Director, Quality Compliance — CAR-T Manufacturing

Bristol-Myers Squibb Co; Bend (OR); On-site; USD 188,000 - 227,000; Full time

Benefits offered by this job

Comprehensive benefits

Stock opportunities

Discretionary incentive bonus

Job summary

Bristol Myers Squibb is seeking a Director of Quality Compliance for the Summit West Cell Therapy Manufacturing Facility in Summit, NJ. You will lead the development and execution of site compliance programs, drive internal audits, health authority inspections, and risk management to ensure inspection readiness.

The role reports to the Senior Director, Quality Systems & Compliance and requires strong cross-functional leadership, strategic thinking, and experience with regulatory requirements in

Qualifications

• Must build strong, trusting relationships across divisions and cultures

Responsibilities

• Oversee end-to-end site preparation and management of audits and regulatory inspections
• Lead internal audits of facility, warehouses, and labs
• Manage health authority inspections (FDA, EMA, Health Canada, PMDA)
• Develop and maintain site compliance risk register and KPI oversight
• Communicate status of quality events to senior leadership
• Develop BPDRs, product defect notifications, and drug shortage notifications
• Own Site Compliance Plan aligned with quality objectives
• Develop budgets, metrics, and staff development

Education

MS in relevant Science or Engineering discipline

Job description

Bristol Myers Squibb is seeking a Director of Quality Compliance for the Summit West Cell Therapy Manufacturing Facility in Summit, NJ. You will lead the development and execution of site compliance programs, drive internal audits, health authority inspections, and risk management to ensure inspection readiness.

The role reports to the Senior Director, Quality Systems & Compliance and requires strong cross-functional leadership, strategic thinking, and experience with regulatory requirements in