Manager, Quality Management Systems – QMS

Eyconis, Inc

. Own the day-to-day operation, governance, and continuous improvement of Eyconis' Quality Management System .

Posted 9/25/2026full-timeRedwood City • California • United StatesMid-LevelSenior💰 $115,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing and improving Quality Management Systems within regulated environments, ensuring compliance with FDA, ICH, and EU GMP standards. Proficient in electronic Quality Management Systems, document control, and quality event management, with a strong focus on collaboration and continuous improvement.

Highest-signal resume keywords

Quality Management SystemsRegulatory ComplianceElectronic Quality Management SystemsDocument ControlQuality Assurance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management System ConfigurationDocument Control ManagementCAPA ManagementChange Control ManagementQuality Metrics EstablishmentData Integrity ComplianceGxP Regulations KnowledgeTraining ManagementQuality Event AdministrationAnalytical Problem-Solving

Soft Skills

Attention to DetailCollaborationProcess DisciplineTrend IdentificationActionable Recommendations

Tools & Technologies

EQMS PlatformsAI-Enabled Productivity Tools

Industry Keywords

Pharmaceutical IndustryBiotechnologyLife SciencesRegulated EnvironmentClinical-Stage SupportOphthalmic Development Programs

About the role

Key responsibilities & impact

Own the day-to-day operation, governance, and continuous improvement of Eyconis' Quality Management System
Serve as the subject matter expert and primary administrator for the electronic Quality Management System
Configure, govern, and provide user support for the current quality system
Execute and oversee 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 deviations, change controls, CAPAs, and investigations and ensure timely, effective resolution
Foster a culture of quality, accountability, and collaboration across the organization
Report to the Executive Director, Head of Quality

Requirements

What you’ll need

Bachelor's degree in life sciences, engineering, pharmaceutical sciences, or a related discipline required
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
Hands-on experience managing or providing significant oversight of electronic Quality Management Systems, including document control, training, deviations, CAPA, change control, supplier quality, audits, and management review, in a GxP-regulated environment
Experience supporting clinical-stage and/or commercial pharmaceutical or biotechnology organizations
Working knowledge of 21 CFR Parts 11, 210, and 211, ICH Q9 and Q10, and applicable data-integrity and computerized-system expectations
Technical proficiency in building and configuring within eQMS platforms, including designing templates, forms, and workflows for document control, training, and quality events
Ability to execute and continuously improve day-to-day quality processes in a growing organization
Strong attention to detail and process discipline
Strong analytical and problem-solving skills
Ability to identify trends, evaluate quality risks, and translate data into actionable recommendations
Ability to collaborate across Quality, Clinical, Regulatory, Technical Operations, and IT stakeholders
Ability to manage multiple priorities in a dynamic, fast-growing biotechnology environment
Ability to apply AI-enabled productivity tools appropriately within a regulated environment
Experience with ophthalmic development programs preferred
Experience establishing quality metrics, dashboards, and Quality Management Review processes preferred
Experience with supplier quality management and oversight of CDMOs, CROs, testing laboratories, and other GxP service providers preferred

Benefits

Comp & perks

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
Gym access