QMS/eQMS Lead — Quality Systems & Compliance

Eyconis, Inc; Redwood City (CA); Sur place; USD 115 000 - 130 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) with employer matching

Flexible work hours

Paid time off

Equity programs

Gym access

Résumé du poste

Eyconis, Inc. in Redwood City, CA, seeks a hands-on Manager of Quality Management Systems to lead Eyconis' eQMS and related quality processes.

You will partner with QA, Regulatory, Clinical Operations, IT, and other functions to keep systems inspection-ready and aligned with regulatory expectations. The role requires 4–6 years in QA/QMS within regulated life sciences, with demonstrated eQMS configuration experience and strong data-driven problem solving.

Qualifications

• Bachelor's degree in life sciences, engineering, pharmaceutical sciences, or related discipline required; advanced degree preferred.
• 4-6 years of experience in QA and QMS within regulated life sciences environments.
• Hands-on experience with electronic QMS platforms (e.g., Qualio, Veeva Vault Quality, MasterControl, TrackWise).
• Experience supporting clinical-stage and/or commercial pharmaceutical or biotech operations.
• Knowledge of 21 CFR Parts 11, 210, 211; ICH Q9/Q10; data-integrity expectations.
• Ability to design templates, forms, and workflows in eQMS with user-friendly interfaces.
• Strong attention to detail and ability to drive day-to-day quality processes in a growing organization.
• Ability to collaborate across QA, Clinical, Regulatory, Technical Operations, and IT.

Responsabilités

• Own the day-to-day operation, governance, and continuous improvement of Eyconis' QMS.
• Serve as SME and primary administrator for the electronic QMS; configure workflows and provide user support.
• Execute and oversee routine QMS activities: document control, training, deviations, CAPA, change controls.
• Support implementation, validation, maintenance, and lifecycle management of electronic quality systems.
• Maintain scalable, phase-appropriate quality processes aligned with FDA, ICH, EU GMP, and global expectations.
• Support inspection readiness and assist during regulatory inspections and sponsor audits.
• Manage quality events and ensure timely, effective resolution.
• Foster a culture of quality, accountability, and cross-functional collaboration.

Connaissances

QMS administration

GxP knowledge

Regulatory compliance

Cross-functional collaboration

Data analysis

AI tools

Formation

Bachelor's degree in life sciences or related

Advanced degree preferred

Outils

Qualio

Veeva Vault Quality

MasterControl

TrackWise

Description du poste

Eyconis, Inc. in Redwood City, CA, seeks a hands-on Manager of Quality Management Systems to lead Eyconis' eQMS and related quality processes.

You will partner with QA, Regulatory, Clinical Operations, IT, and other functions to keep systems inspection-ready and aligned with regulatory expectations. The role requires 4–6 years in QA/QMS within regulated life sciences, with demonstrated eQMS configuration experience and strong data-driven problem solving.