Customer quality manager Jobs in Waldkirch

As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis. Our aim : to meaningfully improve therapeutic practice as well as patient health and well-being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for :

Your tasks

As the " Quality Assurance (QA) GCP Manager“ within the GCP and GVP Quality Department, you will play a pivotal role in maintaining and enhancing the quality management framework in alignment with Good Clinical Practice (GCP) guidelines. Collaborating closely with internal teams and external partners, you will ensure regulatory compliance and promote a robust culture of vigilance and safety. Your primary responsibilities will include, but are not limited to :

Audit, Inspection, and Deviation Management :

• Plan and Conduct GCP Audits : Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

Quality Assurance and Compliance :

Risk Management :

Training and Knowledge Development :

Documentation and Reporting :

Your qualification

Your benefits

If you have any questions, please do not hesitate to contact Laura Höcklin at [email protected] or call 0761 1514 252 . We look forward to receiving yourapplication via our online portal .

HR department

Dr. Falk Pharma GmbH

Leinenweberstraße 5

79108 Freiburg im Breisgau