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 Assurance Manager GMP/GCP (m/f/d)
to join our team at the earliest possible date. The position is located in Jena.
Main tasks and responsibilities:
Maintain and continually improve the company’s Quality Management System;
Review of (laboratory) data and documentation;
Temperature excursion management (incl. evaluation and determination of impact on concerned IMP);
Providing Quality Assurance support for validation activities associated with analytical methods, equipment and computerized systems;
Monitoring and processing of deviations, change controls, risk analyses etc.;
Assistance in processing of complaints and recalls;
Monitoring and processing of corrective and preventive actions (CAPAs);
Planning, preparing, conducting, reporting and follow-up of internal audits;
Vendor qualification incl. planning, preparing, conducting, reporting and follow-up of external audits (Contracted Laboratories, Contracted Research Organizations, Contracted Manufacturing Organizations, etc.);
Management of Quality Documents (e.g. SOPs, working instructions etc.) according to the respective written procedures;
Coordinating, conducting and tracking of GxP-relevant training of new and existing staff incl. development of training materials and applicable measures of success control;
Create, maintain and revise departmental Quality Documents;
Providing support/participating in authority inspections.
Academic degree in life sciences or comparable study or related disciplines or equivalent experienced gained by working in a relevant area;
3+ years’ experience in the field of quality assurance/quality management especially in the area of clinical development as well as the commercial stage preferred;
Thorough understanding of the drug development process;
Thorough understanding of national and international laws, relevant GxP regulations and guidelines (e.g. Good Clinical Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice, Good Distribution Practice);
High level of quality awareness;
Excellent interpersonal, verbal and written communication skills;
Fluent in written and verbal English and German;
Highly motivated, self-driven and dependable;
Strong sense of responsibility, accuracy and attention to detail;
Ability to manage multiple and varied tasks, and prioritize workload;
Sound knowledge of MS Office applications (basic knowledge of Office 365 Cloud applications);
Willingness to travel (national and international traveling) 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 through 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 in English, including CV, motivation letter, and salary expectation, at the following e-mail address: firstname.lastname@example.org.