Senior Manager, GMP Quality

Senior Manager, GMP QualityRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.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, with a strong emphasis on process validation (Drug Substance and Drug Product) and commercial readiness. An individual with a pharmaceutical quality assurance background plays a critical role in GMP Operations and provides quality oversight on GMP production at RevMed's external vendors in addition to processing of all internal & external GxP documentation at RevMed. This position reports to the Director of GMP Quality.Responsibilities:Responsible for providing QA oversight of process validation 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 supporting process validation strategies and oversight of PPQ documentation such as Validation Master Plans (VMP), Criticality Analysis (CA), Risk Assessments (RA), Validation Protocols and Reports. Also provide QA oversight to deviation investigations and change controls associated with PPQ activities.Lead efforts for QA oversight of the manufacture, validation, and disposition of PPQ and commercial product materials, including drug substance (DS), drug product (DP), and final product (FP) at CMOs in partnership with PDM (CMC), Supply Chain, Analytical Development, Quality Control and other functions.Establish and maintain internal quality metrics for the GMP Quality group 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.Provide Quality oversight as well as review and approval of CMO documentation and perform product dispositions, as required.QA lead in periodically reviewing and revising GMP-related SOPs and procedures.Support quality review of regulatory documents (IND/IMPD, NDA) to ensure compliance with late-stage and commercial drug substance (DS) and drug product (DP) validation requirements.Participate in inspection readiness efforts, particularly for late-stage development and commercial launch preparations.Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.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 drug product development and validation, is required.Experience managing quality aspects of development, validation, manufacturing, and testing activities at CMOs, particularly for late-stage DS and DP process validation and commercialization.Experience in process validation (PPQ), late-stage regulatory submissions, and commercial readiness.Experience in Inspection Readiness (domestic and ex-US), particularly related to late-stage drug product validation.Excellent analytical skills and a strong technical background in small molecule process development, validation, 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.The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.Please note that 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.