Job: Director of Quality

The company is a large privately held manufacturer of branded and private label nutritional and dietary supplement products. These nutraceuticals are produced and distributed to major retail and club chains throughout North America.
JOB DESCRIPTION:
1. Responsible for ensuring that the Quality System is effectively implemented and maintained according to local, corporate, federal and international requirements and regulations.
2. Assure compliance to all applicable regulations (21 CFR 110 & 21 CFR 111)
3. Assure the establishment and maintenance of a robust Quality System which includes Document Control, Master Documents; Batch Record Issuance, Review and Release, Change Control, Deviation Reports/Non-Conformance Reports, CAPA’s, Incoming Inspections; raw material, contract microbiology and finished product laboratories, Customer Complaints & Training Systems.
4. Assures timely and appropriate investigation, communication, disposition and root cause corrective actions are implemented.
5. Oversee physical and analytical testing of products to ensure standards, specifications, and customer requirements are meeting compliance.
6. Responsible for final review and release of finished product by providing signature approval of the Certificate of Analysis for each lot number of finished product that deemed compliant with standards, specifications, and customer requirements.
7. Implement, maintain, and improve SQF Programs, HACCP, kosher and organic regulations
8. Establish systems to monitor the quality initiatives and laboratory outputs for cost and efficiency. Work with corporate expenditure requests for Quality impact and appropriateness.
9. Provides leadership, development, coaching, mentoring and support for direct reports. Anticipates and plans for human resource needs.
10. Must provide extraordinary service to all customers, both internal and external.
11. Evaluate existing processes and identify more efficient ways to accomplish goals and meet customer requirements; continuously improve the processes through regular assessment and adjustment.
CRITICAL REQUIREMENTS
1. B.S. degree from a four year university is required in engineering science / life science / chemistry / microbiology/ quality management
2. A minimum 10 years in quality management, regulatory affairs/compliance preferably in Dietary Supplements (Nutraceuticals) and food industry.
3. A minimum 5 years in Quality leadership roles
4. Extensive knowledge of Dietary Supplements & Food cGMP’s, FDA inspections and responses.
5. Understanding of kosher and organic regulations
6. Strong knowledge of chemical characteristics and standard methods for analysis of ingredient, in-process materials, and finished products; principles and practices of the quality assurance and quality control laboratory, laboratory safety practices and procedures; quality and/or statistical sampling techniques and methods, principles of analytical laboratory methods, status of state and federal regulations related to laboratory, quality assurance, safety practices; and data management processing techniques.
7. Skilled in performing standard quality assurance/quality control evaluations procedures, evaluating data using statistical methods of analysis, interpreting results of statistical analysis
8. SQF Practitioner preferred
9. Excellent interpersonal skills and work effectively in a team environment.
10. Good organizational skills and ability to direct others in job duties.
11. Excellent recordkeeping/documentation skills
12. Computer skills including but not limited to Microsoft Word, Excel, PowerPoint, Internet Explorer, etc.