- Sprachen Englisch
- Erfahrung Senior (+5 Jahre)
Our client, a well-known Biopharma company with a innovative products pipeline is looking for his future QA CMO Leader on a Permanent Contract !
You will be responsible for:
– Managing the QA interface with manufacturing and testing partners for assigned products/ projects.
– Evaluating the performances of External partners and manage the identification, negotiation, implementation and follow-up of processes and systems improvements.
– Following the best quality processes to improve the product lifecycle.
– Participating to technology transfer with the CMO’s.
– Be involved in the regulatory affairs inspections of CMO’s as your company representative.
– Build a good relationship with the different external partners to ensure an efficient work collaboration.
For this opportunity, we are looking for someone with:
– Bachelor/Master or phD in scientific field (Pharmacy/Biotech/Chemical/Pharmaceutical/Biochemistry/…)
– A minimum of 5 years experiences in similar roles (Suppliers/Contract manufacturer quality management) in the Pharmaceutical or in the Biotech industry.
– A strong understanding of cGxPs.
– Good knowledge of EU/FDA regulations, knowledge of PDMA (Japenese regulations) is a plus.
– A fluent English speaking is required (B2), German is a plus.
You are well-organized, dynamic, and passionate about negotiation and how to improve the processes between the different services of an organization ?
So don’t hesitate to apply for this opportunity, we’re waiting for you!