Quality Compliance Supervisor

Quality Compliance Supervisor – Pharmaceuticals

Colorado | Mon – Fri | 8 am – 5 pm | $100,000 - $110,000

Intro

A specialty pharmaceutical manufacturer is seeking a Supervisor Quality Compliance to lead and oversee the Quality Compliance team. This role owns internal auditing, inspection readiness, regulatory audits/inspections, Quality Management Review (QMR) and Quality Review Board (QRB) programs, Annual Product Quality Reports, Field Alert/regulatory notification reporting, and the Recall program, ensuring the company's adherence to industry regulations, quality standards, and internal policies.

Responsibilities

• Drive the GxP inspection readiness program, own the Audit Management system, and serve as a primary point of contact for regulatory agencies during inspections, audits, and follow-up responses.
• Facilitate the QMR/QRB process, manage and compile Quality site metrics, and oversee the Annual Product Quality Review, Field Alert/regulatory notification reporting, and Recall program.
• Manage and lead the Quality Compliance team, including hiring, training, performance evaluations, and coaching, while investigating compliance violations and implementing CAPA processes.

Qualifications and Requirements

• Bachelor's degree in a scientific, engineering, or technical discipline
• 8+ years of experience in Quality and/or Compliance in the pharmaceutical industry; 5+ years of inspection management/audit experience and 3+ years leading or managing quality systems elements
• Working knowledge of cGMP and FDA/international regulatory requirements