Director Regulatory & Quality

ROLE:

Lead the Regulatory and Quality Compliance department, directs programs, policies and practices to ensure business practices are in compliance with Food and Drug Administration (FDA), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), and Good Research Practice (GRP). Responsible for the definition and development of standards for company-wide compliance with all applicable Federal, state and local regulations. Reviews and evaluates claims, contract and documents for compliance. Register products for international expansion. Represents organization when engaging with regulatory bodies and agencies.

ESSENTIAL FUNCTIONS:

• Leads and oversees the operational execution of Regulatory and Quality Compliance processes which includes audits, inspection management, product claims, change control, and quality risk management.
• Execute a compliant regulatory and quality assurance program that manages new product development processes, suppliers, third-party manufacturers, warehouse/distributors and. The program must ensure compliance with FDA, Health Canada, and EU regulations for dietary supplements/natural health products. All data must be maintained internally and available upon request.
• Work with Product Development and Operations teams to maintain compliance within the New Product Development/Stage Gate process.Including raw material & product specifications, claims, supplement facts, formulae, clean label certification, Bill of Materials, Contract Manufacturing Quality manuals, shipping and storage, and distribution.
• Ensure licensing of products sold international countries, including Canada NHP application, registration of sites per Health Canada regulations. Ensure compliance to all claims in the US, EU (EFSA) and Asia market: Health Claims, NLEA Authorized Health Claims, Health Claims based on Authoritative Statement, Qualified Health Claims, Nutrient Content Claims, Structure/Function Claims, and Related Dietary Supplement Claims
• Research and apply regulations and laws; identify potential areas of risk and vulnerability and advise senior management on requirements and standards; Make recommendations on potential strategy and activities to ensure compliance.
• Partner with internal customers to develop and deliver communications and training designed to promote an understanding of compliance issues, laws and regulations, as well as the consequences of non-compliance
• Oversee the Root Cause, Corrective Action and Continuous Improvement process to effectively respond to alleged compliance violations, complaints and held product.
• Design and manage Adverse Reaction reports. Responsible for working with legal, when needed, on responses and delivering to customer and consumer.
• Develop strong relationships with 3PL contracts, contract manufacturers and material suppliers to ensure the supply of quality products and compliance to specification and 21 CFR Part 111.
• Monitor and continuously improve processes at co-packers, contract manufacturers and distributors. This involves working with procurement, customer service, sales, and operations, continuously revising to improve and manage business needs. Manage, review and recommend revisions to improve overall quality of systems and processes related to product quality with our vendors and third-party manufacturers.
• Strategize/design Quality and Regulatory programs that manage global compliance effectively as Vimergy grows
• Responsible for the annual internal audit of the QMS and procedures, Contract Manufacturers and material suppliers, and warehouse procedures and third-party distributors.
• Advise and guide product “food” safety requirements and testing for all new materials or processes. Ensure the business and all sites are in compliance with the Bioterrorism act.
• Responsible for the design and maintenance of compliance to Sanitary Transportation Rule, Accredited Lab Rule, Intentional Adulteration Rule, Traceability Rule
• Other duties as assigned

SKILLS:

• Experience within Vitamin Mineral Supplement industry in a Quality or Regulatory department is strongly preferred
• Experience with FDA, recalls, and regulations, meets FDA definition of a “Qualified Individual”
• Ability to work, strategize, project manage, problem solve and find solutions independently
• Strong organization skills, with the ability to work in a fast-paced startup environment
• Must be a proactive team player skilled in communicating with all key stakeholders across multiple departments and management levels
• Experience leading audits.

QUALIFICATIONS AND EDUCATION REQUIREMENTS:

• Bachelor’s Degree: science, engineering or other technical are preferred.
• 10 years in a regulatory & quality compliance or related discipline or equivalent quality management activities.
• Working knowledge of international GXP regulations and directives, including USA (FDA), Canada (HC), EU (EMA), UK (MHRA), Japan (PMDA), China and ICH Guide.
• Experience with product registration in international countries preferred

PHYSICAL REQUIREMENTS:

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds if needed.