Quality Assurance Manager

Smart Hire is looking for a Quality Manager for a client in Lafayette CO. Ideal candidate will have 3+ years of Management experience within a cGMP environment (food or similar), FSSC 22000 and a food safety guidelines. Strong analytical, continuous improvement mindset and problem solving skills needed. This is a Full Time, fully onsite Direct Hire role.

$95k-$105k DOE + annual bonus

Medical, Dental, Vision, Short and Long-Term Disability, 401(k), PTO, Paid Holidays, and much more.

• Build and lead a high-performing Quality team. Recruit, mentor, coach, and develop staff while managing scheduling, performance reviews, and departmental budgeting.
• Identify and assess compliance risks related to regulatory, GMP, GLP, ISO, and customer requirements. Communicate critical risks and nonconformities to leadership and drive resolution.
• In partnership with the Sr. Director of Global Quality, evaluate and strengthen the Quality Management System (QMS) governing manufacturing operations and testing laboratories.
• Establish and maintain robust laboratory and quality processes, including deviation management, OOS investigations, CAPA systems, and product release procedures.
• Ensure change control, standardized work, training programs, deviation handling, CAPA, complaints, and audit processes align with organizational quality objectives.
• Author, revise, and maintain controlled documentation, including SOPs, forms, specifications, and master records.
• Oversee all quality control activities to ensure timely, accurate testing and compliant product disposition.
• Ensure proper maintenance, calibration, and qualification of laboratory and production equipment.
• Review and approve Master Manufacturing Records and Product Specifications.
• Oversee material review and disposition to ensure conformance to established specifications.
• Maintain complete, audit-ready documentation that meets regulatory and certification requirements.
• Prepare clear, actionable audit reports and ensure effective corrective and preventive actions are implemented.
• Maintain certifications and standards, ensuring timely responses to findings and continuous improvement initiatives.
• Lead investigations of customer complaints using structured root cause methodologies and implement sustainable corrective actions.
• Stay current on evolving regulatory and industry standards; advise leadership on business impact and required changes.
• Ensure ongoing audit and inspection readiness across all quality functions.
• Proactively partner with Quality, Supply Chain, Product Development, suppliers, and customers to resolve findings and drive sustained compliance performance.

• Bachelor’s or Master’s degree (or equivalent experience) in a relevant scientific or technical discipline.
• Minimum 3 years of experience working within cGMP and GLP-regulated manufacturing and laboratory environments (ingredients, food, or dietary supplements preferred).
• Minimum 3 years of hands‑on experience in microbiology laboratory testing, including plating and enrichment techniques.
• Demonstrated experience conducting ISO 22000 audits; working knowledge of ISO 17025 laboratory standards and ISO 9001 quality systems.
• Experience conducting hazard analyses and implementing risk-based control strategies.
• Proficiency in both on-site and remote auditing processes.
• Experience with contract manufacturing in regulated industries.
• Prior experience hosting regulatory inspections, developing CAPAs, and preparing formal responses to findings.
• Strong knowledge of best practices within the Natural Health Products industry.
• Demonstrated application of continuous improvement, change control, and risk assessment methodologies.
• Understanding of corporate governance processes and cross-functional business operations.
• Working knowledge of R&D and new product development processes.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Clear, concise, and persuasive communicator with the ability to influence stakeholders at all levels.
• Fluent in English (written and spoken).
• Ability to identify audible and visual safety hazards and comply with GMP, PPE, and company safety requirements.

Smart Talent is an Equal Opportunity Employer