We are looking for a strong and experienced Senior Validation Lead to guide and execute the Computerized System Validation/Assurance of IT systems and projects within our Research and Development (R&D) division. This role is critical in ensuring that our IT systems comply with regulatory requirements and industry standards, thereby supporting our mission to deliver high-quality pharmaceutical products for patients.

The ideal candidate will have extensive experience in FDA 21 CFR Part 11, EU Annex 11, GVP regulations, and GAMP GxP computerized systems validation. Familiarity with the ISPE GAMP AI Guide, AI Guidance for GxP environments, and the EU AI Act will add additional value. The candidate should also possess a solid understanding of Agile development under GxP conditions, act and decide risk based and strengthen this mindset within the team.

In this role, you will guide IT Vendor Management and IT Service Delivery with your regulatory expertise, providing input, support and address IT Vendor audits. You will also guide and supervise corrective and preventive actions (CAPA) as part of the deviation management and continuous improvement process. Collaborating closely with project teams, you will ensure compliance throughout the project lifecycle. With this you are responsible for Audit and Inspection readiness, present and explain compliance documentation and processes during internal audits and external inspections.

Key Responsibilities:

• Lead and manage the validation activities for R&D IT systems, ensuring compliance with regulatory guidelines (e.g., FDA, EMA) and internal policies.
• Develop and implement validation strategies, plans, and documentation (e.g., URS, IQ, OQ, PQ) for new and existing systems.
• Collaborate with cross-functional teams, including IT, Quality Assurance, and R&D, to ensure seamless integration of validation processes into project timelines.
• Conduct risk assessments and gap analyses to identify validation needs and ensure compliance throughout the system lifecycle.
• Provide expert guidance and support during audits and inspections related to validation activities.
• Mentor and train team members on validation best practices and regulatory requirements.
• Stay current with industry trends, regulations, and technologies related to IT system validation.
• Prior hands on experience on validating Veeva Vault applications is mandatory.

Qualifications:

• Bachelor’s degree in Computer Science, Life Sciences, Engineering, or a related field; advanced degree preferred.
• Minimum of 8 years of experience in IT system validation within the pharmaceutical or biotechnology industry.
• Strong knowledge of international GxP regulations, validation methodologies, and risk management principles.
• Proven experience in leading validation projects and managing cross-functional teams.
• Excellent communication, problem-solving, and organizational skills.
• Ability to work independently and collaboratively in a fast-paced environment