PV Process Lead — Enterprise E2E Excellence & Strategy

Takeda Pharmaceutical Company Limited; Cambridge (MA); On-site; USD 212,000 - 333,000; Full time

Job summary

Takeda Pharmaceutical Company Limited in Cambridge, MA is seeking a Senior Director, PV Process Lead to own end-to-end PV processes and set strategy for cross-functional execution. You will partner with Regulatory, QA, Global Development Operations and Medical Affairs to ensure inspection readiness and regulatory compliance.

You will drive governance, define roles, develop procedures, and leverage AI-enabled capabilities to improve efficiency, oversee audits, and enable timely risk mitigation

Qualifications

• Bachelor's degree or international equivalent; Life Sciences preferred.
• 10+ years' experience in the pharmaceutical industry focusing on drug safety and PV.
• Senior leadership experience managing matrix teams and cross-functional partnerships.
• Strong strategic thinking, negotiation, and influencing skills.
• Excellent planning, execution, and communication with results delivery.
• Ability to collaborate across functions, regions, and cultures.
• Healthcare business acumen and PV industry understanding.

Responsibilities

• Owns end-to-end PV processes and ensures regulatory-aligned execution.
• Drives governance, roles clarity, and cross-functional collaboration.
• Develops and maintains procedural documents and templates.
• Identifies risks, escalates issues, and ensures audit readiness.
• Champions tech and AI-enabled capabilities to improve processes.

Skills

PV knowledge

Executive leadership

Strategic influence

Cross-functional collaboration

Project management

Communication skills

Analytical thinking

Education

Bachelor's degree (Life Sciences preferred)

Job description

Takeda Pharmaceutical Company Limited in Cambridge, MA is seeking a Senior Director, PV Process Lead to own end-to-end PV processes and set strategy for cross-functional execution. You will partner with Regulatory, QA, Global Development Operations and Medical Affairs to ensure inspection readiness and regulatory compliance.

You will drive governance, define roles, develop procedures, and leverage AI-enabled capabilities to improve efficiency, oversee audits, and enable timely risk mitigation