QA Senior Manager / Digital Enablement Lead / IT Compliance Expert

4/2023 – offen

AI-powered solution for managing deviations: Pilot an AI-powered solution for managing deviations at one site, with the intention of scaling the solution acrosss subsidiaries. Proof of Concept aims to demonstrate the feasibility of using GenAI for deviations management.

Projektmanagement (IT), Total-Quality-Management

11/2022 – 8/2024

Global Data Integrity Program:
Stream A: Governance
Enhance governance processes globally and at the site level to close gaps, monitor progress, and assses ongoing risk.
Stream B: Procedures
Implementation of an enhanced CSV strategy for I&T Enterprise Systems, Manufacturing Execution Systems, and Laboratory Execution Systems. It includes the cataloging of global procedures and CSV templates for QMS enhancement.
Stream C: CAPA Plan for Existing Systems
Compliance checks of data systems using a standard and uniform methodology to create a CAPA plan for existing systems.
Stream D: Remediation
Based on the output of Stream C, remediation is based on high-risk systems and plan takes timing, ressources into consideration.
Stream E1 & E2: Data Audit Trail Review/ System Periodic Review Support for site Manufacturing and Quality Control for site GxP data system inventory lists and the full implementation of global DATR & SPR procedures against these systems.

Qualitätsmanagement / QS / QA (IT)

7/2019 – 11/2022

Global cloud solution for managing and signing electronic documents:
Evaluating IT security aspects (multi-factor authentication, ISO 27001, HIPAA, Sarbanes Oxley, Service Organisation Control). Creating global work instructions for electronic records (e-archiving). Focus is on the validation activities in the ongoing cloud based global enterprise content system.

Testen, Microsoft SharePoint Server, Business Analysis, Prozessvalidierung