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 support for RevMed commercial programs, with a primary focus on commercial finished product batch review, disposition, and release activities in support of global product supply.
Responsibilities
Serve as the QA lead for commercial finished product (FP) batch review and disposition activities, ensuring timely and compliant release of commercial product for distribution.
Perform comprehensive review and approval of executed batch records, deviations, investigations, analytical data, Certificates of Analysis (CoAs), and associated release documentation for commercial product disposition.
Provide QA oversight for commercial manufacturing, packaging, labeling, testing, storage, and release operations performed at CMOs, contract laboratories, and distribution partners.
Collaborate cross-functionally with Pharmaceutical Development & Manufacturing (PDM/CMC), Supply Chain, Regulatory Affairs, Technical Operations, Validation, and external partners to ensure uninterrupted commercial product supply.
Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the commercial organization, including providing guidance based on current global regulations, industry standards, and best practices.
Support QA activities associated with deviation investigations, CAPA plans, change controls, product impact assessments, complaints, recalls, annual product reviews, and other commercial GMP quality systems.
Ensure compliance with FDA, EMA, ICH, and other applicable global GMP regulations governing commercial manufacturing and product release activities.
Maintain quality metrics related to batch disposition timelines, deviations, product quality trends, and overall effectiveness of commercial quality systems, and communicate risks and compliance challenges to senior management.
Lead periodic review and revision of GMP-related SOPs, work instructions, and quality procedures to ensure alignment with evolving regulatory expectations and business needs.
Support quality review of regulatory submissions and post-approval filings, including NDA supplements, annual reports, and responses to health authority inquiries.
Build positive professional relationships and foster a culture of quality, accountability, collaboration, 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 late-stage /commercial 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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Benefits
Health insuranceVision insurance
Additional Information
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.
Revolutionmedicines · Redwood City, CA