Swiss Responsible Person and GDP Quality Assurance

Rythm is a global biopharmaceutical company focused on developing medicines for rare neuroendocrine diseases. The company is dedicated to improving the lives of patients by challenging conventional approaches and seeking innovative solutions. The role of Swiss Responsible Person and GDP Quality Assurance involves ensuring product quality and regulatory compliance for all commercial distribution activities within Switzerland. The main day-to-day responsibilities include maintaining an effective local Quality Management System (QMS), overseeing authorized activities, and ensuring high-quality, inspection-ready records. The role also involves acting as the primary regulatory and technical contact for Swissmedic, managing communications, and hosting health authority inspections. Additionally, the position requires managing non-conforming medicinal products, handling product quality complaints, and conducting regular self-inspections to monitor GDP compliance. The role also involves approving test reports, ensuring appropriate samples are kept, and managing recalls and deviations. To qualify for this role, candidates must have a university degree in Pharmacy, Chemistry, Medicine, Biology, or a related Life Science field. They must also meet all Swissmedic statutory criteria under MPLO Art. 11/12 to be approved as a Responsible Person (RP). Additionally, candidates need 8+ years of progressive Quality Assurance/GDP experience in the commercial pharmaceutical or biotech sector. Proficiency in English is required, with professional working proficiency or fluency in German and/or French being strongly preferred. Knowledge of Swiss therapeutic products legislation and EU GDP guidelines is also essential. Nice-to-have skills include experience in managing outsourced GDP activities, CMOs, and 3PL logistics partners in a virtual environment. Familiarity with Electronic Quality Management Systems and strong interpersonal and communication skills are also beneficial. The role offers the opportunity to work in a dynamic and growing global team, with a focus on international expansion and product launch readiness. What the role asks for: - University degree in Pharmacy, Chemistry, Medicine, Biology, or related Life Sciences - 8+ years of progressive Quality Assurance / GDP experience in the commercial pharmaceutical or biotech sector - Meet all Swissmedic statutory criteria under MPLO Art. 11/12 to be approved as Responsible Person (RP) - Strong interpersonal and communication skills in English (written and verbal) - Professional working proficiency or fluency in German and/or French - Broad and deep knowledge of Swiss therapeutic products legislation and EU GDP guidelines - Proven experience in managing outsourced GDP activities, CMOs, and 3PL logistics partners in a virtual environment (nice-to-have)