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:
Quality Assurance GVP Manager (m/w/d)
Your tasks
As the "Quality Assurance (QA) GVP 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 Pharmacovigilance Practice (GVP) guidelines. By collaborating with internal teams and external partners, you will ensure regulatory compliance and foster a robust culture of vigilance and safety. Your primary responsibilities will include, but are not limited to:
Audits and Inspections:
- Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits), ensuring adherence to company standards and regulatory requirements
- Oversee Corrective and Preventive Actions (CAPA) specific to PV (internal or external)
Training and Knowledge Development:
- Design and deliver training programs on pharmacovigilance quality principles to ensure staff proficiency and compliance
Documentation and Reporting:
- Maintain accurate QA GVP documentation: Ensure that all QA documentation related to GVP—including audit reports and CAPA plans—is accurate, up-to-date, and readily accessible
Your qualification
- A minimum of 4-5 years of experience in pharmacovigilance quality assurance or related fields within the pharmaceutical industry, a Health Authority or a Contract Research Organisation (CRO)
- Proven experience in managing pharmacovigilance audit programs and teams, including conducting and overseeing global pharmacovigilance audits. Experience with regulatory inspections is preferred
- Degree in Life Sciences, Pharmacy or a related field
- In-depth understanding of global pharmacovigilance regulations and guidelines, including GVP and ICH requirements
- Excellent written and verbal communication skills in both German and English (C1 or above)
Your benefits
- 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