Senior QA Investigations Specialist — Cell Therapy

Regulatory Jobs; Summit (NJ); Sur place; USD 84 000 - 102 000; Plein temps

Avantages offerts par ce poste

Flexible Time Off

11 paid holidays

Comprehensive benefits

Résumé du poste

Bristol Myers Squibb is seeking a Senior Specialist, QA Investigations at the Summit Cell Therapy Facility in Summit, NJ. The role provides quality oversight for deviation investigations and related records, ensuring compliance with FDA/EMA regulations and BMS policies.

Onsite day shift Monday–Friday. Responsibilities include reviewing investigations, CAPAs, risk assessments, and technical reports; ensuring effective corrective actions; and supporting inspections, training, and cross-functional

Qualifications

• Bachelor's degree in STEM field preferred.
• 4+ years of experience in a regulated industry with 1+ year deviation experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Responsabilités

• Review and approve investigations, CAPAs, and effectiveness checks.
• Review technical reports and risk assessments to support deviations.
• Ensure corrective actions and Effectiveness Check plans address root cause.
• Perform routine reporting and analysis to ensure timely closure of quality events.
• Identify improvement opportunities and support continuous improvement goals.
• Lead cross-functional meetings and maintain relationships with partner functions.

Connaissances

Regulatory knowledge

MS Office

Data interpretation

Technical writing

Cross-functional collaboration

Problem solving

Formation

Bachelor's degree in STEM field

High school diploma/Associates with equivalent experience

Outils

Smartsheets

Electronic systems

Document management systems

Description du poste

Bristol Myers Squibb is seeking a Senior Specialist, QA Investigations at the Summit Cell Therapy Facility in Summit, NJ. The role provides quality oversight for deviation investigations and related records, ensuring compliance with FDA/EMA regulations and BMS policies.

Onsite day shift Monday–Friday. Responsibilities include reviewing investigations, CAPAs, risk assessments, and technical reports; ensuring effective corrective actions; and supporting inspections, training, and cross-functional