Head of Validation & Risk Management

Role: Lead Takeda’s global process validation and risk management functions, establishing enterprise strategy, standards, and lifecycle practices across biologics, vaccines, plasma therapies, and synthetic molecules. Responsibilities: develop and oversee validation frameworks for process design, PPQ, CPV, revalidation, cleaning, sterilization, and aseptic processes; serve as senior validation technical authority during inspections and regulatory interactions; build and manage a global team of validation SMEs; define standards, methodologies, and risk management practices; collaborate with manufacturing, R&D, CMC, quality, regulatory, and engineering functions to embed validation into product lifecycle; modernize validation approaches through digital tools and advanced analytics; and report on KPIs to senior leadership. Requirements: Master’s degree in chemical, biochemical engineering, biology, chemistry, pharmacy, or related field; at least 15+ years in pharmaceutical/biotech validation, MSAT, or GMP operations; 12+ years with PhD; 5+ years leadership experience managing global teams; deep expertise in validation lifecycle, QbD, risk management, and GMP standards; strong communication skills for external and internal engagement; willingness to travel 20–30%. Preferred: experience with digital transformation, advanced analytics, industry contributions, certifications, or second-language proficiency. High-Value: validation across biologics, vaccines, or plasma-based therapies, global GMP compliance, regulatory inspection support, and risk-based validation methodologies.