Senior QA Investigations Lead for Cell Therapy

Bristol-Myers Squibb Co; Bend (OR); On-site; USD 84,000 - 102,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work options

Job summary

Bristol Myers Squibb seeks a Senior Specialist, QA Investigations at the Summit Cell Therapy Facility near Bend, OR. You will provide quality oversight of deviation investigations and related records, ensuring compliance with regulations and BMS policies.

This onsite role supports corrective actions and continuous improvement across functions. Key duties include reviewing CAPAs, effectiveness checks, metrics reporting, and assisting inspections.

Qualifications

• Bachelor's degree in STEM field; minimum 4+ years in regulated industry with deviation experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy preferred.
• Strong ability to interpret data, review investigations, and write clear technical communications.

Responsibilities

• Review and approve investigations, CAPAs, and effectiveness checks.
• Review technical reports, risk assessments, and deviation system monitoring reports.
• Ensure corrective/preventive actions address root causes.
• Lead meetings and report on quality metrics to support timely closure of events.
• Support internal and external inspections and cross-functional collaboration.

Skills

Quality oversight

CAPA/Investigation

Regulatory knowledge

Data analysis

MS Office

Education

Bachelor's degree in STEM

Tools

Smartsheets

Electronic systems

Job description

Bristol Myers Squibb seeks a Senior Specialist, QA Investigations at the Summit Cell Therapy Facility near Bend, OR. You will provide quality oversight of deviation investigations and related records, ensuring compliance with regulations and BMS policies.

This onsite role supports corrective actions and continuous improvement across functions. Key duties include reviewing CAPAs, effectiveness checks, metrics reporting, and assisting inspections.