Senior Quality Investigator - Cell Therapy Manufacturing

BioPharma Consulting JAD Group • Boston, MA

3d • Onsite

About The Position

Lead investigations supporting a commercial cell therapy manufacturing plant in Boston, Massachusetts. The role owns deviations, CAPAs, and change controls end to end in an electronic quality management system (eQMS), from triage and GEMBA through root cause analysis and closure. The position works across manufacturing, quality control, materials, facilities, and equipment, and tracks deliverables in Smartsheet.

This is a 12-month contract with a possible extension. The role is on-site, with the shift set by the hiring manager and potentially non-standard. The stated start date is November 2, 2026.

Requirements

• Bachelor's degree in any field.
• 5–10 years of engineering, project management, or pharmaceutical experience.
• Ability to independently own complex investigations.
• Experience with root cause analysis tools.
• Experience with an eQMS such as Veeva, TrackWise, or a similar system.

Nice To Haves

• Cell therapy or aseptic manufacturing experience.

Responsibilities

• Triage deviations, engage subject matter experts, establish containment, and document the initial impact.
• Lead investigations across manufacturing, quality control, materials, facilities, and equipment.
• Own CAPAs, effectiveness checks, and change controls through on-time closure.
• Track deliverables in Smartsheet.

What This Job Offers

• Career Level: Senior