Global Quality Director - Compliance & Risk (cGMP)

UniQure Biopharma B.V.; Lexington (MA); Hybrid; USD 205,000 - 265,000; Full time

Job summary

uniQure is seeking a Director of Corporate Quality to oversee the global Quality Management System (QMS) and ensure adherence to global cGMP regulations. This role leads Quality Systems, training, risk management, and data integrity across the organization to support transformative gene therapy medicines.

The Director will build a high-performing Quality organization, provide strategic vision for growth, and act as main contact for regulatory agencies during inspections and licensing.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences or Engineering.
• 15+ years of GMP experience in pharma/biotech in a Quality role.
• 10+ years in a leadership role directing and managing Quality teams and operations.

Responsibilities

• Oversee the global Quality Management System (QMS) to ensure compliance with global regulations.
• Facilitate CCRB and oversee timely execution and closure of changes and Quality items.
• Ensure data integrity across the organization and management of training/documentation.
• Lead risk management activities and advise stakeholders on regulatory requirements.
• Coordinate internal and external inspection readiness and responses to observations.
• Build and maintain relationships with Regulatory Agencies for inspections and licensing.

Skills

GMP compliance

QMS management

Audits & inspections

Data integrity

Leadership

Education

Bachelor’s/Master’s in Life Sciences or Engineering

Tools

MS Office suite

Job description

uniQure is seeking a Director of Corporate Quality to oversee the global Quality Management System (QMS) and ensure adherence to global cGMP regulations. This role leads Quality Systems, training, risk management, and data integrity across the organization to support transformative gene therapy medicines.

The Director will build a high-performing Quality organization, provide strategic vision for growth, and act as main contact for regulatory agencies during inspections and licensing.