Markus B.

Background

About Markus B.

With over 18 years of experience as a Global Project Manager in highly regulated industries such as aerospace and automotive, I have led complex, safety-critical projects with a strong focus on structure, traceability, and cross-functional collaboration. In the aerospace sector, I coordinated certification projects and submitted regulatory documentation for systems with DO178 Level A software to aviation authorities. In the automotive industry, I managed projects in accordance with IATF 16949, focusing on quality management and process optimization in compliance-driven environments. Additionally I supported plant engineering projects, gaining valuable insight into automation processes, equipment implementation, and commissioning. Through these roles, I developed a solid understanding of validation, compliance, and quality systems. Today, I am actively transitioning into Regulatory Affairs and Quality Assurance within the Life Sciences sector. To support this shift, I have completed targeted training, including: Pharmaceutical Industry Drug Regulatory Affairs (D RA)- Advanced Data Integrity for Pharmaceutical Manufacturing - Pharma Computer System Validation (CSV & Quality)- Basic Good Manufacturing Practices (GMP)- Mastering Medical Device Regulatory Affairs (in progress) I bring a structured mindset, technical leadership, and hands-on experience in authority-facing projects – qualities I am now ready to apply to ensure compliance and support innovation in the pharmaceutical and MedTech industries.