Quality Compliance Manager

Quality Compliance Manager – Pharmaceuticals

Colorado | Onsite Mon - Fri | $135,000 - $140,000

Intro

JCW is partnering with a specialty pharmaceutical company to bring on a Quality Compliance Manager to serve as the site's authority on quality systems and compliance. The Manager will lead inspection readiness, regulatory and supplier audits, QMR/QRB programs, APQRs, Field Alerts, data integrity oversight, and recall readiness.

Responsibilities

• Serve as site Inspection Administrator and lead FDA and partner inspections, including 483 responses and CAPA follow-up.
• Own the QMR/QRB, APQR/PQR, Field Alert, and recall programs, and review and approve key quality records.
• Lead and develop the Quality Compliance team, with full accountability for hiring, performance, and coaching.

Qualifications and Requirements

• Bachelor's degree in a science or engineering field; 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 elements
• Direct experience hosting FDA inspections and strong knowledge of 21 CFR Parts 210, 211, and 11