Quality Assurance Manager

Job Description

Job Description

We are seeking an experienced QA Manager to lead quality assurance and quality control operations for a growing cosmetics and OTC manufacturing company. This role is responsible for ensuring products are manufactured, tested, and released in compliance with FDA regulations, Good Manufacturing Practices (GMP), and internal quality standards.

The ideal candidate is a hands-on leader with strong experience in quality systems and background in laboratory operations, who thrives in a fast-paced, regulated environment.

Key Responsibilities

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• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with GMP, FDA, ISO (e.g., ISO 22716), and USP standards
• Ensure compliance with all regulatory requirements for personal care/cosmetic manufacturing
• Manage deviations, CAPA, change control, and nonconformance investigations
• Support and lead internal audits, supplier audits, and regulatory inspections
• Collaborate with cross-functional teams including Manufacturing, R&D, and Supply Chain
• Oversee validation activities, including equipment, processes, and test methods
• Monitor quality trends and drive continuous improvement initiatives
• Lead, mentor, and develop QA/QC team members
• Lead internal and external audits (FDA, ISO, customer audits) and manage corrective and preventive actions (CAPA)
• Establish and enforce SOPs, specifications, and quality standards
• Collaborate with Production, R&D, and Supply Chain to ensure quality throughout the product lifecycle
• Manage document control systems and ensure proper record-keeping
• Conduct risk assessments and implement quality improvement initiatives
• Train staff on GMP, quality standards, and regulatory requirements
• Monitor and report key quality metrics and trends
• Oversee supplier qualification and raw material approval processes
• Ensure proper handling of non-conforming materials and customer complaints

Qualifications

• Bachelor’s degree in Chemistry, Biology, Engineering, or related field
• 8+ years of QA experience in personal care, cosmetics, pharmaceuticals, or related manufacturing
• Strong working knowledge of GMP, FDA regulations (21 CFR), ISO standards, and USP guidelines
• Experience with leading audits, CAPA, and regulatory inspections
• Familiarity with cosmetic regulations and industry standards (preferred)
• Strong analytical, problem-solving, and organizational skills
• Excellent communication and leadership abilities
• Experience with laboratory testing, validation, and quality systems
• Proven experience supporting audits and regulatory inspections
• 3+ years of leadership or management experience

Preferred Skills

• Experience in personal care or cosmetic manufacturing environments
• Knowledge of ISO 22716 (Cosmetic GMP)
• Experience with ERP/QMS systems
• Six Sigma or Lean Manufacturing experience is a plus

Work Environment

• Combination of office, laboratory, and manufacturing floor
• May require time on the production floor and interaction with multiple departments