Total Quality Systems Manager

About the Role

The Total Quality Management Systems (TQMS) Manager provides strategic oversight of the Quality Assurance, Quality Control, and Regulatory Affairs functions while fostering a culture of quality, continuous improvement, operational excellence, and customer satisfaction. This leadership role ensures all products consistently meet established quality, safety, regulatory, and customer specifications through collaboration with Manufacturing, Engineering, Supply Chain, R&D, Product Development, Sales, and Executive Leadership.

Responsibilities

• Lead the Company's Total Quality Management System (TQMS) strategy and execution.
• Maintain and continuously improve the ISO-certified Quality Management System.
• Ensure ongoing compliance with ISO standards, FDA regulations, customer requirements, and applicable domestic and international regulatory requirements.
• Develop, review, and maintain Quality Manuals, SOPs, Work Instructions, and controlled documentation.
• Manage document control and change management processes.
• Monitor quality KPIs and develop action plans to improve organizational performance.
• Champion Root Cause Analysis, CAPA, and continuous improvement initiatives.
• Direct all Quality Assurance and Quality Control activities throughout manufacturing operations, ensuring incoming materials, in-process production, finished goods, and packaging meet established specifications.
• Oversee laboratory testing, inspections, product release, and quality approvals; analyze quality trends and implement preventive measures.
• Manage customer complaints, non-conforming materials, deviations, and corrective actions; lead investigations utilizing structured problem-solving methodologies.
• Oversee regulatory compliance for personal care, cosmetic, fragrance, and consumer products, including FDA cosmetic regulations, MoCRA requirements, GMPs, OSHA, EPA, IFRA standards, and customer-specific requirements.
• Maintain product documentation supporting regulatory submissions and customer inquiries, including Safety Data Sheets (SDS), Technical Data Sheets (TDS), Certificates of Analysis (COAs), and Certificates of Conformance (COCs).
• Partner with product development teams (Marketing & Sales) to ensure regulatory compliance during product development and commercialization.
• Lead internal quality audits; coordinate external ISO certification audits; support customer audits and supplier qualification audits.
• Develop and oversee corrective and preventive action (CAPA) programs resulting from audit findings; ensure audit readiness across all manufacturing operations.
• Lead, coach, mentor, and develop quality and regulatory team members; establish departmental objectives aligned with company strategic initiatives.
• Promote accountability, collaboration, and continuous learning; develop succession planning and employee development initiatives within the department.
• Partner with Operations to improve manufacturing efficiencies while maintaining product quality; collaborate with Engineering on process validation and equipment qualification.
• Support Supply Chain with supplier qualification, vendor quality management, and raw material approvals.
• Participate in New Product Development/Launch (NPD/NPL) and scale-up activities.
• Serve as the primary quality representative during customer interactions.
• Identify quality risks throughout manufacturing processes; develop mitigation strategies to minimize product quality issues.
• Lead risk assessments including FMEA and process validation activities; ensure business continuity from a quality systems perspective.