Sr. Manager, Manufacturing Execution Systems (MES)
Novartis
August 23, 2026
On-site
Durham, NC
IT
Key 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 (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 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.
Essential Requirements:
- Bachelor’s degree in Biological Sciences, Engineering, Information Systems, Automation, or related technical field.
- Minimum 8 years of experience in manufacturing systems, MES, automation, or regulated manufacturing environments.
- Experience in pharmaceutical or biopharmaceutical industry.
- Strong knowledge of GMP, FDA regulations, electronic manufacturing systems, and data integrity.
- Demonstrated success leading/developing technical or manufacturing-focused teams.
- Ability to lead complex cross-functional projects in a matrix organization.
- Excellent verbal and written communication skills; ability to influence stakeholders.
- Strong collaboration skills across Manufacturing, Quality, MS&T, Engineering, IT, and Finance.
Desirable Requirements:
- Experience with MES roadmaps, manufacturing data analytics, KPIs, and digital manufacturing transformation.
- Experience supporting validation, change control, CAPAs, audit readiness, and regulatory inspections for GMP computerized systems.
- 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 (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 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.
Essential Requirements:
- Bachelor’s degree in Biological Sciences, Engineering, Information Systems, Automation, or related technical field.
- Minimum 8 years of experience in manufacturing systems, MES, automation, or regulated manufacturing environments.
- Experience in pharmaceutical or biopharmaceutical industry.
- Strong knowledge of GMP, FDA regulations, electronic manufacturing systems, and data integrity.
- Demonstrated success leading/developing technical or manufacturing-focused teams.
- Ability to lead complex cross-functional projects in a matrix organization.
- Excellent verbal and written communication skills; ability to influence stakeholders.
- Strong collaboration skills across Manufacturing, Quality, MS&T, Engineering, IT, and Finance.
Desirable Requirements:
- Experience with MES roadmaps, manufacturing data analytics, KPIs, and digital manufacturing transformation.
- Experience supporting validation, change control, CAPAs, audit readiness, and regulatory inspections for GMP computerized systems.