Global Validation & Risk Strategy Leader

Takeda Pharmaceutical Co.; Dublin; On-site; EUR 117,000 - 161,000; Full time

Job summary

Takeda Pharmaceutical Co. Ireland seeks a Head of Validation & Risk Management to lead the global process validation and risk management function, setting enterprise standards for qualification, validation and lifecycle maintenance across sites and partners.

You will own the validation framework for design/QbD, PPQ, CPV, revalidation, cleaning and aseptic processing, acting as senior validation authority with inspectors and regulators, and building a world‑class team of SMEs.

Qualifications

• 15+ years in pharmaceutical/biotech validation
• 12+ years with PhD
• 5+ years people leadership
• Multi-site/global validation programs
• Experience in inspections/regulatory filings
• Strong knowledge of QRM, statistics
• Willing to travel internationally 20–30%

Responsibilities

• Own global validation strategy and standards across sites and partners.
• Lead four senior technical leads and oversee full validation lifecycle.
• Develop and harmonize global SOPs and master plans.
• Represent validation during inspections and regulatory filings.
• Drive continuous improvement and validation KPIs.

Skills

Leadership

Validation strategy

QbD

CPV

Risk management

Regulatory affairs

Statistical methods

Communication

Travel international

Education

Master’s degree

PhD preferred

Job description

Takeda Pharmaceutical Co. Ireland seeks a Head of Validation & Risk Management to lead the global process validation and risk management function, setting enterprise standards for qualification, validation and lifecycle maintenance across sites and partners.

You will own the validation framework for design/QbD, PPQ, CPV, revalidation, cleaning and aseptic processing, acting as senior validation authority with inspectors and regulators, and building a world‑class team of SMEs.