**The position** Joining our company, you will gather an overview of the GBS Enabling Services Organization with a particular focus on the tasks and responsibilities of a process expert for quality data trending. You will work in a globally operating team that designs, builds and continuously improves Boehringer Ingelheim’s global Processes and supporting applications, using agile principles, methods and tools daily. You will be qualified to contribute to a cross-functional team, and as a Senior Process Specialist in Quality data trending. **Tasks & responsibilities** • Act as a Senior Process Specialist, supporting daily validation activities of quality related computer systems, in line with global procedures. • Ensure computer systems remain validated, and support process remain compliant by maintaining system lifecycle documentation, including change requests, impact assessments, test definitions and execution (as required by complexity), test summary reports and updated training material. • Leverage your expertise in Computer Systems Validation to ensure changes are assessed in compliance with validation requirements in close collaboration with other experts. • Participate in Agile-drive projects applying relevant methods and tools effectively. • Work within project frameworks that are measured by KPIs and SLAs continuously identifying and implementing improvement opportunities. • Based on strong communication skills, you manage stakeholder interactions successfully and define the level of standardization for our processes and systems. • Support the management of requirements acquired as part of the processing of demands and projects. • You are familiar with working in projects and being measured against Key Performance Indicators (KPIs) / Service Level Agreements (SLAs) to strive for continuous improvement measures. **About our future employee** You should speak English fluently (min. C1 level) and have at least 5 years of experience in the QA field, preferably within the medical or pharmaceutical sector. **Additionally, we are looking for:** • Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes • Experience across quality domains including Continued Process Verification, Product Quality Review, Annual quality review and related processes. • Experience in SAP, databases, interfaces, and/or related experience (In Process Controls or Quality Control) • Experience in ALM tools or Structured authoring tools (Polarion, AzureDevOps, Docuvera), and related pharma experience (Equipment Qualification and Software Validation) • Experience in electronic Quality Management Systems (TrackWise, Veeva) and/or related pharma experience (Quality Management) • Knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21 CFR Part 11, FDA CSA framework, EU Annex 11, and Data Integrity would be an advantage • Experience with MES or LIMS would be an advantage • Experience with agile methods (e.g. SCRUM, Kanban) and tools (e.g. JIRA, confluence) would be an advantage • Good analytical capabilities and problem-solving competence including a proper understanding of prioritization • Dedicated team player with good communication skills, and a structured way of working. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.