Director GMP Quality - Cell & Gene Therapy

Company: Vertex Pharmaceuticals
Location: Cambridge
Posted on: September 16, 2020

Job Description:

In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treatand even cureseveral of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertexs continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

The Director will be responsible for leading the day-to-day Quality operations at the VCGT cell/gene therapy manufacturing site. The role will also be a key contributor to the implementation and execution of VCGT quality systems including oversight of facility and equipment validation activities. The Director will also be responsible for the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GMP regulations. The Director is recognized for technical expertise both within and outside of the organization. The Director is also responsible for assisting with the strategic alignment of group or team goals with projects and activities and refining those projects and/or activities proactively. The Director reports to the Sr. Director of VCGT GMP Operational Quality.

Key Responsibilities:

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• Responsible for clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition
• Lead the Quality team supporting Analytical activities including method qualification/validation, method transfer, establishing specifications and justification for specifications and stability protocols (clinical and commercial), data and reports. Also including laboratory release testing review.
• Aseptic processing oversight including operator qualification and media run program
• Quality oversight of the environmental monitoring program
• Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions
• QA oversight of equipment/facility/utility validation and requalification program and validation master plan
• Participate in cross-functional projects as Quality expert and leader
• Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends
• Ensure quality staff performs and approves root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
• Ensure quality staff assesses and approves change controls
• Ensure regulatory submissions align with filing strategy. Review and approve submission amendments.
• Ensure raw material risk assessments are performed per USP/ATMP guidance
• Quality oversight of Technical Transfers between development/GMP and site/site
• Review of analytical method qualifications, transfer protocols and lab investigations
• Manufacturing floor quality function
• Non-conformance/CAPA Management support. Review and approve non-conformance reports. Mentor investigators and approvers on the investigation process and technical writing
• Provide Quality oversight of facility design, build and qualification
• Review protocols, data summaries, reports for stability studies
• Perform risk assessments of new programs for entry into the GMP facility
• Review and compile documentation related to GLP material manufacture
• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
• Preclinical Quality Assurance
• Data Management and Analytics
• Lead and manage complex projects/teams within corporate objectives and project timelines
• Provide strategies to address compliance gaps or determines enhancements to cross-functional quality systems
• Foster the demonstration of the Vertex Phenotype and Core Values in others
  
  Required:
  
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  • Bachelor's degree in a scientific or allied health field (or equivalent) and 20+ years of relevant work experience, or Masters degree and 12-15 + years of relevant work experience, or relevant comparable background background in Biologics or Cell and Gene Therapy Manufacturing Quality Assurance implementing and overseeing investigational drug manufacture and aseptic processing GMP operations in a manufacturing facility
  • Experience in providing quality oversight of facility design, build and qualification
  • Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required
  • Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems teams
  • Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
  • Strong knowledge of current industry trends and ability to use the latest technologies
  • Working knowledge of: Aseptic practices and clean room design/operations, auditing techniques.
  • Strong leadership skills with the ability to thrive in a high throughput environment
  • Ability to lead and manage projects/teams within corporate objectives and project timelines
  • Successful in mentoring people managers
    
    Preferred:
    
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    • Project Management / Continuous Improvement
    • Proficiency in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
    • Collaboration / Teamwork / Conflict Management
      
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Keywords: Vertex Pharmaceuticals, Cambridge , Director GMP Quality - Cell & Gene Therapy, Healthcare , Cambridge, Massachusetts