Senior Manager, GMP Quality Assurance

6 days ago

Redwood City, California, United States REVOLUTION Medicines Full time
Job Title: Senior Manager, GMP Quality

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. We are seeking a highly skilled Senior Manager, GMP Quality to join our team and play a key role in ensuring the quality and compliance of our pharmaceutical products.

Job Summary:

The Senior Manager, GMP Quality will be responsible for providing leadership and operational support for RevMed programs through different phases of development. This includes providing QA oversight and support for batch disposition, quality record ownership, and management of QA activities. The successful candidate will also represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization.

Key Responsibilities:
  • Provide QA oversight and support for batch disposition, quality record ownership, and management of QA activities.
  • Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization.
  • Collaborate with internal and external stakeholders on deviation 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 quality metrics at the CMOs 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.
  • Support quality review of regulatory documents (IND/IMPD).
  • Participate in inspection readiness efforts.
  • Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.
Requirements:
  • 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 is required.
  • Experience managing quality aspects of development/validation, manufacturing, and testing activities at CMOs.
  • Experience in Inspection Readiness (domestic and ex-US).
  • 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:
  • Experience in auditing vendors and suppliers is preferred.

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