Senior MES Transformation Lead, GMP Digital Manufacturing

Biopharma Careers; United States; On-site; USD 109,000 - 202,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Paid time off

Job summary

Novartis in Durham, NC seeks a Senior Manager, MES to lead strategy, governance, and operations for Manufacturing Execution Systems across the site. You will align MES with production goals, oversee lifecycle management, and ensure GMP, FDA, data integrity, and quality requirements while supporting 24/7 operations.

You will build and develop a high-performing team, collaborate across Manufacturing, Quality, MS&T, Engineering, IT, and Finance, and drive digital transformation through data-driven

Qualifications

• Minimum eight years of experience in manufacturing systems, MES, automation, or regulated manufacturing environments.
• Experience within the pharmaceutical or biopharmaceutical industry.
• Strong knowledge of GMP, FDA regulations, electronic manufacturing systems, and data integrity principles.
• Excellent verbal and written communication skills with the ability to influence diverse stakeholders.

Responsibilities

• Lead strategy, governance, and operational oversight for MES across the site.
• Align MES priorities with manufacturing goals, project commitments, and production readiness requirements.
• Oversee MES lifecycle management, including support, enhancements, upgrades, and system compliance.
• Ensure manufacturing systems meet GMP, FDA, data integrity, and quality requirements.
• Partner across Manufacturing, Quality, Engineering, and IT to resolve complex system challenges.
• Drive continuous improvement using performance metrics, operational trends, and KPIs.
• Support 24/7 manufacturing operations through effective MES troubleshooting and issue resolution.
• Lead cross-functional projects, balancing resources and priorities to deliver business-critical initiatives.
• Maintain audit-ready systems, documentation, procedures, and compliance practices.
• Develop high-performing teams through coaching, talent development, and a culture of accountability.

Skills

Communication

Leadership

Cross-functional collaboration

Data-driven decision making

Education

Bachelor's degree in a relevant field

Job description

Novartis in Durham, NC seeks a Senior Manager, MES to lead strategy, governance, and operations for Manufacturing Execution Systems across the site. You will align MES with production goals, oversee lifecycle management, and ensure GMP, FDA, data integrity, and quality requirements while supporting 24/7 operations.

You will build and develop a high-performing team, collaborate across Manufacturing, Quality, MS&T, Engineering, IT, and Finance, and drive digital transformation through data-driven