Product Steward – Data-Driven Quality & Process Expert

U473 (FCRS = US473) Novartis Innovative Technologies Inc; Morrisville (NC); On-site; USD 126,000 - 234,000; Full time

Job summary

Novartis Innovative Technologies Inc. in Morrisville, North Carolina, seeks a Product Steward to become the technical expert for product and process knowledge across the commercial lifecycle.

You will apply data analytics, process monitoring, and scientific expertise to keep products in a state of control and drive continuous improvement in manufacturing operations. Responsibilities include leading investigations, overseeing risk assessments, supporting process validation and tech transfers, and

Qualifications

• 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.

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 actions.
• 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 and manufacturing excellence projects.
• Support regulatory readiness, product transfers, and technical change implementation for assigned products.

Skills

Applied Statistics

Change Controls

Data Analytics

GMP

Manufacturing Processes

Manufacturing Production

Process Control

Quality Compliance

Regulatory Compliance

Technical Leadership

Technology Transfer

Education

Bachelor’s degree in Pharmacy/Pharmaceutical Science

Job description

Novartis Innovative Technologies Inc. in Morrisville, North Carolina, seeks a Product Steward to become the technical expert for product and process knowledge across the commercial lifecycle.

You will apply data analytics, process monitoring, and scientific expertise to keep products in a state of control and drive continuous improvement in manufacturing operations. Responsibilities include leading investigations, overseeing risk assessments, supporting process validation and tech transfers, and