Assoc.
Director, Business Analyst, Technical Research & Development (TRD) Job ID: REQ-10018839 Aug 13, 2024 Location: Barcelona, Spain #LI-Hybrid Summary In this role, you will effectively transform the business requirements into an IT solution design specification, ultimately leading to meeting customer expectations while assuring solutions are safe, reliable, scalable, and flexible.
You will act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis.
You will also engage with global business leaders and leverage the appropriate Data Digital and IT (DDIT) teams and Functions to determine requirements and deliver data-driven recommendations to improve efficiency and add value.
About the Role Role Responsibilities: Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments/requirements (if applicable), DDIT Service Portfolio, and industry best practices in leveraging technologies for the business.
Develop project rationale and perform scoping assessments to determine the feasibility of projects.
Highlight/identify gaps in existing functionality and review requirements with stakeholders.
Develop a comprehensive requirement specification that will determine the estimate of cost, time, and resources to deploy solutions.
Develop project estimates and complete financial models (costs, savings, revenue opportunities, investment horizon, etc.).
Liaise with the service development team to suggest a high-level functional solution.
Ensure that relevant stakeholders are involved in the specification of new services and/or major upgrades to existing services.
Ensure the overall user experience is taken into account when designing and deploying new solutions and services.
Ensure consistency and traceability between user requirements, functional specifications, and testing & validation.
Support validation and testing (OQ, PQ, UAT...).
Ensure implemented solutions are according to specifications and fit for purpose.
Support super user training.
Role Requirements: University degree in Informatics, Computer Sciences, Life Sciences, or similar.
A minimum of 10+ years of experience in the Pharma or IT Industry with 8+ years of experience in the Lab IT domain.
A minimum of 6+ years of experience as a business analyst/process expert/business IT lead superuser/Lab data or Digital position.
Expert understanding of business process analysis & design and system architecture concepts.
Expert understanding of the Lab business processes; drug development experience is an advantage.
Expert knowledge of GXP, 21CFR Part 11, and the CSV lifecycle.
Expert knowledge of Lab systems including LIMS systems and Chromatography systems.
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