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Salary: USD 115,000 - 130,000 / annual
Eyconis is seeking a Manager, Quality Management Systems (QMS) to lead the hands-on operation, administration, and continuous improvement of the company's electronic Quality Management System and associated quality processes. This role is critical as Eyconis advances its clinical programs toward late-stage development.
You will partner closely with CMC Quality Assurance, Clinical Quality Assurance, Regulatory Affairs, Clinical Operations, Technical Operations, and IT to ensure quality systems remain effective, inspection-ready, phase-appropriate, and aligned with applicable regulatory requirements. You 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.
Key responsibilities include:
- Own the day-to-day operation, governance, and continuous improvement of the Quality Management System to support clinical development, CMC activities, and organizational growth
- Serve as the primary administrator for the electronic Quality Management System, including configuration, governance, and user support
- Execute and oversee routine QMS activities: 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 in coordination with IT
- Establish and maintain scalable, phase-appropriate quality processes aligned with 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
The position reports to the Executive Director, Head of Quality and is based in Redwood City, California.
REQUIREMENTS:
- Bachelor's degree in life sciences, engineering, pharmaceutical sciences, or a related discipline (advanced degree preferred)
- 4–6 years of experience in the pharmaceutical, biotechnology, or other regulated life sciences industry, with significant experience in Quality Assurance and Quality Management Systems
- Demonstrated hands-on experience managing or providing significant oversight of electronic Quality Management Systems (e.g., Qualio, Veeva Vault Quality, MasterControl, TrackWise, or equivalent platforms) in a GxP-regulated environment, including document control, training, deviations, CAPA, change control, supplier quality, audits, and management review
- Experience supporting clinical-stage and/or commercial pharmaceutical or biotechnology organizations, with working knowledge of 21 CFR Parts 11, 210, and 211, ICH Q9 and Q10, and applicable data-integrity and computerized-system expectations
- Demonstrated technical proficiency in building and configuring within eQMS platforms, including designing templates, forms, and workflows for document control, training, and quality events
- Demonstrated ability to execute and continuously improve day-to-day quality processes in a growing organization, with strong attention to detail and process discipline
- Strong analytical and problem-solving skills with the ability to identify trends, evaluate quality risks, and translate data into actionable recommendations
- Ability to collaborate effectively across Quality, Clinical, Regulatory, Technical Operations, and IT stakeholders
- Ability to manage multiple priorities and operate effectively in a dynamic, fast-growing biotechnology environment
- Ability to apply AI-enabled productivity tools appropriately to improve the efficiency and quality of QA activities within a regulated environment
PREFERRED:
- Experience with ophthalmic development programs
- Experience establishing quality metrics, dashboards, and Quality Management Review processes
- Experience with supplier quality management and oversight of CDMOs, CROs, testing laboratories, and other GxP service providers
