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Associate Director, GxP Electronic Systems Quality Assurance

Revolution Medicines · Redwood City, CA

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Role summary

Revolution Medicines seeks an Associate Director to lead global quality oversight of computerized GxP systems across manufacturing, clinical, and safety environments. The role involves strategic direction for system validation, AI governance, digital platform management, and regulatory compliance across the oncology company's operations.

What they're looking for

  • Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field
  • 10+ years experience in pharmaceutical, biotechnology, or regulated life sciences
  • Expertise in Computerized System Validation (CSV) and Computer Software Assurance (CSA)
  • Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and global GxP requirements
  • Experience overseeing enterprise GxP platforms, cloud/SaaS implementations, and data migrations
  • Demonstrated cross-functional leadership and vendor management capabilities

What you'll be doing

  • Provide global quality oversight for GxP computerized systems across GMP, GCP, GLP, GVP, and GDP environments
  • Lead Computerized System Validation and Computer Software Assurance strategies including risk-based approaches and lifecycle management
  • Develop and mentor team members on CSV/CSA execution, platform oversight, and digital compliance initiatives
  • Establish digital governance frameworks for system ownership, change management, access controls, and data integrity
  • Lead quality governance of AI and emerging technologies in GxP processes with risk-based validation frameworks

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RoleLantern checked active
RoleLantern checkedNeeds clarity
Date posted2 days ago
Last source check1 day ago
Salary listedNeeds clarity
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