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Sr Mgr Quality Assurance Cell Therapy

Boston, Massachusetts


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Sr Mgr Quality Assurance Cell Therapy

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Job ID R0025908 Date posted 02/25/2021 Location Boston, Massachusetts

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Job Description


  • The Sr. Manager, Advanced Therapies QA is responsible for developing and executing quality strategies for external supply chains of clinical-phase cell therapy programs.
  • This position directly manages the development, implementation, and maintenance of cGMP and associated regulated quality processes for clinical-phase cell therapies.
  • This position is responsible for Quality leadership for external partnership programs.
  • The Sr. Manager, Advanced Therapies QA ensures execution of continuous improvement through idea development, plan creation, implementation, and championing project management methodology for projects of high complexity and risk.


  • Provide Quality leadership for responsible programs/ projects in terms of phase-appropriate science-based perspectives in the cross-functional team.
  • Develop and implement strategic approach for qualification/improvement of the critical material supplier’s capability including academia (e.g. virus vector, protein, antibody, plasmid, gRNA) to ensure final product quality and build in the material control strategy.
  • Serve as a qualified lead auditor for the supply chains in the implementation of the strategy, qualify the suppliers and develop Quality Agreement per Takeda procedures.
  • Develop and manage the product Quality infrastructure (e.g. SOPs, training) necessary to oversight Takeda’s external supply chains of clinical-phase cell therapies.
  • Interact with and influence outsourced-based vendor personnel in execution of strategy and identification of continuous improvement opportunities which ensure Takeda quality expectations, minimize compliance risk, and uphold cGMP compliance.
  • Ensure clinical trial sponsor responsibilities are fulfilled to ensure compliant disposition of cell therapy products for use in Takeda clinical studies.
  • Responsible for batch disposition for the critical materials supplied from external vendors for clinical-phase cell therapies.
  • Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance.
  • Develop solutions to complex Quality issues which potentially impact cell therapy manufacturing and testing to ensure patient safety, as well as compliance with cGMP regulations and Takeda quality expectations.
  • Provide leadership to ensure timely, well-documented, and compliant resolution of quality investigations and implementation of corrective actions that maintain a continual state of regulatory compliance for Takeda’s pharmaceutical development activities and GMP operations in cell therapies.
  • Additional duties as assigned.

Education, Behavioral Competencies & Skills

  • Bachelor’s Degree in Chemistry, Biology, Engineering or related field. Masters preferred.
  • Minimum of 10 years of increasing responsibility and experience in the global pharmaceutical industry. At least 3 years of managerial experience.
  • Minimum of 7 years of Quality/cGMP Compliance experience.
  • Specific experience in one or more of the following: cell and/or gene therapy product manufacturing or testing, pharmaceutical development, investigational medicinal products, advanced therapy medicinal products.
  • Experience working in an internal biopharmaceutical development/production environment.
  • Understanding and working knowledge of Quality Management Systems, ability to interpret requirements, anticipate issues, make informed decisions and respond rapidly to emerging quality situations.
  • Experience serving as qualified lead auditor for cGMP compliance including aseptic manufacturing for minimum 3 years.
  • Demonstrated knowledge of current international regulations and guidance associated with cell therapy, gene therapy, etc.
  • Experience in regulatory agency inspection conduct and management, action planning and responses.
  • Demonstrates ability to independently distinguish between criticalities of quality issues and identify issues or topics for management escalation independently. Able to clearly articulate issues in a timely manner.
  • Demonstrates and actively seeks to establish professional relationships and rapport with internal and external peers and higher-level management. Experience working on teams in a complex, matrixed and global environment. Proactive leadership of quality topic discussions.

This job posting excludes CO applicants


Boston, MA

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0025908
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