Pharma Quality Compliance Lead - FDA Inspection Expert

JCW Group; Denver (CO); On-site; USD 150,000 - 190,000; Full time

Job summary

JCW Group partners with a specialty pharmaceutical company to recruit a Quality Compliance Manager in Denver. This role serves as the site's authority on quality systems and compliance, driving inspection readiness and audit programs with data integrity oversight.

The position leads the Quality Compliance team and oversees CAPA, recalls, and regulatory interactions, requiring extensive experience in pharma quality and FDA inspections.

Qualifications

• Bachelor's degree in a science or engineering field required; advanced degree preferred.
• 10+ years in QA, Regulatory, or Compliance in pharma, biotech, or med device.
• 5+ years of inspection management and audit experience; 3+ years managing quality systems.

Responsibilities

• Serve as site Inspection Administrator and lead FDA inspections and 483 responses.
• Own the QMR/QRB, APQR/PQR, Field Alert, and recall programs, and approve key quality records.
• Lead and develop the Quality Compliance team with hiring, performance, and coaching duties.

Skills

Inspection management

Regulatory compliance

Quality systems

FDA inspections

Data integrity

Education

Bachelor's degree in science or engineering

Job description

JCW Group partners with a specialty pharmaceutical company to recruit a Quality Compliance Manager in Denver. This role serves as the site's authority on quality systems and compliance, driving inspection readiness and audit programs with data integrity oversight.

The position leads the Quality Compliance team and oversees CAPA, recalls, and regulatory interactions, requiring extensive experience in pharma quality and FDA inspections.