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 Quality Control aspects associated with clinical and commercial products.
Responsibilities
Responsible for providing QA oversight of all Quality Control activities including but not limited to test method validations, product specifications, stability programs, etc.
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, OOX 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 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.
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.
QA lead in periodically reviewing and revising GMP-related SOPs and procedures.
Support quality review of regulatory documents (IND/IMPD, NDA).
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.
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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