Vice President of Quality Systems

POSITION SUMMARY

The Vice President of Quality Systems (VPQ) is the executive in charge of Wellington Foods’ quality system. This role is responsible for managing the implementation and oversight of programs and procedures to ensure that all products produced at Wellington Foods meet a high quality standard and are produced in conformance with all regulatory requirements. The VPQ has direct management responsibility for the Quality Assurance Manager, Quality Control Laboratory Manager, the Regulatory Compliance Manager, Validation Manager, and the Document Control Coordinator. The VPQ works closely with this team of managers to conduct the daily operation of the Quality Systems Department, including the functions of the Quality Assurance staff, the Quality Control Laboratory staff, the Regulatory Compliance staff, the Validation Department staff, and all document control functions related to the quality system. The VPQ role is primarily a management role, which requires both experience in managing a department with complex tasks, and a good understanding of the responsibility of the quality system. In this capacity, the VPQ must possess competence in the functions under management, and an ability and willingness to teach, train, coach and assist each manager for the successful completion of their responsibilities. The VPQ reports directly to the president of Wellington Foods, works daily with members of many different departments within Wellington Foods, and is the representative of the Quality Systems Department to customers, auditors and the Wellington Foods management team.

MAJOR FUNCTIONS & RESPONSIBILITIES

• Management of the Quality Systems department, including oversight of hiring, training, managing and reviewing Quality Systems employees.
• Ensure regulatory compliance through establishment of policies and procedures which enforce process control.
• Manage the activities of the Quality Systems department to ensure high product quality and regulatory compliance.
• Establish and manage Quality Systems management reviews to ensure continuous improvement, including visibility of quality and compliance metrics, processes, systems, and key performance indicators.
• Manage the establishment and oversight of global compliance processes such as deviations, non-conformance investigations, CAPA, internal audits and customer complaints.
• Communicate with federal and state agencies which regulate our products and license our facilities (FDA, NSF, etc.). Update and maintain all licenses and registrations.
• Participate with the Regulatory Compliance manager in all regulatory and customer audits.
• Manage the administration of a company-wide cGMP training program, conduct training sessions as required and assist in maintaining the training database.
• Serve as partner and resource to other functional areas in the company including Research & Development, Manufacturing, Inventory Control and other needed areas within the operation.
• Promote recognition of quality programs within the company to create a shared continuous improvement mindset across functional departments and reinforce continuous improvement principles.
• Participate with the new product team to give input on quality related issues affecting new products.
• Review and approve analytical and microbiological test methods and protocols (e.g. validations) to ensure they meet all industry and legal standards.
• Review and approve equipment and/or processes validation protocols and subsequent summary reports.
• Investigate complaints related to quality failures and respond accordingly. Track and report trends to senior management.
• Lead Material Review Board in decisions related to material disposition.
• In the event of a major quality failure with a distributed product, conduct in-depth investigation, notify executive management and initiate appropriate action (product hold/reject or market withdrawal or full recall).
• Establish and monitor the CAPA programs to ensure that all non-conformances are addressed and adequate corrective action is taken as necessary.
• Review, provide feedback, and approve Quality Agreements with customers.
• Manage the administration and maintenance of Quality related technology systems such as Master Control (QMS), and Trace Gains (Vendor/Material Quality Document Management).
• Support other company operations with appropriate Quality Systems staffing levels to perform the needed quality work at the appropriate time.
• Other Quality related functions as necessary in the performance of the role.
• This position includes responsibility for ensuring Food Safety.
• This position may serve as a backup for Food Safety in the absence of key personnel.
• Adhere and enforce current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs), safety, company rules, SOPs, and policies.

REQUIRED EDUCATION / WORK EXPERIENCE / SKILLS:

• Advanced knowledge of and experience managing a Quality System governed by cGMP - 21 CFR Part 111 and 21 CFR Part 211.
• Expert knowledge in CAPA, deviation handling and non-conformance.
• Extensive and effective management experience in Quality Systems in a manufacturing environment.
• Minimum of 8 years of management experience in Quality Control/Quality Assurance and/or Regulatory Compliance fields in the dietary supplement industry, and beneficial to have similar experience in the pharmaceutical industry.
• Proven competence in dealing with internal processes and managing personnel.
• Bachelor of Science degree in discipline related to Quality Control/Quality Assurance and/or Regulatory Compliance.
• Excellent critical thinking, strategic and analytical skills as well as a holistic approach to problem solving and decision-making.
• Excellent organizational skills and ability to perform multiple, overlapping tasks.
• Ability to effectively communicate with and persuade executive management.
• Must possess excellent oral, written and listening skills.
• Positive attitude and excellent interpersonal skills.
• Proven competence in creating, administering and managing budgets.
• Ability to analyze present processes to accurately predict and manage to future needs.
• Requires ability to resolve complex technical and regulatory issues and work as needed to support changing business requirements.
• Knowledge of computers, word processing, spreadsheets and statistical programs.
• Must work well with others.
• Must work well under pressure.