Senior Compliance Specialist | Senior Compliance Specialist (m/w/d)

Job Summary

This Senior Compliance Specialist position is vital for ensuring the cGMP-compliant operation of pharmaceutical production facilities, including specialized areas like cleanroom and clothing design. Day-to-day responsibilities involve interpreting and implementing stringent regulatory requirements, particularly EU-GMP and FDA standards, to optimize operational processes. The specialist will actively prepare for and support internal and external audits and inspections, managing observations and implementing necessary Corrective and Preventive Actions (CAPAs). Furthermore, the role involves providing expert compliance consultation for facility lifecycle projects, such as new construction and modifications. The successful candidate will act as the primary contact for GMP-compliant documentation regarding changes, deviations, and events, while continuously developing the quality system to enhance both efficiency and compliance. Candidates must possess a strong background in natural sciences or a relevant Master craftsperson qualification, coupled with practical experience in the pharmaceutical industry and profound knowledge of biopharmaceutical API and Drug Product manufacturing.