Quality System Manager

Job Description

Job Description

Salary : $110,000.00 - $130,000.00 - based on experience

About Arthrosi Therapeutics

Arthrosi Therapeutics is a clinical-stage biotech company committed to transforming the treatment paradigm for gout and related inflammatory diseases. Our lead candidate, AR882, is a best-in-class oral URAT1 inhibitor currently in Phase 3 clinical development. We are seeking to build a strong quality team that will play a pivotal role in our journey to regulatory approval and beyond.

Position Summary

The Quality System Manager, under the supervision of Quality Leadership, is responsible for executing and supporting day-to-day activities of GxP quality systems, with particular emphasis on document control, change control, and deviation management. This role ensures that quality processes are implemented in compliance with applicable regulatory requirements (FDA, EMA, ICH, ISO) and internal quality standards to maintain inspection readiness and support product development through commercialization

Key Responsibilities

Document Control

• Administer the electronic Document Management System (eDMS) ensuring documents are created, reviewed, approved, distributed, and archived in compliance with regulatory and company standards.
• Coordinate controlled document lifecycle : drafting, formatting, issuance, revision, retirement, and archival.
• Maintain document templates, numbering systems, and access permissions.
• Ensure training assignments are linked to new / revised documents.

Change Control

Deviation / Nonconformance Management

Training Support

Audit and Inspection Readiness

Metrics and Reporting

Continuous Improvement

Qualifications

Education

Experience

Knowledge and Skill

Preferred Attributes

Why Join Arthrosi?