Senior Quality Investigator - Cell Therapy Manufacturing

BioPharma Consulting JAD Group; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

BioPharma Consulting JAD Group in Boston seeks a contractor to lead investigations that keep a commercial cell therapy plant running. You will own deviations, CAPAs and change controls end to end in eQMS, from triage and GEMBA to root cause and closure.

The role requires independent ownership of complex investigations, experience with eQMS tools such as Veeva/TrackWise, and a strong background in cell therapy or aseptic manufacturing.

Qualifications

• Bachelor's degree in any field; 5–10 years of engineering, project management or pharmaceutical experience.
• Independent ownership of complex investigations.
• Experience with root cause analysis tools and eQMS (Veeva, TrackWise or similar).
• Cell therapy or aseptic manufacturing experience is a strong plus.

Responsibilities

• Triage deviations, engage SMEs, set containment and document the initial impact.
• Lead investigations across manufacturing, QC, materials, facilities and equipment.
• Own CAPAs, effectiveness checks and change controls through on-time closure.
• Track deliverables in Smartsheet.

Skills

Root cause analysis

Investigation leadership

Project management

Gemba

Education

Bachelor's degree

Tools

eQMS (Veeva/TrackWise)

Smartsheet

Job description

Lead the investigations that keep a commercial cell therapy plant running at a leading biotechnology company in Boston, Massachusetts. You will own deviations, CAPAs and change controls end to end in eQMS, from triage and GEMBA to root cause and closure.

What you'll do

• Triage deviations, engage SMEs, set containment and document the initial impact.
• Lead investigations across manufacturing, QC, materials, facilities and equipment.
• Own CAPAs, effectiveness checks and change controls through on-time closure.
• Track deliverables in Smartsheet.

• Bachelor's degree (any field) + 5–10 years of engineering, project management or pharmaceutical experience.
• Independent ownership of complex investigations.
• Root cause analysis tools; eQMS (Veeva, TrackWise or similar).
• Cell therapy or aseptic manufacturing is a strong plus.

• Contract: 12 months, with possible extension
• Shift: On-site; shift set by the hiring manager (may be non-standard)
• Start: November 2, 2026