at our Philadelphia Navy Yard facility. This individual will play a critical role in ensuring the compliance of QC operations with Adaptimmune policies, procedures, and methods.
Key Responsibilities- Leadership and Management: Ensure employees are properly trained and qualified to perform their assigned tasks, provide performance evaluations, and support career development of direct reports.
- Operational Management: Manage and schedule personnel within the department to meet manufacturing and laboratory schedules and needs.
- Regulatory Compliance: Represent QC cross-functionally with internal and external partners, including regulatory agencies.
- Quality Control Operations: Direct Quality Control operations for delivery of release and stability testing for Raw Materials, In Process, Lentiviral Vector, and T-cell Drug Product tested at the Philadelphia Facility.
- Performance Metrics: Develop, monitor, and report metrics for QC team performance, including improvement plans to meet missed performance targets.
- Investigations and Corrective Actions: Ensure robust laboratory investigations are performed to identify root cause for Out of Specification or unexpected results, including identification of corrective and preventive actions.
- Method Lifecycle Management: Support analytical lifecycle management of test methods and instruments used at Philadelphia Facility, including method validation, transfer, and method performance.
- Financial Management: Develop and manage ~$5M+ operating budget for department.
- Regulatory Strategy: Support strategy development for content provided to regulatory agencies, provide review and approval for QC related content.
- Education: Bachelor's degree required, preferably in Chemistry, Microbiology, or related science. Advanced degree preferred.
- Experience: 12 years of relevant work experience required. 5 years of leadership experience with direct reports required.
- Regulatory Knowledge: Strong knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
- Leadership Skills: Strong planning and resource management skills in a dynamic project environment located across multiple geographies.
- Communication Skills: Strong communication and collaboration skills to build strong, empowered working teams.
- Quality Systems: Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.
Adaptimmune is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to diversity and inclusion in the workplace.
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