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Be a key quality leader ensuring high-quality, compliant analytical testing across Takeda's global network of R&D laboratories. You will provide end-to-end oversight of analytical method development and validation, release and stability testing, and the analytical lifecycle supporting regulatory submissions (IND/CTA/NDA/BLA). With a strong focus on ALCOA+ data integrity and robust quality systems, you'll review and approve critical GMP/GLP documentation, lead or support investigations, audits, and inspections, and drive timely, effective CAPA—partnering closely with Pharmaceutical Sciences, Regulatory, Manufacturing, and QA to protect patients and products across multiple modalities.
Job Responsibility
Provide quality oversight for GxP and non-GxP labs across the R&D pipeline
Review and approve critical GMP/GLP documentation (methods, validations, deviations, CAPAs)
Ensure robust ALCOA+ data integrity controls in lab systems, processes, and records
Lead or support lab-related investigations, audits, and inspections with clear, timely CAPA
Collaborate with Pharmaceutical Sciences, Regulatory, Manufacturing, and QA to align on quality expectations
Requirements
Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field