QA Manager - Biotech Manufacturing CMO Management
Biologics Drug Substance & Drug Product
Our customer is a US-based biopharmaceutical company with an exciting pipeline in oncology going into late phase clinical trials. Beside its own research, the company offers a technology platform and develops numerous successful partnerships for state-of-the-art pharmaceutical drug formulations and applications.
As part of the ongoing expansion plans, a European Hub is planned in the greater Zurich area. The newly defined position as QA Manager is meant to oversee QA/QC activities at Contract Manufacturing Organizations (CMO) in the DACH region. As part of the international QA Team, you are responsible for the overall GMP compliance at CMOs developing and supplying biological drug substances and drug products in various formulations. You provide expertise to support QA operations, manage and execute Master Batch Record Reviews, and execute Batch Record Reviews and Approvals. In addition, you conduct external audits and vendor qualifications, perform the respective risk assessments, write audit reports, and act as principal QA representative at CMOs for partner audits. You are involved in the preparation, revision and/or reviewing of CMC sections of world-wide regulatory filings such as IMPD/IND/CTD/BLA, supplements, amendments and other submissions as needed.
Experience in both biologic drug substance and drug product is an asset. A key success factor will be your influence capability to enforce quality decisions at suppliers. Exceptional negotiation skills, good to excellent German and English communication and presentation skills are key requirements for this role in order to develop strong business partnerships with both internal and external stakeholders. The position requires varying levels of travelling in European countries (DACH region) - estimated around 30%.