Associate Director Quality Assurance GMP

vor 1 Woche


Schlieren, Zürich, Schweiz Molecular Partners AG Vollzeit

Position description :

To complete our skilled QA team, we are looking for a highly experienced and motivated GMP QA Expert with experience in Swiss, European and US Regulations and Guidelines.

In this role, you will be responsible for Molecular Partners' QA activities in GMP. As Associate Director Quality Assurance, you report to the Head of Quality Assurance.

You are part of an interdisciplinary QA team covering GXP, Records Management and IT Compliance and you are working closely with our CMC team responsible for the manufacturing of our products.

This challenging and diverse position will include the following tasks and responsibilities:

Involved in release, approval activities and GMP documentation reviews; Qualification and management of CDMOs; Tracking, assessing and follow-up non-conformities and CAPAs; Monitoring of trends and changes with regard to regulations, guidelines, and identification of areas for improvement to ensure an efficient quality management system in compliance with GXP requirements; Liaise and support other departments in quality relevant activities; Support of the setup of internal audit programs; Preparation, conduct/host and follow-up of internal audits; Participation at and performing of risk management activities; Participation in the preparation, hosting and follow-up of regulatory inspections; Conduct of training for employees involved in GXP-related activities; Support of Records Management and IT compliance in the development and set-up of documentation, processes and maintenance of the eDMS.



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