Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director Quality / Qualified Person (QP) supports Ultragenyx EMEA Quality Systems and ensures batch certification of our investigational and commercial products in accordance with the principles of current Good Manufacturing Practices and the requirements of the Marketing Authorization.

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

• Act as Qualified Person, batch certifying investigational and commercial products manufactured by Ultragenyx in accordance with the requirements of the Marketing Authorization or Product Specification file and the principles of current Good Manufacturing Practice (cGMP).
• Support Ultragenyx global and regional Quality Management Systems and ensure compliance to applicable GMP and/or GCP regulations.
• Lead operational quality initiatives to support regional inspection readiness and maintain compliance with regulatory requirements.
• Verify that each batch of medicinal product is distributed under conditions that meet the GDP guidelines according to European GDP-guidelines (GDP Responsible Person).
• Contributes to the development and control of quality metrics that predict the performance and health of the quality systems and processes.
• Work with cross-functional teams on a global and regional level (Quality Assurance, Quality Control, Regulatory Affairs and Supply Chain) to continuously improve our processes to ensure efficient supply and product quality.
• Participate and act as key decision maker in supplier qualification, external audits and self-inspections.

Requirements:

• Quality professional with extended experience in biologics and sterile manufacturing and proven project leadership skills in quality and project management.
• Minimum of 5 years’ experience as Qualified Person with biologics is required, experience with ATMP (gene therapy) and investigational medicines is preferred.
• Master’s degree in pharmacy or (bio-)sciences as defined by EU regulations (Qualified Person)
• Fluent in English (written and spoken).
• In-depth knowledge of GMP and other applicable regulatory requirements.
• Excellent communication skills and collaborative style of working.
• Provide clear, direct, and timely verbal and written communication to stakeholders.
• Occasional travel to locations within Europe and overseas to support Quality oversight and business needs (5 – 10%). #LI-CK1 #LI-Hybrid