Director of Quality Assurance

Job Description

Precision for Medicine is seeking a Director of Quality Assurance to maintain effective quality oversight and collaboration with project teams and suppliers. The Director will ensure all aspects of Quality Management at ISO17025/ISO/15189/GCP/GCLP are conducted according to regulations. This role involves developing and maintaining processes to support quality systems, collecting and assessing quality KPIs, and managing the resolution of quality and technical problems. The Director will also provide guidance to QA staff, identify quality improvements, and manage internal and external audits.

• 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
• Managing the resolution of quality and technical problems
• Providing guidance to QA staff
• Identifying quality improvements
• Managing internal and external audits

• 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
• Experience in auditing and interacting with regulators, vendors and clients
• Proficient in basic computer applications such as MS Office, Word, Excel, PowerPoint and other relevant industry computerized systems
• Proficiency in written and spoken English and German
• Must possess a valid driver’s license
• Must be able to travel both domestically and internationally

• Opportunity to work with a leading precision medicine clinical research services organization
• Chance to improve the clinical research and development process for new therapeutics
• Opportunity to work with a global team of dedicated professionals