Senior Manager, Quality Systems - Deviation, CAPA, CC

<p>Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.</p> <p><strong>The Opportunity:</strong></p> <ul> <li> <p>Provide day-to-day oversight and management for Change Control, Deviations, and Corrective and Preventive Action (CAPA) programs, ensuring effective execution, compliance, and continuous monitoring including improvement of these processes within the Quality Management System (QMS).</p> </li> <li> <p>Lead or facilitate quality governance forums (e.g., Change Control Review Boards, Deviation/CAPA Review Boards) using risk-based, science-driven decision-making.</p> </li> <li> <p>Ensure timely initiation, investigation, root cause analysis, and closure of deviations and CAPAs in alignment with regulatory expectations and internal quality standards.</p> </li> <li> <p>Collaborate cross-functionally with Regulatory CMC, Analytical Development / Quality Control, Drug Substance, Drug Product, Supply Chain, Clinical Functions and external partners to ensure effective assessment and implementation of changes and CAPAs.</p> </li> <li> <p>Design, maintain, and continuously improve integrated processes for change management and deviation management, including SOPs, work instructions, templates, training materials, and workflows.</p> </li> <li> <p>Develop and deliver training programs and provide subject matter expertise to drive consistent application of quality processes across internal teams and external partners.</p> </li> <li> <p>Establish and maintain dashboards, KPIs, and trend analyses to monitor process performance, compliance, and effectiveness.</p> </li> <li> <p>Support management review activities by providing integrated quality metrics, trend analyses, and insights.</p> </li> <li> <p>Support the overall QMS framework to ensure compliance with FDA, EMA, ICH, and other global regulatory requirements.</p> </li> <li> <p>Serve as a subject matter expert during internal audits, external audits, and regulatory inspections related to change management and deviation/CAPA management processes.</p> </li> </ul> <p><strong>Required Skills, Experience and Education:</strong></p> <ul> <li> <p>Bachelor’s degree in Science, Engineering, Computer Systems, or related field (advanced degree preferred).</p> </li> <li> <p>Minimum 8–10 years of experience in Quality Systems within the pharmaceutical or biotechnology industry.</p> </li> <li> <p>Demonstrated expertise in Change Control, Deviations, and CAPA management, including use of electronic QMS tools (preferably Veeva Quality Vault QMS).</p> </li> <li> <p>Excellent analytical, root cause analysis, and problem-solving capabilities.</p> </li> <li> <p>Ability to influence and collaborate effectively across functions and organizational levels.</p> </li> <li> <p>Strong understanding of GxP regulations, FDA and EMA expectations, and ICH Q10 principles.</p> </li> <li> <p>Experience supporting late-stage development and/or commercial products in an outsourced manufacturing and testing model.</p> </li> </ul> <p><strong>Preferred Skills:</strong></p> <ul> <li> <p>Experience leading governance forums and driving continuous improvement initiatives.</p> </li> <li> <p>Detail-oriented with the ability to balance compliance, efficiency, and business needs. </p> <p class="p1"><span style="color: rgb(255, 255, 255);">#LI-Hybrid #LI-JC1</span></p> </li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>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.</p> <p>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.</p> <p>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.</p> <p>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 <a href="https://www.revmed.com/ccpa-notice">CCPA Notice</a> and <a href="https://www.revmed.com/privacy-policy">Privacy Policy</a>. For additional information, please contact <a href="mailto:privacy@revmed.com">privacy@revmed.com</a>.</p></div><div class="title">Base Pay Salary Range</div><div class="pay-range"><span>$164,000</span><span class="divider">—</span><span>$205,000 USD</span></div></div></div><div class="content-conclusion"><hr> <p><em>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.</em><br><em> </em><br><em>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 <strong>@revmed.com</strong> email address.</em><br><em> </em><br><em>If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to <span style="color: rgb(35, 111, 161);"><strong>careers@revmed.com</strong></span> so we can share these impersonations with our IT team for tracking and awareness.</em></p> <hr> <p> </p></div>