Career Opportunities: IT Quality Senior Associate (Regulatory Compliance Platform - Benefits Risk Management) (859599)

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

IT Quality Senior Associate (Regulatory Compliance Platform - Benefits Risk Management) 

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. Above mentioned, to ensure the quality and compliance of suppliers in adherence with QAAs/ contracts/ SOPs as well as maintain / support audit readiness of GxP applications.

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
• Ensure CSV system compliance / audit readiness and support Internal Audits as Validation SME

Who you are:

• Medical/pharmaceutical/natural science/IT background
• Mandatory professional experience of (1-2 years) in Quality related area
• 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 document management system knowledge ValGenesis will be an advantage
• 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

Location:

Poland : Pomorskie : Gdańsk  

Division:

Enabling Functions 

Reference Code:

859599