Quality Engineering Manager: Change Control & Documentation

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

Benefits offered by this job

Wellbeing support

Flexible Time Off

Company holidays

Job summary

Bristol Myers Squibb, Summit NJ, seeks a Manager of Quality Engineering to oversee Change Control and Document Review. The role focuses on supporting global change control processes, ensuring regulatory compliance, and driving improvements within a high-visibility, cross-functional environment.

Responsibilities include leading review of change controls, coordinating with stakeholders, and preparing technical communications. Requires a BS and 8+ years in pharma/related fields.

Qualifications

• Must have experience with cGMP manufacturing, Quality, and Compliance.
• Must be able to critically evaluate change controls.
• Must understand continuous improvement and quality system compliance.
• Excellent data analysis and reporting to management.

Responsibilities

• Manage the change control quality process for GMP activities.
• Review and approve change controls and related documents.
• Drive process improvement initiatives.
• Support internal and health authority inspections.
• Communicate with cross-functional stakeholders on change control matters.
• Prepare clear written communications for management.

Skills

cGMP knowledge

Quality risk management

Technical writing

Analytical thinking

Cross-functional communication

Decision making

Education

Bachelor of Science

Tools

Change Control systems

Job description

Bristol Myers Squibb, Summit NJ, seeks a Manager of Quality Engineering to oversee Change Control and Document Review. The role focuses on supporting global change control processes, ensuring regulatory compliance, and driving improvements within a high-visibility, cross-functional environment.

Responsibilities include leading review of change controls, coordinating with stakeholders, and preparing technical communications. Requires a BS and 8+ years in pharma/related fields.