full- or part-time, 74321 Bietigheim-Bissingen
QA Manager GCP (m/f/d), mainly remote
Who we are
elderbrook is a comprehensive CRO specializing in biostatistics, clinical data sciences, and digital solutions for the pharmaceutical industry. Our team of experts provides tailored solutions, leveraging advanced technologies and methodologies.
Your responsibilities and functions
- Maintenance, monitoring and continuous improvement of the internal quality management system (QMS) with consideration of all GCP aspects and regulations
- Creation, maintenance and monitoring of QM documents (including SOPs)
- Support with external audits and official inspections
- Preparation and implementation of internal audits
- Planning, tracking and monitoring the effectiveness of corrections (CAPA)
- Monitoring mandatory training and compliance with the company's SOPs and guidelines
- Risk management for projects and coordination of suitable measures
- Collaboration with department heads and support in determining training needs
- Developing an annual training plan and individual training programs
- Maintaining and managing the current qualification certificates for all employees in the GCP area
Your qualifications and competences
- Completed scientific studies or qualification in healthcare or a related field
- Several years of practical experience in regulated quality management (with a focus on clinical quality management or clinical research)
- Very good knowledge of GCP principles and in-depth knowledge of all relevant international and national regulations and legal requirements (e.g. ICH Guidelines, Clinical Trial Regulation, ISO 9001, FDA CFR 21)
- Experience in document management
- Fluent in written and spoken German and English
- Strong communication skills and professional, goal-oriented cooperation with various departments
- Moderation of meetings and presentations
- Confident in handling all MS Office applications
This is how you can reach us:
Please drop us a mail at:
jobs@elderbrook.de
We are looking forward to getting to know you!
