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QA Operations Head (Associate Director)

Novartis
September 04, 2026
Full-time
Remote friendly (Durham, NC)
Worldwide
Operations
Role: Head of Quality Operations at a small molecule manufacturing site, responsible for ensuring compliance, product quality, and operational excellence. Responsibilities include overseeing manufacturing compliance, product release, deviation investigations, continuous improvement initiatives, validation, and inspection readiness. The role also involves leading teams, resource management, and leveraging data and technology for site transformation. Qualifications: Bachelor's or Master's in Life Sciences, Pharmacy, Chemistry, or related field; 8-10+ years in pharmaceutical manufacturing with direct experience in oral solid dosage production, quality leadership, and regulatory inspections (FDA preferred). Experience with deviations, CAPA, validation, and continuous improvement required. Desirable: facility start-up, qualification, Lean/Operational Excellence certifications. High-Value: small molecule manufacturing, quality compliance, FDA inspection experience, process validation, team leadership, and site transformation. Work setup: US-based, with a focus on leadership and compliance across operations.