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.
Requirements- Bachelor's degree in life sciences, engineering, pharmaceutical sciences, or a related discipline required; 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, with an emphasis on identifying efficiencies and maintaining simplicity for end users.
- 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 skills:- 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.
BenefitsExpected Salary Range and Benefits summary- The base pay range for this position is expected to be $115,000 - $130,000 annually.
- Base pay offered may vary depending on job-related knowledge, skills, capabilities, and experience.
Eyconis offers a comprehensive benefits package including Health, dental and vision insurance, 401(k) with employer matching, flexible work hours, generous paid time off, paid new parent leave, employee support and equity programs, free meals, healthy snacks, and gym access to support the well-being of our employees.
