Quality Assurance Systems Manager

Job brief

We are looking for a Quality Assurance Systems Manager is responsible for overseeing quality systems with a focus on change control, document control, investigations, and CAPAs within a GMP-regulated environment. This role ensures compliance with internal policies, regulatory standards, and industry best practices, while supporting audit readiness and continuous improvement initiatives. The QA Systems Manager partners with cross-functional teams, provides oversight of quality records and metrics, and may supervise direct reports.

Responsibilities

• Manage site quality systems, including change control, document control, and quality records management.
• Review and approve investigations, CAPAs, and GMP documentation to ensure timely closure and regulatory compliance.
• Prepare quality metrics, reports, and system performance updates for and leadership reviews.
• Support internal and external audits, including responses and execution of corrective and preventive actions.
• Collaborate with cross-functional teams to maintain a high level of audit readiness and promote continuous improvement.
• Provide training and guidance on quality system requirements to site personnel.
• Supervise and develop staff, ensuring effective resource management and knowledge transfer.

Requirements