Stellenbeschreibung

Quality Manager in CMC - Protein Science – Munich – Permanent - €75.000             I am actively recruiting for one of the best biotech companies in Europe. They are working in close collaboration with 10 globally renowned pharmaceutical companies and CROs and are looking for a Quality Manager to join their team in Munich.Responsibilies:Will be the interface between the Quality Assurance and Regulatory Affairs Department, you will also be working closely with CMO/CROs, receiving the coordination from the Head of Quality Assurance departmentCoordinate both Regulatory and Quality CMC-related activities such as SOPs, canges, deviations.In charge of preparing the regulatory documents, particularly focusing on the Quality sections: IMPDs/INDs. Also assist in compilation of different regulatory documents: IBs.Constantly ensure compliance with the 2-step release process of the batch.Support the Quality Assurance specialists with CMC related matters, including auditsSupport compilation of quality agreements with the CROs’.Protein Science expert for the relevant GMP guidelines. Collaborate closely with the Regulatory Affairs DepartmentConstantly update knowledge on the latest guidelines for Protein Science and ensure the team is fully informed and trained on it.Requirements:A good degree in a Life Sciences-related discipline.Extensive knowledge of GMP regulations for IMPs (investigational medicinal products)Minimum 2 years’ experience of procedures related to Quality Management in the area of drug development and biologicsMinimum 2 years’ experience in GMP/Quality Assurance environment. People with background in biologics will have an advantageMinimum 2 years’ experience in CMC (QA, GMP)Technical or scientific background in the manufacturing and testing of investigational medicinal productsFluency in English and German             The company is currently working on new technologies in various therapeutic areas, such as Oncology, Allergy, Diabetes, Cardiovascular, etc. If your profile matches the requirements and wish to take over the responsibilities, then do not hesitate to apply for this position.