Quality Manager OTC Skincare and Feminine Hygiene

Medical Group Care; Naples (FL); On-site; USD 110,000 - 140,000; Full time

Job summary

Medical Group Care in Naples, FL is seeking a driven Quality Manager to lead QA across OTC, skincare, and feminine hygiene lines. You will own quality systems, ensure cGMP compliance, and align with MoCRA requirements.

This role demands deep regulatory knowledge, supplier oversight, and collaboration with R&D and retail partners to safeguard product safety, labeling accuracy, and recalls readiness.

Qualifications

• 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.

Responsibilities

• Maintain and enforce quality systems in compliance with 21 CFR Parts 210/211, 700 series, and MoCRA.
• Develop, review, and update SOPs, batch records, specifications, and quality agreements.
• Monitor regulatory intelligence for changes affecting OTC, cosmetics, and medical device-adjacent categories.
• Conduct supplier qualification, ongoing oversight, and periodic audits for contract manufacturers and raw material suppliers, with emphasis on international 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 vendor quality agreements.
• Oversee incoming, in-process, and finished goods quality control for OTC, skincare, and feminine hygiene products.
• 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.
• 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.
• 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.
• 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.

Skills

Leadership

Communication

Organizational skills

Regulatory knowledge

CAPA systems

Root cause analysis

Quality management

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field

Job description

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:

• 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.