Quality Assurance Manager

The Quality Assurance Manager is responsible for leading all quality assurance functions at the manufacturing facility to ensure consistent compliance with cGMP (current Good Manufacturing Practices), ISO 22716 (Cosmetics GMP), ANSI 455-4 standards, and applicable regulatory requirements for OTC drug and cosmetic products.

This role provides strategic oversight of daily quality operations, drives proactive quality systems and risk management, leads investigations and continuous improvement initiatives, coaches and develops a high-performing quality team, and serves as a key partner in communicating quality performance and risks to senior leadership.

Quality Manager’s responsibilities will include, but are not limited to the following:

• Lead and ensure full compliance with all applicable regulations and standards governing the manufacturing, packaging, labeling, testing, storage, and distribution of finished OTC drug products and cosmetic products, including cGMP, ISO 22716, ANSI 455-4, and relevant FDA/ICH guidance.
• Develop, implement, and continuously improve robust quality management systems (QMS) that promote product quality, safety, and regulatory compliance while supporting efficient operations.
• Provide strong leadership, supervision, and professional development to the Quality Assurance team; ensure team members demonstrate appropriate accountability for quality decisions in accordance with company policies and applicable laws.
• Oversee the management and effectiveness of core quality systems, including deviation management, CAPA (Corrective and Preventive Actions), change control, nonconforming materials and products, finished product review/testing/release, and raw material/packaging component/label receipt and release.
• Make timely, science-based, risk-informed quality decisions regarding product disposition, release, and compliance based on data, cGMP principles, ISO/ANSI standards, and regulatory expectations.
• Lead and/or support thorough, on-time investigations into quality events, deviations, out-of-specification (OOS) results, and complaints; ensure robust root cause analysis and effective corrective/preventive actions.
• Oversee the development, review, approval, and periodic maintenance of all quality-related Standard Operating Procedures (SOPs), work instructions, and controlled documents.
• Champion a culture of quality and compliance throughout the organization by providing guidance, training support, and technical expertise to manufacturing, operations, R&D, and other departments.
• Monitor quality performance metrics, identify trends, and proactively drive initiatives to prevent quality issues, reduce risks, and enhance overall product quality and process reliability.
• Serve as a primary point of contact for internal and external quality audits/inspections, regulatory interactions, and customer quality inquiries related to the facility.
• Collaborate closely with the Quality Director and executive leadership to report on quality system health, emerging risks, compliance status, and continuous improvement opportunities.
• Perform other duties as assigned to support facility and organizational objectives.

Required:

• Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or a related Life Science field (Master’s degree preferred).
• Minimum 7+ years of progressive experience in quality assurance/compliance within the cosmetics, personal care, and/or OTC drug manufacturing industry.
• At least 3+ years of direct supervisory or managerial experience leading a Quality Assurance team in a regulated manufacturing environment.
• In-depth expertise in current Good Manufacturing Practices (cGMP) for OTC drugs, ISO 22716 (Cosmetics GMP), ANSI 455-4, and relevant FDA regulations/guidance documents.
• Strong technical knowledge of microbiological and chemical testing methods, including interpretation of results, out-of-specification (OOS) investigations, and product compliance determination.
• Proven experience developing, implementing, and maintaining robust quality management systems (QMS), including SOPs, CAPA, deviation management, change control,…