Quality Manager

Job Description

Job Description

Job Description

About the Opportunity

A growing manufacturer in the health product industry is looking for a Quality Manager to lead its Quality Assurance and Quality Control functions. This is a hands-on leadership role focused on maintaining regulatory compliance, product safety, and continuous improvement in a fast-paced, GMP-compliant environment.

Leadership & Team Development

• Lead and mentor a QA/QC team, fostering a culture of accountability and continuous improvement

• Serve as the site lead during audits, inspections, and client interactions

• Track and report on quality KPIs and site scorecard metrics

Quality Assurance (QA)

• Oversee and maintain the Quality Management System (QMS)

• Ensure compliance with GMP, HACCP, and FDA 21 CFR Part 111 regulations

• Manage internal audits, supplier qualification, deviations, CAPAs, and change controls

• Approve validation protocols and quality documentation

Quality Control (QC)

• Supervise testing of raw materials, in-process checks, and finished goods

• Manage environmental and microbial monitoring programs

• Review and approve lab data, Certificates of Analysis (COAs), and results

• Collaborate with R&D and production during product scale-up and validation

Training & Compliance

• Develop and manage GMP training programs

• Ensure training records are updated and regulatory standards are met

• Support and respond to regulatory and third-party audits

Continuous Improvement

• Lead root cause analysis and implement corrective/preventive actions

• Analyze trends to drive proactive quality improvements

• Provide regular reports and quality metrics to senior leadership

• Previous experience in a quality management or senior QA/QC role

• Strong working knowledge of GMP, HACCP, FDA 21 CFR Part 111, and QMS tools

• Demonstrated success leading audits and ensuring regulatory compliance

• Excellent communication, leadership, and analytical skills

• A dynamic work environment with purpose-driven products

• Opportunities for growth in a rapidly expanding sector

• Competitive salary package based on experience and qualifications