About this Senior QA Specialist, Global Document Control Management role at 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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Support the development, implementation, and continuous improvement of the global GxP Document Management Program, ensuring document control processes, governance, and systems remain compliant, efficient and aligned with regulatory requirements and industry standards.
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Review and coordinate Document Change Controls (DCCs) and document workflows to ensure GxP procedures, forms, templates, and other controlled documents are managed throughout their lifecycle in accordance with global requirements and company procedures.
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Serve as the subject matter expert (SME) for the electronic Document Management System (eDMS/eQMS), driving global standardization, governance, system optimization, user support, and continuous improvement initiatives.
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Partner cross-functionally with global RevMed functions, sites, and affiliates to evaluate document management process effectiveness, identify improvements, and implement sustainable solutions that enhance the operational excellence.
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Support strategic document management initiatives, including workflow optimization, system enhancements, document migrations, periodic reviews, global expansion activities, training programs, and process improvement projects.
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Monitor, analyze, and communicate key quality metrics and KPIs related to document lifecycle management and process performance, driving appropriate corrective and preventive actions.
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Support the development, implementation, and maintenance of global SOPs, work instructions, governance frameworks, and best practices supporting document management of quality systems while promoting process consistency, governance, and user adoption.
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Support internal audits, regulatory inspections, and inspection readiness activities and foster a culture of quality, accountability, and continuous improvement.
Required Skills, Experience and Education:
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BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
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Minimum 5 years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment.
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Experience in developing and implementing GxP quality systems to meet current regulatory and industry standards.
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Direct experience managing global GxP document management and training systems.
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Excellent working knowledge and understanding of GxP requirements, proficiency in applying regulatory requirements, and ICH guidelines.
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Direct experience working with Veeva QualitySuite electronic platforms (QualityDocs, Training, QMS).
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Proficient with Microsoft Office including Word, Excel, PowerPoint experience is a plus.
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Excellent communication skills, both oral and written to clearly and concisely communicate with internal and external team members.
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Ability to work independently and collaboratively across cross-functional teams in a dynamic environment
Preferred Skills:
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Strategic thinking and project management skills.
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Direct experience with handling and/or participating in regulatory body inspections.
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A continuous improvement mindset and willingness to take initiative in solving problems.
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Experience in both virtual sponsor and scaling global organization models.
#LI-Hybrid #LI-JC1
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.
