Senior Manager, GMP Quality

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, 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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