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Snr Quality Specialist (GxP Quality Compliance Expert) - SAP Life Sciences (7-12 yrs)

SAP

Bangalore, IN, 560066Mid
Sign in to applyVerified 1h ago
Location
Bangalore, IN, 560066
Work model
On-Site
Level
Mid

Skills

SAP

About this role

We help the world run better At SAP, we keep it simple: you bring your best to us, and we'll bring out the best in you. We're builders touching over 20 industries and 80% of global commerce, and we need your unique talents to help shape what's next. The work is challenging – but it matters. You'll find a place where you can be yourself, prioritize your wellbeing, and truly belong. What's in it for you? Constant learning, skill growth, great benefits, and a team that wants you to grow and succeed.        What you'll build 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

Listing verified 1h ago. Applications go through the company's official careers site.

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Snr Quality Specialist (GxP Quality Compliance Expert) - SAP Life Sciences (7-12 yrs) at SAP, Bangalore, IN, 560066 | Yoinka