Quality Compliance Manager

$135k - $140k

Full-time

JCW Group

Denver, CO

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

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Vacancy posted 19 hours ago

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