Join a high growth beauty company!

The Director of QA/RA is a critical member of the management team. He or she will lead daily QC and inspections including but not limited to raw material control, incoming inspection of packaging, product evaluation/analysis and in-process batch adjustments. He/she will lead and maintain audit functions and the company’s regulatory affairs compliance program including validation studies and compliant investigations.
 Responsible for all phases of physical, chemical, and microbiological evaluation and analysis of raw materials, bulk product, and finished goods.
 Assist in development of departmental budget; monitor purchases and expenses on routine basis.
 Interact with management, vendors, consultants, and customers to assure high quality goods.
 Communicate with suppliers and contractors with regard to performance of analytical and microbiological evaluation conformance issues related to raw material and product integrity.
 Perform and participate in cGMP and/or regulatory quality audits where necessary. Develop response reports and monitor corrective actions.
 Coordinate and review internal investigations performed of product and packaging related customer complaints. Approve final compliant investigation reports before submission to customer.
 Direct, review and approve out-of-specification (OOS) and corrective and preventive action (CAPA) investigations.
 Create and/or review and approve all Fill & Assembly Specifications for filled and assembled goods.
 Review and approve all master formula (formulation, processing instructions, product specifications) documentation prior to manufacture.
 Approve changes requested for internal documentation including but not limited to master formulas, specifications, procedures and forms.
 Communicate with marketing, development, planning, purchasing, and production prior to manufacture of new, revised, or non-conforming products to minimize the potential for creating defective goods.
 Participate in intra-departmental meetings designed to improve product quality efficiency and promote a continuous improvement environment.
 Prepare and present statistical evaluation of quantitative data for executive management
 Understand, exercise, and enforce all cGMP and safety requirements and procedures.
 Interface effectively with all other departments in routine technical matters.
 Responsible for collection of information and documentation required to compile submissions, license renewals, periodic updates and registration to regulatory agencies.
 Organize regulatory information resources and track/control submissions.
 Responsible to review labels, labeling, protocols and manufacturing or control changes for compliance with regulatory filings.

REQUIRED EXPERIENCE
 7-10 years of experience in the personal care, OTC pharmaceuticals, and/or the cosmetics industry in quality and regulatory functions
 Global Regulatory Affairs (domestic and international) experience
 Experience in fast paced, process oriented, new product development company/companies
 Knowledge of US and International OTC and non-OTC cosmetics FDA regulations and requirements
 Proficiency with customer and/or government audits
 Excellent analytical ability with strong attention to detail and systems development
 Strong oral and written communication skills
 Strong customer service orientation
 Strategic mind-set, capable of thinking conceptually while still being able to handle realistic, real-time day to day situations and make business decisions and recommendations

QUALIFIED CANDIDATES PLEASE SUBMIT YOUR RESUME AND CURRENT COMPENSATION PARAMETERS. UTMOST CONFIDENTIALITY.

• Location: Burbank, CA
• Principals only. Recruiters, please don’t contact this job poster.
• Please, no phone calls about this job!
• Please do not contact job poster about other services, products or commercial interests.