Manager GMP Quality Operations
$118,400–$177,600 year
On-site · Boston, Massachusetts, United States
Job Summary
Oversees GMP Quality Operations for Vertex’s Cell & Gene Therapy manufacturing programs, providing QA support across manufacturing, analytical, and materials-management operations. Drives and supports activities related to product disposition, deviations, in-process data, and QC release testing, while advancing intelligent digitized solutions for backlog triage, metrics generation, records reconciliation, and archiving to improve operational efficiency, compliance, and data integrity. Develops and maintains quality metrics, dashboards, and reports (Python, Power BI, Smartsheet) to provide visibility into QMS performance and process trends; partners with External CDMOs to identify efficiencies; supports audit and inspection readiness; leads AI-enabled record-keeping and lifecycle management initiatives, and contributes to continuous improvement projects across quality and manufacturing domains.
Required Qualifications
- Bachelor's degree in a Business / Sciences field
- 5+ years of QA experience in a GMP-regulated environment
- Hands-on experience with ATMPs (cell therapy, gene therapy, tissue-engineered products) strongly preferred or with Biologicals/sterile
- Demonstrated AI skills and digital capability to design and deliver intelligent solutions that improve Quality operations, including backlog triage, metrics generation, records reconciliation, and archiving within a GMP-regulated environment
- Demonstrated experience providing QA support to GMP manufacturing operation
- Experience with Oracle, TrackWise, Veeva
- Strong communication skills (written and verbal)
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