Director of Quality Assurance – Quality Systems

About the role

This senior leadership position is responsible for shaping and governing a global Pharmaceutical Quality System (PQS) that supports both clinical and future commercial activities. Reporting to senior management, the Director will design, implement, and continuously improve phase‑appropriate GxP quality frameworks while ensuring regulatory compliance and scalability across the organization.

Key responsibilities

• Lead the design, implementation, and ongoing improvement of a global PQS aligned with GxP and regulatory requirements.
• Own the enterprise electronic Quality Management System (eQMS), overseeing document control, training, deviations, CAPA, change control, risk management, and audit functions.
• Drive validation, administration, and continuous optimization of the eQMS platform.
• Manage the internal audit program and ensure inspection readiness across sites and functions.
• Coordinate and support regulatory inspections, audits, and assessments with agencies, partners, and third parties.
• Partner with supplier quality, manufacturing, and development teams to align external quality systems with PQS requirements.
• Build, mentor, and lead a high‑performing quality systems team.
• Ensure compliance with FDA regulations, ICH guidelines, and other global quality standards while enabling scalable growth.

Required profile

• 10+ years of experience in pharmaceutical or biotechnology quality assurance, with deep expertise in quality systems.
• At least 5 years of leadership experience managing PQS or quality systems teams.
• Proven track record of implementing and leading enterprise eQMS platforms and quality system transformations.
• Strong knowledge of GxP regulations, FDA CFR requirements, and ICH guidelines.
• Experience hosting regulatory inspections and leading remediation activities.
• Excellent project‑management skills with the ability to handle multiple priorities in a fast‑paced environment.

Required skills

• eQMS implementation and administration
• GxP compliance
• FDA CFR and ICH guideline expertise
• Regulatory inspection management
• Project management

What we offer

• Strategic leadership role in a fast‑evolving biotech environment
• Opportunity to shape global quality systems and drive organizational growth
• Collaborative, high‑visibility environment with cross‑functional impact