Senior Specialist, Digital Quality, Risk

Bayer

Pymble, Australia
**
Gxp oversight of cloud and data platforms
Computer software assurance (csa) transition
Automated evidence collection in agile/devops
** Bayer is seeking a Senior Specialist in Digital Quality and Risk to ensure regulatory compliance and data integrity within their digital ecosystem. The position involves overseeing cloud and data platforms, transitioning to AI-driven quality assurance, and managing audits while fostering a culture of continuous improvement. **

Job Summary

  • 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).
  • 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’.

Matching Summary

Match Score: 75

** Bayer is seeking a Senior Specialist in Digital Quality and Risk to ensure regulatory compliance and data integrity within their digital ecosystem. The position involves overseeing cloud and data platforms, transitioning to AI-driven quality assurance, and managing audits while fostering a culture of continuous improvement. **

Skills & Requirements

Must-have

  • GxP oversight of cloud and data platforms
  • Computer Software Assurance (CSA) transition
  • Automated evidence collection in Agile/DevOps
  • Risk assessments for data environments
  • Global audit support for digital controls
  • Infrastructure-as-Code (Terraform) change control

Nice-to-have

  • AI/ML model governance know-how
  • Reduce compliance friction
  • Dynamic Shared Ownership (DSO) environment

Key Requirements

  • 6-9 years of experience in IT Quality, CSV, or Digital Compliance
  • Bachelor’s degree in computer science, Engineering, Life Sciences, or related field
  • Working knowledge of AWS, Databricks, Snowflake governance
  • Deep expertise in 21 CFR Part 11, EU GMP Annex 11, GAMP 5
  • Experience in Agile/DevOps environments
  • Strong understanding of ALCOA+ principles

Work Rights

Not specified

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