Quality Systems Manager/Senior Manager

obsidiantherapeutics; Bedford (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Obsidian Therapeutics is seeking a Quality Systems Manager/Senior Manager to own and mature scalable QMS frameworks in a clinical-stage biopharma setting. The role focuses on implementing Obsidian's eQMS and owning critical processes such as Change Control, CAPA, Deviations, and QMR, ensuring FDA/ICH/GxP compliance.

You will collaborate across Regulatory Affairs, Manufacturing, QC/QA, and Digital Solutions to align workflows and governance.

Qualifications

• Bachelor's degree in related field with 6+ years QA in clinical late-stage biopharmaceuticals.
• 3+ years direct process ownership or administration of quality systems, including change control.
• Experience implementing an eQMS (eQuality Management System).

Responsibilities

• Manage the Quality Management System (QMS) as process owner for Change Control, CAPA, deviations, and QMR.
• Ensure compliance with FDA, ICH, and GxP; maintain inspection readiness.
• Author and maintain SOPs, forms, templates, and training materials.
• Monitor QMS performance and drive continuous improvements.
• Lead internal and external audits, regulatory inspections, and eQMS initiatives.

Skills

Quality systems

Change control

Process ownership

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree

Tools

Veeva

MasterControl

TrackWise

Job description

About Us ...

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian's programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian's lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.

We're proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity...

We are looking for a highly motivated Quality Systems Manager/Senior Manager, with a strong background in owning, maturing, and modernizing scalable Quality Systems.

A key contributor within Quality Systems & Compliance, you'll implement Obsidian's eQMS and serve as process owner for critical quality system processes including Change Control, Product Complaints, Deviations, CAPA, Vendor Notifications, and Quality Management Review, as we advance our first clinical stage autologous cell therapy program targeting solid tumors.

As a member of our Technical Operations team, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki -cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE ® platform. This is a unique opportunity to be a valuable contributor in a clinical-stage company with field-leading advisors, best-in-class partners, and an experienced team.

This is a Hybrid role based out of our Bedford, MA location.

You Will...

Core responsibilities

• Manage the Quality Management System (QMS), serving as process owner for Change Control, Product Complaints, Deviations, Corrective and Preventive Actions (CAPA), Vendor Notifications, and Quality Management Review (QMR).
• Ensure quality system processes remain compliant with applicable FDA, ICH, and GxP requirements while maintaining inspection readiness.
• Author, revise, and maintain SOPs, forms, templates, training materials, and other quality system documentation.
• Monitor quality system performance, identify systemic process issues, and drive continuous improvement initiatives.
• Support internal audits, external audits, and regulatory inspections.
• Serve as the Quality business lead for eQMS selection, implementation, validation, deployment, and ongoing optimization.
• Partner with Digital Solutions & Technology, Regulatory Affairs, Manufacturing, Supply Chain, QC, and QA stakeholders to define business requirements and future-state workflows.
• Lead process mapping, workflow design, system configuration, validation activities, data migration, training, communication, and change management efforts to ensure successful adoption.
• Establish and maintain governance processes, SOPs, and administration practices supporting ongoing system enhancements and continuous improvement.
• Own the Change Control program, including governance, process monitoring, effectiveness assessments, Change Control Review Board (CCRB) activities, and continuous improvement initiatives.
• Ensure deviations, investigations, CAPAs, product complaints, and vendor notifications are managed in a timely, compliant, and risk-based manner.
• Provide coaching and guidance to investigation owners on root cause analysis, risk assessment, and effective problem-solving methodologies.
• Monitor quality event closure timelines, extensions, recurring trends, and overall process effectiveness.
• Develop and maintain quality metrics, dashboards, scorecards, and executive-level reporting to support Quality Management Reviews.

You Bring...

Core Qualifications

• Bachelor's degree and 6+ years of experience in QA within clinical late stage biopharmaceutical environments
• 3+ years of direct process ownership or administration of quality systems, including change control
• Successful experience leading or playing a significant role in implementation of an eQMS
• Management of systems such as Veeva, MasterControl, TrackWise, or equivalent platforms
• Strong working knowledge of FDA, EU GMP, ICH, and applicable GxP regulations
• Excellent planning, coordination, and time management skills
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.
• Ability to build and maintain productive relationships with department management, peers, and other colleagues across the organization
• Collab