QA Operations Head (Associate Director)

Novartis • Durham, CA

4d • $138,600 - $257,400 • Onsite

About The Position

Join Novartis as our QA Operations Head and play a pivotal role in ensuring patients receive high-quality medicines that meet the highest standards of safety, compliance, and reliability. This is an opportunity to lead a critical Quality Operations organization at our new small molecule manufacturing site in Morrisville, partnering closely with Manufacturing, Quality Control, and technical teams to drive operational excellence, product quality, and regulatory compliance. As a visible site leader, you will empower and develop high-performing teams, champion continuous improvement, and help shape the future of quality within a dynamic and growing manufacturing environment.

Requirements

• 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 which can include expert 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 Heath Authority inspections (preferably FDA) and regulatory procedures
• Proven experience leading deviation investigations, corrective and preventive actions, validation activities, and continuous improvement initiatives.

Nice To Haves

• Previous involvement with facility start-ups, qualifications, validations, transfers
• Qualifications or certification in Lean Management, Operational Excellence, or continuous improvement methodologies.

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.

Benefits

• health
• life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Manager