Global Quality Director (QMS, Compliance & Regulatory)

UniQure NV; Lexington (MA); On-site; USD 205,000 - 265,000; Full time

Job summary

uniQure seeks a Director of Corporate Quality to lead the global QMS and ensure compliance with cGMP across the organization, aligning processes with company strategy. You will oversee audits, CAPA, change control, training, data integrity, and vendor qualification, while partnering with regulators and internal stakeholders to enable safe, scalable gene therapy medicines.

This leadership role requires building a high-performing team, driving continuous improvement, and delivering clear metrics

Qualifications

• 15+ years GMP experience in pharma/biotech quality roles.
• 10+ years leadership directing quality teams and operations.
• Bachelor's or master's in Life Sciences or Engineering.

Responsibilities

• Oversee global QMS to ensure compliance with cGMP and company strategy.
• Lead CCRB, change control, CAPA, deviations, and audits.
• Partner with regulatory agencies for inspections and licensing.
• Develop and maintain a high-performing quality organization.

Skills

GMP knowledge

Regulatory inspections

Leadership

Data integrity

MS Office

Education

Life Sciences or Engineering degree

Tools

Validation software

Job description

uniQure seeks a Director of Corporate Quality to lead the global QMS and ensure compliance with cGMP across the organization, aligning processes with company strategy. You will oversee audits, CAPA, change control, training, data integrity, and vendor qualification, while partnering with regulators and internal stakeholders to enable safe, scalable gene therapy medicines.

This leadership role requires building a high-performing team, driving continuous improvement, and delivering clear metrics