Head of Validation & Risk Management

Takeda•Lexington, MA

6d•$177,000 - $278,080•Onsite

About The Position

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.

Requirements

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 20–30%.

Nice To Haves

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.

Responsibilities

Global role accountable for validation strategy, standards and risk management across Takeda’s internal manufacturing network and external partners, spanning biologics, vaccines, plasma-derived therapies and synthetic molecule operations.
Lead four senior technical leads and governs the full validation lifecycle from process design/QbD through PPQ, CPV, revalidation, cleaning/sterilization validation and aseptic process simulation.
Design global standards and serves as Takeda’s senior validation authority; execution and product disposition remain with sites and Quality.
Define and continuously improve global validation strategy, master plans, policies, standards and SOPs across Takeda’s manufacturing network and CMOs.
Lead the global validation and risk management department, including priorities, resources, budget, talent development and coaching of senior technical experts.
Govern the process validation lifecycle, including Stage 1 process design/QbD, Stage 2 PPQ and Stage 3 CPV, ensuring strategies are grounded in process understanding, statistics and risk-based rationale.
Own global methodology for cleaning validation, sterilization validation and aseptic process simulation, including harmonized expectations for cross-contamination control, limits, worst-case rationale, cycle qualification and inspection readiness.
Direct validation risk management, establish QRM/FMEA/criticality methodology, identify network risks and lead time-bound interventions on high-impact issues.
Set standards for sufficient validation evidence and build reusable knowledge from platform, prior qualification, development, engineering and model-based data to avoid unnecessary repeat studies.
Partner with Manufacturing, PharmSci, CMC, Tech Transfer, Engineering/CQV, Quality, Regulatory Affairs and Data & Analytics to embed validation requirements into launches, transfers, startups, process changes and lifecycle management.
Represent Takeda as the validation SME during inspections, audits and health authority interactions; support validation-related filing content, commitments and responses.
Govern validation impact of change control, deviations, investigations and CAPAs, ensuring corrective actions restore and sustain the validated state.
Translate evolving global regulations and industry guidance into practical Takeda requirements, retiring legacy expectations that add cost without assurance.
Define and report validation KPIs to senior leadership and use insights to drive continuous improvement.
Recognized expert across process design / QbD, PPQ, CPV, revalidation, cleaning, sterilization and aseptic process simulation, with deep command of global GMP expectations, QRM, statistics and validation implications of advanced analytics/modeling across internal sites and external partners.
Set a multi-year vision for global validation and translates it into standards, roadmaps and measurable outcomes. Leads a global team of senior experts and drives harmonization, simplification and science-/risk-based validation largely through influence across sites, functions and cultures.
Operate with high autonomy, setting global validation requirements, evidence expectations, risk methodology, escalation criteria, priorities and budget. Decisions affect launch timing, PPQ success, inspection outcomes, supply continuity and avoided cost; product disposition and final GMP decisions remain with Quality and accountable business owners.
Partner globally with PharmSci, CMC, Tech Transfer, Quality, Engineering/CQV, Manufacturing, Regulatory, Analytical Lifecycle Management and Data & Digital. Externally represents Takeda with health authorities, inspectors, CMOs/CDMOs, suppliers and industry forums.
Modernize validation practice by advancing digital execution, reusable structured data, automated statistical review, platform/prior-knowledge reuse and advanced analytics where scientifically justified. Promote Communities of Practice and takes considered, well-reasoned risk to simplify or retire legacy practices.