Associate Director, EMES Operational Excellence and Compliance

Bristol Myers Squibb; New Brunswick (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking an Associate Director for EMES Operational Excellence and Compliance. This role involves overseeing operational strategies, ensuring compliance with regulatory standards, and fostering a culture of continuous improvement across manufacturing sites. The ideal candidate will have extensive experience in quality operations, strong leadership skills, and the ability to influence in a matrix environment. Join a team dedicated to innovative biologics manufacturing and employee well-being.

Benefits

Competitive salary

Bonus

Pension

Health insurance

Qualifications

• Minimum 10 years in pharmaceutical quality operations, with at least 6 years in GMP execution systems.
• Experience with process automation, MES, and validation standards.

Responsibilities

• Develop and oversee EMES operation strategies, including incident and crisis management.
• Act as liaison for quality and CSV organizations, oversee validation activities.
• Collaborate on standards supporting recipe-driven manufacturing.

Skills

Leadership

Communication

Cross-functional collaboration

Regulatory experience

Tools

GMP execution systems

MES

Process automation

Batch manufacturing standards

Validation standards

Job description

Associate Director, EMES Operational Excellence and Compliance

Join to apply for the Associate Director, EMES Operational Excellence and Compliance role at Bristol Myers Squibb.

This role reports to the Senior Director, Enterprise MES & Manufacturing Architecture, GPS BI&T, Product Acceleration & Capabilities IT. It provides oversight and support for operational excellence and compliance strategies for the BMS Enterprise Manufacturing Execution System (EMES) solution. The individual will partner with IT Quality, IT Validation, and cross-functional teams to ensure systems meet regulatory and cybersecurity standards. Key responsibilities include overseeing EMES operational and continuous improvement, supporting EMES deployment at new sites, and fostering an operational excellence culture across manufacturing sites.

Key Duties and Responsibilities

1. Operation Excellence: Develop and oversee EMES operation strategies, including tier meetings, demand management, incident and crisis management, KPI management, training, and knowledge management. Drive continuous improvement using methodologies like Agile, Lean, or AI.
2. IT Compliance & Methodology: Act as liaison for quality and CSV organizations, oversee validation activities, provide IT compliance guidance, manage change strategies, and ensure alignment with global MES design.
3. Development and Standards: Collaborate on standards supporting recipe-driven manufacturing and ensure deployment and upgrade protocols are followed.

Qualifications, Knowledge, and Skills

• Minimum 10 years in pharmaceutical quality operations, with at least 6 years in GMP execution systems.
• Experience with process automation, MES, batch manufacturing standards (ISA S88 & S95), and validation standards (21 CFR Part 11, GAMP).
• Strong communication, cross-functional collaboration, and regulatory experience, including with US FDA.
• Leadership skills with ability to make difficult decisions and influence in a matrix environment.
• Ability to travel domestically and internationally up to 20%.

Location

This position is available at BMS offices in NJ, MA, or Dublin.

Why You Should Apply

• Contribute to patient health by supporting innovative biologics manufacturing.
• Work in a company that values diversity, leadership development, and employee well-being.
• Enjoy competitive salary and benefits including bonus, pension, health insurance, and more.