The (Senior) Manager Quality Assurance will be an integral part of the Quality Assurance team and responsible for establishing and maintaining quality awareness in the company with a focus on quality assurance / quality management for clinical trials.
Role:
Role:
- Responsible for all quality-related activities in-house and at external vendors
- Ensure compliance with all relevant GxP, ICH and international regulations
- Participation in the evaluation, selection, qualification and approval of external suppliers and service providers (CMO, CRO, Contract Laboratories)
- Evaluation of clinical studies and processes with regard to potential risks
- Review of planning documents, reports and relevant documents
- Participate in further SOP and QA process development and other department initiatives
- Creation, review, updating and archiving of documents, SOP/document management
- Internal consulting on applicable regulatory requirements (GCP, GLP, GMP)
- Trainings in the GxP area
- Travel as needed
YOUR PROFILE
- BSc degree in Life Sciences required; master's degree preferred
- 5+ years of experience in the field of Quality Assurance; experience as quality manager in a GCP environment preferred
- Expert knowledge of GCP, ICH guidelines, national and international laws and regulations
- Excellent knowledge of relevant software
- Excellent interpersonal, written, and verbal communication
- Great organizational skills
- High level of flexibility and willingness to contribute hands-on or lead an cross-functional team
- Fluency in verbal and written English required; good command of German language desirable