Isagenix · 3 months ago
Director of Global Quality
Gilbert, AZ
Full-time
Onsite
Director/Executive
10+ years expIsagenix International is a global wellbeing company that has been creating proven products since 2002. The Director of Global Quality is responsible for strategic development and implementation of quality initiatives, ensuring compliance with regulations, and overseeing QA activities to maintain product safety and quality.
Dietary SupplementsDirect SalesHealth CareMulti-level MarketingNutrition
Responsibilities
Maintain compliance with all company, domestic and international regulatory requirements
Establish quality and reliability standards of products
Maintain product quality by collaborating with other members of management and contributing to team results
Actively work within the Isagenix Quality Management System (QMS), QualityOne, to support the quality functions in an efficient manner
Create, review, and revise Isagenix required documentation to ensure compliance to market regulations FDA 21 CFR 111, 117, and others as applicable
Oversee Document Control and Change Control systems
Manage activities relevant to external and internal audits
Develop and implement process for managing the out-of-specification (OOS) and investigations from in-house QC and contract laboratories
Maintain the training program for internal personnel to ensure personnel are adequately trained
Manage 3rd party manufacturers ensuring compliance to regulatory and company requirements
Manage the Supplier Qualification activities including the supplier audit program
Organize and ensure the completion of all product investigations and CAPAs
Work with process owners, managers, and other complaint Investigators to ensure compliance to the complaint handling process. Coordinate with the Complaint Handling Team to determine if the reported complaint was associated with an adverse or serious adverse event and whether the complaint documentation is complete and accurate
Provide expertise in Quality System improvements within the department and company
Prepare periodic reports, quality scorecards and analyses to executive management
Develop Standard Operating Procedures (SOPs) and implement other quality assurance policies and procedures
Maintain professional and technical quality knowledge
Achieve financial objectives by preparing and managing the quality assurance budget
Direct and oversee the work of QA and QC professionals, including training, mentoring, and insuring professional development
Qualification
Required
Bachelor's degree from an accredited institution or equivalent quality assurance experience
10 years of experience in cGMP environment, such as Drugs, Cosmetics, Dietary Supplements or Medical Devices and 6 years of management experience
Professional experience working with quality assurance or FDA regulations
Solid understanding of food manufacturing processes and troubleshooting
No dietary restrictions or allergies
Must be a non-tobacco user and will not use tobacco products on or off the job during the tenure of employment in Quality Assurance, as it may affect taste accuracy testing
Skilled in the use of Microsoft office software to include Word, Excel, PowerPoint, and Outlook
Strong interpersonal skills, detail oriented and able to coordinate/manage multiple tasks simultaneously
The office environment requires the use of standard office equipment and personal computers
Bachelor's degree in science, chemistry, biology, physical sciences or applied sciences
Preferred
Experience in Six Sigma, Lean or equivalent
ASQ Certifications (CQE, CQA etc.), knowledge of FSMA, SQF regulations
Company
Isagenix
Established in 2002, Isagenix International has created simple, scientifically proven products that optimize human health and performance.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$2.4M2021-12-03Series A· $0M
2018-08-17Series Unknown· $2.3M
2018-02-14Seed· $0.1M
Leadership Team
Jennifer Spar
President and CEO Health And Wellness Coach
Jennifer Young
Independent CEO/Business Owner
Recent News
2025-06-26
Company data provided by crunchbase