Job Title: Quality Assurance Systems Manager
Summary
The 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.
Key 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 site 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.
Qualifications
Bachelor’s degree in a scientific, engineering, or related field preferred (equivalent experience considered).
8+ years of quality experience in a regulated industry;medical device or pharmaceutical experience strongly preferred.
Proven experience with change control, document control, investigations, and CAPAs.
Familiarity with quality management systems (e.G., TrackWise, Documentum, SAP, or similar).
Knowledge of GMP, ISO, and EU regulatory requirements (MDR experience a plus).
Strong communication, organizational, and leadership skills.
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