Global Quality Assurance Specialist - Remote

Overview

The Global QA Specialist at Alira Health supports the development, implementation, and continuous improvement of quality systems across Alira Health’s global operations, ensuring compliance with applicable regulatory standards and internal procedures.

In Short

• Support the development and maintenance of the Quality Management System (QMS).
• Conduct internal and vendor audits.
• Assist in the preparation for audits and inspections.
• Document and track quality events.
• Ensure compliance with regulatory standards like ICH GCP and ISO 27001.
• Collaborate with stakeholders to maintain quality oversight.
• Participate in risk assessments and due diligence activities.
• Provide training and support for quality-related topics.
• Contribute to quality metrics tracking and trend analysis.
• Promote a strong quality culture within the organization.

Requirements

• BS/BA in Life Sciences or equivalent experience.
• 3+ years of experience in Quality Assurance in the pharmaceutical or biotechnology industry.
• Experience with electronic Quality Management Systems (eQMS).
• Knowledge of audit lifecycles and reporting standards.
• Understanding of clinical investigation regulations.
• Strong organizational skills and detail-oriented.
• Fluent in English; Italian or French is a plus.
• Proficient in MS Office Suite.

Benefits

• Professional development opportunities.
• Global travel opportunities.
• Flexible work programs.
• Collaborative work environment.