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Manager, Cell Therapy Quality Assurance (QA)

Boston, Massachusetts

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Manager, Cell Therapy Quality Assurance (QA)

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Job ID R0029818 Date posted 02/25/2021 Location Boston, Massachusetts

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Job Description

The Manager, Cell Therapy QA is responsible for ensuring compliance to regulations and Takeda procedures for internal cGMP manufacturing and testing of clinical-phase cell therapy programs.  This position:

  • Leads and manages strategic GMP QA operational activities associated with Takeda’s internal GMP cell therapies manufacturing facility

  • Directly manages the development, implementation, and maintenance of cGMP quality operational processes for clinical-phase cell therapies

  • Independently manage projects and make sound decisions related to product quality issues

Accountabilities

  • Employ GMP QA expertise and principles during the development, manufacturing, testing, and disposition of clinical-phase cell therapies to ensure product quality and achieve business goals

  • Review batch record documentation, ensure compliance and accuracy, and conduct final release disposition of cell therapy investigational material for use in Takeda-sponsored clinical studies

  • Serve as QA subject matter expert for internal GMP operations as well as in the resolution of deviations and out-of-specification investigations

  • Reviewing and approving raw material specifications

  • Approving and releasing raw materials for internal manufacturing

  • Manage internal quality improvement initiatives; evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs

  • Ensure clinical trial sponsor responsibilities are fulfilled to ensure compliant disposition of cell therapy products for use in Takeda clinical studies

  • 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 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

  • Understanding and working knowledge of Quality Management Systems, ability to interpret requirements, anticipate issues, make informed decisions and respond rapidly to emerging quality situations

  • Demonstrated knowledge of current international regulations and guidance associated with cell therapy, gene therapy, etc

  • 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

Minimum Requirements

  • Bachelor’s Degree in Biology, Chemistry, Engineering, or related field

  • 7+ years of experience in the biotech industry

  • 5+ years of Quality/cGMP Compliance experience

  • 1 year in cell therapy quality

  • Specific experience in the following:

    • Cell and/or gene therapy product manufacturing or testing

    • Investigational medicinal products

  • Experience working in an internal bio-pharmaceutical development/production environment

Preferred Requirements

  • Master’s Degree in Biology, Chemistry, Engineering, or related field

“This job posting exclude Colorado applicants.”

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0029818
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