Associate Director, GMP Quality Assurance
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Job Location:
Redwood City, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team you will join other outstanding Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
The Associate Director GMP Quality Assurance will play a critical role in providing quality oversight and decision-making authority for commercial manufacturing and batch release activities across Drug Substance (DS) Drug Product Intermediate (DPI) Drug Product (DP) and Commercial Packaging operations. This position is responsible for ensuring GMP compliance product quality and inspection readiness throughout the commercial supply chain and in late-stage clinical programs transitioning to commercialization.
This role will serve as a key Quality partner to internal cross-functional teams and external CDMOs packaging vendors and suppliers with a strong focus on end-to-end batch disposition deviation management and continuous improvement of commercial quality processes.
Key Responsibilities include:
Provide QA oversight review and final disposition support for commercial DS DPI DP and commercial packaged product batch release ensuring compliance with GMPs regulatory filings and internal quality standards.
Review and approve quality events including deviations investigations OOS/OOT results change controls CAPAs and specification-related documents impacting batch release.
Lead Quality Governance forums and operational meetings with CDMOs and packaging partners to ensure alignment on quality expectations timelines and release readiness.
Support and maintain a robust GMP Quality System including SOP development review and approval; vendor qualification; and ongoing supplier oversight.
Support regulatory submissions inspections and post-approval lifecycle activities including supplements variations and responses to health authority inquiries.
Maintain CPV data quality metrics and KPI trend analysis for commercial batches.
Provide GMP Quality Assurance support for clinical development programs and ongoing process validation activities across Drug Substance Drug Product and packaging operations.
Required Skills Experience and Education:
A Bachelors degree in a scientific or technical discipline is required.
A minimum of 10 years of experience in GMP Quality in the pharmaceutical industry with experience in late-stage drug product development and commercial activities.
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.).
Experience in working with external partners contract manufacturing/packaging organizations.
Experience with the preparation and/or review of regulatory filing submissions (IND/IMPD/NDA).
Preferred Skills:
Experience in Commercial batch disposition is preferred.
#LI-Hybrid #LI-JC1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role level and location. Individual base pay salary is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.
Please note that base pay salary range 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.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect process and use any personal data that you provide to us in accordance with ourCCPA additional information please contact.
Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
