Quality Engineering Manager, Change Control & Doc Review

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

Benefits offered by this job

Wellbeing benefits

Retirement plan

Insurance offerings

Job summary

Bristol Myers Squibb in Madison, NJ seeks a Manager of Quality Engineering, Change Control/Document Review to lead change control activities across the site and ensure regulatory compliance. You will serve as SME for the Change Control process with cross-functional influence and drive process improvements.

The role requires strong writing, data analysis, and collaboration skills, with a focus on advancing quality systems and supporting inspections.

Qualifications

• Must have experience with cGMP manufacturing, Quality, and Compliance.
• Strong authorship and ability to critically evaluate change controls with QA principles.
• Ability to recognize quality issues and propose solutions for complex issues.
• Understanding of continuous improvement for compliance and efficiency.
• Ability to convey data analysis clearly to management.

Responsibilities

• Oversee change control quality process for GMP activities across cross functional areas.
• Review and approve change controls and related documents for regulatory compliance.
• Drive process improvements and support inspections.
• Provide SME support during internal and health authority inspections.
• Communicate with stakeholders and manage quality issues with clear recommendations.

Skills

cGMP manufacturing

Quality

Compliance

Change control

Documentation

Data analysis

Communication

Problem solving

Leadership

Education

Bachelor of Science

College degree required

Job description

Bristol Myers Squibb in Madison, NJ seeks a Manager of Quality Engineering, Change Control/Document Review to lead change control activities across the site and ensure regulatory compliance. You will serve as SME for the Change Control process with cross-functional influence and drive process improvements.

The role requires strong writing, data analysis, and collaboration skills, with a focus on advancing quality systems and supporting inspections.