Overview

Join to apply for the Senior Quality Assurance Process Specialist role at Boehringer Ingelheim.

The position involves gathering an overview of the GBS Enabling Services Organization with a focus on the tasks and responsibilities from Demand to Deploy. You will work in a globally operating team that designs, builds and continuously improves Boehringer Ingelheim’s global Processes, using agile principles, methods and tools daily. You will contribute within a cross-functional team and serve as a Senior Process Specialist throughout the lifecycle of computer systems that support quality processes, including initiating and analyzing change requests, performing impact analyses, creating documentation and testing to ensure systems remain validated.

Responsibilities

• Act as a Senior Process Specialist (process subject matter expert), supporting daily validation activities of quality-related computer systems, in line with global procedures.
• Maintain System Lifecycle documentation to ensure systems remain validated and processes stay compliant, including change requests, impact assessments, test definitions and execution (as required by complexity), test summary reports, and updated training materials.
• Leverage expertise in Computer System Validation to ensure changes are assessed in compliance with validation requirements, in close collaboration with other experts.
• Participate in Agile-driven projects, applying relevant methods and tools effectively.
• Work within project frameworks measured by KPIs and SLAs, continuously identifying and implementing improvement opportunities.

Qualifications

• Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes.
• 5 years of experience in QA, preferably within the medical or pharmaceutical sector; English fluency (min. C1).
• Extensive experience across multiple quality domains, including Design Control of Medical Devices, Computer System Validation, Data Integrity, Equipment Validation, Process Validation, Cleaning Validation, Control Strategy, Quality Risk Management and/or Annual Product Review.
• Profound knowledge of Computer Systems Validation regulation (CSV), including GAMP5, 21CFR Part 11, FDA CSA framework, and EU Annex 11; Data Integrity knowledge is a plus.
• Hands-on experience with systems such as Trackwise, Valgenesis, Kneat, Doors, Polarion, HP ALM.
• Experience with agile methods (e.g., SCRUM, Kanban) and tools (e.g., JIRA, Confluence) is advantageous.
• Strong analytical and problem-solving skills with good prioritization abilities.
• Dedicated team player with good communication and a structured way of working.

About Boehringer Ingelheim

With us, you can develop your own path in a company that values diversity and innovation, and that is committed to making millions of lives better. We support your development and offer a respectful, friendly environment where everyone is valued and welcomed. We also provide programs focused on health and wellbeing and drive global accessibility to healthcare.

Want to learn more? Visit https://www.boehringer-ingelheim.com