Quality Assurance Manager

We’re working with a well-established, leading manufacturer of personal care and household cleaning items that is searching for a Quality Manager. This person will ensure compliance with FDA OTC drug and cosmetic regulations, GMP standards, and internal quality requirements. The QA Manager will drive a culture of quality, maintain inspection readiness, and lead continuous improvement initiatives. This role will report to the Director of Quality Systems.

Location: Long Island, NY

Job Responsibilities:

• Develop, implement, and maintain the Quality Management System covering document control, CAPA, deviation management, audits, and supplier qualification.
  • Ensure compliance with FDA OTC regulations.
  • Review and approve GMP documentation including master batch records, production records, testing protocols, and validation documents.
  • Lead investigations, root cause analysis, and corrective/preventive actions.
  • Prepare for and manage internal, supplier, and external (FDA or customer) audits.
  • Support new product introductions ensuring compliance with quality and regulatory requirements.
  • Oversee supplier quality performance, raw material specifications, and incoming inspection processes.
  • Collaborate cross-functionally with manufacturing, R&D, packaging, and regulatory teams to ensure product quality at every stage.
  • Maintain calibration and maintenance programs for testing and inspection equipment.
  • Lead, train, and develop the QA team, fostering a proactive quality culture.

Required Skills/Qualifications:  

• Bachelor’s degree in Microbiology, Chemistry, Life Sciences, Engineering, or related discipline required.
• 5+ years of progressive experience in Quality Assurance or Quality Systems within FDA-regulated industries.
• 2+ years of leadership experience managing quality teams and laboratories in a cGMP-compliant manufacturing environment, ideally within OTC or personal care products.
• Strong knowledge of FDA OTC regulations, GMP, and quality systems management.
• Excellent communication, leadership, and problem-solving skills.
• Familiarity with root cause analysis, CAPA management, and continuous improvement tools.
• ASQ or equivalent quality certification is a plus.
• Effective communicator.

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