About the Role:
Medical Group Care is looking for a driven and detail-oriented Quality Manager to lead quality assurance efforts across our OTC, Skincare, and Feminine Hygiene product lines in Naples, FL. This is an exciting opportunity to take ownership of quality systems in a fast-paced, consumer health environment where your expertise directly impacts product safety and customer trust.
Key Responsibilities:
Regulatory Compliance & Quality Systems
• Maintain and enforce quality systems in compliance with 21 CFR Parts 210/211 (cGMP for OTC drugs), 21 CFR Part 700 series (cosmetics), and applicable MoCRA requirements.
• Develop, review, and update SOPs, batch records, specifications, and quality agreements to reflect current regulatory standards.
• Monitor regulatory intelligence for changes affecting OTC, cosmetic, and medical device-adjacent product categories.
Supplier Quality Management
• Conduct supplier qualification, ongoing oversight, and periodic audits for contract manufacturers and raw material suppliers, with emphasis on international (primarily China-based) supply chains.
• Review and approve Certificates of Analysis, testing protocols, stability data, and manufacturing documentation.
• Manage the Supplier Corrective Action (SCAR) process and track resolution of quality events.
• Maintain the Supplier Oversight Program (SOP-QA) and associated vendor quality agreements.
Product Quality & Testing
• Oversee incoming, in-process, and finished goods quality control for OTC drug products (cough/cold, antacids, analgesics, etc.), skincare (lotions, cleansers, sun care/SPF), and sanitary/feminine hygiene products (pads, panty liners).
• Establish and maintain product specifications, sampling plans, and release criteria.
• Coordinate third-party laboratory testing, including microbiological, chemical, and stability testing.
• Lead or support product complaint investigations and adverse event reporting as required.
Retail & Customer Compliance
• Interface with quality contacts at major retail partners to address QA deductions, audit requirements, and product documentation requests.
• Manage retailer-specific quality portals and ensure timely response to compliance inquiries, QAT deduction codes, and chargeback documentation.
• Support product recall coordination at the retail level, including lot traceability, retailer notification, and disposition documentation.
Documentation & Labeling
• Review product labels for OTC drug fact compliance, ingredient accuracy, and regulatory claim substantiation.
• Maintain the document control system and ensure version-controlled quality records are audit-ready.
• Assist in preparation of regulatory submissions and private label compliance packages for new product launches.
Cross-Functional Collaboration
• Partner with SVP of R&D on new product development, formula review, and launch readiness from a quality standpoint.
• Support legal counsel on product liability, litigation holds, and quality-related dispute documentation as needed.
Requirements:
Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field
5+ years of quality management experience in OTC, cosmetics, or consumer health products
Strong knowledge of FDA regulations, cGMP, and 21 CFR Part 211
Experience with CAPA systems, risk management, and root cause analysis
Familiarity with skincare and/or feminine hygiene product manufacturing is highly preferred
Excellent leadership, communication, and organizational skills
ASQ Certified Quality Manager (CQM) or similar certification is a plus
About Us:
Medical Group Care is a trusted name in consumer health and personal care products, committed to delivering safe, effective, and high-quality solutions to customers. Our team in Naples, FL thrives on innovation, collaboration, and a shared passion for improving everyday wellness. We pride ourselves on a supportive work culture where talented professionals are empowered to make a real difference.