Director of Quality, Regulatory & Compliance

Mercola • Cape Coral, FL

1d • Hybrid

About The Position

This is an opportunity to become a trusted guardian behind products that earn lifelong confidence. You will be the person whose judgment protects customers, empowers innovation, and gives an entire organization the confidence to grow. Every decision made strengthens trust, every improvement introduced creates lasting impact, and every product approved becomes part of your professional legacy. You'll work alongside passionate people who believe quality is more than a requirement—it is a promise. You'll experience the satisfaction of bringing clarity where complexity once existed and confidence where uncertainty once lived. You'll become the leader colleagues seek when the highest standards matter most. Your influence will reach across products, partnerships, and global operations while helping remarkable ideas become trusted realities. You'll help reshape the future of quality leadership by setting a new standard for integrity, accountability, and operational excellence. This is meaningful work with visible impact every single day.

Requirements

• Bachelor's degree in a scientific, regulatory, quality, or related discipline.
• 8–10+ years of Quality Assurance, Regulatory Affairs, and Compliance experience.
• 3–5+ years leading quality and regulatory organizations.
• Direct experience with Foreign Supplier Verification Program (FSVP).
• Working knowledge of: DSHEA, 21 CFR 111, FSMA / 21 CFR 117, MoCRA, FDA labeling, USDA-APHIS, FDA Prior Notice, HTS Classification.
• Experience qualifying and auditing domestic and international contract manufacturers.
• Experience owning enterprise Quality Management Systems.
• Experience reviewing labeling, advertising, educational materials, and marketing claims.
• Strong cross-functional leadership and communication skills.
• Experience with documentation governance systems such as DocuSign.

Nice To Haves

• Advanced scientific or regulatory degree.
• PCQI certification.
• FSVP Qualified Individual training.
• HACCP certification.
• RAC, ASQ CQA, or CMQ-OE certification.
• Experience with animal-origin ingredients.
• Experience with liposomal, peptide, or nanoparticle products.
• Experience leading FDA inspections and audit readiness.
• Experience supporting wholesale partner compliance.

Responsibilities

• Serve as the enterprise Quality Unit across multiple operational locations, owning the Quality Management System (QMS).
• Lead regulatory affairs and quality compliance across dietary supplements, functional foods, and cosmetic products.
• Own the Foreign Supplier Verification Program (FSVP) and maintain importer-of-record compliance.
• Lead regulatory classification decisions across dietary supplement, conventional food, cosmetic, and drug categories before import or commercialization.
• Direct compliance with DSHEA, 21 CFR 111, FSMA, 21 CFR 117, MoCRA, FDA labeling requirements, and applicable import regulations.
• Qualify, audit, and manage domestic and international contract manufacturers and quality agreements.
• Review and approve labeling, marketing materials, educational content, and commercial documentation for regulatory compliance.
• Exercise release-hold and stop-ship authority to prevent non-compliant products from launching or shipping.
• Maintain continuous inspection and audit readiness while mitigating enterprise regulatory risk.
• Provide leadership across Quality, Regulatory, Product Development, Marketing, and Commercial Operations.

Benefits

• Medical, Dental, and Vision coverage
• Accident, Hospital Indemnity, and Critical Illness
• Employee Assistance Program (EAP)
• Employer Paid Life and AD&D Insurance
• Optional Supplemental Life and AD&D Insurance
• Short- and Long-Term Disability Insurance
• Flexible Spending Accounts
• Health Spending Accounts
• Dayforce Wallet – get paid as you earn
• Employee Discount
• Retirement Planning (401k with matching contribution)
• Pet Insurance
• Wellness Program Offerings
• Paid Time Off, accrued per pay period based on years of service, starting at 25 days annually.
• 9 Paid Holidays per year, including 1 floating holiday.

What This Job Offers

• Job Type: Full-time
• Career Level: Director