Executive Vice President of Compliance and Regulatory Affairs

7 days ago

Corona, California, United States Wellington Foods Inc Full time

**Job Title:** Executive Vice President of Compliance and Regulatory Affairs

**Company Overview:** Wellington Foods Inc. is a leading manufacturer of dietary supplements, committed to delivering high-quality products that meet the needs of our customers.

**Salary:** $175,000 - $200,000 per year, depending on experience.

Job Description:

The Executive Vice President of Compliance and Regulatory Affairs will be responsible for ensuring that all products manufactured by Wellington Foods Inc. comply with regulatory requirements and industry standards.

Responsibilities:

  • 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 Skills and Qualifications:

  • 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.

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