Senior Manager, 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 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.
11ff 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 GDPoperations, 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 and promptly notify Swiss medic of any major change according to Art. 41 of MPLO.
• Ensure that appropriate Corrective and Preventive Actions (CAPAs) are clearly defined as required and effectively managed throughout their implementation.
• Ensure potential quality and supply chain risks are thoroughly analyzed and managed effectively.
• Establish and maintain formal Deputy/Backup Responsible Person delegation procedures to guarantee continuous license oversight and coverage during absences.

Global GDP Operations & Quality Systems Support:

• Support global GDP operations by reviewing documents, preparing batch disposition and return paperwork, and coordinating approval processes within Veeva.
• Manage temperature excursions and distribution events ensuring all incidents are properly recorded, root causes investigated, and corrective actions are implemented in line with global GDP standards.
• Support GDP audits and self-inspections, including management of records within Veeva eQMS and tracking audit remediation commitments.
• Support maintenance and authoring of global GDP procedures, work instructions, forms, and templates to ensure consistent execution across all Rhythm GDP markets.
• Contribute to global GDP change control, deviation, CAPA, and quality event administration, ensuring consistent documentation and follow-up across regions.
• Coordinate and…