Quality Manager

Position Summary

The Director, Quality is responsible for leading all Quality Assurance, Quality Control, Food Safety, Compliance, and Quality Systems activities at the Actylis manufacturing facilities (Ogden & Centerville), Utah. The incumbent serves as the senior quality leader for the site and is accountable for ensuring products are manufactured, tested, released, stored, and distributed in compliance with applicable regulatory requirements, food safety standards, customer expectations, and Actylis Quality Management System requirements.

This role provides strategic and operational leadership for the site's Quality Management System (QMS), Quality Control Laboratory, MasterControl platform, supplier quality activities, customer quality support, audit readiness, batch disposition, continuous improvement initiatives, and compliance programs. The Director, Quality partners closely with Operations, Supply Chain, Procurement, R&D/Product Development, Regulatory Affairs, and Commercial teams to drive product quality, operational excellence, and regulatory compliance while supporting business growth.

Responsibilities

• Serve as the senior quality representative for the Utah manufacturing facilities (Ogden & Centerville).
• Act as a member of the Site Leadership Team and primary Quality business partner to the Site Director.
• Maintain and continuously improve the site Quality Management System.
• Ensure effective implementation and oversight of deviations, CAPA, change controls, investigations, risk assessments, document management, training programs, internal audits, management review, and product quality reviews.
• Ensure compliance with corporate quality policies, procedures, and applicable regulatory and customer requirements.
• Serve as Site Business Owner for the MasterControl Quality Management System.
• Ensure effective implementation and utilization of applicable MasterControl modules, including Document Control, Training Management, Quality Events, Audit Management, and Supplier Management.
• Lead process automation initiatives and continuous improvement efforts within the electronic quality system.
• Provide leadership and oversight of site Quality Control operations, including external contract testing labs.
• Ensure laboratory activities comply with approved methods, specifications, procedures, and data integrity expectations.
• Maintain authority for final product quality disposition decisions, consistent with site and corporate procedures.
• Ensure timely review and disposition of raw materials, intermediates, batches, and finished products.
• Review and approve quality-related investigations and product release documentation.
• Ensure compliance with applicable requirements, including FSMA, 21 CFR Part 117, HACCP, GMP requirements, and customer-specific standards.
• Support regulatory inspections, certification audits, and customer audits in partnership with Corporate Quality and Regulatory Affairs.
• Lead investigation and resolution of customer complaints associated with the Utah manufacturing sites.
• Ensure robust root cause investigations and implementation of effective corrective and preventive actions.
• Support major customer audits, technical reviews, and customer qualification activities.
• Serve as escalation point for significant quality-related customer issues.
• Partner with Corporate Supplier Quality and Procurement teams to ensure qualification and ongoing monitoring of raw material suppliers.
• Support risk assessments for critical suppliers and materials.
• Ensure supplier-related quality issues are effectively investigated, escalated, and resolved.
• Maintain continuous inspection readiness across QA, QC, production, warehouse, and support functions.
• Lead site preparation for FDA inspections, certification audits, customer audits, and internal audits.
• Report audit outcomes, compliance trends, and significant quality risks to executive leadership.
• Establish and monitor site quality KPIs, including Right First Time, customer complaints, CAPA closure effectiveness, audit findings, training compliance, laboratory turnaround time, supplier performance, and cost of poor quality.
• Use data analytics to identify improvement opportunities and drive risk-based decision-making.
• Recruit, develop, coach, and retain a high-performing quality organization.
• Establish clear performance expectations, development plans, and accountability mechanisms for team members.
• Drive employee engagement, ownership, collaboration, and operational excellence.
• Build succession plans and leadership capability throughout the Quality organization.

Required Experience & Knowledge

Bachelor's degree in Chemistry, Food Science, Microbiology, Biochemistry, Engineering, Pharmaceutical Sciences, or related scientific discipline. Master's degree preferred.

Minimum 10 years of progressive Quality leadership experience within food, nutritional ingredients, dietary supplements, specialty ingredients, or regulated manufacturing environments. Minimum 5 years managing Quality Assurance and Quality Control functions in a manufacturing site. Previous experience leading customer, certification, or regulatory inspections. Experience implementing and managing electronic Quality Management Systems. MasterControl experience strongly preferred.