Andreas Kuehn

With a strong skillset in business strategy & quality performance, project management & leadership, and a commitment to continuous improvement, I am the ideal candidate for this role.  Throughout my past roles, I have gained experience successfully leading CSV projects: I am experienced in qualification of manufacturing and laboratory equipment as well as validating MES (SAP MES) & SAP systems (S4/Hana). Additionally, I am well-versed in the strict regulatory requirements of the pharmaceutical and medical device industry and have ample experience implementing these requirements throughout technical projects. My experience allows me to quickly recognize correlations between the conformity of regulatory requirements and ISO guidelines.  I am a results-driven project manager and motivating executive leader: Throughout the past two decades, I have led several significant technical projects.

In my role as Head of CSV & MDM QA Department at Legacy Pharmaceuticals GmbH, I used tools such as Jira, WinDream, and SAP S4/Hana to lead system and data validation and implement quality management systems for IT. I also developed a master data governance team to create, change, or consolidate master data across the enterprise system landscape and trained the staff on QMS, and CSV. If given the opportunity, I look forward to bringing my skillset in agile, adaptable leadership and business strategy to SKAN AG.  I am committed to continuous improvement: In the past, I have successfully identified areas that need improvement, developed strong plans to improve the required systems, and led projects that had a significant impact on efficiency and usability.

For example, one key project that I led as CSV Manager at Roche in 2013 involved changing the system documentation of all global SAP systems from paper documents such as Word and Excel to a database (HP ALM), which is still used by the company today. The impact of this project was significant, leading to greater efficiency & usability for the team. I also converted testing in projects and change management from SAP Solution Manager to HP ALM.

With my wealth of relevant experience leading continuous improvement in the industry, I believe I would be an excellent fit for the role of QA Performance & Continuous Improvement Manager, and I look forward to taking on the next project and challenge.  Now I bring Medical Device / ISO and Pharma regulations together ensuring above all data integrity. I am an QA professional and a confident, adaptable leader, and I excel at leading high-performing teams and technical projects from inception to launch. I look forward to the opportunity to connect with an organization that prioritizes innovation and service.

More than 20 years in Medical Device and Pharma Industries

Dipl. Ing. Mechanical Engineering

ISACA CISA