MES Leader: Digital Manufacturing & Compliance

NCBiotech; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis is seeking a Senior Manager, Manufacturing Execution Systems (MES) to lead MES strategy and governance across a major site in Durham, NC. You will drive digital transformation, ensure GMP compliance, and guide a cross-functional team through complex projects that improve manufacturing performance and data integrity.

You will collaborate with Manufacturing, Quality, MS&T, Engineering, IT, and Finance to align priorities, manage lifecycle upgrades, and maintain audit-ready systems while

Qualifications

• Bachelor's degree in Biological Sciences, Engineering, Information Systems, Automation or related technical field.
• Minimum eight years of experience in manufacturing systems, MES, automation, or regulated environments.
• Experience in pharmaceutical or biopharmaceutical industry.
• Strong knowledge of GMP and FDA regulations and data integrity.
• Proven ability to lead cross-functional projects in a matrix organization.
• Excellent verbal and written communication with diverse stakeholders.
• Collaboration across Manufacturing, Quality, MS&T, Engineering, IT, and Finance.

Responsibilities

• Lead strategy, governance, and operational oversight for MES across the site.
• Align MES priorities with manufacturing goals, project commitments, and production readiness.
• Oversee MES lifecycle management, including support, enhancements, upgrades, and system compliance.
• Ensure systems meet GMP, FDA, data integrity, and quality requirements.
• Partner across multiple functions to resolve complex system challenges.
• Drive continuous improvement using metrics and KPIs.
• Support 24/7 manufacturing operations through MES troubleshooting.
• Lead cross-functional projects and manage resources and priorities.
• Maintain audit-ready systems, documentation, and compliance practices.
• Develop high-performing teams through coaching and accountability.

Skills

Leadership

Cross-functional collaboration

Data analysis

Communication

Education

Bachelor's degree in Biological Sciences, Engineering, Information Systems, Automation

Job description

Novartis is seeking a Senior Manager, Manufacturing Execution Systems (MES) to lead MES strategy and governance across a major site in Durham, NC. You will drive digital transformation, ensure GMP compliance, and guide a cross-functional team through complex projects that improve manufacturing performance and data integrity.

You will collaborate with Manufacturing, Quality, MS&T, Engineering, IT, and Finance to align priorities, manage lifecycle upgrades, and maintain audit-ready systems while