Über diese Associate Director, GxP Electronic Systems Quality Assurance Stelle bei Revolution Medicines
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 RAS. Founded 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 rigor—all in service of patients.
The Opportunity:
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Provide Global Quality oversight for GxP computerized systems, ensuring compliant implementation and lifecycle management across GMP, GCP, GLP, GVP, and GDP environments.
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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.
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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.
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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.
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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.
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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.
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Develop risk-based frameworks for AI qualification, validation/assurance, change management, and ongoing monitoring in alignment with evolving regulatory expectations.
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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.
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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:
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Bachelor’s 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.
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Demonstrated experience in Computerized System Validation (CSV), Computer Software Assurance (CSA), and Quality oversight of GxP computerized systems across the system lifecycle.
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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.
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Experience providing Quality oversight for enterprise GxP platforms, cloud/SaaS applications, system implementations, upgrades, integrations, and data migrations.
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Demonstrated ability to lead cross-functional initiatives and effectively partner with Quality, IT, system owners, business process owners, and technology vendors.
Preferred Skills:
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Advanced degree in Life Sciences, Engineering, Computer Science, Information Systems, or a related discipline.
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Experience with Veeva Vault Quality Suite or comparable enterprise Quality Management platforms.
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Experience implementing or providing Quality governance for AI, generative AI, machine learning, AI agents, intelligent automation, or other emerging technologies within a regulated environment.
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Knowledge of evolving FDA, EMA, PMDA and global regulatory expectations for AI, digital technologies, cloud platforms, and risk-based computer software assurance.
#LI-JC1 #LI-Hybrid
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected].
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.
