Senior Quality Operations Manager
3 weeks ago
The Director, Data is responsible for the quality oversight of operations of the manufacturing site for the manufacture of Cell Product, including management of direct reports and defining daily priorities to execute the team's responsibilities.
The role is responsible for Quality oversight on the manufacturing floor and product disposition of clinical and commercial drug product.
The role will lead initiatives and participate in cross-functional project teams for the development of Cell & Genetic Therapeutic Programs as well with the roadmap to transforming to a commercial level operation.
Responsible for Quality oversight of Vertex Cell and Gene Therapy manufacturing internal operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
Key Responsibilities- Collaborate with internal business partners to prioritize and resolve complex quality issues, product quality impact assessments and identify compliant solutions
- Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.
- Review and approval of manufacturing documents such as technical and analytical protocols/reports
- Support GMP release of incoming raw material and components
- Responsible for timely identification of compliance risks and gaps for GMP processes, and implementing mitigating controls
- Lead audit and inspection readiness activities
- Assist with addressing product complaints
- Assists department with routine/quarterly Quality System data review metrics and reporting
- Lead and participate in Cell & Genetic Program and Quality projects and drive continuous improvement activities
- Provides information to assist in budgeting, scheduling, project planning within GMP Operational Quality
- Responsible for the culture of the Quality team; Manages team workload and priorities to ensure tasks are completed
- In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting
- Demonstrated experience working in a manufacturing site, managing operations/ QA Operations and oversight of GMP manufacturing operations
- Experience with network-based applications such as Oracle, TrackWise, Veeva
- Understanding of regulatory environment including quality systems and compliance
- Knowledge of aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing
- Ability to evaluate quality matters and make decisions utilizing risk-based approach
- Lean Transformation and/or Continuous Improvement experience
- Bachelor's degree in a scientific or allied health field (or equivalent degree) or ~ 8+ years of commercial GMP industry Manufacturing and Quality Assurance experience in, in a regulated biotechnology/regulated pharmaceutical environment
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