IT Quality Senior Associate (Regulatory Compliance Platform - Safety Case Processing Squad)

Job purpose:

To ensure that IT systems and documentation meet regulatory and quality standards. This includes drafting and updating validation deliverables for system rollouts, conducting formal checks of validation and qualification documentation, maintaining data quality in systems, managing access requests, and providing support to local teams during system rollout activities. Additionally, the activities involve maintaining training curricula and acting as a key user for document management systems to ensure that documentation and processes align with compliance requirements and best practices. 

What you do:

• Gather local/site-specific compliance / organizational requirements for local roll-outs of global IT systems


• Draft validation deliverables for repetitive system rollouts in close collaboration with global and local QA, ensuring compliance with regulatory standards


• Update global validation documentation post-rollout to reflect any changes or enhancements


• Support local teams during global system rollout activities


• Conduct initial formal document checks to ensure compliance with quality standards before QA approval


• Review validation and qualification documentation for readability, accuracy, and consistency across projects and propose concrete improvements


• Support project teams to ensure data quality in systems in scope


• Initiate and handle approval workflows for validation and qualification documentation


• Contribute to continuous improvement initiatives to enhance the efficiency and effectiveness of IT system rollout process and validation documentation


• Prepare standardized KPI reporting’s


• Manage user access requests to systems in scope


• Prepare periodic user access rights review documentation for systems in scope


• Act as a key user for the documentation management systems in scope, providing support and guidance to users and contributing to system enhancements


• Change Management, including managing teams of different parties.

Who you are:

• Medical/pharmaceutical/natural science/IT background


• Professional experience of (1-2 years) in Quality related area will be beneficial


• Passionate about quality & compliance, technology, and global collaboration


• English language knowledge minimum at B2 level


• Intermediate Microsoft Office (e.g Excel, Word)


• Intermediate knowledge and experience in usage of digital collaboration tools (e.g Teams, SharePoint)


• Basic SAP knowledge 


• Basic document management system knowledge - preferably ValGenesis 


• Familiarity with ISO requirements and general quality standards


• Ability to lead global teleconference calls


• Detail-oriented person with a focus on accuracy, compliance, and completeness in documentation and work results


• Willingness to learn, extend skills and share knowledge


• Communication and collaboration skills, with the ability to work effectively with cross-functional project teams across diverse cultures and geographies