Job Summary: The Director of Quality will lead the Quality Assurance (QA) and Quality Control (QC) functions to ensure the highest standards of product quality and regulatory compliance for our OTC and cosmetic skincare products. This role will oversee all quality-related activities, including manufacturing, packaging, and distribution, to ensure products meet or exceed customer expectations and regulatory requirements.
Key Responsibilities:
Quality Management System (QMS): Develop, implement, and maintain a robust QMS in compliance with FDA regulations, GMP, ISO standards, and other relevant guidelines.
Regulatory Compliance: Ensure all products comply with applicable regulations, including FDA, EU, and other international standards. Prepare and submit regulatory filings as needed.
Quality Assurance: Oversee the QA team to ensure proper documentation, process controls, and validation activities. Conduct internal audits and manage external audits and inspections.
Quality Control: Lead the QC team in performing routine testing and inspections of raw materials, in-process products, and finished goods. Ensure timely and accurate reporting of results.
Continuous Improvement: Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve operational efficiency. Implement corrective and preventive actions (CAPA) as necessary.
Supplier Quality Management: Develop and maintain strong relationships with suppliers. Conduct supplier audits and manage supplier quality performance.
Training and Development: Provide training and development opportunities for QA/QC staff to ensure they are knowledgeable about current regulations and best practices.
Customer Complaints: Investigate and resolve customer complaints related to product quality. Implement corrective actions to prevent recurrence.
Cross-Functional Collaboration: Work closely with R&D, Production, and other departments to ensure quality is integrated into all aspects of product development and manufacturing.
Qualifications:
Education: Bachelor's degree in Chemistry, Biology, Engineering, or a related field. Advanced degree preferred.
Experience: Minimum of 10 years of experience in quality assurance/control in the OTC, cosmetic, or pharmaceutical industry, with at least 5 years in a leadership role.
Knowledge: In-depth knowledge of FDA regulations, GMP, ISO standards, and other relevant guidelines. Experience with regulatory filings and audits.
Skills: Strong leadership, communication, and problem-solving skills. Ability to work effectively in a fast-paced, dynamic environment.
Certifications: Quality-related certifications (e.g., ASQ Certified Quality Manager, Six Sigma) are a plus.