Senior QA Investigations Lead: Deviation & CAPA

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

Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

11 paid holidays

Job summary

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

You will lead cross-functional teams, maintain compliance with FDA/EMA requirements, and help deliver continuous improvement. Strong writing and data interpretation skills are essential.

Qualifications

• Bachelor's degree in STEM or equivalent work experience considered.
• 4+ years in a regulated industry with deviation handling experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy preferred.

Responsibilities

• Review and approve investigations/CAPAs/effectiveness checks across manufacturing, materials, laboratory, facility and computer systems.
• Review technical reports such as risk assessments and deviation monitoring to support the program.
• Ensure corrective/preventive actions address root causes and are robust.
• Perform routine reporting/analysis to ensure timely closure of quality events.
• Identify improvement opportunities and support continuous improvement goals.
• Support internal and external inspections as required.
• Deliver training content and support cross-functional team knowledge sharing.
• Lead meetings and represent the function in cross-functional discussions.

Skills

Regulatory guidelines

Data interpretation

Technical writing

Cross-functional teamwork

MS Office

Smartsheets

Education

Bachelor's degree in STEM field

High school diploma/Associates with experience

Tools

Smartsheets

MS Office

Electronic systems (databases)

Job description

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

You will lead cross-functional teams, maintain compliance with FDA/EMA requirements, and help deliver continuous improvement. Strong writing and data interpretation skills are essential.