Swiss Responsible Person and GDP Quality Assurance

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them.

Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them.

Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Rhythm is seeking an experienced Quality leader to serve as the Responsible Person (RP) for Switzerland under the Swiss medic Wholesale Distribution License (WDL). The RP is fully accountable for product quality and regulatory compliance under Art. 11 ff of the Medicinal Products Licensing Ordinance (MPLO; SR 812.212.1) for all commercial distribution activities within the Swiss territory. In addition to Swiss RP duties, the role provides operational, technical, and compliance support to the global GDP operations, ensuring alignment and consistency across GDP processes, records, electronic systems, and compliance activities across international markets.

Swiss Responsible Person (RP) & Swiss medic Regulatory Compliance:

• Maintain an effective local QMS, overseeing authorized activities and ensuring accurate, inspection-ready, high-quality records.
• Act as the primary regulatory and technical contact person for Swiss medic, managing communications and hosting health authority inspections.
• Ensure non-conforming medicinal products, such as expired goods or those failing to meet specifications, are clearly labelled, segregated, quarantined, and not released to the market, and that packaging complies with current Swiss medic approvals.
• Decide on the final disposition of returned, rejected, recalled, or falsified products for the Swiss market.
• Effectively manage product quality complaints, inquiries, and temperature excursions in accordance with local regulations.
• Conduct regular self-inspections according to a set schedule, monitor GDP compliance, and implement corrective actions as needed.
• Approve test reports and technical documentation for finished medicinal products or returning saleable products.
• Ensure appropriate samples are taken and kept as retention samples in accordance with Swiss regulatory standards.
• Complete and document all mock or actual recalls accurately and within the specified regulatory time frame.
• Oversee that medicinal products in Switzerland are supplied only to customers and entities authorized to distribute or dispense them under GDP.
• Ensure suppliers, distributors, 3PLs, and subcontracted activities are approved and qualified.
• Ensure that initial and continuous GDP training programs are implemented and maintained for relevant personnel. Ensure Swiss-specific assessment and evaluation of APQRs are conducted in accordance with Swiss medic timelines.
• Conduct Annual Management Reviews for the Swiss establishment license.
• Manage deviations and changes appropriately…