Description:
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. We are seeking a motivated individual with a pharmaceutical quality assurance background to play 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 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.).