Manager, Cell Therapy Quality Assurance (QA)
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Manager, Cell Therapy Quality Assurance (QA)Apply Now
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
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
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
Master’s Degree in Biology, Chemistry, Engineering, or related field
“This job posting exclude Colorado applicants.”
Time TypeFull time
Job ID R0029818