Director Quality
About The Position
Actylis is a global solutions provider with over 75 years of experience, specializing in streamlining the management of critical ingredients and raw materials for our business partners. We offer both sourcing and manufacturing solutions tailored to meet diverse and evolving needs, ensuring a reliable, agile, and secure supply network. Our commitment to customization allows us to create flexible solutions, whether it’s a unique specification, custom packaging, or tailored logistics strategies. With deep expertise in quality and regulatory compliance, sourcing and logistics management, analytical services, and R&D support, we reduce complexities and mitigate risks, empowering our partners to focus on growing their business. In furtherance of that goal, Actylis is seeking new members of the team. This expansion, coupled with a comprehensive benefits package, and opportunities for challenge and growth, make Actylis the ideal place to work and thrive. We hope you’ll consider joining us!
Requirements
- Bachelor's degree in Chemistry, Food Science, Microbiology, Biochemistry, Engineering, Pharmaceutical Sciences, or related scientific discipline.
- 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.
Nice To Haves
- Master's degree preferred.
- MasterControl experience strongly preferred.
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 but not limited to 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 in alignment with Corporate Quality Objectives and initiatives.
- 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.
Benefits
- comprehensive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Director
