Manager

• Provide Quality oversight across Takeda’s investigational medicinal product development lifecycle, from early clinical development through commercialization.
• Support diverse and often complex programs, including biologics, synthetic molecules, plasma-derived therapies, cross-modality conjugates, combination products, and new modalities.
• Oversee final release and disposition of Clinical Trial Material across multiple modalities and complex development programs.
• Review and approve batch documentation, master/executed records, labels, specifications, analytical methods, protocols, and stability plans.
• Ensure deviations, Out of Specification/Out of Trend, complaints, and other quality issues are fully investigated and addressed with effective CAPAs.
• Collaborate closely with Pharmaceutical Sciences, Global Clinical Supply Chain, and other partners to resolve quality events.
• Identify applicable regulations, assess compliance gaps, and propose solutions to maintain cGMP compliance.
• Serve as GMP QA authority for Pharm Science Teams and provide strategic quality guidance internally and to CMOs/partners.
• Support or lead continuous improvement initiatives that enhance R&D GMP Quality processes and operational efficiency.
• Contribute technical quality content to regulatory filings and collaborate with CMC submission teams.
• Participate as SME in external audits, support PAI readiness, and contribute to supplier qualification and Quality Technical Agreements.
• Build strong cross-functional relationships to enable agile pharmaceutical development and high-quality outcomes.

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