Quality Assurance Director

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

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.