Senior QA Investigations Lead – Cell Therapy & CAPA

Bristol Myers Squibb; Summit (NJ); On-site; USD 84,000 - 102,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

11 paid holidays

Stock opportunities

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Senior Specialist, QA Investigations to provide quality oversight for deviation investigations and related records at the Summit Cell Therapy Facility. You will review investigations, CAPAs, and effectiveness checks, ensure robust corrective actions, and support inspections.

The role emphasizes regulatory compliance, data analysis, and cross-functional collaboration in a fast-paced biopharma setting.

Qualifications

• Candidates must understand and apply internal policies and regulatory guidelines.
• Strong data interpretation and ability to assess CAPA with limited variables.
• Ability to write clear, technical communications for management.
• Experience with deviations, CAPAs and effectiveness checks preferred.

Responsibilities

• Review and approve investigations, CAPAs and effectiveness checks across sites.
• Review technical reports including risk assessments and deviation monitoring.
• Ensure corrective actions address root cause and are robust.
• May perform routine reporting and analysis of quality metrics.
• Identify improvement opportunities and support site goals.
• Assist with inspections and training content delivery.
• Lead cross-functional meetings and share knowledge with teams.

Skills

Regulatory knowledge

MS Office

Data analysis

Root cause analysis

Technical writing

Teamwork

Attention to detail

Cross-functional

Self-motivation

Decision making

Critical thinking

Education

Bachelor's degree in STEM

High school diploma / Associate degree with equivalent experience

4+ years in regulated industry with 1+ year deviation experience

Electronic systems and databases experience

Root-cause analysis tools experience (5-Why, Ishikawa, etc.)

Tools

MS Office

Smartsheets

Job description

Bristol Myers Squibb in Summit, NJ is seeking a Senior Specialist, QA Investigations to provide quality oversight for deviation investigations and related records at the Summit Cell Therapy Facility. You will review investigations, CAPAs, and effectiveness checks, ensure robust corrective actions, and support inspections.

The role emphasizes regulatory compliance, data analysis, and cross-functional collaboration in a fast-paced biopharma setting.