Summary

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The company is pioneering a new class of therapeutics that target oncogenic RAS mutations, which are among the most common drivers of human cancers. Revolution Medicines employs a unique approach to drug discovery, leveraging deep insights into RAS biology to develop small molecule inhibitors that can address previously undruggable targets. Their pipeline includes multiple clinical-stage candidates designed to inhibit various RAS pathway mutations, with a particular focus on KRAS G12C and other RAS variants. The company's scientific platform combines structural biology, medicinal chemistry, and computational approaches to design highly selective inhibitors. Revolution Medicines aims to transform cancer treatment by developing therapies that can overcome resistance mechanisms and provide durable clinical benefits for patients with RAS-driven malignancies. Their research represents a significant advancement in the field of targeted cancer therapy, addressing one of the most challenging areas in oncology drug development.

Job description

The Opportunity

Lead GxP internal audits and external audits including completing audit reports and follow-up on corrective actions.
Maintain the internal/external audit schedules.
Assure GMP/GxP compliance with suppliers.
Oversight of all aspects of GxP vendor / supplier program management to ensure compliance with GxP regulations and RevMed internal standards.
Demonstrate the ability to multi-tack. Prioritize work and independently solve problems.
Collaborate with vendors and internal teams to draft and complete Quality Agreements.
Perform Risk Assessments, qualifications, and monitor Suppliers/CMOs.
Collaborate with cross-functional teams and represent Quality Vendor Management at meetings.
Create and implement any tools to improve compliance, consistency, and efficiency for GMP/GXP auditing and Vendor management.
Provide support preparation of anticipated regulatory inspections (including those at contracted organizations), and partner audits with cross-functional teams.
Maintain supplier management program, ensuring requirements, plans, processes, metrics, and tracking system for GxP suppliers are established and followed.
Responsible for qualifications of GMP suppliers including performing audits, generation of audit reports, and follow- up with suppliers for addressing observations from audits.
Negotiate, draft, and manage quality technical agreements (QTA) and/or contracts with suppliers, ensuring alignment with internal standards, regulations, and industry standards.
Lead meetings for alignment, communication, and resolution of issues.
Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to RevMed procedures.
Lead supplier performance metrics to monitor the health of systems, drive proactive identification of risk, and mitigate compliance issues.
Generate slides and presentations for reviews and communication to stakeholders.
Update Veeva, track KPIs, assure GxP audits.
Maintain the approved GxP supplier list and the annual audit schedules.

Required Skills, Experience and Education

BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
Minimum experience required 8+ years of pharmaceutical/Biotech experience with a minimum of 5+ years’ GMP Lead Auditor experience.
5 years of QTA and Supplier Quality Management experience.
ASQ Certified Quality Auditor or equivalent certifications.
Excellent leadership and people management/development skills as required.
Direct experience working with Quality System electronic databases.
Strong written and oral communication skills as well as negotiation skills.
Ability to travel occasionally (up to 25%) to perform external audits.
Flexible, and an ability to navigate through rapid growth and adapt to rapid change.
Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required.

Preferred Skills

Direct experience writing and negotiating Quality Agreements with Suppliers and partners.
Vendor Qualification and risk assessment experience.
Strategic thinking, and project management skills.
Extensive experience leading audits, evaluating CAPA and developing presentations analyzing complex data.

Requirements

BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
Minimum experience required 8+ years of pharmaceutical/Biotech experience with a minimum of 5+ years’ GMP Lead Auditor experience.
5 years of QTA and Supplier Quality Management experience.
ASQ Certified Quality Auditor or equivalent certifications.
Excellent leadership and people management/development skills as required.
Direct experience working with Quality System electronic databases.
Strong written and oral communication skills as well as negotiation skills.
Ability to travel occasionally (up to 25%) to perform external audits.
Flexible, and an ability to navigate through rapid growth and adapt to rapid change.
Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required.

Benefits

Competitive cash compensation
Equity awards
Health benefits
Learning and development opportunities

Company overview

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The company is pioneering a new class of therapeutics that target oncogenic RAS mutations, which are among the most common drivers of human cancers. Revolution Medicines employs a unique approach to drug discovery, leveraging deep insights into RAS biology to develop small molecule inhibitors that can address previously undruggable targets. Their pipeline includes multiple clinical-stage candidates designed to inhibit various RAS pathway mutations, with a particular focus on KRAS G12C and other RAS variants. The company's scientific platform combines structural biology, medicinal chemistry, and computational approaches to design highly selective inhibitors. Revolution Medicines aims to transform cancer treatment by developing therapies that can overcome resistance mechanisms and provide durable clinical benefits for patients with RAS-driven malignancies. Their research represents a significant advancement in the field of targeted cancer therapy, addressing one of the most challenging areas in oncology drug development.