QA Operations Head (Associate Director)

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

Benefits offered by this job

Health benefits

401(k) with company match

Disability benefits

Generous PTO

Job summary

Novartis is seeking a QA Operations Head for our new Morrisville site to lead quality operations and ensure the highest safety and regulatory standards. You will collaborate with Manufacturing, Quality Control and technical teams to drive excellence and shape the site’s quality culture.

As a visible site leader, you will empower high-performing teams, manage capacity and metrics, and champion continuous improvement aligned with the Novartis Technical Operations strategy.

Qualifications

• Bachelor or Master in Life Sciences, Pharmacy, Chemistry, Biotechnology or related discipline; advanced degree preferred.
• Minimum 8-10 years pharma experience including oral solid dosage manufacturing and QA/Engineering roles.
• Experience leading deviation investigations, CAPA, validation, and continuous improvement.

Responsibilities

• Provide quality leadership for product release, batch record review and disposition.
• Lead QA Operations oversight to ensure compliance across manufacturing activities.
• Drive investigations of deviations, out-of-spec results, and complaints with effective corrective actions.
• Support validation, technology transfer, and commissioning of new processes.
• Ensure inspection readiness and support internal and regulatory audits.

Skills

Quality Operations leadership

Regulatory compliance

Team leadership

Data analytics

Education

Bachelor/Master in Life Sciences or related

Job description

SummaryJoin 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.

SummaryJoin 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.

About The Role

Key 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.

Essential 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.

Desirable Requirements

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

The salary for this position is expected to range between $138,600 and $257,400 per year. The final salary offered is determined based on factors like, but not limited to, 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.

To learn more about the culture, rewards and benefits we offer our people click here.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.

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EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility & Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.