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. Responsibilities 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 stakeholder 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 Qualifications 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
