Associate Director, R&D Quality Laboratory Oversight

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Takeda

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• 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; MS/PhD preferred. • 7+ years’ experience in GxP laboratory quality oversight (GMP/GLP, analytical testing, inspections). • Strong knowledge of analytical methods and lab operations for small molecules and biologics (other modalities a plus). • Proven skills in data integrity, deviation/CAPA management, and quality risk management. • Clear communicator and collaborator, effective in a global matrix environment with competing priorities.

🏖️ Benefits

• Allowances: Commutation, Housing, Overtime Work etc. • Salary Increase: Annually • Bonus Payment: Twice a year • Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45 • Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year) • Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave. • Flexible Work Styles: Flextime, Telework • Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.