(Senior) Quality Manager (gn)

DAS UNTERNEHMEN

For a dynamic and growing clincal-stage biotech-company, we are currently assigned to recruit a (Senior) Quality Manager (gn). In this function you will play a central role for maintaining and optimising the QMS (Quality Management System); additionally, you will help the firm regarding inspection-readiness and audit-planning. 

IHRE AUFGABEN

• You implement and secure QMS and processes according to the relevant regulations and standards (ISO, 21 CFR Part 11, ICH GCP)
• You secure inspection-readiness and manage relevant regulatory inspections and audits
• You provide consistent reports and guidance related to audits (internal and external) 
• You closely collaborate with internal stakeholders and are able to "translate" regulatory needs to the operative units
• You report regularly to the management team and make sure that quality needs are met

IHR PROFIL

• Degree in natural sciences or similar
• Professional experience in the pharmaceutical or biotech industry in a quality-related role is a MUST
• Profound knowledge in GCP and other relevant quality standards 
• Experience with quality mangement systems, ideally also with the implementation of these
• Affinity to CSV is an advantage 
• Very good command of English, German language skills are a plus

BENEFITS

• impactful role in a promising biotech environment
• highly flexible