Vice President – Quality

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Vice President of Quality

The Vice President of Quality develops and deploys the quality system to ensure that systems and procedures are compliant with applicable government regulations, industry standards, and company specifications and policies. This role periodically reviews the suitability and effectiveness of the quality system with Executive Management. The position 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 regulatory and third-party audits.

•Ensure all test methods comply with current GMP regulations and company policies; investigate laboratory anomalies, evaluate laboratory trends, and archive raw data and results for easy retrieval.

•Manage the Quality Organization in support of business division or company initiatives.

•Interface with Production, Regulatory Affairs, Marketing, New Product Development, and other departments to maintain awareness of Quality operations.

•Be responsible for results related to product quality and conformance to government regulations, industry standards, and company policies.

•Understand and deploy processes to ensure conformance to government regulations, industry standards, and company specifications and policies.

•Periodically review the suitability and effectiveness of the quality system with Executive Management.

•Assess and advise Executive Management on quality decisions.

•Manage interactions with vendors, suppliers, and regulatory inspectors regarding the quality of products, systems, and processes.

•Identify and manage 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; interface with Regulatory Affairs to interpret and implement these regulations to ensure compliance.

•Develop the Quality Organization budget and ensure adherence.

•Manage quality compliance for Contract Manufacturers for domestic and international products.

Minimum Requirements

•Bachelor’s degree in science or engineering; advanced degree preferred.

•Minimum of ten years of management experience in Quality Assurance and Quality Control in the nutritional supplement and/or pharmaceutical products manufacturing industry, including 7 years of management experience.

•Strong knowledge of FDA (or applicable) regulatory requirements for pharmaceutical manufacturing.

•Strong leadership and demonstrated success managing a large team.

•Strong analytical and critical thinking skills.

•Demonstrated success working with multifunctional, global teams.

•Excellent interpersonal, communication, influencing, and negotiation skills.

•Demonstrated critical thinking skills.

•Strong human relations skills in selecting, developing, and motivating people.

•Excellent motivation 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 invites accidents.

•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.

•When immediate correction is not possible, supervisors must implement temporary precautionary measures.

•Supervisors must follow up to ensure corrective actions are completed in a timely manner.

Prevent Lingering Unsafe or Unhealthful Conditions

•Supervisors must train and periodically remind employees 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 it.

Incidents Reporting

•Immediately ensure first aid is provided by the Emergency Response Team (ERT) and ensure there is no immediate danger to others.

•Arrange additional medical treatment if necessary.

•Provide emergency transportation if needed.

•Notify additional rescue/response teams if necessary.

•Immediately notify EHS personnel seeking medical treatment for work-related incidents and ensure employees complete their sections of the safety incident report.

•Complete the incident report and email it to Incident Response before the end of the shift.

•Begin incident investigation, secure the scene, keep it unchanged to accurately collect facts, and obtain photos if needed.

•Coordinate with EHS to form a cross-functional team to perform 5 WHY root-cause investigation (or other tools for more complex investigations).

•Agree upon corrective actions based on root cause.

•Once complete and agreed upon, email the completed investigation to Incident Reporting.

 

JOB ID: 181712

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Jessie Dodson

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