Cell Therapy QA Investigations Lead (CAPA)

VetJobs; New Jersey; On-site; USD 75,000 - 102,000; Full time

Job summary

Bristol Myers Squibb is hiring a Senior Specialist, QA Investigations, to provide quality oversight for deviation investigations and related records. The role ensures product quality in compliance with regulations and company guidelines at the Summit Cell Therapy Facility.

The position requires strong data interpretation, investigative writing, and cross-functional collaboration with internal and external stakeholders. On-site schedule supports a Monday–Friday day shift in Summit, NJ.

Qualifications

• Experience in a regulated industry with deviation experience.
• Knowledge of FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
• Ability to interpret data and assess technical conclusions with quality risk management principles.

Responsibilities

• Review and approve deviation investigations, CAPAs, and effectiveness checks.
• Review technical reports, risk assessments, and deviation system monitoring reports.
• Ensure corrective/preventive actions address root causes and are robust.
• Participate in internal/external inspections and support training content delivery.
• Lead cross-functional meetings and share data across teams.

Skills

Quality investigations

Regulatory knowledge

Analytical thinking

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in STEM

High school diploma/Associate degree with experience

Tools

MS Office

Smartsheets

Electronic systems/databases

Job description

Bristol Myers Squibb is hiring a Senior Specialist, QA Investigations, to provide quality oversight for deviation investigations and related records. The role ensures product quality in compliance with regulations and company guidelines at the Summit Cell Therapy Facility.

The position requires strong data interpretation, investigative writing, and cross-functional collaboration with internal and external stakeholders. On-site schedule supports a Monday–Friday day shift in Summit, NJ.