QA Operations Leader - Pharma Quality & Compliance

Novartis Group Companies; Durham (NC); On-site; USD 138,600 - 257,400; Full time

Job summary

Novartis Group of Companies is seeking a QA Operations Head to lead a new small molecule manufacturing site in Morrisville, NC. You will guide Quality Operations, drive product release, disposition of batch records, and oversee deviations and CAPAs, while enabling continuous improvement and site transformations with cross-functional teams.

You will champion inspection readiness, develop high‑performing teams, and partner with Manufacturing, QC, and technical groups to ensure regulatory

Qualifications

• Bachelor of Science or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific discipline; advanced degree preferred.
• Minimum 8-10 years of relevant pharmaceutical experience including direct experience in oral solid dosage manufacturing including roles in Production, Manufacturing Science and Technology and/or Engineering, in addition to Quality.
• Demonstrated Quality Operations leadership experience with responsibility for product release, compliance, inspection readiness, people leadership, talent development, performance management, and cross-functional collaboration.
• Experience with Health Authority inspections (FDA preferred) and regulatory procedures
• Proven experience leading deviation investigations, corrective and preventive actions, validation activities, and continuous improvement initiatives.

Responsibilities

• Lead Quality Operations oversight to ensure compliance across manufacturing activities and QA Operational Excellence.
• Provide quality leadership for product release, batch record review, and disposition activities.
• Drive investigation of deviations, out-of-expectation results, and complaints, ensuring effective corrective actions.
• Lead continuous improvement initiatives to strengthen quality performance, compliance, and operational excellence.
• Support validation, technology transfer, commissioning, and implementation of new manufacturing processes and equipment.
• Ensure ongoing inspection readiness and successfully support internal, customer, and regulatory audits and inspections.
• Develop, coach, and lead high-performing teams while fostering a culture of accountability and learning.
• Manage resources, capacity planning, and quality metrics to achieve business and compliance objectives.
• Explore the potential of data and technology to support the manufacturing site's transformation journey in line with Novartis Technical Operations strategy.

Skills

Collaboration

Data Integrity

Decision Making

Leadership

Education

Bachelor/Master in Life Sciences/Pharmacy/Ct or related

Job description

Novartis Group of Companies is seeking a QA Operations Head to lead a new small molecule manufacturing site in Morrisville, NC. You will guide Quality Operations, drive product release, disposition of batch records, and oversee deviations and CAPAs, while enabling continuous improvement and site transformations with cross-functional teams.

You will champion inspection readiness, develop high‑performing teams, and partner with Manufacturing, QC, and technical groups to ensure regulatory