Kai Rothermel

Informatics Product Line Lead - Quality Assurance @Roche

Mannheim, DE
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2022 — Present

Informatics Product Line Lead - Quality Assurance @Roche

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Visionary IT executive with a passion for pivoting technology organizations into strategic business drivers within the pharmaceutical and diagnostics sectors. Currently serving as the Global Product Line Lead for Technical Operations Quality Assurance, overseeing a diverse portfolio including Quality Management Systems (QMS), Release & Certification, and Product Sustainability. Lead a global, cross-functional workforce of approximately 180 contributors across agile delivery teams, orchestrating enterprise-scale digital roadmaps on SAP, Veeva, and Salesforce platforms. Proven track record of transforming delivery models into durable, self-managed agile setups that free up innovation bandwidth while meeting strict financial targets and Total Cost of Ownership (TCO) objectives. dedicated to bridging the gap between digital strategy and GxP compliance, empowering teams to deliver high-value outcomes that ensure patient safety and rapid response to global regulatory challenges.

EDUCATION

1992 — 1995

DHBW Mannheim

Diplom-Ingenieur, Computer Engineering

1983 — 1992

Peter Petersen Gymnasium

Abitur, Physik, Mathematik

SKILLS

Supply Chain ManagementValidationInfectious DiseasesHardware DiagnosticsQuality ManagementSapPharmaceutical IndustryBusiness Process ImprovementRegulatory AffairsLifesciencesChange ManagementComplexity Management21 Cfr Part 11Life SciencesStrategyIT StrategyChange ControlBusiness ProcessQuality SystemProduct Lifecycle ManagementProject Portfolio ManagementIT ManagementProcess ImprovementSupply ChainInternationales ProjektmanagementSix SigmaProduct LaunchGxpProduct ManagementErpComputer System ValidationQuality AssuranceGmpCross-Functional Team LeadershipBiotechnologyProject ManagementMedical Devices

ABOUT KAI ROTHERMEL

Visionary Global IT Leader with 20+ years of experience driving digital transformation within the life sciences and diagnostics sectors. Proven track record in pivoting legacy IT organizations into agile, product-centric engines that deliver high-value business outcomes. Expert in navigating complex regulatory environments (GxP, FDA) while scaling modern technology stacks (AI/ML, Data Mesh, Cloud). Empathetic leader of large-scale international teams (180+) with a focus on empowering self-managed organizations and driving operational excellence.Being a visioner and transforming ideas into valuable outcomes has always been the guiding principle of my work. I had the opportunity to grow as a leader in complex IT & business programs and in management roles in various areas. I demonstrated leadership strength and coaching skills for both individual talents and high-performing teams to create the foundational structure for creativity and growth. I have a strong ability to align people on a common goal and the empathy to adequately manage expectations of stakeholders. I like to be a catalyst of change and to re-invent myself and my eco-system.

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Kai Rothermel — Informatics Product Line Lead - Quality Assurance at Roche in Mannheim, DE | Unifers