Job Description

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.

JOB DUTIES AND RESPONSIBILITIES:

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.

QUALIFICATIONS:

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, nonconformance handling, supplier qualification, annual product quality reviews, and self-inspection programs.
• Demonstrated ability to lead quality investigations, root cause analysis, and effective corrective/preventive actions in a fast-paced manufacturing setting.
• Excellent written and verbal communication skills, with the ability to collaborate across departments, prepare regulatory documentation, and present quality metrics/risks to senior leadership.

Preferred:

• Experience specifically in liquid OTC drug formulations and manufacturing.
• Familiarity with quality agreements, quality manuals, and audit/inspection readiness (internal, FDA, customer).
• Certifications such as ASQ Certified Quality Auditor (CQA), Six Sigma, or similar quality/regulatory credentials.

PHYSICAL DEMANDS AND WORKING ENVIRONMENT ACKNOWLEGEMENT:

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• This role involves a mix of office work and occasional time in lab/production areas.
• Regularly required to sit at a desk, use a computer, stand, walk short distances, talk, hear, and handle paperwork or samples.
• Occasionally required to lift and carry items up to 25 pounds (such as lab supplies, product samples, or files), reach overhead, bend, or kneel.
• Requires good vision for reading labels, documents, and test results (close vision, color distinction, and ability to adjust focus).
• Prolonged computer use and fine hand movements for data entry and documentation.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Primarily an office and laboratory setting in a cGMP-regulated manufacturing facility.
• Occasional exposure to production floor areas with moderate noise from equipment, typical manufacturing temperatures (cool to warm), light odors/fragrances from cosmetic products, and minor airborne particles (dust/powders).
• Required to wear appropriate personal protective equipment (PPE) when entering lab or production zones, such as lab coats, safety glasses, and gloves. In designated GMP production areas, additional hair covers (bouffant caps) and beard covers (if facial hair is present) are also required to prevent contamination.
• Noise level is usually moderate in the office/lab and can be louder on the production floor.
• Standard business hours with occasional extended hours or weekend support needed for audits, investigations, or production issues.

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