Senior Manager, Swiss Responsible Person and GDP Quality Assurance
Rhythm Pharmaceuticals · Zug, Zug ·
- Seniority
- Senior
- Category
- QA
- Experience
- 8+ years
Company Overview
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.
Opportunity Overview
Rhythm is seeking an experienced Quality leader to serve 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) 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.
Responsibilities and Duties
Swiss Responsible Person (RP) & Swissmedic Regulatory Compliance:
Qualifications and Skills
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 melanocortin-4 receptor (MC4R) pathway 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
Inherent in our core values is the commitment to act ethically and with integrity in all we do.
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.
Opportunity Overview
Rhythm is seeking an experienced Quality leader to serve 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) 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.
Responsibilities and Duties
Swiss Responsible Person (RP) & Swissmedic 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 Swissmedic, 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 Swissmedic 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 Swissmedic timelines.
- Conduct Annual Management Reviews for the Swiss establishment license.
- 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.
- 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.
- 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 facilitate global GDP training activities.
- Collaborate cross-functionally with Supply Chain, Regulatory Affairs, and Commercial Teams to support international expansion and product launch readiness.
Qualifications and Skills
- University degree in Pharmacy, Chemistry, Medicine, Biology, or related Life Sciences; must meet all Swissmedic statutory criteria under MPLO Art. 11/12 to be approved as Responsible Person (RP).
- 8 +years of progressive Quality Assurance / GDP experience in the commercial pharmaceutical or biotech sector.
- Broad and deep knowledge of Swiss therapeutic products legislation and EU GDP guidelines.
- Excellent documentation, organisational, and administrative skills
- Proven experience in managing outsourced GDP activities, CMOs, and 3PL logistics partners in a virtual environment
- Demonstrated experience with Electronic Quality Management Systems.
- Strong interpersonal and communication skills in English (written and verbal); professional working proficiency or fluency in German and/or French is strongly preferred for Swissmedic interactions.
- Proven ability to lead cross-functional investigations, risk assessments, and decision-making in a fast-paced, matrixed global biotech organization.
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 melanocortin-4 receptor (MC4R) pathway 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
Inherent in our core values is the commitment to act ethically and with integrity in all we do.