Snr Quality Specialist (GxP Quality Compliance Expert)

Job Summary

At SAP, we're transforming how Life Sciences companies innovate, manufacture, and deliver products that improve lives. As a GxP Quality Compliance Expert, you'll help ensure that SAP Life Sciences solutions, Industry AI offerings, AI assistants, and AI agents remain trusted, compliant, and inspection-ready across highly regulated environments. You'll define and advance quality and compliance strategies for SAP products and cloud services, ensuring alignment with global regulatory frameworks such as FDA 21 CFR Part 11, EU Annex 11, ICH guidelines, and GAMP 5. Your expertise will help SAP and its customers confidently adopt innovative technologies while maintaining the highest standards of quality, compliance, and patient safety. You'll lead compliance and validation activities across the solution lifecycle, from requirements and risk assessments through validation, release management, and operational support. Driving risk-based validation approaches, evaluating data integrity controls, and ensuring audit readiness are core aspects of the role. Your work will directly influence product quality, regulatory confidence, and the successful adoption of SAP Life Sciences and Industry AI solutions around the world. As SAP continues to innovate with cloud technologies, Business AI, and intelligent applications, you'll help shape modern approaches to compliance, including Computer Software Assurance (CSA), while ensuring regulatory expectations remain fully addressed. Working closely with product teams, engineers, architects, quality specialists, and industry experts, you'll embed quality and compliance into every stage of product development and delivery.

What you'll bring

You bring strong expertise in GxP compliance, computer system validation, and regulated business processes within pharmaceutical, biotechnology, or medical device industries. Deep knowledge of validation methodologies, risk-based quality frameworks, and data integrity principles is essential. Experience with SAP Life Sciences solutions and the ability to evaluate compliance impacts across complex technology landscapes will set you up for success in this role. You have hands-on experience supporting validation lifecycle activities, regulatory inspections, change and release management processes, and quality oversight of enterprise applications. The ability to independently assess risk, challenge assumptions, and provide pragmatic compliance guidance is critical. A strong understanding of emerging regulatory expectations related to GxP, cloud technologies, AI-enabled solutions, and evolving validation approaches is highly valued. You combine analytical thinking with excellent communication skills and thrive when collaborating across diverse technical and business teams. Experience with SAP Solution Manager, SAP Cloud ALM, SAP S/4HANA transformations, cloud validation, or SAP Life Sciences solutions such as Quality Management (QM) and Advanced Track Trace for Pharmaceuticals (ATTP) will help you excel. Knowledge of FDA, EMA, MHRA, Annex 11, ICH Q9, and GAMP 5 frameworks is highly desirable.

Where you belong

You will be part of a growing global team of AI and Life Sciences experts dedicated to helping customers across the Americas, Europe, and Asia transform their businesses and unlock new opportunities through SAP technology. Our team brings together deep industry expertise, quality and compliance leadership, and cutting-edge AI innovation to solve complex customer challenges. We work collaboratively across product, engineering, architecture, and industry organizations to develop scalable solutions that create measurable business value. You'll find an environment that values curiosity, ownership, inclusion, and continuous learning. New ideas are encouraged, diverse perspectives are welcomed, and innovation is balanced with responsibility and trust. If you're passionate about enabling innovation while safeguarding quality, data integrity, regulatory compliance, and patient trust, you'll find meaningful ownership, global impact, and exceptional growth opportunities here. Together, we'll help Life Sciences organizations innovate with confidence and bring out their best.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.