What You'll Do

• Lead, coach, and develop a team of Quality professionals.
• Foster a culture of accountability, continuous improvement, and operational excellence.
• Ensure adequate cross-training and team readiness to support internal and external quality requirements.
• Drive efficiency, productivity, and performance across the Quality function.
• Oversee and evaluate team performance through coaching, development, and performance management.
• Ensure compliance with ABEC Standard Operating Procedures (SOPs), quality systems, and industry best practices.
• Support and maintain quality processes aligned with cGMP, GDP, ISO standards, and applicable regulatory requirements.
• Participate in internal, external, vendor, and customer audits.
• Manage and support CAPA activities, including root cause analysis and corrective/preventive action implementation.
• Lead Continuous Improvement initiatives that enhance processes, quality outcomes, and operational efficiencies.
• Coordinate Quality System Change Management activities.
• Oversee site calibration programs and quality system documentation.
• Monitor, analyze, and report key quality metrics and performance indicators.
• Support Material Review Board (MRB) processes and trend analysis activities.
• Partner with cross-functional teams to achieve site objectives and business goals.
• Support company core values, key initiatives, and strategic quality objectives.
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