Novartis
QA Operations Head (Associate Director)
Durham · Director
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About the role
- Provide quality leadership for product release, batch record review, and disposition activities.
- 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.
- 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.
Responsibilities
- Lead Quality Operations oversight to ensure compliance across manufacturing activities and QA Operational Excellence.
- 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.
- 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.
Requirements
- Experience with Heath Authority inspections (preferably FDA) and regulatory procedures
Nice to have
- Bachelor of Science or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific discipline
- advanced degree preferred.
Skills
- Collaboration, Data Integrity, Decision Making, Leadership
Compensation
- $138,600.00 - $257,400.00
Benefits
- Develop, coach, and lead high-performing teams while fostering a culture of accountability and learning.
This listing is sourced directly from Novartis's careers page and normalized into a canonical job model.