Senior Quality Investigator - Cell Therapy Manufacturing
BioPharma Consulting JAD Group
Summary
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.
Job description
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.
Qualifications
- 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.
Details
- Contract: 12 months, with possible extension
- Shift: On-site; shift set by the hiring manager (may be non-standard)
- Start: November 2, 2026
Requirements
- 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
Company overview
BioPharma Consulting JAD Group is a specialized consulting firm operating in the biotechnology and pharmaceutical sectors. The company provides expert advisory services to biopharmaceutical companies, research institutions, and healthcare organizations. Their consulting services likely encompass strategic planning, regulatory compliance, market access strategies, clinical development optimization, and commercialization support for biotech and pharmaceutical products. As part of the JAD Group network, the firm leverages collective expertise to address complex challenges in drug development, manufacturing, and market entry. Their focus on biotechnology research suggests they work closely with emerging biotech companies to navigate the intricate landscape of drug discovery, clinical trials, and regulatory pathways. The consulting group serves as a bridge between scientific innovation and commercial success, helping clients accelerate their research and development timelines while ensuring compliance with global regulatory standards.