Vice President of Quality

Summary of the Position:  The Vice President of Quality Develops and deploys the quality system for Nutramax Laboratories to assure systems and procedures are compliant in pursuant to government regulations, industry standards and Company specifications and policies. Periodically reviews the suitability and effectiveness of the quality systems with Executive Management. This role has ultimate responsibility for making quality decisions for products in the human and animal health areas.

Roles and Responsibilities:

· Oversee all Quality Control and Analytical Development operations including personnel.

· Oversee all Quality Assurance Operations and personnel.

· Host all regulatory and third-party audits for Nutramax Laboratories

· Ensures all test methods comply with cGMP regulations and company policies, investigates laboratory anomalies, evaluates laboratory trends, and archives raw data and results for easy retrieval.

· Manages the Quality Organization in support of business division or Company initiatives.

· Interfaces with Production, Regulatory Affairs, Marketing, New Product Development, and other necessary departments to maintain awareness of Quality Operation activities.

· Responsible for results in terms of product quality and conformance to government regulations, industry standards, and Company policies.

· Understands and deploys processes to assure conformance to government regulations, industry standards and Company specifications and policies.

· Periodically reviews the suitability and effectiveness of the quality system with Executive Management.

· Assesses and advises Executive Management on quality decisions.

· Manages interactions with vendors, suppliers and FDA inspectors concerning the quality of products, systems, and processes.

· Identifies and manages continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability, and cost improvements.

· Maintain awareness of current government regulations and interface and interpret with Regulatory Affairs, to apply and implement these regulations to assure compliance.

· Develops budget for Quality Organization and ensures adherence to the budget.

· Manages quality compliance for Contract Manufacturers for domestic and international Products.