BioTalent is pleased to be working with an exciting internationally oriented healthcare group. With over 20 companies and more than 70 drug approvals, they are a global leader in the areas of intelligent bacteria, innovative pain therapies and chemical-free medicines.

Currently looking for a Team Lead Clinical Quality Assurance/Project Manager to join the team in Munich, Germany.

The ideal candidate will be responsible for the quality of drug studies, ensuring compliance with GCP specifications as well as team lead the Clinical Quality Assurance team. They will be responsible for the planning and execution of projects. With duties including planning, designing, executing and monitoring every aspect of a specific project.

This position will require you to travel to the office in Munich a few days a week.

In this role, you will:

• Lead the Clinical Quality Assurance Team
• Develop and implement oversight strategies to eliminate possible compliance issues
• Qualify, monitor and evaluate our vendors in the context of clinical studies
• Evaluate findings from monitoring CROs, auditors and inspectors at vendors and test centers
• Responsible for the TMF including planning, structuring, maintenance, quality assurance and archiving
• Support the preparation of authority inspections

You will have:

• BS/BA or MS/MA degree in medicine, natural sciences, pharmacy, biotechnology
• Minimum 5 years of experience in clinical research as a project manager
• A comprehensive understanding of Quality Assurance and Regulatory requirements including ICG GCP
• Experience in creating SOPs, study-specific plans and WIs
• Experience in dealing with authorities, vendors and investigators
• Self-motivated, structured, precise and solution-oriented manner
• Business fluent German skills (at least C1 level) and very good English skills

If you would like to learn more about this exciting opportunity or to recommend a valued professional from your network, you can share your CV to or reach out via Reem.Iskandarani@biotalent.com.

BioTalent Ltd are acting as an employment agency in relation to this opportunity.