Senior Manager, Quality Compliance (GMP)

Company: THIRD ROCK VENTURES, LLC
Location: Redwood City
Posted on: March 18, 2023

Job Description:

Senior Manager, Quality Compliance (GMP) 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. The Sr. Manager, Quality Compliance will play a key role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed programs through different phases of development. Although this role is focused on GMP, there will be elements that span GXP. The Opportunity: Lead GMP quality audits of various manufacturing, testing, and supply vendors. Prepare and distribute audit reports. Manage audit schedule and CAPAs. Develop and coordinate internal audit program to ensure stakeholder system compliance with existing policies and procedures, and cGMP requirements, standards, and guidelines. Coordinate inspection preparedness activities to support the Inspection Management program while identifying GMP compliance gaps or risks throughout different phases of development. Maintain and report cGMP compliance audit trends and metrics. Support regulatory filings, as needed. Partner with QA Document Control and Training to maintain cGMP related Vendor Management files and oversight of vendors. Serve as primary QA contact for CSV related projects. Support Quality Operations, as deemed appropriate. Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork. Required Experience, Skills, and Education: Bachelor's degree in a scientific or technical discipline required. Minimum of 8 years of experience in GMP Quality in the pharmaceutical industry required. Direct experience with regulatory compliance inspections (US and ex-US health authority agencies). Qualified Lead Auditor for various service providers (e.g., manufacturing, analytical labs, etc.). Practical technical experience related to small molecule manufacturing. Excellent analytical skills and understanding of QMS to ensure comprehensive evaluation of third-party vendors. Working knowledge and direct experience with CSV projects. Knowledge of applicable US and Global compliance regulations and industry practices (including, but not limited to, GAMP 5). 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, initiative-taking 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.) Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company's offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law. 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. 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 ourCCPA Notice andPrivacy Policy .For additional information, please contactprivacy@revmed.com . 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 ourCCPA Notice andPrivacy Policy .For additional information, please contactprivacy@revmed.com .

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