Job Description

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, Inc.

• 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 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.

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 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.

Additional Job Duties:

• 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

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