Senior Manager Quality Assurance GMP
4 weeks ago
Revolution Medicines is seeking a Senior Manager, GMP Quality, to provide leadership and operational support for RevMed programs through different phases of development.
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.
- 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.
- Support quality review of regulatory documents (IND/IMPD).
- 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.
- Strong teamwork, collaboration, and management skills.
- Ability to manage multiple priorities and aggressive timelines.
- Highly proficient with various Microsoft and other computerized systems.
The base salary range for this full-time position is $135,000 to $175,000 for candidates based at our headquarters in Redwood City, CA.
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.
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