Associate Director, EMES Operational Excellence and Compliance

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

Job summary

Join a leading biopharma company as an Associate Director overseeing operational excellence and compliance strategies. This role involves collaboration with IT and cross-functional teams to ensure regulatory compliance and continuous improvement across manufacturing sites. Enjoy a competitive salary and benefits while making a meaningful impact on patients' lives.

Benefits

Health insurance

Pension contributions

Career advancement opportunities

Qualifications

• Minimum 10 years in pharmaceutical quality operations.
• 6+ years in GMP execution systems.

Responsibilities

• Develop and execute EMES operational strategies.
• Liaise with quality and CSV teams, lead validation activities.
• Collaborate on creating standards for manufacturing systems.

Skills

Communication

Cross-functional collaboration

Regulatory experience

Tools

GMP execution systems

Process automation

MES

Batch manufacturing standards

Validation

Job description

Associate Director, EMES Operational Excellence and Compliance

Join Bristol Myers Squibb as an Associate Director, EMES Operational Excellence and Compliance.

About Us

Working at Bristol Myers Squibb offers challenging, meaningful, and life-changing work. We operate across various departments, from optimizing production lines to pioneering breakthroughs in cell therapy, all aimed at transforming patients' lives. We provide opportunities for growth and thrive on high-achieving teams.

We value work-life balance and offer competitive benefits, including health insurance, pension contributions, and more. Learn more at careers.bms.com/working-with-us.

Our Ireland Operations

Since 1964, Bristol Myers Squibb Ireland employs over 650 staff at Cruiserath Biologics Campus in Dublin, a state-of-the-art biologics manufacturing facility crucial to our global network. Recognized as Biopharma Company of the Year 2019 and a Great Place to Work, we are committed to excellence and innovation.

The Role

Based at BMS Cruiserath or in US offices (NJ or MA), the Associate Director will oversee operational excellence and compliance strategies for the EMES solution, collaborating with IT Quality, Validation, and cross-functional teams to ensure regulatory and cybersecurity compliance. The role involves supporting EMES deployment, continuous improvement, and harmonization across manufacturing sites.

Key Responsibilities

• Operational Strategy: Develop and execute EMES operational strategies, manage KPIs, incident and crisis management, demand intake, and training initiatives.
• IT Compliance & Validation: Liaise with quality and CSV teams, lead validation activities, and ensure compliance with Data Integrity, change control, and incident management standards.
• Standards Development: Collaborate on creating standards for recipe-driven manufacturing systems, including deployment and data management activities.

Qualifications

• Minimum 10 years in pharmaceutical quality operations, with 6+ years in GMP execution systems.
• Experience in process automation, MES, batch manufacturing standards (ISA S88/S95), and validation (21 CFR Part 11, GAMP).
• Strong communication skills, cross-functional collaboration, and regulatory experience, including FDA interactions.

Why Join Us

• Help patients fight serious diseases.
• Be part of a company that values diversity, innovation, and leadership development.
• Enjoy a competitive salary, benefits, and opportunities for career advancement.

We encourage candidates to apply even if their experience doesn't match all listed qualifications. Join us and be part of life-changing work.