Senior Manager, Swiss Responsible Person & GDP Quality Assurance

About the role

Rhythm seeks an experienced Quality leader to act as the Swiss Responsible Person (RP) under the Swissmedic Wholesale Distribution License and to support global GDP operations.

Key responsibilities

• Maintain a local QMS, ensure inspection‑ready records, and act as primary contact for Swissmedic.
• Manage product quality complaints, temperature excursions, recalls, and disposition of non‑conforming or returned products.
• Conduct self‑inspections, annual management reviews, and ensure compliance with Swiss MPLO regulations.
• Support global GDP by reviewing documents, handling batch disposition, managing temperature excursions, and maintaining records in Veeva eQMS.
• Coordinate global GDP training, change control, CAPA, and collaborate with Supply Chain, Regulatory Affairs, and Commercial teams.

Required profile

• University degree in Pharmacy, Chemistry, Medicine, Biology or related life sciences meeting Swissmedic statutory criteria.
• 8+ years progressive QA/GDP experience in commercial pharma/biotech.
• Deep knowledge of Swiss therapeutic product legislation and EU GDP guidelines.
• Proven experience managing outsourced GDP activities, CMOs and 3PL partners.
• Strong interpersonal and communication skills in English; German and/or French proficiency preferred.

Required skills

• Electronic Quality Management Systems (eQMS) – Veeva.
• Good Distribution Practice (GDP) processes and documentation.
• Regulatory compliance with Swissmedic MPLO Art. 11‑41.