Head of Validation & Risk Management

Head Of Validation & Risk Management

As the Head of Validation & Risk Management, you will lead Takeda's global process validation and risk management function, setting enterprise strategy and standards for qualification, validation and lifecycle maintenance across internal sites and external partners. You will own the global validation framework across process design / QbD, PPQ, CPV, revalidation, cleaning, sterilization and aseptic process simulation, ensuring a consistent science- and risk-based approach across sites and modalities. You will also serve as Takeda's senior validation technical authority for health authorities, inspectors, governance forums and the network's highest-risk validation challenges. You will build and lead a global team of validation SMEs, strengthening network capability through standards, tools, training and technical communities.

Location: Lexington, MA

What you bring to Takeda:

• Master's degree in chemical/biochemical engineering, biotechnology, chemistry, biology, pharmacy or related scientific/engineering discipline; PhD strongly preferred.
• 15+ years in pharmaceutical/biotechnology validation, MSAT, technical operations or quality in a GMP environment; 12+ years considered with PhD.
• 5+ years people leadership experience, including leading senior technical professionals and building high-performing teams.
• Demonstrated ownership of multi-site/global validation programs, including master planning, standards/SOPs and harmonization.
• Deep hands-on expertise in process validation lifecycle, PPQ, CPV, cleaning/sterilization validation, technology transfer and new product introduction.
• Experience representing validation in inspections and supporting validation content in regulatory filings.
• Strong command of QRM, validation statistics, deviations/CAPA, change control and defending technical positions under uncertainty.
• Excellent written/verbal communication with executives, site teams and regulators; able to travel internationally 2030%.

Desired

• Experience leading digital or paperless transformation of validation/quality processes; knowledge of advanced analytics, SPC, modeling or digital twins.
• Industry contribution or certification, such as ISPE/PDA/BioPhorum participation, publications/patents, Lean/Six Sigma/Agile/change management, or second-language proficiency.