Quality Systems Manager - Hybrid, eQMS Lead, Stock Options

Socket.dev; Bedford (MA); Hybrid; USD 117,000 - 165,000; Full time

Benefits offered by this job

Stock options

Excellent benefits package

401(k) and retirement plan

Paid time off

Job summary

Obsidian Therapeutics is seeking a Quality Systems Manager/Senior Manager to lead the Quality Management System and modernize our eQMS across critical processes such as Change Control, CAPA, Deviations, and QMR. You will partner with Regulatory Affairs, Manufacturing, and QA to ensure FDA/ICH/GxP compliance and readiness for our autologous TIL program.

The role demands 6+ years in QA in late-stage biopharma, with hands-on eQMS experience, SOP development, and strong cross‑functional

Qualifications

• Bachelor's degree in life sciences or QA with at least 6 years in QA in late-stage biopharma.
• Experience owning or administering quality systems, incl. change control.
• Experience implementing an eQMS environment is required.
• Excellent communication and process‑improvement capabilities.

Responsibilities

• Manage QMS and own process areas: Change Control, CAPA, deviations, and QMR.
• Ensure compliance with FDA, ICH, EU GMP, and GxP requirements; maintain readiness.
• Author and maintain SOPs, templates, training materials, and docs.
• Drive continuous improvement and monitor quality system performance.
• Support audits, regulatory inspections, and vendor notifications.
• Lead eQMS selection, implementation, validation, and optimization.

Skills

QA in clinical biopharma

eQMS implementation

Cross-functional collaboration

Documentation & SOP writing

Education

Bachelor's degree in life sciences or QA

Tools

Veeva

MasterControl

TrackWise

Job description

Obsidian Therapeutics is seeking a Quality Systems Manager/Senior Manager to lead the Quality Management System and modernize our eQMS across critical processes such as Change Control, CAPA, Deviations, and QMR. You will partner with Regulatory Affairs, Manufacturing, and QA to ensure FDA/ICH/GxP compliance and readiness for our autologous TIL program.

The role demands 6+ years in QA in late-stage biopharma, with hands-on eQMS experience, SOP development, and strong cross‑functional