Merle Norman Cosmetics
Director of Regulatory Affairs & Quality Assurance
Merle Norman Cosmetics, Los Angeles, California, United States, 90079
Director of Regulatory Affairs & Quality Assurance
Merle Norman Cosmetics provided pay range
This range is provided by Merle Norman Cosmetics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $110,000.00/yr - $120,000.00/yr
Position Type:
Full Time, Exempt
On-site
Salary Range:
$110,000.00 - $120,000.00 annually*
* The posted range is only one component of Merle Norman Cosmetics, Inc. benefits package.
Director of Regulatory Affairs and Quality Assurance will oversee the activities of both Regulatory and Quality Assurance functions. Responsible for providing regulatory and QC expertise (domestic and international) and leadership to ensure new and revised products comply with applicable safety and regulatory requirements to support the continued growth of Merle Norman Cosmetics.
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.
Regulatory Duties
Perform formula regulatory reviews for domestic international and marketplaces.
Review product labels, product claims and additional copy for 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 maintain 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.
Ensure systems are in place to distribute information internally and externally as appropriate.
Quality Assurance Duties
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 provide 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.
Additional Job Duties
Develop and maintain 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.
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.
Working knowledge of FDA regulations pertaining to cosmetic manufacture, testing, validation, 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.
Manage training and ongoing use of ERP system.
Seniority level Director
Employment type Full-time
Job function Quality Assurance
Industries Personal Care Product Manufacturing
Referrals increase your chances of interviewing at Merle Norman Cosmetics by 2x
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Base pay range $110,000.00/yr - $120,000.00/yr
Position Type:
Full Time, Exempt
On-site
Salary Range:
$110,000.00 - $120,000.00 annually*
* The posted range is only one component of Merle Norman Cosmetics, Inc. benefits package.
Director of Regulatory Affairs and Quality Assurance will oversee the activities of both Regulatory and Quality Assurance functions. Responsible for providing regulatory and QC expertise (domestic and international) and leadership to ensure new and revised products comply with applicable safety and regulatory requirements to support the continued growth of Merle Norman Cosmetics.
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.
Regulatory Duties
Perform formula regulatory reviews for domestic international and marketplaces.
Review product labels, product claims and additional copy for 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 maintain 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.
Ensure systems are in place to distribute information internally and externally as appropriate.
Quality Assurance Duties
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 provide 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.
Additional Job Duties
Develop and maintain 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.
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.
Working knowledge of FDA regulations pertaining to cosmetic manufacture, testing, validation, 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.
Manage training and ongoing use of ERP system.
Seniority level Director
Employment type Full-time
Job function Quality Assurance
Industries Personal Care Product Manufacturing
Referrals increase your chances of interviewing at Merle Norman Cosmetics by 2x
#J-18808-Ljbffr