Quality Compliance Supervisor

JCW Group; Denver (CO); On-site; USD 110,000 - 160,000; Full time

Job summary

JCW Group in Denver, CO, seeks a Quality Compliance Supervisor for Pharmaceuticals to lead the Quality Compliance team and own inspection readiness, regulatory audits/inspections, QMR/QRB programs, and recall activities. This role ensures adherence to cGMP, FDA and international standards across the site.

You will manage audits, CAPA, and regulatory reporting, mentor staff, drive continuous improvement, and coordinate with cross-functional teams to maintain compliant operations and product

Qualifications

• 8+ years of experience in Quality and/or Compliance in the pharmaceutical industry.
• 5+ years of inspection management/audit experience.
• 3+ years leading or managing quality systems elements.
• Working knowledge of cGMP and FDA/international regulatory requirements.

Responsibilities

• Lead and oversee the Quality Compliance team and CAPA processes.
• Own internal auditing, inspection readiness, regulatory audits/inspections and QMR/QRB programs.
• Manage reporting for Annual Product Quality Review, Field Alert/regulatory notification and Recall programs.
• Serve as primary contact for regulatory agencies during inspections and follow-up responses.

Skills

Regulatory compliance

Auditing

Leadership

Education

Bachelor's degree in a scientific, engineering, or technical discipline

Job description

Quality Compliance Supervisor – Pharmaceuticals

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