FLSA Status: Exempt Grade Level: S10
Department: ARx Quality Reports To: ARx Director of Quality
Direct Reports: Principal Scientist, Quality Analyst, QC Chemist 1, II and III
Job Summary:
The Quality Control (QC) Manager leads the daily operations of the QC Laboratory, ensuring timely, compliant, and efficient testing of raw materials, in-process materials, finished products, and stability samples. This role oversees laboratory compliance, inspection readiness, investigations, and continuous improvement initiatives while providing leadership to QC staff and driving operational excellence, continuous improvement, cost efficiency, and performance results.
Essential Functions:
• Manage daily operations of the Quality Control Laboratory.
• Ensure timely execution and completion of testing activities for raw materials, bulk products, finished products, and stability programs.
• Develop and manage laboratory schedules, workload balancing, and resource allocation to meet business and production requirements.
• Ensure laboratory equipment is properly maintained, calibrated, qualified, and available for use.
• Maintain laboratory compliance with applicable regulatory requirements, company policies, and quality standards.
• Ensure the laboratory remains in a constant state of inspection readiness.
• Review, approve, and maintain laboratory documentation including test results, specifications, procedures, protocols, investigations, and reports.
• Lead and support internal audits, customer audits, regulatory inspections, and third-party assessments.
• Ensure adherence to data integrity requirements and Good Manufacturing Practices (GMP).
• Monitor laboratory quality metrics (KPIs) and implement corrective actions as needed.
Additional Responsibilities:
• Lead, coach, mentor, and develop QC Laboratory personnel.
• Conduct performance evaluations and support employee career development plans.
• Foster a culture of accountability, continuous learning, and operational excellence.
• Ensure adequate staffing, training, and competency assessments for laboratory personnel.
• Oversee laboratory investigations including Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and laboratory errors.
• Ensure timely and thorough root cause investigations and implementation of effective corrective and preventive actions (CAPA).
• Monitor recurring issues and drive sustainable improvements to prevent recurrence.
Job Specifications:
• Bachelor's degree in Chemistry or related scientific discipline required; advanced degree preferred with a minimum of 10 years related experience.
• 5+ years of leadership or management experience.
• Experience managing laboratory investigations, audits, inspections, and quality systems.
• Strong knowledge of GMP, GLP, data integrity requirements, and applicable regulatory standards.
• Strong leadership and people management skills.
• Excellent problem-solving and root cause analysis abilities.
• Effective communication and cross-functional collaboration skills.
• Experience with laboratory systems, testing methodologies, and equipment qualification.
• Strong organizational and project management skills.
• Ability to drive continuous improvement and operational excellence initiatives.
• Proficiency in data analysis, metrics management, and performance reporting.
