Merle Norman Cosmetics · 1 week ago
Director of Regulatory Affairs & Quality Assurance
Los Angeles, CA
Full-time
Onsite
Director/Executive
$150K/yr - $190K/yr
10+ years expMerle Norman Cosmetics is seeking a Director of Regulatory Affairs and Quality Assurance to oversee regulatory and quality assurance functions. The role involves ensuring compliance with safety and regulatory requirements for new and revised products, as well as managing quality assurance processes and staff.
Consumer GoodsHealth CareLifestyleMedicalRetail
Responsibilities
Formalize & maintain processes through clear & simple procedures
Ensure consistency and effectiveness of processes described in procedures to support the daily performance management
Validate equipment/process/product changes from a quality standpoint
Manage the site internal audit program to ensure compliance between daily practices and the documented quality system, and actively support continuous improvement projects across site
Implement and maintain site sanitation Standard Operating Procedures and provide training to operations team as required
Perform formula regulatory reviews for domestic international and marketplaces
Review product labels, product claims and additional copy for and domestic international marketplaces
Advise on all topics related to regulatory compliance for cosmetics and cosmetic OTCs in the lifecycle of a product
Advise on importation and exportation regulation
Prepare submissions of regulatory documents to customers and regulatory review bodies
Ensure compliance with applicable local, state, federal, and global product regulations
Review and/or prepare submissions of regulatory documents to FDA and related authorities
Review all new and revised specifications to ensure adherence to regulatory requirements
Ensure product documentation (e.g. formulas, ingredient lists, dossiers, MSDS) are completed as required for product development and international registration
Work with cross-functional teams to provide regulatory guidance on development projects and ongoing matters
Develop and maintains pertinent regulatory files for products
Monitor regulatory trends to provide expert guidance on potential issues to minimize impact on business
Interpret new and revised global regulations, and develop strategies for compliance as necessary
Review and approve labeling & promotional materials for studio and consumer facing communication
Provide and manage all product documentation (e.g. testing reports, specifications, letters of compliance) to customers as required
Develop and maintain pertinent regulatory files for products. Ensure systems are in place to distribute information internally and externally as appropriate
Manage staff in the Quality Assurance department; supervise, train, and conduct job performance evaluations for direct reports
Manage test programs to ensure that safety/efficacy/stability have been established for new/revised products
Review laboratory testing of raw materials, bulk product, and finished product in accordance with internal procedures and all applicable governmental regulations
Maintain programs for documentation and technical assurance of raw material, packaging, bulk product, and finished product release specifications in addition to master batch instructions
Ensure appropriate lab testing is conducted at manufacturers and per SOPs
Audit suppliers and manufacturers to ensure compliance and continuous quality improvement
Oversee audits of contract manufacturers to ensure compliance
Establish and review external manufacturer’s quality performance and provides summaries to upper management
Investigate and resolve product issues or customer complaints
Ensure that departments and manufacturers meet quality expectations, including overseeing inspection and storage of samples of finished goods and packaging
Provide technical guidance in packaging and product development
Ensure internal and external requirements are met when issuing new or revised specifications
Develop and maintains department SOPs
Manage additional projects as directed by management
Other duties as assigned by supervisor
Develop staffing plan to manage resources needed to support any clinical trials, claim/label reviews, and regulatory reporting obligations
Ensure supplier's chemical and microbiological testing programs (methods and sampling plans) for raw materials, packaging materials, In-process checks and finished products are adhered to, in order to guarantee product and process safety and conformance
Review and manage disposition of all non-conformance/deviations within product production
Monitor consumer complaints and conduct investigations in a timely manner
Ensure supplier and 3rd Party manufacturing compliance by ensuring all delivered materials and products meet specifications as agreed
Qualification
Required
Minimum 10 years' experience in Regulatory Compliance in Cosmetic and Cosmetic OTCs, and FDA-regulated environment
Minimum 5-7 years' experience in manufacturing and/or Quality Assurance
Working knowledge of FDA regulations pertaining to cosmetic manufacture, testing, validation, labelling, formulations, and documentation
Experience with cosmetics, OTC or pharmaceutical products, and global product regulatory support
Good understanding of Good Manufacturing Practices (GMP's) and industry regulations, and thorough knowledge of FDA
Experience with QA systems in the areas of auditing, training, implementation, and remediation
Excellent analytical skills and problem solving ability
Strong English oral & written communication skills
Strong technical writing abilities
Demonstrates leadership skills and fosters teamwork with others
Able to handle employee and customer issues with a high degree of confidentiality
Able to successfully communicate and interact with internal and external customers
Strong knowledge of computer programs (e.g. Excel, Word, MS Project, Access)
Able to work on numerous simultaneous projects to meet established timelines
Must be extremely detail oriented
ERP system experience
Project management experience
Manage training and ongoing use of ERP system
Company
Merle Norman Cosmetics
Merle Norman Cosmetics is a leading brand of premium skin care, foundations and color cosmetic products.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Tami Hillebrand
General partner/Studio Owner
Recent News
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