Senior Manager, Quality Records & CAPA – On-Site 2nd Shift

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

Benefits offered by this job

Annual bonus

Annual equity awards

Commuting subsidy

Student loan repayment

401(k)

Generous paid time off

Job summary

Vertex Pharmaceuticals Incorporated is seeking a Senior Manager, Manufacturing Technical Operations (MTO) to lead the quality-record strategy for quality events across CGT manufacturing. You will oversee CAPAs, deviations, change controls, and investigations with a focus on compliance and continuous improvement.

You will partner with Manufacturing, Quality Assurance, and cross-functional teams to drive timely closures, implement best practices, and enable inspection readiness.

Qualifications

• Bachelor's degree in engineering, Life Sciences, or related technical discipline; equivalent combos may be considered.
• 6+ years in biopharma manufacturing, quality, or process engineering.
• 2+ years mentoring or supervising staff.
• Experience with GMP environments and investigations preferred.
• Cell and gene therapy manufacturing experience preferred.

Responsibilities

• Lead a team responsible for quality-record execution including CAPAs, deviations, change controls, and investigations.
• Provide strategic oversight for complex CAPA and change-control records.
• Lead cross-functional investigations to determine root cause and actions, presenting findings to leadership.
• Promote MTO and QA best practices to advance quality-event excellence.
• Support inspection readiness and ensure timely, compliant quality records.

Skills

GMP knowledge

Leadership

Cross-functional collaboration

Project management

Analytical thinking

Communication

Quality systems

Education

Bachelor's degree in engineering or Life Sciences

6+ years biopharma/manufacturing quality

2+ years people management

Job description

Vertex Pharmaceuticals Incorporated is seeking a Senior Manager, Manufacturing Technical Operations (MTO) to lead the quality-record strategy for quality events across CGT manufacturing. You will oversee CAPAs, deviations, change controls, and investigations with a focus on compliance and continuous improvement.

You will partner with Manufacturing, Quality Assurance, and cross-functional teams to drive timely closures, implement best practices, and enable inspection readiness.