QA Operations Head (Associate Director)

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

Job Description Summary

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.

Job Description

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.

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 and 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 [e-mail] 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.

Salary Range

$138,600.00 - $257,400.00

Skills Desired

Collaboration, Data Integrity, Decision Making, Leadership

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