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
- Bachelors 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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