(Senior) Quality Manager (gn)
(Senior) Quality Manager (gn)
Ansprechpartner
Dilsâd Babayigit
+49 (0)89 7263 210 - 00
babayigit@ageneo.de
Branche
Biotechnologie
Berufsfeld
QM
Region
Bayern
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 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
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
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