Sr Mgr Quality Assurance Cell Therapy
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Sr Mgr Quality Assurance Cell TherapyApply Now
- 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
Time TypeFull time
Job ID R0025908