Senior Manager, Manufacturing Quality & CAPA Operations

Vertex Pharmaceuticals

Boston (MA)

On-site

USD 142,000 - 213,000

Full time

6 days ago

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Job summary

The Senior Manager, Manufacturing Technical Operations (MTO) at Vertex Pharmaceuticals in Boston leads the quality-record program for CGT manufacturing, overseeing CAPAs, change controls, deviations, and investigations to ensure compliant, timely closures.

Reporting to Manufacturing and Quality Assurance, you will manage a team of five+, drive cross-functional collaboration, and focus on data-driven improvements, inspection readiness, and scalable quality-event practices on-site, including

Qualifications

Bachelor's degree in engineering, Life Sciences, or related technical discipline.
6+ years of biopharmaceutical manufacturing, quality, or process development experience.
2+ years mentoring, supervising, or managing staff.
Experience leading complex investigations, CAPAs, deviations, and change controls in GMP environments.
Cell and gene therapy manufacturing experience is preferred.

Responsibilities

Lead and develop a high-performing team for quality-record execution, including change controls, CAPAs, deviations, and investigations.
Provide strategic oversight for CAPA and change-control records.
Lead cross-functional investigations to determine root cause and actions.
Establish best practices to advance quality-event center-of-excellence.
Monitor performance metrics and data trends to prioritize work and allocate resources.
Support inspection readiness and compliant documentation.