Position Summary
The Senior Manager/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 Senior Manager/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.
Essential Duties and ResponsibilitiesSite Quality Leadership
· Serve as the senior quality representative for the Utah manufacturing facilities (Ogden & Centerville).
· Establish and maintain a strong culture of quality, compliance, food safety, and accountability throughout the organization.
· Provide strategic leadership and direction to Quality Assurance and Quality Control teams.
· Act as a member of the Site Leadership Team and primary Quality business partner to the Site Director.
· Partner with Operations leadership to ensure quality is embedded into all manufacturing activities.
· Drive site quality objectives, annual goals, and continuous improvement initiatives.
Quality Management System (QMS)
· 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.
· Promote disciplined execution, timely closure of quality records, and effective quality governance.
MasterControl System Ownership
· 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 (CAPA, Deviations, Change Control, NONC, Customer Complaints, SCAR), Audit Management, and Supplier Management.
· Lead process automation initiatives and continuous improvement efforts within the electronic quality system.
· Ensure data integrity, compliance, reporting accuracy, and timely closure of quality records.
· Develop quality dashboards and site metrics using MasterControl data and supporting reporting tools such as Power BI, where applicable.
Quality Control Laboratory & External Contract Lab Oversight
· 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.
· Ensure testing activities support manufacturing operations and business requirements.
· Review laboratory performance metrics and drive improvements in cycle time, reliability, and efficiency.
· Ensure appropriate calibration, maintenance, qualification, and validation of laboratory equipment, as applicable.
· Oversee OOS, OOT, atypical result, and laboratory investigations, as applicable.
Product Release & Batch Disposition
· 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 all released products meet specifications, regulatory expectations/guidelines, and customer requirements.
Food Safety & Regulatory Compliance
· Ensure compliance with applicable requirements, including FSMA, 21 CFR Part 117, HACCP, GMP requirements, and customer-specific standards.
· Maintain site readiness for customer, certification body, and regulatory inspections.
· Lead food safety and quality risk management programs.
· Support regulatory inspections, certification audits, and customer audits in partnership with Corporate Quality and Regulatory Affairs.
Customer Quality & Complaint Management
· 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.
· Develop and monitor complaint trends and quality performance indicators.
Supplier Quality
· Partner with Corporate Supplier Quality and Procurement teams to ensure qualification and ongoing monitoring of raw material suppliers.
· Participate in supplier audits and supplier performance reviews, as required.
· Support risk assessments for critical suppliers and materials.
· Ensure supplier-related quality issues are effectively investigated, escalated, and resolved.
Audit & Inspection Readiness
· 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.
· Ensure timely completion and effectiveness verification of audit-related CAPAs.
· Report audit outcomes, compliance trends, and significant quality risks to executive leadership.
Quality Metrics & Operational Excellence
· 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.
· Drive continuous improvement projects supporting safety, quality, service, cost, and compliance objectives.
· Promote practical, business-oriented quality solutions while maintaining regulatory and customer confidence.
People Leadership
· 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.
QualificationsEducation
· Bachelor's degree in Chemistry, Food Science, Microbiology, Biochemistry, Engineering, Pharmaceutical Sciences, or related scientific discipline.
· Master's degree preferred.
Experience
· 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.
Knowledge, Skills & Competencies
Technical Competencies
Leadership Competencies
FSMA / 21 CFR Part 117
Strategic Thinking
HACCP / FSSC 22000
Operational Excellence
GMP and Food Safety Systems
Accountability
Root Cause Analysis / CAPA
Talent Development
Risk Management
Business Partnership
Supplier Quality
Change Leadership
Laboratory Management
Decision Making
Audit Management
Continuous Improvement
MasterControl
Executive Presence
Data Analytics and KPI Reporting
Customer Focus
Success Profile
The successful candidate will be a visible and hands-on quality leader who can confidently operate on the manufacturing floor, in the laboratory, during customer audits, and within executive leadership discussions. This individual will combine strong technical knowledge with pragmatic business leadership to ensure the Utah site consistently delivers safe, compliant, high-quality nutritional ingredient products while driving operational excellence and continuous improvement.
Pay: $120,000.00 - $135,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Work Location: In person
