Senior Quality Investigator - Cell Therapy Manufacturing

Biopharma-Consulting-Jad-Group; Boston (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Biopharma-Consulting-Jad-Group in Boston, MA is seeking a contract investigator to lead investigations that keep a commercial cell therapy plant running. You will triage deviations, engage SMEs, set containment and document initial impact while coordinating cross-functional teams.

The role covers end-to-end CAPAs, effectiveness checks, and change controls, with on-site shifts and possible extension. Start date is November 2, 2026, with a 12-month contract.

Qualifications

• Triage deviations and document initial impact.
• Independent ownership of complex investigations.
• Experience with root cause analysis tools and eQMS.
• Cell therapy or aseptic manufacturing experience is a plus.

Responsibilities

• Lead investigations across manufacturing, QC, materials, facilities and equipment.
• Own CAPAs, effectiveness checks and change controls to on-time closure.
• Track and report deliverables using Smartsheet.

Skills

Investigation leadership

CAPA management

Change control

Cross-functional collaboration

Smartsheet proficiency

Education

Bachelor's degree (any field)

Tools

eQMS (Veeva or TrackWise)

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