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.

Senior Specialist, Digital Quality, Risk 

POSITION PURPOSE:

The Senior Specialist, Digital Quality & GxP Compliance is a pivotal role responsible for ensuring the integrity, security, and regulatory compliance of our modern digital ecosystem. As we transition toward an AI-driven organization, this role will lead the shift from traditional "Validation" to Computer Software Assurance (CSA).

While the core of this role is grounded in robust GxP oversight of cloud and data platforms, you will be expected to help shape the future of compliance by integrating automation and gaining proficiency in AI-driven quality techniques.

YOUR TASKS AND RESPONSIBILITIES:

• Platform Quality Leadership: Act as the primary Quality/Compliance point of contact for high-velocity platforms including AWS, Databricks, and Snowflake, ensuring they meet global regulations (FDA, EMA) and internal QMS standards.
• Modern Lifecycle Management: Oversee the compliance of IT applications within an Agile/DevOps framework, moving away from document-heavy waterfall methods toward automated evidence collection.
• Automation for Assurance: Collaborate with engineering teams to guide automated testing strategy, ensuring that automated scripts and CI/CD logs provide sufficient evidence for regulatory audit trails.
• Risk-Based Oversight: Lead risk assessments for complex data environments, identifying potential GxP or Data Integrity gaps before they impact the production environment.
• AI & Future Readiness: Partner with the AI/ML teams to gain a foundational "know-how" of model governance. You will be tasked with evolving our current GxP frameworks to eventually include AI model drift monitoring and algorithmic transparency.
• Global Audit Support: Manage internal and third-party audits, providing expert guidance on cloud-native controls, digital signatures, and electronic records.
• Qualification Strategy: Define and approve qualification plans and summary reports for infrastructure and platform updates.
• CI/CD Integration: Ensure that "Infrastructure-as-Code" (Terraform) changes follow the required change control and validation protocols.
• Audit Trail Review: Periodically review system audit trails and automated logs to ensure continued compliance and data integrity.
• Continuous Improvement: Actively look for ways to reduce "compliance friction" by suggesting automated workflows for IQ/OQ/PQ tasks.

WHO YOU ARE:

• Platform Know-How: Working knowledge of AWS (IAM, S3, EC2), Databricks (Unity Catalog), and Snowflake governance.
• Compliance Fundamentals: Deep expertise in 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
• Agile & DevOps Proficiency: Experience working in an Agile environment using modern tools like ADO, Valgenesis, ROBOT framework.
• Testing & Automation: Ability to guide technical teams on "what" to test for assurance purposes, with a focus on shifting from manual to automated regression testing.
• Data Integrity: Strong understanding of ALCOA+ principles as they apply to cloud-native data lakes and warehouse environments.
• Communication: Ability to translate complex regulatory requirements into actionable technical tasks for developers and engineers.
• Experience: 6–9 years of experience in IT Quality, CSV, or Digital Compliance within a regulated industry (Life Sciences/Pharma preferred).
• Education: Bachelor’s degree in computer science, Engineering, Life Sciences, or a related field.
• Future Focus: A strong interest in AI/ML and a willingness to participate in specialized training to lead AI compliance initiatives in the near future.
• Certifications (A plus): CISA, ASQ-CSQE, or foundational Cloud certifications (AWS Practitioner).

Ever feel burnt out by bureaucracy? Us too. That's why we're changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here

https://www.bayer.com/enfstrategyfstrategy

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