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 organization

We offer you:

ITDS Business Consultants is involved in many various, innovative and professional IT projects for international companies in the financial industry in Europe. We offer an environment for professional, ambitious, and driven people. The offer includes:

• Stable and long-term cooperation with very good conditions 

• Enhance your skills and develop your expertise in many different industries

• Work on the most strategic projects available in the market

• Define your career roadmap and develop yourself in the best and fastest possible way by delivering strategic projects for different clients of ITDS over several years

• Participate in Social Events, training, and work in an international environment

• Access to attractive Medical Package

• Access to Multisport Program

• Access to Pluralsight

• Flexible hours & remote work