About the role
Quality Compliance Manager – Pharmaceuticals Colorado | Onsite Mon - Fri | $135,000 - $140,000 IntroJCW 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
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