A leading manufacturacturing company in Charlottetown, PE is seeking a Quality Manager to lead and oversee all aspects of Quality Assurance (QA) and Quality Control (QC) functions. This is an opportunity to join a fast-paced and growing organization committed to product innovation and regulatory excellence.

Key Responsibilities

Leadership & Management

• Lead, coach, and develop a cross-functional QA/QC team.
• Foster a culture of quality and compliance across all departments.
• Represent the site during audits, inspections, and key customer interactions.
• Track and improve KPIs and quality metrics.
• Provide regular feedback and development plans for team members.

Quality Assurance (QA)

• Oversee implementation and maintenance of the Quality Management System (QMS), including document control, training, deviation management, CAPA, and change control processes.
• Ensure compliance with all applicable regulatory standards including FDA 21 CFR Part 111, GMP, and HACCP.
• Manage internal audits, supplier qualifications, and regulatory inspections.
• Review and approve investigations, CAPAs, deviations, and validation protocols.

Quality Control (QC)

• Manage QC operations such as raw material, in-process, and finished product testing.
• Oversee microbial and environmental monitoring programs.
• Approve Certificates of Analysis (COAs) and review laboratory data for compliance.
• Collaborate with R&D and production on new product validations and process scale-up.

Training & Compliance

• Maintain a GMP training program and ensure proper training documentation.
• Support regulatory inspections and ensure timely resolution of any findings.
• Ensure training records are complete and maintained within the QMS.

Continuous Improvement

• Lead root cause analysis and corrective actions in response to non-conformances, audit findings, and customer complaints.
• Analyze trends in quality performance and implement preventive actions.
• Collaborate with cross-functional teams to enhance quality systems and product integrity.
• Report quality metrics to executive leadership and propose actionable improvements.

Qualifications

• Proven experience in a quality management role within a regulated manufacturing environment (natural health, food, pharmaceutical, or related).
• In-depth knowledge of GMP, HACCP, FDA regulations, and QMS best practices.
• Strong leadership, communication, and problem-solving skills.
• Experience with audits, validations, and continuous improvement initiatives.