Job Description
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: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:
- Create and regularly update quality standard operating procedures (SOPs), policies, and checklists to ensure compliance with current GCP standards
Risk Management:
- Implement Risk Mitigation Strategies at all levels
Training and Knowledge Development:
- Develop and implement targeted training programs on GCP and quality assurance principles to ensure staff proficiency and compliance
Documentation and Reporting:
- Analyse and present quality metrics and audit findings to senior management to support decision-making
- A minimum of 4-5 years of experience in GCP quality assurance or related fields within the pharmaceutical industry or a Health Authority
- Degree in Life Sciences, Pharmacy or a related field
- Extensive knowledge of GCP guidelines, ICH-GCP standards, and global regulatory frameworks (e.g., EMA, FDA, MHRA, etc.)
- Strong understanding of clinical trial methodologies and quality management systems
- Excellent written and verbal communication skills in both German and English (C1 or above)
- Supportive, respectful and appreciative work atmosphere in a small, dedicated team
- Diverse learning culture and individual development opportunities
- International and growing family business with short decision-making processes, financial independence and long-term perspective
- New work, flexible working hours and mobile working
- Wide range of benefits (free beverages, health and sports benefits, canteen, JobRad)
- Comprehensive onboarding and mentoring program