- Location
- Redwood City, California, United States · published
- Type
- Full-time
- Department
- Management
- Seniority
- Manager
- Source
- Workable
Description
The Manager, Quality Management Systems (QMS) will be responsible for the hands-on, day-to-day operation, administration, and continuous improvement of Eyconis's electronic Quality Management System (eQMS) and associated quality processes.
This role will partner closely with CMC Quality Assurance, Clinical Quality Assurance, Regulatory Affairs, Clinical Operations, Technical Operations, and IT to ensure that quality systems remain effective, inspection-ready, phase-appropriate, and aligned with applicable regulatory requirements.
The Manager will serve as a key QMS subject matter expert, supporting the Head of Quality in the continued development and scaling of Eyconis’ Quality Management System as the company advances its clinical programs toward late-stage development.
The position is based in Redwood City, California, and reports to the Executive Director, Head of Quality.
Key Responsibilities
- Own the day-to-day operation, governance, and continuous improvement of Eyconis' Quality Management System to support clinical development, CMC activities, and organizational growth.
- Serve as the subject matter expert and primary administrator for Eyconis' electronic Quality Management System, including day-to-day configuration, governance, and user support of the current Quality system, under the direction of the Head of Quality.
- Personally execute and oversee routine QMS activities, including document workflows, training assignments, quality-event administration, user/access support, record maintenance, reporting, and system troubleshooting.
- Support implementation, configuration, validation/qualification, maintenance, upgrades, and lifecycle management of electronic quality systems, under the direction of the Head of Quality and in coordination with IT.
- Establish and maintain scalable, phase-appropriate quality processes aligned with applicable FDA, ICH, EU GMP, and other global regulatory expectations.
- Support inspection readiness and collaborate with QA colleagues during regulatory inspections and sponsor audits.
- Manage quality events (deviations, change controls, CAPAs, and investigations) and ensure timely and effective resolution.
- Foster a culture of quality, accountability, and collaboration across the organization.