Product Steward
Listed on 2026-07-10
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Pharmaceutical
Quality Engineering, Regulatory Compliance Specialist
Location:
Morrisville, North Carolina
Are you passionate about turning data into insights that improve product quality and manufacturing performance? Join Novartis as a Product Steward and become the technical expert responsible for maintaining deep product and process knowledge throughout the commercial lifecycle. In this highly visible role, you will use data analytics, process monitoring, and scientific expertise to ensure products remain in a state of control, drive continuous improvement initiatives, and support robust, reliable manufacturing operations.
Working across multiple functions, you will play a key role in product stewardship, process validation, technical investigations, and operational excellence while helping deliver high-quality medicines to patients.
- Serve as the product subject matter expert throughout the commercial manufacturing lifecycle.
- Monitor process performance through data trending, statistical analysis, and ongoing product oversight.
- Lead technical investigations and drive effective corrective and preventive actions for process-related issues.
- Maintain product-specific quality risk assessments and support robust process control strategies.
- Ensure products remain in a continued state of validation through ongoing process verification activities.
- Partner with cross-functional teams to deliver process improvements, optimization initiatives, and manufacturing excellence projects.
- Support regulatory readiness, product transfers, and technical change implementation for assigned products.
- Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific degree.
- Minimum five years of experience in Oral Solid Dosage pharmaceutical manufacturing environments.
- Strong understanding of pharmaceutical manufacturing processes, regulatory requirements, and GMPs.
- Experience using data trending, statistical analysis, and process monitoring to drive decision‑making.
- Proven ability to investigate process issues, identify root causes, and implement effective corrective actions.
- Demonstrated experience working collaboratively across technical, quality, and manufacturing functions.
- Master of Science degree in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field.
- Experience supporting product transfers, process optimization initiatives, and manufacturing excellence programs.
The salary for this position is expected to range between $126,000 and $234,000 per year. The final salary offered is determined based on 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.
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