Manager, Cell Therapy Quality Assurance (QA)

Manager, Cell Therapy Quality Assurance (QA)

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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