Validation Lead

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

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 10 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.


• Clinical experience will be preferred.


• 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

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!