Validation Lead

Become The Next Validation Lead in a Global Pharma Project!

Warsaw-based opportunity with the possibility to work fully remote!

As a Validation Lead, you will be working for our client, a global pharmaceutical and life sciences company currently undertaking a critical, regulated IT transformation project. This role requires both strategic oversight and hands-on involvement, including steering external providers, running workshops, and monitoring the overall implementation of compliance measures. Your contributions will help secure regulatory readiness and long-term system reliability.

Your main responsibilities: Define validation and qualification strategy in collaboration with the Quality Lead

• Manage validation-related project activities and timelines
• Oversee the creation and approval of validation deliverables
• Steer and coordinate external providers involved in validation tasks
• Conduct workshops and knowledge transfers for the project team
• Support the development and execution of the testing strategy
• Ensure compliance with internal quality measures and regulatory expectations
• Monitor the fulfilment of quality requirements throughout the project
• Review and approve key validation and qualification documentation
• Manage validation workflows within ValGenesis, QDoc, and SSM

You’re ideal for this role if you have:

• 3+ years of experience in a similar role
• Advanced knowledge of GxP requirements and guidelines (GSOP 2002–2006, IT-MS-000036)
• In-depth understanding of good GxP documentation practices (GSOP 257)
• Proven experience managing validation activities within regulated GxP environments
• Familiarity with IT infrastructure/service qualification (GSOP 2028)
• Strong project management and stakeholder coordination skills
• Hands-on experience with validation tools such as ValGenesis, QDoc, or SSM
• Excellent skills in creating, reviewing, and maintaining validation documentation
• Ability to lead cross-functional workshops and facilitate knowledge transfer
• Proficient in test management within regulated frameworks
• Strong communication skills and the ability to work in a global matrix organisation

#GETREADY  to meet with us!

We would like to meet you. If you are interested please apply and attach your CV in English or Polish, including a statement that you agree to our processing and storing of your personal data. You can always also apply by sending us an email at recruitment@itds.pl.

Internal number #7241