Description

Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. 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 learn, adapt and our tenacity to overcome barriers, together.

Opportunity Overview
This role serves as the Responsible Person (RP) for Switzerland under the Swissmedic 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).

In addition to Swiss RP duties, the role provides overall support to the global GDP operations, ensuring alignment and consistency across GDP processes, records, electronic systems, and compliance activities.

Responsibilities and Duties
The RP must (aligned with Swissmedic and GDP expectations):

Maintain an effective QMS, overseeing authorized activities and ensuring accurate, high-quality records.
Ensure non-conforming medicinal products, such as expired goods or those failing to meet specifications, are clearly labelled and not released to the market, and that packaging complies with current Swissmedic approvals.
Deciding on the final disposition of returned, rejected, recalled, or falsified products.
Effectively manage product quality complaints and temperature excursions.
Conduct regular self-inspections according to a set schedule, monitor GDP compliance, and implement corrective actions as needed.
Approve test reports for finished medicinal products or returning saleable products.
Ensure appropriate samples are taken and kept as retention samples.
Complete all mock or actual recalls accurately and within the specified time frame.
Supplying medicinal products in Switzerland only to customers authorised to distribute them under GDP.
Ensure suppliers and subcontracted activities are approved and qualified.
Ensure that initial and continuous training programs are implemented and maintained.
Act as contact person for Swissmedic.
Ensure Swiss-specific assessment and evaluation of APQRs are conducted in accordance with Swissmedic timelines.
Conduct Annual Management Reviews.
Manage deviations and changes appropriately, and promptly notify Swissmedic 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.
Ensuring potential risks are thoroughly analyzed and managed effectively.

Overall Support for Global GDP Operations
The role will:

Support global GDP operations by reviewing documents, preparing batch disposition and returns paperwork, and coordinating approval processes within Veeva.
Manage temperature excursions and distribution events ensuring all incidents are properly recorded and corrective actions are implemented in line with global GDP standards.
Support GDP audits and self‑inspections, including management of records within Veeva eQMS.
Support maintenance 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 global GDP training activities.

Qualifications and Skills

Meets requirements to serve as RP under Swissmedic WDL
Preferred with 8 +years of relevant industry work experience
Broad knowledge of EU GDP
Excellent documentation, organizational, and administrative skills
Proven experience in managing outsourced GDP activities in a virtual environment
In-depth knowledge of the Swiss healthcare system, medical landscape, and current trends in industry
Willingness to travel

More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.

At Rhythm Our Core Values Are
•      We are committed to advancing scientific understanding to improve patients’ lives
•      We are inspired to tackle tough challenges and have the courage to ask bold questions
•      We are eager to learn and adapt
•      We believe collaboration and ownership are foundational for our success
•      We value the unique contribution each individual brings to furthering our mission

Swiss Responsible Person and GDP Quality Assurance

Description

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