Director, Corporate Quality

Key result areas (major duties, accountabilities and responsibilities)

• Manages development, implementation, maintenance, and improvement of all relevant Quality Management Systems and processes to ensure compliance in line with global regulations and in alignment with the company’s strategy
• Facilitates Change Control Review Board (CCRB) and provides oversight for timely execution and closure of changes. Facilitates issuance and tracking of Quality Management items (e.g., Dev, CAPA, OOS) and holds stakeholders accountable for closure on agreed timelines
• Responsible for computer system validation activities in support of Quality initiatives
• Responsible for data integrity across the organization
• Maintenance of training and documentation processes
• Oversees the risk management process to ensure compliance with current regulations
• Provides Quality and corporate department stakeholders guidance that is aligned with global regulations and internal Quality Management Systems
• Provides strategic vision to influence the growth and development of uniQure capabilities needed to support a fully commercial gene therapy company
• Responsible for developing, implementing and improving Quality System Metrics and for reporting performance trends and risks to senior management
• Responsible for developing, implementing, and improving a risk based internal and external audit program
• Responsible for internal inspection readiness activities
• Responsible for coordinating effective and timely internal stakeholder responses to inspection observations
• Responsible for assessing the impact of any new or updated regulations on the company’s Quality Management Systems
• Responsible for developing and maintaining a high-performing Quality organization to effectively execute organizational responsibilities
• Act as the main contact person for local and international Regulatory Agencies in relation to inspections and licensing and manage these relationships effectively