Associate Director, GMP Quality Assurance

Revolution Medicines; San Francisco (CA); On-site; USD 186,000 - 233,000; Full time

Job summary

Revolution Medicines, a late-stage clinical oncology company, seeks an Associate Director for GMP Quality Assurance to oversee DS/DPI batches, ensure GMP compliance, and support CMC submissions. You will partner with Technical Operations and CDMOs to maintain quality and inspection readiness for clinical and commercial programs.

Ideal candidates bring 10+ years in GMP quality, strong risk assessment and leadership, and experience with DS/DPI manufacturing, validation, and regulatory filings.

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• 10+ years of progressive GMP Quality experience in late-stage or commercial DS/DPI.
• Quality oversight of CDMOs supporting technology transfer, validation/PPQ, manufacturing, testing, and batch release.
• Inspection readiness experience in the United States and ex-US markets.

Responsibilities

• Provide QA oversight and disposition for clinical and commercial DS/DPI batches, ensuring GMP compliance and release readiness.
• Review and approve master and executed batch records, specifications, COAs, and release packages.
• Review deviations, investigations, OOS/OOT, CAPAs, changes controls, and risk assessments.
• Lead Quality Governance meetings with CDMOs and contract labs on manufacturing readiness and timelines.
• Provide QA oversight for technology transfer, scale-up, process validation/PPQ, cleaning validation, and method transfer.
• Support CMC submissions, inspections, lifecycle changes and health authority responses.
• Maintain GMP Quality System and inspection readiness through SOPs and supplier qualification.

Skills

GMP quality experience

CDMO oversight

Inspection readiness

CMC submissions

Data integrity

Regulatory knowledge

Risk assessment

Leadership

Stakeholder management

Multi-priority management

Analytical thinking

MS Office

Education

Bachelor's degree

Tools

Electronic quality management systems

Job 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, GMP Quality Assurance will provide quality oversight and decision-making authority for development, technology transfer, manufacture, testing, and batch disposition of small molecule Drug Substance (DS) and Drug Product Intermediate (DPI). The role ensures GMP compliance, product quality, data integrity, and inspection readiness for late-stage clinical and commercial programs.

This role will be the primary Quality partner to Technical Operations, CMC, Regulatory, Supply Chain, Analytical Development, and external CDMOs, with end-to-end oversight of DS and DPI manufacturing, quality events, validation, release, and continuous improvement.

Key Responsibilities

• Provide QA oversight and disposition support for clinical and commercial small molecule DS and DPI batches, ensuring compliance with GMPs, regulatory filings, specifications, and internal standards.
• Review and approve master and executed batch records, specifications, methods, certificates of analysis, and release packages.
• Review and approve deviations, investigations, OOS/OOT results, change controls, CAPAs, and risk assessments affecting DS and DPI; ensure scientifically sound product-impact evaluations.
• Lead Quality Governance and operational meetings with CDMOs and contract laboratories to align on manufacturing readiness, issue escalation, release timelines, and performance.
• Provide QA oversight for technology transfer, scale-up, process validation/PPQ, cleaning validation, analytical method transfer, and continued process verification.
• Support CMC submissions, inspections, lifecycle changes, and health authority responses.
• Maintain inspection readiness and the GMP Quality System through SOPs, supplier qualification, metrics, and oversight of critical materials, CDMOs, and laboratories.

Required Skills, Experience and Education

• A Bachelor's degree in a scientific or technical discipline is required.
• A minimum of 10+ years of progressive GMP Quality experience, including late-stage or commercial small molecule DS and/or DPI manufacturing.
• Quality oversight of CDMOs supporting technology transfer, validation/PPQ, manufacturing, testing, and batch release.
• Inspection readiness experience in the United States and ex-US markets.
• Technical knowledge of small molecule process chemistry, process controls, impurity management, analytical testing, specifications, and validation.
• Knowledge of applicable US and global GMP regulations and industry practices.
• Experience with deviations, investigations, OOS/OOT, CAPAs, change controls, and risk assessments.
• Ability to assess complex manufacturing and analytical issues and make risk-based Quality decisions.
• Strong leadership, collaboration, and stakeholder management skills.
• Ability to manage multiple priorities, external partners, and aggressive timelines.
• Sound judgment, attention to detail, self-motivation, and commitment to product quality.
• Proficiency with Microsoft Office and electronic quality/document management systems.
• Experience reviewing CMC content for IND/IMPD/NDA submissions and post-approval changes.

Preferred Skills

• Commercial DS/DPI disposition and post-approval change experience is preferred.

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 [e-mail].

Base Pay Salary Range

$186,000 - $233,000 USD