Digital Business Lead

Job description

Position Summary The business lead for the Electronic Batch Record (eBR) system is accountable for the global business strategy, roadmap, and lifecycle of a cGMP computerized system that supports pharmaceutical manufacturing and quality processes. In this role, you define and lead the global product vision from a business perspective, ensuring CBR remains fit for intended GxP use, compliant with data integrity requirements, and aligned with global process and quality standards across departments and sites. You will steer a network of Local Business Owners (LBOs) and cross-functional stakeholders (Tech, QA, SMEs) to translate business needs into robust user requirements, test strategies, and releases that deliver value to operations. The position offers the opportunity to influence global ways of working, drive harmonization across sites, and develop your leadership profile through ownership of roadmap, audits, deviations, and continuous improvement initiatives. Responsibilities Define and lead the business roadmap for eBR across divisions ensuring the system is aligned with process requirements, sites deployment and fit for intended use in cGMP environments. Create, prioritize and maintain User Requirements in collaboration with LBOs, SMEs (Subject Matter Expert), Tech, QA (Quality Assurance); Create and maintain global business documentation (e.g., RSD, global SOPs (Standard Operating Procedure), eCC (electronic Change Control) Oversee global business test activities (including dry-runs, E2E scenarios, and business test cases), is accountable for validation and global auto-Inspection. Define the global training strategy for eBR and related business processes, develop and maintain global training materials, build and lead a network of LBOs and key stakeholders, and proactively communicate upcoming changes, releases, and their process, documentation, training, and reporting impacts to ensure consistent understanding and adoption across sites. Ensure data generated and maintained in eBR is compliant and controlled, fit for purpose for regulatory submissions, overseeing data integrity risk identification and mitigation, supporting sites during audits and inspections, and providing global oversight that the system and processes remain compliant and fit for purpose. Own system-related global deviations and associated CAPAs (Corrective and Preventive Action), provide second-line business support and trend oversight. Participate in transverse forums on cross-system impacts and drive continuous improvement and harmonization opportunities across the network. Partner closely with Tech (Product Management, Technical Product Owner, development, validation) and QA (Global and Local) to align on priorities, risk and compliance expectations, validation strategies, and incident/deviation outcomes throughout the system lifecycle. Some international travel may be required (up to 10%). Why YouBasic Qualifications: Bachelor's degree in engineering, life sciences, computer sciences or related technical discipline. Minimum 6 years of experience in pharmaceutical manufacturing (vaccines, biopharmaceuticals, small molecules) or manufacturing execution systems (vaccines, biopharmaceuticals, small molecules). Experience in eBR, Mendix/low-code application development platforms. Experience working in cGMP-regulated environments, including regulatory requirements and data integrity practices. Experience in solution development, testing, validation, implementation. Experience in project management and delivery. Experience conducting troubleshooting, problem analysis, and risk assessments. Written and verbal communication in English required and French will be an added advantage. Preferred Qualifications: Ph.D. in a technical discipline (engineering, life sciences, computer sciences, etc.) or M.S. in these disciplines with relevant experience in one of the following areas: Manufacturing execution systems used in pharmaceutical manufacturing (vaccines, biopharmaceuticals, small molecules, etc.) Lab/pilot/commercial scale pharmaceutical manufacturing (vaccines, biopharmaceuticals, small molecules, etc.) Knowledge in multiple areas within pharmaceutical process development, technology transfer, scale-up, process engineering, and/or cGMP batch execution, including experience across multiple functions or modalities (vaccines, biopharmaceuticals, sterile manufacturing, ADCs, oligonucleotides, small molecules). Possesses excellent troubleshooting/problem analysis/risk assessment skills, including experience with Lean Sigma and Root Cause Analysis methodologies. Work Arrangements: This is a hybrid role based in Wavre, Belgium with 2 days of onsite presence required with close collaboration across functions. How to apply: If this role aligns with your skills and experience, we encourage you to apply. Please submit your CV and a short statement outlining your interest in the role. We welcome applicants from all backgrounds and are committed to inclusion. Skills Biopharmaceuticals, Bioprocessing, Cell Line Development, Drug Development, Experimental Methods, Molecular Cell Biology, Pharmaceutical Industry, Pharmaceutical Manufacturing, Quality by Design, Regulatory Submissions, Simulation Models, Technical Writing, Technology Transfer Belgium Salary Range / Fourchette salariale – Belgique: EUR 72,225 to EUR 120,375The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Le salaire de base mensuel brut minimum pour les nouvelles recrues à ce poste est indiqué ci dessus pour chaque lieu applicable. Ce salaire de base mensuel brut minimum tient compte de plusieurs facteurs, notamment les compétences, l’expérience et le niveau de formation du/de la candidat(e), ainsi que le taux du marché pour le poste. En outre, ce poste peut donner droit à un bonus annuel ainsi qu'une éligibilité pour participer à notre programme de long term incentive basé sur des actions, en fonction du niveau du rôle. Des informations plus détaillées sur l’ensemble du package salarial seront fournies au cours du processus de recrutement. Ce poste étant ouvert à des candidat(e)s basé(e)s dans plusieurs pays, des fourchettes de salaire sont également indiquées pour certains lieux. Les fourchettes salariales pour d'autres localisations sont mentionnées parce que certains marchés ont des lois en matière de transparence salariale qui imposent que les informations sur les salaires soient affichées dans les offres d’emploi, et que ces pays sont des lieux potentiels pour ce poste. Si aucune fourchette salariale n’est indiquée dans l’offre d’emploi pour un lieu ou un pays spéci