Head of In-Market Quality Europe
il y a 1 semaine
Make your mark for patients
UCB is seeking a dynamic Head of In-Market Quality, Europe to join our Global Quality team. The ideal candidate will be energetic, committed to continuous improvement and possess clear communication skills. The position is open to candidates located in Belgium or at a UCB affiliate location in Europe .
About the role
This key leadership role involves overseeing Quality operations for our Commercial affiliates in the European Union, United Kingdom, Switzerland and global Alliance partners within the region, ensuring strong guidance and support.
The primary objectives of this role are to seamlessly integrate quality practices at commercial affiliates, ensuring compliance with local and international regulatory requirements across UCB, and providing effective quality oversight for global Alliance partners commercializing and distributing UCB products in Europe. This position also entails responsibility for staff and talent management, including performance management and professional development.
Who you'll work with
The Head of In-Market Quality, Europe, reports to the Head of Global Distribution and In-Market Quality and works in strong collaboration with the In-Market QA Heads of the other regions to ensure consistency of quality operations within the commercial affiliate network.
The ideal candidate will also partner with peers and internal stakeholders at global and regional level (e.g., other Quality Units, Global Supply Chain, Pharmacovigilance, etc.).
What you'll do
Ensure the right talents are in place and appropriate resources allocated to achieve quality compliance in-line with UCBs vision and values, stimulating the integration and collaboration between the territories. Oversee the local Quality organization to deliver best in class service and ensure implementation, maintenance and continuous improvement of the local Quality System in order to drive compliance of all relevant cGxP with local/International regulatory requirements and UCB global standard operating procedures. Ensure quality governance and quality planning in the Territories through the establishment and implementation of appropriate Key Quality Indicators, Quality Risk Management Assessments and execution of periodic Management Review of Quality Systems. Ensure Affiliate readiness for all GxP regulatory inspections. Serve as the primary Regional Affiliate Quality contact for operational matters and collaborate with local operations and management to ensure that processes are aligned with prevailing international requirements. Keep current on all-pertinent regulatory publications, international regulations, guidelines and requirements, identify shortcomings and initiate working groups to implement changes following the gap analyses, in line with the RIN global process. Connect internal and external stakeholders with Local Quality organizations to facilitate a holistic approach of GxP regulatory compliance. Ensure quality oversight and direction to local vendors and partners and ensure that they are qualified to perform their activities in compliance with UCB Quality Standards. Ensure quality management of external partners to secure, establish, optimize and elevate Alliance Quality capabilities and capacities.Interested? For this role we're looking for the following education, experience, and skills
Master's Degree in Scientific and/or Pharmaceutical field and/or Engineering Previous leadership experience in the Biopharmaceutical industry within regulated areas (e.g., Manufacturing, Distribution) and/or Quality Assurance expertise (ideally 10 years relevant experience) In depth knowledge and understanding of the complexity of the BioPharma business and GXP principles, including the interpretation and practical application of applicable regulations. Able to act in most circumstances without direct supervision and handle complex/ difficult situations. Excellent communication skills, clear and effective in both written and verbal communication Strong negotiation abilities, skilled in mediating and capable of aligning team members towards a unified decision. Effective Decision-Maker, skilled at making well-informed and prompt decisions in challenging situations. Natural ability to lead, inspire and motivate a remote team using collaboration tools. High Autonomy and Self-Motivation, able to work independently with minimal supervision, proactive and resilientIf you are interested to learn more about R&D within UCB, please find more information here .
RANDATUCB
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
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