Senior QA Investigations & CAPA Lead

Bristol-Myers Squibb Co; Summit (NJ); On-site; USD 94,000 - 114,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

11 paid holidays

Job summary

Bristol-Myers Squibb Co is hiring for a Manager, QA Investigations in Summit, NJ. This role provides QA oversight for deviation investigations, CAPAs, and effectiveness checks across manufacturing operations at the Summit Cell Therapy Facility.

You will review complex investigations, author technical reports, ensure robust CAPAs, and coach staff on quality issues. The position may be an IC or People Manager and includes comprehensive benefits and a focus on a culture of quality.

Qualifications

• Bachelor's degree in STEM required or equivalent.
• 6+ years of experience in a regulated industry with deviation experience preferred.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy recommended.
• Proficiency with electronic systems and databases.

Responsibilities

• Review and approve complex investigations/CAPAs and effectiveness checks across manufacturing processes.
• Author/review/approve technical reports including risk assessments and deviation monitoring.
• Ensure corrective/preventive actions address root causes and closures meet timelines.
• Coach and mentor staff on deviations/investigations and participate in audits.

Skills

QA investigations

CAPA

Quality oversight

Root cause analysis

Regulatory compliance

MS Office

Data analysis

Mentoring

Education

Bachelor's degree in STEM

Tools

Electronic data systems

Databases

Job description

Bristol-Myers Squibb Co is hiring for a Manager, QA Investigations in Summit, NJ. This role provides QA oversight for deviation investigations, CAPAs, and effectiveness checks across manufacturing operations at the Summit Cell Therapy Facility.

You will review complex investigations, author technical reports, ensure robust CAPAs, and coach staff on quality issues. The position may be an IC or People Manager and includes comprehensive benefits and a focus on a culture of quality.