Quality Assurance Systems Manager
Quality Assurance Systems Manager
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Job Description
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.
Employment Type
Full Time
