Director of Quality and Regulatory

The responsibilities of the Director of Quality & Regulatory for a cosmetic brand are

Key Responsibilities:

1. 
   
   Quality Management System (QMS):
   • Develop, implement, and maintain a robust Quality Management System (QMS) for the cosmetic product lifecycle.
   • Oversee the review and approval of product specifications, testing protocols, and manufacturing processes to ensure consistency and compliance with established quality standards.
   • Ensure continuous monitoring and improvements to maintain product quality, safety, and efficacy.
2. 
   
   Regulatory Compliance:
   • Monitor and interpret domestic and international cosmetic regulations (e.g., FDA, EMA, Health Canada, ASEAN Cosmetics Directive) to ensure that all products are compliant before market launch and throughout their lifecycle.
   • Prepare and submit regulatory filings, including product registrations, ingredient approvals, and claims substantiation.
   • Manage communication with regulatory authorities, responding to inquiries and providing necessary documentation as required.
3. 
   
   Product Development Support:
   • Work closely with R&D and Product Development teams to ensure regulatory requirements and quality standards are integrated into product formulations, packaging, and labeling from the outset.
   • Review and approve product formulations, raw materials, and finished product specifications for regulatory and quality compliance.
4. 
   
   Risk Management and CAPA (Corrective and Preventive Actions):
   • Identify and assess risks related to product quality and regulatory compliance.
   • Lead and manage CAPA processes, ensuring timely resolution of issues, complaints, or regulatory non-conformances.
   • Ensure root-cause analysis is performed for any quality issues, product recalls, or regulatory violations and implement corrective actions.
5. 
   
   Audits and Inspections:
   • Plan and conduct internal and external audits to ensure compliance with regulatory requirements and industry standards (e.g., ISO, GMP).
   • Lead regulatory inspections and handle any non-compliance issues, preparing the company for inspections by FDA, local health authorities, or other regulatory agencies.
6. 
   
   Team Leadership and Development:
   • Lead and mentor a team of quality and regulatory professionals, promoting professional growth and ensuring alignment with company goals and objectives.
   • Provide training on regulatory requirements, quality standards, and industry best practices to internal teams and external partners.
7. 
   
   Labeling and Claims Compliance:
   • Oversee product labeling to ensure compliance with all relevant laws, including ingredient disclosure, claims substantiation, and marketing language.
   • Ensure proper claims documentation and compliance with advertising standards.
8. 
   
   Supplier and Manufacturer Relations:
   • Manage relationships with suppliers, manufacturers, and contract manufacturers to ensure raw materials and finished products meet quality and regulatory standards.
   • Conduct supplier audits and establish quality control measures with external partners.
9. 
   
   Strategic Input and Continuous Improvement:
   • Provide strategic input to senior management on regulatory trends, changes in global laws, and potential risks.
   • Lead initiatives for continuous improvement in quality and compliance processes to enhance efficiency and product integrity.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.