Global Quality Director

Position Summary

Develop a comprehensive enterprise quality strategy and roadmap that integrates Corporate Quality, Regulatory Compliance, Supplier Quality, and Field Operations Quality into a unified management system. Established standardized processes, governance, and performance metrics that aligned API and ISO requirements across the organization, strengthened supplier oversight, improved field execution, and create a culture of continuous improvement and operational excellence.

Key Responsibilities

• Develop and implement a strategic roadmap for the Corporate Quality Management System (QMS), establishing standardized processes and governance across corporate, supplier, and field operations.
• Maintain and ensure compliance with all applicable API, ISO, customer, and regulatory standards.
• Lead certification activities, surveillance audits, and recertification efforts.
• Oversee Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and continuous improvement initiatives.
• Ensure effective utilization of quality management and reporting systems, including Vector and GEMS.
• Establish quality metrics, monitor performance trends, and provide executive-level reporting.
• Develop and maintain quality policies, procedures, and best practices across the organization.
• Develop and manage the supplier quality management program.
• Conduct supplier qualifications, onboarding audits, and risk assessments.
• Lead Quarterly Quality Reviews (QQRs) with strategic suppliers.
• Oversee annual supplier audits and regulatory compliance assessments.
• Manage Supplier Corrective Action Requests (SCARs), NCRs, CAPAs, and supplier performance improvement plans.
• Collaborate with suppliers to improve product quality, reliability, delivery performance, and cost competitiveness.
• Ensure all operational locations maintain compliance with API, ISO, customer, and internal quality requirements.
• Conduct and facilitate Quarterly Quality Reviews across field locations.
• Develop and deliver regulatory compliance, quality systems, and reporting training programs.
• Review and improve quality investigation processes to ensure accuracy and effectiveness.
• Standardize quality procedures and work instructions to ensure consistency across all locations.
• Support service quality assurance initiatives and customer satisfaction improvement efforts.
• Drive implementation of a unified quality management framework across the organization.
• Lead Lean Manufacturing and Continuous Improvement initiatives across the organization and key suppliers.
• Facilitate Kaizen events focused on supplier performance, process improvement, waste reduction, and cost savings.
• Develop and implement internal Lean training programs for employees and leadership teams.
• Promote a culture of operational excellence through the use of Lean, Six Sigma, and problem-solving methodologies.
• Identify and execute productivity, quality, and cost-reduction opportunities throughout the value stream.
• Track and report measurable financial benefits resulting from continuous improvement initiatives.

Qualifications & Experience

• Bachelor's degree in Engineering, Manufacturing, Quality Management, Operations Management, or related field required. Master's degree preferred.
• 10+ years of progressive leadership experience in Quality, Regulatory Compliance, Manufacturing, or Operations.
• Experience managing API and ISO certification programs.
• Strong background in supplier quality management and auditing.
• Demonstrated success leading CAPA, RCA, and continuous improvement initiatives.
• Experience developing and implementing Lean Manufacturing programs.
• Multi-site quality leadership experience preferred.

Preferred Certifications

• ASQ Certified Quality Manager (CMQ/OE)
• ASQ Certified Quality Engineer (CQE)
• Lean Six Sigma Black Belt or Master Black Belt
• API Auditor Certification
• ISO 9001 Lead Auditor Certification

Benefits

• Health insurance
• Vacation pay based on years of relevant experience (not tenure with the company)
• Sick pay
• Paid holidays
• 401(k)-retirement plan with 4% employer matching
• On-site gym and locker rooms
• Free parking