Quality Systems Lead

Establishment, implementation, and continuous improvement of the company’s Quality Management System (QMS) to support its clinical-stage biopharmaceutical development programs while ensuring compliance with applicable regulatory requirements (e.G., FDA, EMA, ICH) and GxP standards (GMP, GDP, GCP, GLP).

Cross-functional collaboration to embed a proactive quality culture, align GxP activities with corporate quality objectives, and drive operational excellence as the organization advances toward late-stage and commercial readiness.

Duties and responsibilities :

QMS Development & Implementation

• Develop, implement, and maintain a phase-appropriate Quality Management System aligned with FDA, EMA, and ICH requirements.
• Establish, review, and update Quality System documentation (SOPs, policies, templates) to support GxP operations (GMP, GDP, GCP, GLP).
• Serve as system owner for the electronic QMS (e.G., Veeva,) and ensure effective document control.
• Drive QMS maturity and scalability as programs advance from early clinical to IND, IMPD, and BLA stages.
• Monitor QMS performance through defined KPIs and implement continuous improvement initiatives

Compliance, Audits & Quality Oversight

Deviation, CAPA, and Change Control

Document & Training Management

Inspection Readiness and Continuous Improvement

Qualifications and Experience

This position operates in an office setting, in person.

Job may additionally require incumbent to be available outside of these hours to handle priority business needs.