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Senior Quality Manager (REMOTE)
Remote · Cincinnati, Ohio, United States or High Point, North Carolina, United States
Job Summary
Senior Quality Manager (REMOTE) leads global quality initiatives for the Oral Solid Dose unit, driving continuous improvement, compliance, and performance across sites. Serves as liaison between global quality functions and site leadership, supporting global quality strategies, inspection readiness, and proactive, risk-based quality management. Oversees complex investigations, CAPA effectiveness, quality performance reviews, and cross-site improvement using Practical Process Improvement (PPI), data-driven decision-making, and standardized best practices; collaborates with regulatory, operations, technical teams, and client-facing functions; travels up to 50% and supports inspections and customer audits. Strong knowledge of GMP, ISO, FDA requirements; experience with quality tools (FMEA, Risk Analysis, Root Cause Analysis); leading quality investigations, CAPA, change control; demonstrates excellent communication and cross-functional leadership; proficient with quality management software; committed to building a culture of quality and continuous improvement across global sites.
Required Qualifications
- BS degree required (science/engineering/related technical field)
- Advanced degree preferred
- 5 years quality management/leadership experience in pharmaceutical/medical device or regulated life sciences
- Experience implementing continuous improvement initiatives
- Experience with FMEA, Risk Analysis, and Root Cause Analysis
- Experience hosting regulatory inspections and customer audits
- Expert knowledge of global quality standards (ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR)
- Strong data analysis and problem-solving abilities
- Excellent project management and cross-functional leadership
- Ability to travel up to 50%
- Proficiency with quality management software systems
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