Regulatory Quality Lead: FDA & CAPA Champion

Unilever; Raeford (NC); On-site; USD 89,000 - 133,000; Full time

Benefits offered by this job

Culture for Growth

Health & Well Being Benefits

Global Reach

Careers with Purpose

World Class Career Development

Job summary

Unilever is seeking a Quality Compliance Lead in North Carolina to drive FDA cGMP compliance, audits, CAPA oversight, and inspection readiness. You will partner with Quality, Operations, Engineering, and R&D to strengthen quality systems and reporting of KPIs.

A strong background in regulatory affairs and data integrity is required for success. You will lead cross-functional teams, manage corrective actions, and help define KPIs and scorecards to drive quality improvements using advanced

Qualifications

• ESSENTIAL: 3 years substantial experience in Quality Assurance, regulatory compliance, manufacturing quality, validation, or related cGMP function.
• ESSENTIAL: Working knowledge of FDA cGMP requirements applicable to OTC or Drug manufacturing.
• ESSENTIAL: Working knowledge of Data Integrity, Validations and CAPA.
• PREFERRED / DESIRABLE: Experience in FDA-regulated OTC drug or pharmaceutical environments.
• PREFERRED / DESIRABLE: Strong analytic and technical thought process.
• PREFERRED / DESIRABLE: Excellent oral and written communication and facilitation skills.

Responsibilities

• Lead the site’s regulatory compliance program and oversee audits and certifications.
• Manage and track CAPAs ensuring timely closure and effectiveness verification.
• Coordinate inspection readiness activities and responses to regulatory observations.
• Provide oversight of deviation investigations, root cause analyses and CAPA implementation.
• Ensure consumer complaint investigations are thorough and timely.
• Oversee data integrity programs including audit trails and electronic records.
• Monitor calibration, maintenance, and GMP equipment-related quality.
• Lead validation programs including cleaning and process validation.

Skills

Analytical thinking

Communication skills

Project coordination

Regulatory awareness

Problem solving

Education

Bachelor’s degree in technical discipline

Biology, Chemistry, Engineering, Food Science or Microbiology

Job description

Unilever is seeking a Quality Compliance Lead in North Carolina to drive FDA cGMP compliance, audits, CAPA oversight, and inspection readiness. You will partner with Quality, Operations, Engineering, and R&D to strengthen quality systems and reporting of KPIs.

A strong background in regulatory affairs and data integrity is required for success. You will lead cross-functional teams, manage corrective actions, and help define KPIs and scorecards to drive quality improvements using advanced