Director of Quality Compliance — Cell Therapy & Inspections

Bristol Myers Squibb; Summit (NJ); On-site; USD 188,000 - 227,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work models

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Director of Quality Compliance for the CAR T manufacturing facility. You will lead site-wide compliance programs, oversee audits, inspections, and regulatory interactions, and drive continuous improvement to ensure inspection readiness across QA, QC and related functions.

The role reports to the Senior Director of Quality Systems & Compliance and requires strong leadership, strategic thinking, and cross-functional collaboration in a regulated

Qualifications

• 12+ years of management experience in a regulated industry.
• Experience managing global health authority inspections and remediation.
• Working knowledge across QA, QC, Quality Systems, validation, and regulatory.
• Proven leadership in matrix environments.

Responsibilities

• Oversee end-to-end site preparation and management of audits and inspections.
• Lead fact-finding meetings for significant events and ensure QMS documentation.
• Manage regulatory notifications and risk signals; trend quality data.
• Develop and oversee site internal audit program and site compliance plan.

Skills

Leadership in quality programs

Excellent communication

Strategic thinking

Project management

Cross-functional collaboration

Regulatory knowledge

Data integrity knowledge

Education

BS in Science or Engineering

MBA

MS in Science or Engineering

Job description

Bristol Myers Squibb in Summit, NJ is seeking a Director of Quality Compliance for the CAR T manufacturing facility. You will lead site-wide compliance programs, oversee audits, inspections, and regulatory interactions, and drive continuous improvement to ensure inspection readiness across QA, QC and related functions.

The role reports to the Senior Director of Quality Systems & Compliance and requires strong leadership, strategic thinking, and cross-functional collaboration in a regulated