Senior Director, Quality

About the role

The Senior Director, Quality leads the entire quality organization for a clinical‑stage biotechnology company developing engineered Tr1 cell therapies. The role is responsible for establishing a culture of quality, overseeing all GxP operations, and ensuring product integrity, patient safety, and regulatory compliance.

Key responsibilities

• Provide oversight of quality risks and report them to senior stakeholders.
• Manage a global audit program to monitor vendor and supplier performance and compliance.
• Maintain and continuously improve the Quality Management System (QMS) that governs GxP data.
• Ensure compliance with FDA, EMA, and ICH guidelines and other applicable regulatory requirements.
• Set strategic direction for the quality team, aligning it with company objectives.
• Drive continuous‑improvement initiatives to increase efficiency of quality processes.
• Represent the company in interactions with regulatory agencies and external partners.
• Lead team building, career development, budget planning, and long‑term departmental strategy.

Required profile

• Senior leader with extensive experience in quality assurance within the biotech or pharmaceutical sector.
• Proven ability to make critical decisions impacting product integrity and regulatory compliance.
• Strong stakeholder management skills, both internal and external.
• Experience overseeing global audit programs and managing cross‑functional quality teams.

Required skills

• GxP compliance
• FDA regulations
• EMA regulations
• ICH guidelines
• Quality Management System (QMS) implementation
• Audit program management
• Vendor/supplier compliance oversight