Manager of Quality Operations-EU

Summary

The Manager of Quality Operations-EU will be responsible for all Quality activities for ARTBIO in Europe in the GMP area, ensuring the quality of our products, their compliance with applicable regulations, and their timely supply to the market.

This role will provide support for the management and continuous improvement of ARTBIO's Quality Management System. The ideal candidate will ensure compliance with the cGxP rules, ensuring full compliance with applicable local regulations. The individual will also be the owner of key quality targets along with the oversight of all EU-based ARTBIO cGMP activities. Additionally, the Manager of Quality Operations-EU will build collaborative and strategic relationships with senior business leaders cross-functionally across ARTBIO and the industry.

The role will be critical to support an external engagement strategy for Quality topics within the EU and contribute to the overall strategy of ARTBIO, supporting and implementing Quality strategies that will enable ARTBIO's growth.

• Together with the ARTBIO Quality Leadership will support the Europe operations Quality long term vision and mission in line with ARTBIO strategy in Europe and collaborate closing with Quality operations US team to ensure alignment and working together.
• Ensure that Europe Quality organization is fully in alignment and following ARTBIO Quality objectives and strategy.
• Establish and maintain collaborative relationships with ARTBIO leaders , regionally and globally to achieve ambitious goals in quality & compliance.
• Lead an efficient Quality operations organization in Europe, compliant with cGxP requirements of EMA, MHRA, and as required) and the ARTBIO Quality Management System related to the GMP manufacturing, testing, release and distribution of pharmaceuticals. Provide support to clinical and preclinical Europe activities as needed.
• Ensure the Europe Quality oversight over all Quality activities, including Notification to Management, Quality Alignment, Market actions, Quality Councils and others.
• Ensure the implementation and continuous improvement of the ARTBIO Quality Management System in Europe to ensure compliance of existing and evolving guidelines, to increase the efficiency of the quality processes and quality systems and to identify and execute corrective and preventive actions, where applicable.
• Ensure external oversight of the contracted sites across the EU and ensure inspection readiness in case of inspection observations, implementation of corrective and preventive actions in a timely manner meeting EMA; MHRA and any local applicable Health Authorities expectation as Swiss medic, Norwegian HAs.
• Help develop and optimize the investigation management system including oversight over external European contracted activities, CAPAs plans, CAPA effectiveness and timely reporting in accordance to regulatory requirements in Europe.
• Coordinate and lead Change Control Review Board meetings and change management proposals, including applicable impact and risk assessments for scope to EU sites and patient safety.
• Implement for EU optimization and efficiency processes requiring KPI's to measure and drive actions for improvement across ARTBIO and the CMO network.
• Identify Europe ARTBIO trends in compliance performance and industry new trends and guidelines and define actions for the annual compliance lifecycle.
• Manage in Europe the relationships and interface with internal stakeholders and external partners/vendors.
• The role will be part of the ARTBIO Quality Leadership team

• Education Required:
  
  Master’s Degree with a major or concentration in Science, Life Sciences, Engineering, Pharmacy or related.
• Experience
  
  Required:
  
  Minimum 10 years in leading pharmaceutical operations with a clear expertise in Quality with at least 3 year of US experience. A mix of experiences in Operations and Quality leadership roles is preferred including knowledge in GMP. Desirable knowledge in GCP and GLP.
• Deep knowledge of Quality Compliance, Regulatory and cGxP practices and guidelines for EU and UK including experience with EU and European inspection and interactions