Senior Manager, GMP Quality

The Opportunity:

Revolution Medicines is seeking a Senior Manager, GMP Quality who will play a key role within Quality Assurance and is responsible for providing leadership and operational GMP QA support for RevMed clinical programs, with a primary focus on clinical batch record review, product disposition, and release activities supporting global clinical trials.

Responsibilities:

• Serve as the primary QA lead for clinical batch disposition activities, including comprehensive review and approval of executed batch records, deviations, investigations, and associated release documentation to ensure timely disposition of clinical trial materials.

• Provide QA support for the manufacture, packaging, labeling, testing, storage, and release of clinical drug substance (DS), drug product (DP), and final product (FP) manufactured at CMOs and other GMP service providers.

• Partner cross-functionally with Pharmaceutical Development & Manufacturing (PDM/CMC), Supply Chain, Regulatory Affairs, Clinical Operations, Analytical Development, and external CMOs to support uninterrupted supply of clinical trial materials.

• Review and approve GMP documentation associated with clinical manufacturing and release activities, including master batch records, executed batch records, specifications, Certificates of Analysis, stability data, label proofs, shipping documentation, and analytical test results.

• Collaborate with internal and external stakeholders to support quality systems and serve as QA SME for deviation investigations, CAPAs, change controls, product impact assessments, shelf-life extensions, and other GMP quality processes impacting clinical supply.

• Ensure compliance with applicable global GMP regulations, ICH guidelines, company procedures, and industry best practices related to clinical manufacturing and release activities.

• Support QA oversight of clinical manufacturing campaigns at CMOs, including on-site or remote support for manufacturing operations, batch review, and disposition activities as needed.

• Drive continuous improvement initiatives to enhance batch review efficiency, release timelines, and overall effectiveness of GMP quality systems supporting clinical operations.

• Review and approve GMP SOPs, work instructions, and controlled documents to ensure alignment with current regulatory expectations and company practices.

• Support quality review of regulatory submissions and responses, including INDs/IMPDs and other clinical regulatory filings, as applicable.

• Build positive professional relationships and foster a culture of quality, collaboration, accountability, and continuous improvement across internal teams and external partners.

Required Skills, Experience and Education:

• A Bachelor's degree in a scientific or technical discipline is required.

• A minimum of 8 years of experience in GMP Quality in the pharmaceutical industry, with experience in early to late-stage drug product development.

• Excellent analytical skills and a strong technical background in small molecule process development, and testing are strongly desired.

• Knowledge of applicable US and Global compliance regulations and industry practices.

• Ability to critically evaluate and troubleshoot complex problems with diligence.

• Strong teamwork, collaboration, and management skills.

• Ability to manage multiple priorities and aggressive timelines.

• Highly responsible, self-motivated professional with enthusiasm and passion for the work.

• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Preferred Skills:

• Hands-on experience working in a manufacturing environment overseeing QA responsibilities for commercial and late-stage programs is preferred. 

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