Process Expert
Listed on 2026-07-01
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Quality Assurance - QA/QC
Production QC/QA, Regulatory Compliance Specialist
Summary
Step into a role where your technical expertise directly drives the success of life‑changing medicines. As a Process Expert, you will be at the heart of manufacturing operations, ensuring processes run smoothly, compliantly, and efficiently. You will act as the go‑to specialist on the shop floor—solving complex challenges, supporting production teams, and continuously improving quality, safety, and productivity. This is an opportunity to make a tangible impact while working in a collaborative, fast‑paced environment where innovation and operational excellence go hand in hand.
AboutThe Role
- 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.
- Provide frontline expert support for process‑specific issues in manufacturing operations.
- Act as Subject Matter Expert for assigned products and processes.
- Coordinate production activities to ensure on‑time execution aligned with approved documentation.
- Troubleshoot technical issues and implement effective corrective and preventive actions.
- Review batch records and ensure timely completion of batch documentation.
- Maintain accurate and up‑to‑date production documentation to support compliance and audits.
- Support validation activities and changeover processes between production campaigns.
- Deliver training programs and build technical capabilities of production teams.
- Collaborate with training teams to define and maintain qualification standards.
- Promote strong quality and health, safety, and environmental culture on the shop floor.
- University degree in Science, preferably Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent experience.
- Minimum 2 years of experience in a GMP manufacturing process support role.
- Minimum 7 years of experience in relevant field for candidates without a university degree.
- Strong knowledge of GMP and regulatory requirements across multiple health authorities.
- Solid scientific and technical understanding, including manufacturing and automation principles.
- Good understanding or ability to quickly learn production processes.
- Experience with manufacturing systems such as MES, SAP, or similar platforms.
- Strong teamwork, communication, influencing skills, and ability to adapt and work under pressure.
The salary for this position is expected to range between $85,400 and $158,600 annually.
The final salary offered is determined based on factors such as 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. Employees are also eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO StatementThe 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 veteran status, disability, or any other legally protected status.
Accessibility & Reasonable AccommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e‑mail to or call and let us know the nature of your request and your contact information.
Please include the job requisition number in your message.
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