QMS Operations Lead — Quality & Compliance

Eyconis, Inc.; Redwood City (CA); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

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

Gym access

Job summary

Eyconis, Inc. in Redwood City, California, seeks a Manager, Quality Management Systems (QMS) to lead the hands-on operation, administration, and continuous improvement of the eQMS and related quality processes.

The role partners with CMC QA, Clinical QA, Regulatory Affairs, Clinical Operations, Technical Operations, and IT to ensure the quality system remains inspection-ready and aligned with FDA, ICH, and EU GMP expectations as Eyconis advances its clinical programs.

Qualifications

• Bachelor's degree in life sciences, engineering, or related field.
• 4–6 years in pharma/biotech quality assurance or QMS.
• Hands-on experience with eQMS platforms (e.g., Qualio, Veeva Vault Quality).
• Knowledge of 21 CFR Part 11, ICH Q9/Q10 is preferred.
• Experience in document control, training, deviations, CAPA, change control.

Responsibilities

• Oversee daily QMS operations to support clinical development and CMC activities.
• Serve as QMS subject matter expert and admin for the eQMS.
• Manage quality events (deviations, CAPAs, change controls, investigations).
• Ensure inspection readiness and support regulatory audits.
• Develop scalable, phase-appropriate quality processes aligned with FDA/ICH/EU GMP.

Skills

Quality Assurance

Quality Management Systems

eQMS configuration

Regulatory knowledge

Cross-functional collaboration

AI tools in QA

Education

Bachelor's degree in life sciences or engineering

Advanced degree preferred

Tools

Qualio

Veeva Vault Quality

MasterControl

TrackWise

Job description

Eyconis, Inc. in Redwood City, California, seeks a Manager, Quality Management Systems (QMS) to lead the hands-on operation, administration, and continuous improvement of the eQMS and related quality processes.

The role partners with CMC QA, Clinical QA, Regulatory Affairs, Clinical Operations, Technical Operations, and IT to ensure the quality system remains inspection-ready and aligned with FDA, ICH, and EU GMP expectations as Eyconis advances its clinical programs.