Director, GLP Quality Assurance

Director, GLP Quality Assurance

Redwood City, California, United States

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 Director, 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. Responsibilities include research laboratory vendors that perform work to support regulated clinical studies.

Develops the annual vendor audit plan.

The Director 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.
• Development and/or review of Quality Agreements

Performs or participates in internal audits.

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.

Monitors vendor QA units for compliance with applicable regulations including review of vendor study specific QA audit reports.

Advises Sponsor(s) on compliance requirements for test and control article used in GLP studies.

Liaises and/or consults with GLP vendor QA departments on study-related issues such as deviations, investigations, CAPAs and other compliance issues.

Provides annual GLP training or liaises with an external trainer to provide GLP training to RevMed functional team(s).

Attends functional area meetings (e.g., NDCP and Biomarker group) to discuss and review new or on-going issues, projects, and/or studies.

Works with QA management for resource planning, as needed.

Attends periodic clinical QA group meetings, as needed.

Provides periodic quality and compliance updates to QA management.

Develops/prepares standard operating procedure (SOPs) content to GLP audits, and reviews functional area and QA SOPs for GLP compliance.

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.

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.

$211,000 - $264,000 USD