Director of Global Quality - Isagenix

Position Summary:

The Director of Global Quality is responsible for strategic development and implementation of all quality initiatives and ensuring strict adherence to all applicable regulations. This role will be overseeing QA activities regarding the safety, quality of our products, thereby ensuring the availability of accurate and safe product for our Associates and customers. This includes developing, implementing, and maintaining QA programs to improve product quality and ensure products are produced in compliance with product standards, good manufacturing practices and in accordancewith government regulations. In addition, this role will be required to provide guidance and consultation on QA tasks and manage a staff of quality assurance and quality control leaders and professionals.

Essential Duties & Responsibilities (Other duties may be assigned):

• 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.

Minimum Qualifications (These are the requirements that all applicants MUST HAVE to be considered for this position):

• 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.

Preferred Qualifications:

• Bachelor’s degree in science, chemistry, biology, physical sciences or applied sciences.
• Experience in Six Sigma, Lean or equivalent.
• ASQ Certifications (CQE, CQA etc.), knowledge of FSMA, SQF regulations.

Company Overview:

Established in 2002, Isagenix International has created simple, proven products that optimize what your body is capable of—helping you protect your greatest asset, your health. For more than twenty years, Isagenix has made holistic science an art with transparency and integrity—creating products and systems that address nutrition, stress, fitness, energy, natural beauty, focus and financial wellbeing. The global wellbeing company, based in Gilbert, Arizona, markets their products through a network of independent distributors in 22 key markets: the United States, Canada, Puerto Rico, Australia, New Zealand, Mexico, the United Kingdom, Ireland, the Netherlands, Belgium, Spain, Austria, Denmark, Finland, France, Germany, Italy, Norway, Poland, Portugal, Sweden, and Switzerland. For more information, visit Isagenix.com. 

EEO:

Isagenix International, LLC is an equal opportunity employer and affords equal opportunity to all applicants for all positions without regard to race, color, religion, sex, national origin, age, disability, veteran status or any other status protected by law.