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Cell Therapy Qa Manager

4+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The Cell Therapy QA Manager position at Takeda in Cambridge, MA focuses on ensuring the quality of clinical-phase cell therapies within Takeda's internal GMP (Good Manufacturing Practice) manufacturing facility. This role involves overseeing quality assurance operations, ensuring compliance with regulations, and managing GMP activities throughout the cell therapy development process.

Key Responsibilities:

  • Serve as the GMP QA subject matter expert for clinical-phase cell therapies, ensuring product quality and regulatory compliance.
  • Manage and resolve deviations, investigations, and Corrective and Preventive Actions (CAPAs).
  • Review and issue GMP documentation, such as batch records and SOPs.
  • Make final disposition decisions regarding investigational materials for Takeda-sponsored clinical studies.
  • Collaborate with various teams (manufacturing, quality, etc.) to address issues and troubleshoot quality concerns.
  • Represent QA in site operations from material thaw to drug product filling and labeling.
  • Manage quality improvement programs, propose process improvements, and update relevant SOPs.

Required Qualifications:

  • Bachelor's degree in Biology, Microbiology, Chemistry, or related field (Master's degree preferred).
  • 4+ years of experience in cGMP Quality Assurance, particularly in cell or gene therapy product testing, manufacturing, or development.
  • Knowledge of global regulatory requirements for cell therapy products.

Important Considerations:

  • The role may require wearing personal protective equipment (PPE) and working in clean room environments.
  • Must be prepared to work in cold, wet environments and may require multiple shifts or weekend work.
  • Exposure to chemicals like alcohol, acids, and buffers may require additional safety measures (e.g., respiratory protection).

Takeda’s Commitment:

  • Takeda is focused on transforming patient care through the development of innovative therapies and patient support programs. The company fosters a diverse and inclusive workplace and is committed to providing equal employment opportunities to all applicants, regardless of race, gender, disability, or other protected characteristics.

Compensation and Benefits:

  • The salary for this position will depend on the applicant’s qualifications and experience, with additional benefits such as medical, dental, vision insurance, a 401(k) plan, paid time off, sick leave, and more.

This position offers an opportunity to contribute to cutting-edge cell therapy products while ensuring the highest quality standards in a dynamic and supportive environment.