Director of Quality Assurance

Job Description

Precision for Medicine is seeking a Director of Quality Assurance to join their team in Berlin, Germany. This role is crucial for maintaining effective quality oversight and collaboration with project teams and suppliers, ensuring all aspects of Quality Management at ISO17025/ISO/15189/GCP/GCLP are conducted according to regulations and Precision for Medicine expectations. The Director will develop and maintain processes to support quality systems, collect and assess quality KPIs, and manage the resolution of quality and technical problems. They will also provide guidance to QA staff, identify quality improvements, and lead internal and external audits.Responsibilities:

• Maintaining effective Quality oversight and collaboration with project teams and suppliers.
• Developing, implementing, and maintaining processes to support quality systems.
• Collecting, reporting, and assessing quality KPIs and metrics.
• Managing and supporting the resolution of quality and technical problems.
• Providing guidance to QA staff and identifying quality improvements.
• Leading internal and external audits and regulatory inspections.

Requirements:

• Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field.
• > 5 years of supervisory experience in a regulated environment.
• 10-12 years’ experience working in a Quality driven life science, regulated environment.
• Keen knowledge of QMS, GLCP, ISO13485, ISO 17025 ISO15189, ISO 9001, ICH GCP, EMEA Guidelines.
• Experience with Client and regulatory authority audits, Dakks.
• Ability to lead and manage a quality team.
• Proficiency in written and spoken English and German.

Precision for Medicine offers:

• Opportunity to work in a global precision medicine clinical research services organization.
• A role that involves travel up to 30%, including international travel.
• A chance to contribute to improving the clinical research and development process for new therapeutics.