VP of Quality Systems & Regulatory Excellence

Wellington Foods Inc; Corona (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Wellington Foods Inc. seeks a strategic Vice President of Quality Systems to lead the Quality Systems department, ensuring cGMP compliance and high product quality across all products.

The role manages QA, QC, Regulatory Compliance, Validation and Document Control, reporting to the president and coordinating with auditors, customers and other departments. Requires 8+ years in QA/Regulatory roles and a BS in a related field.

Qualifications

• Advanced knowledge of and experience managing a Quality System governed by cGMP - 21 CFR Part 111 and 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 in the dietary supplement industry (pharma experience beneficial).
• Bachelor of Science degree in related QA/Regulatory Compliance field.
• Excellent critical thinking, strategic and analytical skills with strong problem solving.
• Excellent organizational skills with ability to multitask.
• Strong communication and ability to influence executive leadership.
• Ability to resolve complex technical and regulatory issues with cross-functional teams.

Responsibilities

• Manage the Quality Systems department, including hiring, training, supervising and reviewing staff.
• Ensure regulatory compliance through policies and procedures that enforce process control.
• Oversee activities to deliver high product quality and regulatory adherence.
• Lead management reviews to monitor quality metrics, systems, and KPIs.
• Oversee global compliance processes: deviations, non-conformances, CAPA, audits, and complaints.
• Coordinate with federal and state agencies for licenses and registrations.
• Partner with Regulatory Compliance on audits and regulatory filings.
• Administer cGMP training programs and maintain training databases.
• Collaborate with R&D, Manufacturing and Inventory to support quality goals.
• Promote continuous improvement of quality programs across departments.
• Provide input to new product teams on quality issues and validation.
• Review and approve test methods, validation protocols and reports.
• Investigate quality incidents and track trends for senior management.

Skills

Quality Systems Management

Regulatory Compliance

CAPA & NCR

Executive Communication

Leadership

cGMP Knowledge

Budget Management

Education

Bachelor of Science in Quality/Regulatory/QA

Tools

Master Control (QMS)

TraceGains

Job description

Wellington Foods Inc. seeks a strategic Vice President of Quality Systems to lead the Quality Systems department, ensuring cGMP compliance and high product quality across all products.

The role manages QA, QC, Regulatory Compliance, Validation and Document Control, reporting to the president and coordinating with auditors, customers and other departments. Requires 8+ years in QA/Regulatory roles and a BS in a related field.