Associate Director, GxP Electronic Systems Quality Assurance

Revolution Medicines is a global commercial-state oncology company dedicated to discovering developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform the company is advancing a broad integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active cancer-driving state of on rigorous scientific inquiry and a willingness to challenge long-held assumptions Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science challenge assumptions act with urgency and hold ourselves to a high standard of rigorall in service of patients.

The Opportunity:

• Provide Global Quality oversight for GxP computerized systems ensuring compliant implementation and lifecycle management across GMP GCP GLP GVP and GDP environments.

• Provide strategic quality eadership for Computerized System Validation (CSV) and Computer Software Assurance (CSA) including risk-based validation approaches system changes upgrades integrations data migrations and periodic reviews.

• Lead develop and mentor the team providing strategic direction and ensuring effective execution of CSV/CSA Quality platform oversight AI implementation and digital compliance priorities.

• Own Quality oversight and governance of enterprise Quality digital platforms including Veeva Vault and other GxP qualiy applications ensuring platforms remain validated inspection-ready scalable and fit for intended use.

• Establish and maintain digital Quality governance including system ownership change/release management vendor oversight access controls audit trails electronic records/signatures and data integrity requirements.

• Lead Quality governance and implementation of Artificial Intelligence (AI) and emerging technologies within GxP processes including generative AI AI agents machine learning and intelligent automation.

• Develop risk-based frameworks for AI qualification validation/assurance change management and ongoing monitoring in alignment with evolving regulatory expectations.

• Partner with Quality Information Science Clinical teams Regulatory Pharmacovigilance PDM and other business functions to develop and execute the digital Quality roadmap and identify opportunities for compliant automation and process optimization.

• Serve as the Digital Systems QA SME for regulatory inspections and audits maintaining inspection readiness and monitoring evolving FDA EMA PMDA GAMP 5 21 CFR Part 11 EU Annex 11 data integrity CSA and AI-related regulatory expectations.

Required Skills Experience and Education:

• Bachelors degree in Life Sciences Engineering Computer Science Information Systems or a related discipline with 10 years of experience in pharmaceutical biotechnology or another regulated life sciences environment.

• Demonstrated experience in Computerized System Validation (CSV) Computer Software Assurance (CSA) and Quality oversight of GxP computerized systems across the system lifecycle.

• Strong knowledge of applicable regulations and industry guidance including 21 CFR Part 11 EU Annex 11 GAMP 5 data integrity principles and global GxP requirements.

• Experience providing Quality oversight for enterprise GxP platforms cloud/SaaS applications system implementations upgrades integrations and data migrations.

• Demonstrated ability to lead cross-functional initiatives and effectively partner with Quality IT system owners business process owners and technology vendors.

Preferred Skills:

• Advanced degree in Life Sciences Engineering Computer Science Information Systems or a related discipline.

• Experience with Veeva Vault Quality Suite or comparable enterprise Quality Management platforms.

• Experience implementing or providing Quality governance for AI generative AI machine learning AI agents intelligent automation or other emerging technologies within a regulated environment.

• Knowledge of evolving FDA EMA PMDA and global regulatory expectations for AI digital technologies cloud platforms and risk-based computer software assurance.

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