Mark this as favouriteSenior Validation Manager

We are seeking a Senior Validation Manager (40hrs/onsite, maternity cover) to join a major biopharmaceutical company engaged in the development of innovative cancer immunotherapy.

Offer

•        Temporary agency contract for via Grafton (based on CLA ABU), with potential 6 months extension

•        Start date: ASAP

•        End date: 31 December 2025

•        Salary: € 8.013,- gross per month based on 40 hours excl. 8% holiday allowance, 28 vacation days, paid public holidays, pension scheme via StiPP will switch with a total contribution of 23.4% (15.9% employer, 7.5% employee)

•        Opportunity to work an international fast-paced biopharmaceutical company curing cancer

The role

The Senior Validation Manager provides strategic and operational leadership for the site validation function, ensuring GMP compliance, effective resource management, and successful delivery of multiple concurrent capital and operational projects and routine operations. This role combines people leadership, technical oversight, and strong collaboration with site and global stakeholders.

Depending on business needs and project phase, the role may also include direct involvement in the review and approval of qualification deliverables, ownership and oversight of CAPA actions, and hands‑on support to ensure timely closure, compliance, and quality.

Validation Leadership & Operations

• Lead the day‑to‑day activities of the Validation department, ensuring effective execution of CQV programs across equipment, utilities, facilities, and systems.
• Provide oversight of multiple projects simultaneously, monitoring progress, risks, and delivery against agreed timelines and objectives.
• Manage and maintain the site Validation Master Plan, including requalification and periodic review programs.

People & Resource Management

• Serve as a senior people manager with a strong focus on operational resource planning and deployment.
• Lead, develop, and coach a Validation team, ensuring alignment to business priorities and customer needs.
• Address and resolve people management issues and provide expert guidance to managers on technical, operational, and people‑related topics.

Governance, Policy & Continuous Improvement

• Develop, review, implement, and recommend updates to site and company validation policies, procedures, and standards.
• Exercise sound judgment within defined policies when selecting validation approaches, methods, and evaluation criteria.
• Analyze industry trends and anticipate changes in the regulatory or competitive landscape, adjusting strategies as needed.
• Ensure projects are executed safely, efficiently, and in compliance with applicable codes and Kite/Gilead standards.

Strategic & Cross‑Functional Collaboration

• Serve as the Validation representative in strategic planning and operational discussions with senior site leadership.
• Work closely with Manufacturing, Quality, Engineering to enable compliant and efficient CAR‑T operations.

Required Qualifications

Education

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline.

Experience

·      Minimum of 8–10 years of experience in commissioning, qualification, and validation within a GMP‑regulated environment; 10+ years preferred.

·      Demonstrated experience leading validation teams and managing complex CQV programs.

Technical & Regulatory Expertise

·      In‑depth knowledge of GMP and GxP regulations.

·      Strong understanding of regulatory expectations from authorities such as FDA and EMA.

·      Experience with risk‑based validation strategies and quality risk management.

Interested?

Please do reach out to Marcella Henryati, Recruitment Consultant

Phone: 06-58811958 / E-mail: marcella.henryati@grafton.com

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