Sr. Manager, Manufacturing Execution Systems (MES
Listed on 2026-08-03
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Manufacturing / Production
Regulatory Compliance Specialist, Quality Engineering
Job Description Summary
Unlock the future of pharmaceutical manufacturing as a leader at the forefront of digital operations and manufacturing excellence. As Senior Manager, Manufacturing Execution Systems (MES), you will play a critical role in enabling safe, compliant, and efficient production that helps bring innovative therapies to patients around the world. Working across Manufacturing, Quality, Manufacturing Sciences and Technology, Engineering, Information Technology, and Automation, you will shape the strategy, performance, and evolution of our manufacturing systems while leading a high-performing team.
This is an opportunity to drive digital transformation, influence site-wide priorities, and make a meaningful impact on both operational success and patient outcomes through data-driven decision making, continuous improvement, and collaborative leadership.
This position will be located in Durham, NC and will be an onsite role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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, 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.
- Bachelor's degree in Biological Sciences, Engineering, Information Systems, Automation, or a related technical field.
- Minimum eight years of experience in manufacturing systems, MES, automation, or regulated manufacturing environments.
- Experience with in the pharmaceutical or biopharmaceutical industry.
- Strong knowledge of GMP, FDA regulations, electronic manufacturing systems, and data integrity principles.
- Demonstrated success leading and developing technical or manufacturing-focused teams.
- Proven ability to lead complex cross-functional projects within a matrix organization.
- Excellent verbal and written communication skills with the ability to influence diverse stakeholders.
- Strong collaboration and relationship-building skills across Manufacturing, Quality, MS&T, Engineering, IT, and Finance.
- Experience with MES roadmaps, manufacturing data analytics, KPIs, and digital manufacturing transformation initiatives.
- Experience supporting validation, change control, CAPAs, audit readiness, and regulatory inspections for GMP computerized systems.
The salary for this position is expected to range between $108,500 and 201,500 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
The Novartis Group of Companies are Equal Opportunity Employers.
We do not discriminate in recruitment, hiring, training, promotion or other employment…
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