Director, GLP Quality Assurance at Revolution Medicines

Redwood City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

31 Jul, 26

Salary

264000.0

Posted On

02 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Good Laboratory Practice, Quality Assurance, Audit Management, Regulatory Compliance, Risk-based approach, Vendor Management, SOP Development, Computer Systems Validation, Clinical Pharmacology, Nonclinical Development, CAPA, Data Integrity, Project Management, Strategic Oversight, Communication

Industry

Hospitals and Health Care

Description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Associate Director (AD) Good Laboratory Practice Quality Assurance (GLP QA) is responsible for ensuring Good Laboratory Practices (GLP) compliance at RevMed and external vendors contracted to perform regulated work on behalf of RevMed including all GLP vendors. The AD GLP QA responsibilities include for research laboratory vendors that perform work to support regulated clinical studies. The AD GLP QA develops the annual vendor audit plan. The AD GLP QA performs and/or manages vendor audits including: Development of the audit plan, audit conduct, and reporting Tracking and coordination of audit closure tasks including review of observation responses from vendor(s) in conjunction with operational subject matter experts (SMEs), as applicable. Provision of vendor approval recommendations Maintenance of vendor approval status in Veeva. The AD GLP QA performs or participates in internal audits. The AD GLP QA provides QA review of CRO study protocols and reports for compliance utilizing a risk-based approach, as needed and serves as an advisor to the Nonclinical Development and Clinical Pharmacology (NDCP) to resolve compliance issues. The AD GLP QA monitors vendor QA units for compliance with applicable regulations including review of vendor study specific QA audit reports. The AD GLP QA advises Sponsor(s) on compliance requirements for test and control article used in GLP studies. The AD GLP QA liaises and/or consults with GLP vendor QA departments on study-related issues such as deviations, investigations, CAPAs and other compliance issues. The AD GLP QA provides annual GLP training or liaises with an external trainer to provide GLP training to RevMed functional team(s). The AD GLP QA attends functional area meetings (e.g., NDCP and Biomarker group) to discuss and review new or on-going issues, projects, and/or studies. The AD GLP QA works with QA management for resource planning, as needed. The AD GLP QA attends periodic clinical QA group meetings, as needed. The AD GLP QA provides periodic quality and compliance updates to QA management. The AD GLP QA develops/prepares standard operating procedure (SOPs) content to GLP audits, and reviews functional area and QA SOPs for GLP compliance. The AD GLP QA provides consultative QA guidance for computerized system vendors (and systems) supporting GLP studies. Required Skills, Experience and Education: Bachelor’s or Master’s Degree. 12+ years of experience in global Good Laboratory Practice (GLP) Quality Assurance (QA). Extensive audit and inspection management experience. Preferred Skills: Registered Quality Assurance Professional – Good Laboratory Practice (RQAP-GLP). Planning and scheduling expertise. Experienced in effective prioritization of competing initiatives and tasks across multiple projects. Ability to communicate effectively with senior leadership, management and cross functional teams. Ability to manage workstreams to maintain delivery timelines through disciplined planning, tracking and follow-up. Ability to balance detail-oriented execution with strategic oversight. Experienced with the proactive identification, assessment and mitigation of risks and with timely issue escalation, as applicable. Regulatory expertise with at least the following regulations and guidance: 21CFR Part 58 Good Laboratory Practice 21 CFR Part 11 Electronic Records; Electronic Signatures OECD #1 – 24 Standards and Advisory Documents on Good Laboratory Practices ICH E6 (R2 and R3) Good Clinical Practices Japanese Ministry of Health Labor and Welfare (MHLW) – Good Laboratory Practice Applicable US and EU guidance documents including bioanalytical, in vitro and in vivo genetic, Phototox, and hERG toxicology studies Experience with the following audit types. Testing facilities. Bioanalytical and PK data analysis Labs. hERG and Phototoxicity testing facilities. Archives – biorepositories, paper and electronic data storage. Computer Systems Validation. Biomarker Labs (including Artificial Intelligence and Machine Learning). Central Laboratories. #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 privacy@revmed.com. Base Pay Salary Range $211,000—$264,000 USD 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 careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.

Responsibilities

The Director of GLP Quality Assurance is responsible for ensuring GLP compliance across internal operations and external vendors through rigorous audit planning and oversight. They provide consultative guidance on regulatory requirements, manage vendor approval statuses, and support nonclinical development teams in resolving compliance issues.