Maintenance Lead, Operations Management, Regulatory Compliance Specialist

Job Description Summary Imagine leading the strategy, performance, and future of a critical manufacturing site's maintenance organization. As a Maintenance Lead, you'll play a pivotal role in ensuring equipment reliability, operational excellence, and GMP compliance while shaping a high-performing team that supports the delivery of innovative medicines. This is an opportunity to influence site-wide engineering initiatives, drive continuous improvement, champion safety and quality, and make a lasting impact on patients by ensuring manufacturing operations run efficiently and reliably every day.

This position will be located in Morrisville, 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.

• Lead site Maintenance & Calibration operations to ensure safety, compliance, reliability, and business continuity.
• Develop and execute maintenance strategies that improve asset performance and equipment uptime.
• Drive TPM and Asset Lifecycle Management initiatives across manufacturing and engineering operations.
• Ensure GMP, FDA, quality, and HSE requirements are embedded in all maintenance activities.
• Lead, coach, and develop a high-performing maintenance organization and frontline leadership team.
• Oversee contractor performance, service providers, and maintenance-related third-party partnerships.
• Manage maintenance budgets, resource planning, and capital investments to meet business objectives.
• Champion continuous improvement initiatives that enhance efficiency, reliability, and cost performance.
• Maintain inspection readiness and support regulatory audits, customer audits, and PAI activities.
• Partner cross-functionally with Manufacturing, Quality, Engineering, and Technical Operations to achieve site goals.

• Bachelor's degree in Engineering or a related technical discipline.
• 8+ years of engineering experience within a regulated manufacturing environment.
• 5+ years of maintenance leadership experience with direct people management responsibilities.
• Proven experience leading Maintenance & Calibration programs in a GMP-regulated environment.
• Demonstrated expertise in Asset Lifecycle Management, reliability, and asset performance improvement.
• Experience managing large capital projects, maintenance contractors, and external service providers.
• Strong knowledge of FDA, GMP, GxP, Quality, and HSE requirements.
• Proven ability to lead cross-functional teams, drive continuous improvement, and deliver business results.

The salary for this position is expected to range between $114,100 and $211,900 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 practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or…