Product Steward
Listed on 2026-07-10
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering -
Pharmaceutical
Regulatory Compliance Specialist, Quality Engineering, Pharmaceutical Manufacturing
Job Summary
Band Level 4 Product Steward role in Morrisville, North Carolina. Responsible for maintaining deep product and process knowledge throughout the commercial lifecycle, turning data into insights to improve product quality and manufacturing performance.
Responsibilities- 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 an 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.
Salary range: $126,000 to $234,000 per year, with performance‑based cash incentive and, depending on the role level, eligibility for annual equity awards.
Eligible employees receive a comprehensive benefits package including health, life, and disability benefits, a 401(k) with company contribution and match, and additional benefits. A generous time‑off package includes vacation, personal days, holidays, and other leaves.
EEO StatementNovartis Group of Companies is an Equal Opportunity Employer. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
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