Senior Compliance Specialist (25% Part-Time) | Senior Compliance Specialist (m/w/d) TZ 25%

Job Summary

This Senior Compliance Specialist role, offered on a 25% part-time basis, is a critical position within an innovative pharmaceutical global player. The specialist will primarily ensure the continuous CGMP compliance of pharmaceutical production buildings, focusing on facility design, cleanroom standards, and clothing requirements. Key responsibilities include interpreting and implementing regulatory guidelines (EU-GMP and FDA), preparing for and presenting during customer and regulatory audits, and managing resulting observations and CAPAs. The successful candidate will advise business units on the GMP-compliant documentation lifecycle regarding facility changes and continuously improve the existing quality system. This hybrid role requires a Master’s degree in a natural science discipline or equivalent professional experience, coupled with extensive knowledge of biopharmaceutical manufacturing and European and US CGMP regulations. Strong communication and presentation skills are essential for success in this highly regulated environment.