Region CQV Lead, Europe​/Asia

About the Role

Lead and coordinate CQV and Compliance Engineering activities across a defined region, ensuring compliant, efficient, and standardized execution across CAPEX projects and lifecycle phases. Support inspection readiness and site preparedness, oversee CQV activities (Commissioning, Qualification & Validation) across CAPEX projects, and promote the use of paperless validation systems. Drive continuous improvement, innovation, and digitalization in CQV and Compliance Engineering, including AI‑ and data‑driven approaches.

• Actively lead and support CQV and Engineering Compliance strategy.
• Act as Single Point of Contact (SPoC) for sites on CQV and Compliance Engineering topics.
• Coordinate and oversee CQV and Compliance Engineering activities across assigned sites.
• Drive and implement global initiatives and ensure implementation at site level.
• Contribute to and actively participate in the Community of Excellence (CoE).
• Lead Communities of Practice (CoPs) across sites.
• Partner with Global Quality, Engineering, and site functions to ensure alignment and inspection readiness.

• Ensure consistent and compliant execution of CQV activities across CAPEX projects.
• Support planning and coordination of CQV activities to meet timelines and regulatory expectations.
• Ensure alignment with global CQV standards and regulatory requirements.
• Collaborate with CSV / OT while maintaining clear accountability boundaries (not ownership of IQ/OQ/PQ).

• Lead and ensure implementation of validation maintenance across sites.
• Ensure lifecycle validation activities (e.g., periodic review and requalification) are executed and maintained in a compliant state.

• Support implementation of Compliance Engineering frameworks, standards, and initiatives at site level, including support for inspection readiness and site preparedness.
• Act as site interface for Compliance Engineering topics, ensuring coordination and alignment between sites and global functions.
• Provide feedback, input, and lessons learned from sites to global Compliance Engineering.

• Act as regional key contact for paperless validation systems.
• Support and enable effective use of digital validation tools across sites.
• Support system adoption, onboarding, and usage.
• Drive adoption and consistent use of digital and paperless validation solutions.
• Act as back‑up for the Global Paperless Validation Lead to ensure continuity of operations and support.

• Drive continuous improvement and standardization of CQV and Compliance Engineering activities across sites.
• Lead implementation of innovation and digitalization initiatives (e.g., AI‑driven approaches) at site level.
• Promote best practice sharing and harmonization across sites and within Global Engineering.
• Drive adoption of digital and paperless validation solutions.
• Lead global and site‑level initiatives to enhance efficiency, quality, and standardization across CSV & OT compliance.

• Required Degree in engineering, pharmaceutical science, or equivalent.
• 5+ years of experience managing CQV activities in major CAPEX projects.
• Experience in a GMP‑regulated project management or operations role in the pharmaceutical industry.
• Strong knowledge of GxP, CQV processes, and validation lifecycle.
• Strong communication skills, analytical mindset, and ability to work under pressure.
• Strong collaboration and stakeholder management skills.
• Preferred:
  Experience in manufacturing or operations.
• Preferred:
  Experience with digital validation tools.

Experience with manufacturing or operational environments and familiarity with digital validation tools.

Zurich, Switzerland

Base Salary Range: CHF  – CHF

Worker Type:
Employee Sub‑Type:
Regular Time Type Full time

Takeda is an equal opportunity employer.