Band
Level 3
Job Description Summary
Imagine leading C&Q activities that ensure the safe, compliant, and efficient delivery of innovative manufacturing capabilities that help bring life-changing medicines to patients. As a Commissioning & Qualification Expert at Novartis, you will play a critical role in driving GMP and GxP compliance across capital projects and manufacturing operations. You will partner with cross-functional teams to develop qualification strategies, oversee project execution, manage risk, and strengthen inspection readiness while advancing operational excellence. This is an exciting opportunity for a technically skilled leader to influence complex projects, shape engineering standards, and make a meaningful impact on patients worldwide.
Job Description
Location:
- 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.
Shift:
- Shift schedule will be phased in as the site approaches go-live. We are planning for 12-hour rotating shifts which will include at least one weekend day.
Key Responsibilities:
- Lead C&Q activities for GMP facilities, utilities, equipment, and systems across capital projects and operations.
- Develop and execute qualification strategies, plans, protocols, and documentation to maintain GxP compliance.
- Drive project risk assessments and implement effective risk mitigation strategies throughout the project lifecycle.
- Partner with cross-functional teams to deliver projects safely, on schedule, and within quality expectations.
- Oversee qualification deviations, investigations, and CAPAs to ensure timely and compliant resolution.
- Establish, implement, and continuously improve engineering standards, SOPs, templates, and best practices.
- Support internal audits, regulatory inspections, and PAI activities while strengthening inspection readiness.
- Manage vendor and contractor relationships, including selection, contracting, performance monitoring, and compliance oversight.
- Provide leadership, coaching, and technical guidance to build high-performing engineering teams.
- Monitor and report KPIs related to qualification status, deviations, CAPAs, compliance, and project performance.
Essential Requirements:
- Bachelor's or Master's degree in Engineering or a related technical discipline.
- Minimum 5 years of experience in engineering projects, C&Q, validation, or compliance within GMP environments.
- Minimum 5 years of pharmaceutical industry experience supporting regulated manufacturing operations.
- Strong knowledge of GMP, GxP, qualification lifecycle, validation principles, and regulatory expectations.
- Proven project management experience delivering complex engineering projects safely and compliantly.
- Demonstrated experience leading and influencing cross-functional teams, contractors, and external partners.
- Strong problem-solving skills with experience managing deviations, investigations, risk assessments, and CAPAs.
- Fluent English communication skills with the ability to effectively engage technical and business stakeholders.
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $98,700 and $183,300 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.
Salary Range
$98,700.00 - $183,300.00
Skills Desired
Business Continuity, Cost Management, Operational Excellence, Quality Compliance
