Quality System Manager

Summary:

The Quality Systems Manager is responsible for the management, effectiveness, and continuous improvement of the organization's Quality Management System (QMS). This role provides oversight of electronic QMS workflows including document control, training management, change control, and quality metrics. The Quality Systems Manager partners across departments to ensure processes remain compliant, effective, and aligned with organizational objectives while driving continuous improvement initiatives.

Responsibilities:

Quality Management System

• Maintain quality system processes and standards
• Lead the implementation and continuous improvement of QMS workflows and modules
• Facilitate the development of global QMS processes and workflows
• Configure and maintain user accounts in QMS
• Develop and maintain Quality dashboards

Documents & Training

• Oversee document control processes by facilitating the development, revision, and maintenance of procedures, work instructions, forms, training materials, and other controlled documents.
• Support change management activities by coordinating reviews, routing approvals, tracking implementation actions, and maintaining associated records.
• Establish training program requirements and ensure alignment with operational needs
• Develop and monitor training effectiveness through completion tracking, reporting, user feedback, and periodic review of training requirements.
• Support employee onboarding by facilitating quality systems training and ensuring new personnel complete required training assignments.

Continuous Improvement

• Lead cross-functional continuous improvement initiatives focused on improving business processes, operational effectiveness, and quality outcomes.
• Prepare reports and visuals for management review of QMS data, including trend analysis and identification of initiatives to improve quality system effectiveness
• Promote quality awareness throughout the organization by serving as a resource for quality processes, documentation requirements, and training expectations.

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• 5+ years of experience in Quality Systems, Quality Assurance, or related regulated industries.
• Experience administering electronic QMS platforms, preferably MasterControl.
• Strong understanding of GDP, training management, and document control principles.
• Demonstrated experience leading process improvement initiatives.
• Experience coordinating training programs, maintaining training records, and supporting compliance training activities is preferred.

Skills

• Proficient in Microsoft Word, PowerPoint, Excel, Visio, SharePoint, and other business productivity tools.

• Strong data analysis, data management, and quantitative skills.

• Ability to work independently with minimal supervision.

• Strong written communication skills, including technical writing and procedure development.

• Detail-oriented with strong follow-through and accountability.

• Strong organizational skills with the ability to management multiple priorities and deadlines.

• Patient and supportive when guiding users through processes, systems, and training requirements.