Revolution Medicines · 8 hours ago
Associate Director, Clinical Quality
San Francisco Bay Area
Full-time
Onsite
Lead/Staff, Director/Executive
$186K/yr - $233K/yr
8+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Associate Director, Clinical Quality Assurance will provide leadership and compliance support for clinical trials, ensuring adherence to regulatory requirements and quality standards.
Health CareLife ScienceMedical
Responsibilities
Support the development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines
Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support
Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue
Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management
Collaborate with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits
Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments
Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation)
Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management
Escalate identified issues to QA Management and other relevant leadership as needed in a timely manner
Enable other assigned GCP or GXP related tasks, as appropriate
Support GCP audits and inspections of RevMed, Vendors, and clinical investigator sites by regulatory authorities or business partners
Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork
Qualification
Required
Bachelor's degree in scientific or technical discipline
A minimum of 8 years of experience in GCP Quality in the pharmaceutical or biotechnology industry
8 years in any of the following areas: audit or audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities
Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (minimally US FDA) regarding applicable drug development regulations
Effective communication (verbal and written)
Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners
Ability to create innovative solutions to problems, while integrating stakeholder input and feedback
Ability to critically evaluate and troubleshoot complex problems with diligence
Ability to manage multiple priorities and aggressive timelines
Highly responsible, self-motivated professional with enthusiasm and passion for the work
Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.)
Preferred
Good knowledge of Computer System Validation
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase