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The Quality Control Manager is responsible for leading the Quality Control laboratory in West Point and Harleysville and the incoming sampling functions for the West Point, PA manufacturing facility.  This role provides leadership for analytical, raw material, finished products, and stability testing activities to ensure safe, compliant, and reliable support of manufacturing operations and customer requirements.  
The Quality Control Manager is accountable for laboratory compliance, efficient operational performance, department leadership, alignment of QC capabilities with current and future business needs, and clear, professional communication with employees, cross-functional partners, customers, and site leadership. This role partners closely with Manufacturing, Quality Assurance, Regulatory, Technical Services, Supply Chain, Engineering, EHS and other site leadership to improve performance, support growth, reduce risk, and ensure the laboratory is positioned to meet evolving business needs.  This position reports to the Senior Quality and Regulatory Manager at West Point.  

Responsibilities& Duties

• Manage, coach, and develop a team of chemists, microbiologists, analysts, and laboratory personnel, including hiring, training, performance management, development planning, and succession planning.
• Ensure all laboratory activities are performed in compliance with applicable cGMP, cGLP, safety, quality, regulatory, customer, and internal requirements.
• Maintain laboratory data integrity through strong documentation practices, system controls, analyst training, and timely investigation of nonconformances.
• Ensure effective execution of laboratory quality systems including SOP governance, training compliance, deviations, CAPAs, change controls, calibration, and preventative maintenance.
• Own and monitor QC performance metrics, including testing turnaround time, first-time right, calibration and training compliance, and laboratory deviations and nonconformances.
• Partner with manufacturing and quality teams to identify root causes, reduce repeat issues, and improve first-time right performance.
• Develop and execute capacity plans to support production schedules, new business, customer and internal requirements, equipment needs, and future site strategy and growth.
• Ensure stability testing requirements are planned, executed, reviewed, and completed in accordance with applicable procedures.
• Partner with site leadership to resolve issues, support production priorities, improve quality performance, and advance site objectives.
• Identify and lead continuous improvement initiatives to improve laboratory safety, compliance, productivity, utilization, and operational performance.
• Support customer complaint investigations, technical inquiries, internal nonconformance investigations, and other business-critical issue resolution.
• Maintain the QC laboratory in a state of readiness for internal, customer, regulatory, and global audits.
• Build and maintain a laboratory culture focused on safety, compliance, accountability, collaboration, technical excellence, teamwork, and continuous improvement.