Head Of Quality Braine Manufacturing

Job description

Make your mark for patients To strengthen our Manufacturing Quality department we are looking for a talented profile to fill the position of: Head of Quality Braine Manufacturing – Braine l’Alleud, Belgium About the role The Head of Quality Braine Manufacturing is the senior Quality executive for one of UCB’s key manufacturing sites, with end-to-end accountability for Quality across commercial Drug Substance and Drug Product operations. The position leads the development of a unified, high-performing Quality organization, driving quality culture, operational excellence, continuous improvement, digital transformation, and organizational capability to support current operations and future business growth. As a member of the Site Leadership Team and the Internal & Clinical Manufacturing Quality Leadership Team, the role actively contributes to site strategy, investment priorities, organizational capability and transformation. The position acts as a trusted partner and constructive challenger to Manufacturing and other site leaders, ensuring that Quality considerations are embedded in business decisions from strategy through execution. You will work with You will collaborate closely with Manufacturing and Site Leadership, as well as key partners across Supply, Technical Operations, MSAT, Regulatory, Engineering, HSE and External Manufacturing Quality. You will also work across the broader UCB Quality network and engage with regulatory authorities to ensure strong alignment on quality, compliance, operational performance and site priorities. What you will do Leadership & Management Provide strategic leadership to the Braine Quality organization and serve as a key member of the Site Leadership Team, shaping site strategy, priorities, investment choices and long-term capabilities. Create an empowered leadership team with clear accountability, strong collaboration and the capability to translate strategy into sustainable performance. Develop people capability (technical, behavioral and managerial); ensure development plans, succession plans are in place to sustain the organization and retain key talent. Foster a culture of quality, compliance and continuous improvement across Quality and Manufacturing on the site and within UCB. Nurture strong top-down, bottom-up and transversal communication; promote continuous feedback and reduce variability to deliver One Quality Voice. Own Quality workforce and financial planning and budget, ensuring resources and investments are aligned with strategic priorities and deliver sustainable value. Quality Transformation & Future Readiness Define and execute the strategic roadmap for the Braine Quality organization, aligned with site and UCB Quality priorities. Lead the transformation toward a simpler, more agile and scalable Quality operating model that enables growth while maintaining strong compliance. Accelerate adoption of digital, data, automation and AI capabilities to strengthen insight, decision-making, productivity and employee experience. Challenge legacy ways of working and remove unnecessary complexity, ensuring Quality resources are concentrated on activities that create the greatest patient, compliance and business value. Quality Assurance & Quality Systems Ensure effective deployment and execution of global Quality Management System (QMS) processes and standards at site level, while driving harmonization and simplification Organize adequate quality oversight of GMP documentation and activities; drive proactive deviation, investigation, CAPA and change control management supported by quality indicators. Supervise quality governance for site operations and support functions; regularly review efficiency of the operating model with stakeholders Prepare product and process quality reports by collecting, analyzing and summarizing data and trends, to drive improvement. Escalate significant/critical quality risks and issues to the right management levels per UCB QMS standards Chair the site Quality Management Review (ICH Q10) and own the site quality risk register; apply Quality Risk Management (ICH Q9(R1)) consistently in decisions. Own the site Data Integrity program (ALCOA+) Quality Operations & Release Ensure the QP certification chain is robust across DS and DP Collaborate closely with the External Manufacturing Quality organization that manages the starting materials, components, suppliers and vendors that are used on the site. Maintain a robust and sustainable QP governance model, including formal succession, delegation, and competency frameworks, ensuring uninterrupted certification capability across products and operations. Own quality aspects of the site manufacturing & import authorization(s) and GMP certificates; ensure variations and site-master-file updates are timely and accurate. Ensure compliance with the Falsified Medicines Directive (safety features/serialization) for products certified at Braine Quality Support, Validation & Sterility Assurance Ensure site facilities, equipment, personnel, methods, processes and procedures conform to internal and regulatory standards. Ensure Quality Support teams support projects (e.g., facility expansion) and lifecycle activities (periodic review, maintenance, calibration). Ensure the validated state of facilities, utilities, equipment, processes, cleaning and computerized systems (Annex 11, Annex 15), including risk-based CSV/CSA. Inspection Readiness & Regulatory Interactions Act as primary liaison for regulatory inspections (foreign and domestic); direct all support and coordination and provide appropriate resources; own resulting improvement plans. Represent the Braine site Quality organization in interactions with regulatory authorities, notably AFMPS, ensuring credibility, transparency, and proactive engagement on quality and compliance matters. Ensure a single, operational site inspection-readiness program covering both DS and DP. Ensure effective deployment of the Regulatory Intelligence Network (RIN) process within the organization, translating emerging regulatory requirements into timely impact assessments, implementation plans, and sustainable compliance strategies. Product Protection, Crisis & Business Continuity Lead quality decision-making for product complaints, quality events, market actions and recalls originating from the site, in line with UCB recall and crisis procedures. Drive a proactive quality framework for quality risk management, operational resilience, and business continuity, ensuring the site can effectively respond to and recover from significant operational events (e.g., utility/HVAC failures, contamination events). Projects, New Product Introduction & Growth Support ramp-up, new product introductions and major project execution (e.g., expansion, digitalization). Ensure quality oversight of technology transfers, process performance qualification and launch readiness, including pre-approval inspection readiness. Monitor the quality organization design through growth phases and propose adjustments as required. Continuous Improvement Identify improvement opportunities and lead initiatives to enhance quality, compliance, efficiency, and organizational effectiveness across the value stream. Establish and monitor a balanced set of quality and operational performance indicators, leveraging both leading and lagging metrics to proactively identify trends, risks, and improvement opportunities. Drive right-first-time performance, cycle-time reduction, simplification, and waste elimination across quality processes (e.g., batch disposition, deviation management, change control, and release activities). Implement best practices, digital solutions, and innovative approaches that enhance performance, scalability, and employee experience, while sharing learnings across the UCB quality network. Ensure robust governance and periodic review of process performance, translating insights into targeted improvement plans with clear accountability and measu