Chief Quality Officer

United 1 Laboratories
  • Ogden, Utah
    15 days ago

    Job Description

    Key Responsibilities:

    • Lead the development, implementation, and maintenance of quality management systems in compliance with all FDA regulations and GMP standards.
    • Oversee the entire quality control process, including raw material verification, in-process quality checks, and finished product testing.
    • Oversee laboratory operations.
    • Manage and enhance the supplier qualification program to ensure raw materials meet required quality and regulatory standards.
    • Coordinate with R&D and production teams to implement quality standards and improve product consistency and safety.
    • Lead internal audit programs to identify potential quality issues and implement corrective actions in a timely manner.
    • Maintain up-to-date knowledge of industry trends, new regulatory requirements, and best practices in quality management.
    • Train and mentor quality assurance staff and oversee their daily activities and performance.
    • Manage the handling of customer relations related to product quality, investigating issues and developing solutions to prevent recurrence.
    • Prepare and present detailed quality reports to senior management and relevant regulatory bodies.
    • Collaborate with external auditors and regulatory officials during inspections and provide necessary documentation.
    • Serve as Quality representative to all external organizations.
    • Establish key metrics and Quality Strategy in line with Company objectives.

    Required Qualifications:

    • Minimum Bachelor’s Degree in a scientific field such as Food Science, Chemistry, Biochemistry, Engineering, or related field.
    • Minimum of 15 years’ experience in quality control or quality assurance in the dietary supplement or pharmaceutical industry, with at least 5 years in a managerial capacity.
    • Deep understanding of FDA regulations (CFR 21 part 111, 210, 211 and 11), GMP, HACCP, and ISO standards relevant to dietary supplements.
    • Deep understanding or dietary supplement and pharmaceutical standards – experience in GRMA certification programs.
    • Proven experience in handling audits and compliance with regulatory bodies.
    • Strong leadership skills and experience managing a quality assurance team.
    • Excellent organizational, communication, and interpersonal skills.
    • Knowledge of modern IT solutions in the space of Quality Management System

    Preferred qualifications:

    • Master’s degree in a relevant scientific discipline.
    • Certifications related to quality management (e.g., Certified Quality Auditor, Certified Quality Manager).
    • Experience with lean manufacturing and continuous improvement processes.
    • Experience in managing laboratory operations.
    • Experience in managing External Manufacturers and vendors.
    • Prove track record in digitalization and management of transformation.
    • Experience in implementing QMS.
    • Experience in automation and in-line process controls.
    • Proven track record in establishing effective teams.
    • Experience in creation and implementation of Quality strategy.

    Skills:

    • Exceptional analytical and problem-solving skills.
    • Ability to multitask and manage multiple projects simultaneously under tight deadlines.
    • Strong attention to detail and a commitment to delivering high-quality products.
    • Proficient in using quality management software and tools.

    Numbers & Facts

    LocationOgden, Utah
    Websitehttps://www.inw-group.com/about

    Skills

    • Analysis Skillsunmatched
    • Auditingunmatched
    • Automationunmatched
    • Best Practicesunmatched
    • Biochemistryunmatched
    • Biotech and Pharmaceuticalunmatched
    • Check Processingunmatched
    • Chemistryunmatched
    • Code of Federal Regulationsunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Customer Relationsunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • External Auditunmatched
    • FDA Requirementsunmatched
    • Food Scienceunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • ISO (International Organization for Standardization)unmatched
    • Identify Issuesunmatched
    • Industry/Trade Analysisunmatched
    • Internal Auditunmatched
    • Interpersonal Skillsunmatched
    • Laboratoryunmatched
    • Laboratory Managementunmatched
    • Laboratory Operationsunmatched
    • Leadershipunmatched
    • Lean Manufacturingunmatched
    • Maintain Complianceunmatched
    • Mentoringunmatched
    • Multitaskingunmatched
    • Operations Managementunmatched
    • Organizational Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Control Engineeringunmatched
    • Process Qualityunmatched
    • Product Safetyunmatched
    • Product Testingunmatched
    • Project/Program Managementunmatched
    • Quality Assuranceunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Research & Development (R&D)unmatched
    • Systems Maintenanceunmatched
    • Time Managementunmatched

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