Senior QA Investigations Manager – Cell Therapy

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

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Annual Global Shutdown

Job summary

Bristol Myers Squibb in Summit, NJ seeks a Manager of QA Investigations to provide quality oversight of deviation assessments, investigations, and CAPA records. You will ensure compliance with regulations and company policies while leading cross-functional teams.

If you have a strong background in regulatory quality, RCA tools, and excellent writing skills, you will help drive a culture of quality and support internal/external inspections.

Qualifications

• Bachelor's degree in STEM preferred; alternative education with equivalent experience considered.
• 6+ years in a regulated industry with 2+ years in deviations.
• Experience with electronic systems and databases.
• Strong root cause analysis skills (5-Why, fishbone, IS/IS-NOT, etc.).
• Excellent written and verbal communication; ability to present data clearly.
• Ability to work in a fast-paced team and lead peers.

Responsibilities

• Review and approve complex investigations and CAPAs.
• Author and review technical reports to support the deviations program.
• Ensure corrective actions robustly address root causes.
• Coach staff and lead investigations.
• Support inspections and audits as needed.
• Monitor metrics and ensure timely disposition of quality events.

Skills

Quality Oversight

Deviation Investigations

CAPA Management

Regulatory Knowledge

Data Analysis

Technical Writing

Leadership

Education

Bachelor's degree in STEM

Tools

MS Office

Smartsheets

Job description

Bristol Myers Squibb in Summit, NJ seeks a Manager of QA Investigations to provide quality oversight of deviation assessments, investigations, and CAPA records. You will ensure compliance with regulations and company policies while leading cross-functional teams.

If you have a strong background in regulatory quality, RCA tools, and excellent writing skills, you will help drive a culture of quality and support internal/external inspections.