Quality Engineering Manager - Change Control SME

Bristol-Myers Squibb Company; Madison (NJ); On-site; USD 117,000 - 141,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Paid vacation

Job summary

Bristol Myers Squibb is seeking a Manager, Quality Engineering, Change Control/Document Review for the Summit Cell Therapy Manufacturing site. The role leads the change control quality process across GMP activities, partnering with cross-functional teams to ensure compliant documentation and timely execution.

The incumbent will serve as the subject matter expert for Change Control, drive process improvements, and support internal and health authority inspections.

Qualifications

• Experience with cGMP manufacturing, quality and compliance.
• Strong writers who can critically evaluate change controls.
• Ability to analyze data and communicate clearly to management.
• Experience supporting internal and health authority inspections.
• Ability to interpret complex results and recommend solutions.

Responsibilities

• Manage the change control quality process for GMP activities with cross-functional teams.
• Review and approve change controls to ensure regulatory and internal compliance.
• Drive process improvements and support inspections with SME input.
• Prepare written communications and present issues/solutions to management.
• Support change control writing and guidance across the organization.

Skills

cGMP manufacturing

Quality & Compliance

authorship

data analysis

Change controls

Quality risk management

communication

process improvement

Education

Bachelor of Science degree

College or university degree

Job description

Bristol Myers Squibb is seeking a Manager, Quality Engineering, Change Control/Document Review for the Summit Cell Therapy Manufacturing site. The role leads the change control quality process across GMP activities, partnering with cross-functional teams to ensure compliant documentation and timely execution.

The incumbent will serve as the subject matter expert for Change Control, drive process improvements, and support internal and health authority inspections.