Senior QA Investigations Specialist (Cell Therapy)

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

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, QA Investigations at the Summit Cell Therapy Facility. You will provide quality oversight, approve deviation investigations and CAPAs, and ensure compliance with regulatory standards across materials, manufacturing, and laboratory operations.

The role requires strong data interpretation, written communication, and collaboration with cross-functional teams.

Qualifications

• Bachelor's degree in STEM or equivalent required.
• 4+ years in a regulated industry with deviation experience preferred.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy is a plus.
• Proficiency with root-cause analysis tools and data interpretation is expected.

Responsibilities

• Review and approve investigations, CAPAs and effectiveness checks across multiple domains.
• Review technical reports, risk assessments and deviation system monitoring reports.
• Ensure robust corrective/preventive actions address root causes.

Skills

Regulatory guidelines

Data interpretation

Documentation writing

Cross-functional collaboration

MS Office

Education

Bachelor's degree in STEM

High school diploma or Associate degree

Tools

Smartsheets

Electronic systems

Job description

Bristol Myers Squibb is seeking a Senior Specialist, QA Investigations at the Summit Cell Therapy Facility. You will provide quality oversight, approve deviation investigations and CAPAs, and ensure compliance with regulatory standards across materials, manufacturing, and laboratory operations.

The role requires strong data interpretation, written communication, and collaboration with cross-functional teams.