Director, Regulatory and Quality

Company: Danessa Myricks Beauty
Location: New York
Posted on: February 21, 2025

Job Description:

The Director of Regulatory and Quality will be responsible for ensuring the global compliance of all products, as well as creating, implementing, and maintaining SOPs to support the brand's quality management system (QMS). They will work closely with product development, packaging, operations, marketing, creative, and sales to drive the company's quality and regulatory programs and strategies, including global registration, articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, holding vendors and suppliers accountable, maintaining all documentation and recordkeeping, and deploying initiatives to focus internal and external partners on continuous improvement. This role will report to the SVP of Product Innovation. This position is onsite, located in Farmingdale, New York.ROLES & RESPONSIBILITIES:

• Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for all products and ensure alignment with overall business strategy.
• Proactively partner with R&D, Marketing, and other groups to provide regulatory review on copy/claims, guidance on meeting global requirements and share imminent regulation updates to support roadmaps for revisions as needed.
• Oversee the performance of internal and external audits.
• Reviews, upkeeps, and maintains all departmental policies and procedures, including trainings for customer-facing employees, CAPAs, NCRs and enforcing quality agreements with vendors and manufacturing partners.
• Maintain meticulous recordkeeping and documentation for all SOPs, updating as needed.
• Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/QC functions.
• Manages all quality agreements with suppliers, ensuring adherence and monitoring/reporting performance.
• Oversee the review and approval of product testing and finished goods release protocols to ensure consistency and compliance with established quality standards.Regulatory Compliance:
  • Review all product artworks; ensure that all product claims, warnings and usage meet all domestic and international regulations/packaging/labeling/label laws.
  • Proactively review all raw material documentation and finished good specifications to ensure all products meet quality and regulatory standards.
  • Maintain regulatory documentation of product formulations, product specifications, Certificates of Analysis, material safety data sheets, manufacturing information & product labeling.
  • Upkeep all formulation and raw material documentation within regulatory software.
  • Work in tandem with external regulatory consultant to ensure all formula reviews, registration documents, and claims substantiation are complete before market launch.
  • Drive and track product registration process, proactively communicating CNF, CPNP/UKCP and all other required registration information to sales teams.
  • Monitor and interpret domestic and international cosmetic regulations (e.g., FDA/MoCRA, Prop 65, Health Canada, EU Directive, etc.) to ensure that all products are compliant throughout their lifecycle.
  • Manage communication with regulatory authorities, responding to inquiries and providing necessary documentation as required.
  • Stay abreast of the constantly changing global cosmetic regulations, providing timely updates to key stakeholders.Labeling and Claims Compliance:
    • Oversee product labeling to ensure compliance in all markets, including ingredient declarations and claims substantiation for all artwork files.
    • Ensure proper claims documentation, testing protocols, and compliance with advertising standards.Builds and updates Quality Management System (QMS):
      • Development of SOPs to satisfy 21 CFR Part 211.
      • Develop, implement, and maintain a robust Quality Management System (QMS) for the cosmetic product lifecycle.
      • Ensure document control procedure is implemented.
      • Ensure continuous monitoring and improvements to maintain product quality, safety, and efficacy, reporting status to ELT to proactively highlight any improvements required.
      • Recordkeeping - ensure proper records and documents are maintained within compliance with 21 CFR Part 211.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 non-conformances (quality issues, product recalls, or regulatory violations) and implement corrective actions.IQC & IPQC, FGQC:
          • Implement a system for all batch and finished goods approval (including filing of COAs and micro release reports), monitoring CM performance with the goal of moving to self-release.
          • Build and maintain documentation and filing system.
          • Ensure all SOPs are followed both externally and internally.Audits and Inspections:
            • Plan and conduct internal and external audits to ensure compliance with regulatory requirements and industry standards (i.e. ISO, cGMP) and establish quality control measures.
            • Ensure validation post audit (ongoing quality metrics to ensure continuous improvement).Team Leadership and Development:
              • Lead and mentor 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.
              • Support customer-facing team members with training on standardized FAQ replies and consistent review of customer complaint logs.Strategic Input and Continuous Improvement:
                • Provide strategic input to ELT 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 (considering any customer complaints).PERSONAL QUALIFICATIONS:
                  • You are a strong leader. You have a demonstrated ability to drive change within a fast-paced environment, supporting the necessary education and process development for team members at all levels.
                  • You can see the big picture without missing critical details. You can easily discern between many tasks to identify the highest priority items; you possess a proven ability to work on high-visibility projects under tight deadlines with strong project management capability.
                  • You are incredibly organized. You maintain detailed and organized files and documentation, project history and specifications for all projects. You can manage a multitude of programs all at once, while ensuring thorough review of all attributes.
                  • You're flexible. You possess the ability to pivot and adapt to new processes and ways of working as needed for a growing business and you thrive in a dynamic entrepreneurial environment.PROFESSIONAL QUALIFICATIONS:
                    • 10+ years' experience in regulatory and quality for the cosmetics industry (color cosmetics experience strongly preferred).
                    • Exemplary understanding of domestic and international registration requirements and demonstrated track record of successful product launches in global markets.
                    • Experience in product safety testing, protocol development and review, and claims substantiation.
                    • Proven track record of building quality management systems and SOPs and deploying the required training and education for internal and external partners.
                    • Broad understanding of cGMP, FDA, ISO, compliance and applicable regulations and industry standards for color cosmetics.
                    • Proven ability to create culture of accountability and ownership.
                    • Demonstrates excellent oral and written communication skills and works well with diverse teams and stakeholders in multiple locations.
                    • Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects.Judgment And Decision MakingThe ideal candidate would be able to operate successfully with intermittent supervision, yet able to flexibly collaborate closely as needed with cross-functional partners & senior management at DMB. Sound judgment, discretion & decision-making skills are of utmost importance.Other Essential RequirementsAbility to travel on site for factory audits and production scale-up as needed.Primary LocationUS - (Long Island, NY)Please note: This job description does not list all duties of the job. Employees may be asked by management to perform other duties. The employer has the right to revise this job description at any time.We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.
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Keywords: Danessa Myricks Beauty, New York , Director, Regulatory and Quality, Executive , New York, New York