Senior QA Investigations Specialist (Cell Therapy)

Bristol-Myers Squibb Co; Harvard (MA); On-site; USD 90,000 - 109,000; Full time

Job summary

Bristol-Myers Squibb Co. seeks a Senior Specialist in QA Investigations at our Devens, MA cell therapy site to oversee deviation investigations and related records in compliance with regulations and company policies.

The role emphasizes quality assurance of manufactured products, robust CAPAs, and collaboration with cross-functional teams. Strong data interpretation and technical writing are essential to support inspections and continuous improvement.

Qualifications

• Bachelor's degree in STEM field preferred. Higher degrees or additional experience may be considered.
• 4+ years of experience in a regulated industry with 1+ year deviation experience.
• Experience with electronic systems and databases.
• Experience with root-cause analysis tools such as 5-Why, Ishikawa Diagram, and related methodologies.

Responsibilities

• Review and approve investigations, CAPAs, and effectiveness checks across manufacturing, materials, lab, facility, and computer systems.
• May author/review technical reports, including risk assessments and deviation system monitoring reports.
• Ensure corrective/preventive actions robustly address root causes.
• Lead meetings and communicate data across cross-functional teams.
• Support internal and external inspections as required.
• Maintain training content and deliver it to cross-functional teams.

Skills

Regulatory guidelines

MS Office

Smartsheets

Data interpretation

Quality risk mgmt

Cross-functional collaboration

Written communication

Education

Bachelor's degree in STEM field

Tools

Electronic systems & databases

Job description

Bristol-Myers Squibb Co. seeks a Senior Specialist in QA Investigations at our Devens, MA cell therapy site to oversee deviation investigations and related records in compliance with regulations and company policies.

The role emphasizes quality assurance of manufactured products, robust CAPAs, and collaboration with cross-functional teams. Strong data interpretation and technical writing are essential to support inspections and continuous improvement.