Senior Manager, Manufacturing Quality & CAPA Operations

Vertex Pharmaceuticals; Boston (MA); On-site; USD 142,000 - 213,000; Full time

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.

Skills

cGMP knowledge

GMP regulatory understanding

Project management

Analytical thinking

Communication skills

Leadership

Education

Bachelor's degree in engineering, Life Sciences, or related technical discipline

Job description

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