Equipement & Data Integrity Manager

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Make your mark for patients.We’re here because we want to build the future and transform patients’ lives for the better.At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?To strengthen our Sites Quality Operations-Analytical Processes & Operationsteam, we are looking for a high caliber, self-motivated, Equipment & Data Integrity Manager based in Braine l’Alleud, BelgiumAt UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.As Equipment & Data Integrity Manager You Ensure

• That data and access to QC laboratory equipment and systems are secured
• That data Integrity principles are applied and periodically reviewed
• The management of Laboratory projects under scope from initiative to closure

You like to work in an environmentwhere you will be:

• Managing Data Integrity risk assessment, defining administration procedures, securizing laboratory systems and executing annual periodic review
• Managing the laboratory Digitalization projects and portfolio and ensuring alignment between QC specific projects and resource capacity of the Laboratory Digitalization team
• Supporting projects linked to Labware LIMS (Laboratory Information Management System). Your goal will be to link business needs and IT constraints, to deliver lean processes within the modules and ensure sustainability thanks to E2E testing

Your Accountabilities Will Revolve Around 3 Pillars As laboratory systems and equipment Data Integrity Manager You Manage And Contribute With The Team To

• Deliver data integrity risk assessment for QC equipment (this includes participation to discussions with suppliers)
• Deliver equipment administration procedure ensuring integrity of access and of data
• Execute systems periodic reviews
• Improve the computerized systems administration process
• Ensure follow up of new guidance & Manage creation/update of general procedures and instructions in the field
• Ensure audit readiness, participate to the preparation and provide support during audits, and manage follow-up.

As a Project Manager

• You lead and ensure delivery in time, in quality and in budget of projects under scope from beginning to end
• You collaborate with IT & vendor project managers to coordinate the activities of UCB’s:
• Business stakeholders (subject matter experts, compliance & QA representatives from discovery, technical development, and quality control departments)
• IT teams (system owners, infrastructure, security, validation, etc.)
• External partners (such as Labware experts)
• You are influential and make sure that everyone appropriately contributes to the delivery of the project on time, in full and with quality (incl. proper reporting, risk & issue management)
• More specifically, you lead the gathering & formalization of user requirements (including process & data flows and metadata management), the acceptance testing & performance qualification of the delivered solution and the training of end-users, guaranteeing that our needs are properly defined (and aligned across departments) and supported by the final product
• You ensure alignment of timeline and resource availability and needs with QC specific (new equipment) project managers.
• Specific to Glims related projects, you support Business solution role for all projects impacting directly (new modules, new version) or indirectly (new interfaces, data interchange with other systems like DARTH) the Labware LIMS

As Quality Gardian For Your Activities

• You ensure update or creation of procedures and instructions
• You ensure follow-up of corrective actions and preventive actions
• You ensure the follow-up of deviations and appropriate root cause analysis to address the right action plan
• You ensure adequate training/coaching of team linked to the Laboratory Digitalization project activities are requested and performed

Interested? For this position you’ll need the following education, experience andskills:

• You have a master’s degree in scientific field
• You have one or more of the following certifications: APICS, LSS Green Belt, PMI project management
• You have 3 years or more of experience in transversal (multi-departmental) project management and interdepartmental interaction with business, IT, QA
• You are experienced in Project and Stakeholders’ management
• You have 2 years of experience in securization, and data integrity, of laboratory systems and equipment
• You have 2 years or more of experience with Labware LIMS system
• You are experienced in system interfacing and data management
• You have 2 years of experience in QC activities, analyses, and processes
• You are skilled in laboratory (mainly QC, but not limited to) business process management
• You are system minded: you understand quickly how systems functionalities can support business requirements
• Knowlegde labware LIMS is an asset.
• Knowledge in SQL language, LIMS BASIC is an asset.
• You are knowledgeable of Data Integrity requirements
• You have strong written and oral communication skills, and are fluent in English / French
• You have practical experience dealing with system (GxP) validation and data integrity compliance
• You can acquire new knowledge required for the correct execution of the function regarding innovation and new technologies related to laboratory processes and data management

Mindset And Behaviors We Are Looking For

• You are a team player
• You are open to new ideas
• You are resilient / perseverant
• You are inclusive
• You are always striving for continuous improvement
• You can think transversally end to end
• You have an analytical mind-set with a capacity to see the bigger picture
• You have strong negotiation skills
• You are self-driven, results-oriented with a positive outlook and a clear focus on high quality
• You are a fast learner

Why you should applyWe can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams. Opportunity to grow as leader through participation in project teams and our career/personal development programs.At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.About Us.UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.Curious to know more? Please visit our website www.ucb.com .UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.