InflaRx is a NASDAQ listed biotechnology company with offices in Jena and Munich, Germany. We research and develop new medicines for the treatment of inflammatory diseases within a global development approach. We stand out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort.
To support our Quality Assurance team we are looking for a
Quality Manager GCP (m/f)
to join our team at the earliest possible date.
As Quality Manager in the GCP area,you will be part of the Quality Assurance (QA) department and report to the Head of QA. The position is located in Jena or Munich.
Maintenance and further development of the internal quality management system regarding GCP aspects
Creation of audit programs for clinical studies
Preparation, participation, conduct, reporting and follow-up of internal and external audits (investigator sites, CROs, contract laboratories, etc.)
Managing contracted QA service providers
Contribution to the further development of the clinical QA system
Ensuring quality processes are conducted in accordance with guidelines, regulations and InflaRx (written) procedures
Providing help, advice and guidance to operational departments on matters of GCP and company procedures
Conducting training of new and existing staff
Assistance in authority inspections
Maintaining working knowledge in international and local applicable regulations
Academic degree in life sciences or related disciplines
Minimum of five years quality assurance experience or relevant experience in the pharmaceutical and/or biotech industry in particular including clinical quality management, clinical development, or regulatory compliance with a minimum of three years in clinical quality assurance
Thorough understanding of drug development process as well as international and national GCP regulations and guidelines
Wide range of auditing skills including those related to risk based quality assurance
Strong verbal and written communication skills
Fluent in written and verbal English and German
Highly motivated, self-driven and dependable
Ability to travel (national and international travel is required)
We offer you a challenging and varied opportunity with an innovative, dynamic and expanding company. InflaRx strives to be a company that is recognized by its employees as best place to work for in the industry. We want to accomplish this by working with passion and professionalism on thru medical innovation. We pride ourselves in maintaining a friendly, honest and trusting relationship with each other. If you think you fit the profile, we look forward to receiving your application, including CV, motivation letter, and salary expectation, at the following e-mail address: