Vice President of Quality

Description

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.

Requirements

· Bachelor’s degree in science or engineering; Advanced degree preferred.

· Minimum of ten management experience in Quality Assurance and Quality Control in the nutritional supplement and/or pharmaceutical products manufacturing industry; with 7 years’ management experience.

· Strong Knowledge of FDA government regulatory requirements pertaining to manufacturing of pharmaceutical products.

· Strong leadership and demonstrated success in managing a large team.

· Strong analytical and critical thinking skills.

· Success working with multifunctional, global teams.

· Excellent interpersonal/communication/influencing/negotiation skills required.

· Demonstrated critical thinking skills.

· An elevated level of human relations skills in selecting, developing, and motivating people.

· Excellent motivational and cross-functional team building skills.

· International experience preferred

· Knowledge of animal health regulations is a plus.

Supervisory Responsibilities:

• •QC and QA Personnel
• •Enforce Safe Work Practices: It is the supervisor’s responsibility to enforce safe work practices and procedures; failure to do so is an invitation for accidents to occur. Workers must be encouraged to identify unsafe or unhealthful workplace conditions or hazards.
• •Correct Unsafe Conditions: Supervisors must take immediate steps to correct unsafe or unhealthful workplace conditions or hazards within their authority and ability to do so. When an unsafe or unhealthful workplace condition or hazard cannot be immediately corrected, the supervisor must take temporary precautionary measures. Supervisors must follow-up to ensure that corrective measures are completed in a timely manner to address the hazard.
• •Prevent Lingering Unsafe or Unhealthful Workplace Conditions or Hazards: It is the supervisor's responsibility to train and periodically remind employees of what to look for and how to correct or report unsafe conditions or hazards. If a hazard is identified, the supervisor must act to correct.
• •Incidents Reporting: Immediately ensure first aid is provided by an ERT member and ensure there is no immediate danger to others. Arrange additional medical treatment for the employee if necessary. Provide emergency transportation, if needed. Notify additional rescue/response teams if necessary.
• •Immediately notify EHS employees seeking medical treatment for work related incidents. Ensure employees complete their sections of the safety incident report.
• •Complete the incident report and email to Incident Response before the end of your shift. Begin incident investigation Secure the scene. Keep it unchanged to accurately collect the facts. Obtain photos if needed.
• •Coordinate with EHS to form a cross functional team to perform 5 WHY - Root Cause investigation – Other investigation tools may be utilized for more complicated investigations. Corrective action(s) will be agreed upon by the cross functional team based on the root cause. Once the investigation is complete and agreed upon by the cross functional team, email the completed investigation to Incident Reporting