What are the responsibilities and job description for the Senior Manager, GMP Quality position at Revolution Medicines?
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
Check out the role overview below If you are confident you have got the right skills and experience, apply today.
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 support for RevMed programs through different phases of development.
- Responsible for providing QA oversight and support for batch disposition, quality record ownership, and management of QA activities.
- Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices.
- Collaborate with internal and external stakeholders on deviation investigations, CAPA plans, change controls, shelf-life extensions, and revisions to documentation.
- Lead efforts for QA oversight of the manufacture and disposition of pre-clinical, clinical, and commercial product materials, DS, DP, and FP at CMOs in partnership with PDM (CMC), Supply Chain, Analytical Development, and other functions.
- Execution of Quality Systems as Quality SME for Deviations, CAPAs, Change Controls, and other Quality processes.
- Lead and actively participate in continuous improvement initiatives and projects, ensuring a focus on increasing both efficiency and quality output from all processes used by cross-functional partners.
- Establish quality metrics at the CMOs that predict the performance and health of the quality systems and processes and effectively communicate compliance-related metrics, risks, and compliance challenges to senior management.
- In collaboration with the Analytical Development function, provide quality oversight for GMP activities including, approval of Method Validation, Specifications, Release testing, and Stability for Drug Substance and Drug Products.
- Review and approval of CMO documentation (e.g., specification documents, master batch records, label proofs, etc.) as well as review executed batch records, applicable test data (in-process and release), and performing product dispositions.
- Support quality review of regulatory documents (IND / IMPD).
- Participate in inspection readiness efforts.
- Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.
Required Experience, Skills, and Education :
Preferred Skills :
The expected salary range for this role is $135,000 to $175,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary 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.
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Salary : $135,000 - $175,000
