Associate Director, Quality Systems

Posted 9 Days Ago
Be an Early Applicant
Redwood City, CA
In-Office
180K-225K Annually
Senior level
Healthtech • Biotech
The Role
Lead and oversee quality systems operations, focusing on GxP compliance, document management, training programs, and process improvements in a clinical-stage biopharmaceutical setting.
Summary Generated by Built In

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.

The Opportunity:

  • Provide leadership and operational oversight for enterprise quality systems, with primary accountability for GxP Document Control, GxP Training, and Veeva Quality Suite platform governance.

  • Develop and execute the global Quality Systems strategy in alignment with company goals and regulatory expectations.

  • Build, lead, and mentor a high-performing team responsible for Document Control, GxP Training, and Veeva Quality Suite operations.

  • Provide strategic leadership by mentoring and coaching direct reports, translating organizational and Quality goals into clear departmental objectives, and fostering a culture of accountability, continuous improvement, and operational excellence.

  • Serve as Global Process Owner for Document Control, ensuring GxP documentation is compliant, controlled, and inspection/Audit ready in accordance with region specific regulatory requirements.

  • Responsible for document retention, archival, and electronic data archival. Oversees the development, review, approval, issuance, and archival of controlled documents in compliance with applicable regulatory requirements and internal quality standards.

  • Provide strategic oversight of the global GxP Training Program, including governance, curriculum design, and role-based training matrices.

  • Ensure global training compliance, deploy scalable training solutions, and implement system integrations to support organizational growth.

  • Define and monitor training metrics to ensure accountability and continuous improvement.

  • Act as Business Process Owner for Veeva Quality Suite platforms and oversee configuration, enhancements, integrations, and release management.

  • Ensure data integrity, workflow efficiency, and strong user adoption across GxP functions by implementing robust data governance and data management aligned with ALCOA+ principles.

  • Oversee Veeva QualitySuite system validation, upgrades, and compliance with 21 CFR Part 11 and Annex 11.

  • Support audit and inspection support activities, including document retrieval, training records, and system demonstrations.

  • Establish and manage global KPIs/KQIs for Document Control, Training, and Veeva platform performance.

  • Lead cross-functional quality improvement projects to simplify processes, reduce cycle times, and increase automation.

  • Proactively identify and implement opportunities to strengthen compliance, efficiency, and user experience.

Required Skills, Experience and Education:

  • Bachelor’s degree in Life Sciences, Engineering, or related field required; advanced degree preferred.

  • Minimum 12 years of progressive GxP Quality systems experience in the biopharmaceutical or related industry.

  • Minimum 5 years of leadership experience managing global quality systems teams.

  • Deep expertise in Veeva Quality Suite (QualityDocs, Training, and related QMS modules).

  • Strong knowledge of global GxP regulations and expectations (FDA, EMA, ICH).

  • Demonstrated success in building and leading high-performing teams.

  • Experience supporting global regulatory inspections and audits.

Preferred Skills:

  • Leadership experience supporting late-stage development and commercial launch readiness.

  • 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].

Base Pay Salary Range
$180,000$225,000 USD

Top Skills

Gxp Quality Systems
Veeva Quality Suite
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The Company
Redwood City, California
548 Employees
Year Founded: 2014

What We Do

We are Revolutionaries – passionate in our singular pursuit of discovering, developing and delivering innovative, targeted medicines for patients living with cancer. To deliver on our vision, we work relentlessly in pursuit of cutting-edge therapeutic approaches to some of the toughest cancers. Our current focus is on RAS-addicted cancers, which account for 30 percent of all new human cancer diagnoses

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