Quality-Event Leader, Manufacturing & CAPA

Vertex Pharmaceuticals

Boston (MA)

On-site

USD 142,000 - 213,000

Full time

3 days ago
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Benefits offered by this job

Annual bonus
Equity awards
Overtime pay (as applicable)
Medical, dental, vision benefits
Paid time off

Job summary

Vertex Pharmaceuticals in Boston, MA, is seeking a Senior Manager for Manufacturing Technical Operations to lead quality-record execution across CAPAs, deviations, and change controls in a CGT manufacturing setting.

The role requires 2nd shift/weekend availability to support manufacturing needs and a strong background in cGMPs, quality systems, and complex investigations. Collaboration with QA, Manufacturing, and other functions is essential to drive improvements and ensure inspection readiness.

Qualifications

  • Bachelor's degree in engineering, Life Sciences, or related technical discipline; equivalent combinations may be considered.
  • 6+ years of experience in biopharmaceutical manufacturing, quality, manufacturing sciences, process engineering, or process development.
  • Experience mentoring, supervising, or managing staff is preferred.

Responsibilities

  • Lead a high-performing team responsible for quality-record execution (CAPAs, deviations, change controls).
  • Provide strategic oversight for complex CAPA and change-control records.
  • Lead cross-functional investigations to determine root cause and recommend corrective actions.

Skills

Leadership experience
Quality systems
GMP knowledge
Cross-functional collaboration
Root cause analysis
Project management
Data-driven decisions
Communication skills
Biopharma manufacturing
Cell & Gene Therapy familiarity

Education

Bachelor's degree in engineering or life sciences

Job description

Vertex Pharmaceuticals in Boston, MA, is seeking a Senior Manager for Manufacturing Technical Operations to lead quality-record execution across CAPAs, deviations, and change controls in a CGT manufacturing setting.

The role requires 2nd shift/weekend availability to support manufacturing needs and a strong background in cGMPs, quality systems, and complex investigations. Collaboration with QA, Manufacturing, and other functions is essential to drive improvements and ensure inspection readiness.

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