Bio Manufacturing Science and Technology

Make your mark for patientsTo strengthen our External and Clinical Supply Quality department we are looking for a talented individual to fill the position of: Bio Manufacturing Science and Technology (MSAT) Quality Lead – Braine l’Alleud, Belgium.About the role The Bio Manufacturing Science and Technology (MSAT) Quality Lead ensures global quality oversight for MSAT activities in both internal and external manufacturing of bio drug substances, products, and packaging. This role involves leading and providing QA expertise for strategic and operational quality assurance, overseeing processes and investigations, troubleshooting, facilitating technical transfers, process validation, and continuous improvement. Additionally, the position ensures compliance with regulatory requirements and diligent management of quality issues.You will work with This will be achieved through close partnering in an efficient and collaborative way with Internal and External Bio MSAT, Bio MSAT Quality, Supply Chain, IT, Regulatory, Internal and External manufacturing operations and other team leaders in External & Clinical Supply Quality and within the Quality organization.What you will do Establish and build a network with UCB key stakeholders in relation to Internal and External MSAT for Bio Drug Substances and Drug Products.Provide expert QA advice, support and management for technical operational QA and general QA matters associated with Internal & External Bio MSAT, with the following focus: Troubleshooting and ensure issues are resolved in accordance with policies and proceduresProcess improvement and life cycle management strategyProcess industrialization and Technical transfers within commercial manufacturing facilitiesComplex investigations and associated CAPA plan implementationOversight of process validation and continued process verification (CPV) Provide expert QA advice as required for the analytical activities associated with process transfers, process validation and investigations, including for example: analytical validation and transfercomparability (release, stability and characterisation)specification reassessment Support assignments associated with the products, or transversal projects across multiple productsBuild, establish and develop a governance model and process for Quality oversight of Internal and External MSAT for Bio Drug Substance and Drug Products which fosters continuous quality process improvement, optimized resource utilization and key indicator-based performance monitoringWork closely with Global QA teams (CMC Quality, External & Clinical Supply Quality, etc), Patient Supply Teams and Business stakeholders in an effective and efficient wayPromote quality best practices throughout the Internal Manufacturing Quality Team and the wider Global Quality Organisation and where possible business stakeholders. Create as needed simplified, efficient processes and procedures to support the team’s activities.Work in accordance with UCB HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development Interested? For this position you’ll need the following education, experience and skills A master’s degree is required, ideally in a relevant field such as pharmaceutical sciences, biotechnology, chemistry, or a related disciplineExcellent command of English, both written and spoken, with strong communication across all levelsMust be knowledgeable in multiple areas of Biopharma incl manufacturing and analytical testing, including the interpretation and practical application of applicable regulations.Excellent knowledge of the Biopharmaceutical industry from a business and technical perspectiveAble to work independently without direct supervision, handling complex situations that impact multiple departmentsSkilled in influencing senior internal and external stakeholders on project and product mattersProven ability to manage global projects, lead and motivate teams, and maintain professionalism in challenging situationsStrong interpersonal, verbal, and written communication skills, particularly with senior managementGenerate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the departmental/company vision.Skilled in operating in multi-cultural environments and across global geographiesExpertise in root cause analysis, risk management, and risk assessmentAbility to independently analyze data, identify risks, propose corrective actions, and develop innovative solutions through extensive quality experience.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