Swiss Responsible Person, GDP Compliance Leader

Rhythm Pharmaceuticals Inc.; Zug; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Rhythm Pharmaceuticals Inc. seeks an experienced Quality leader to serve as the Responsible Person (RP) for Switzerland under the MPLO.

You will maintain the local QMS, act as Swissmedic contact, ensure compliant labeling and packaging, and oversee GDP activities across the Swiss market and global operations. The role requires a university life sciences degree, 8+ years in QA/GDP, and fluency in English with German or French preferred for regulatory interactions.

Qualifikationen

• University degree in Pharmacy, Chemistry, Medicine, Biology, or related Life Sciences required.
• 8+ years of progressive Quality Assurance / GDP experience in pharma or biotech.
• Broad knowledge of Swiss and EU GDP guidelines.
• Excellent documentation and administrative skills.
• Experience managing outsourced GDP activities, CMOs, and 3PLs.

Aufgaben

• Maintain an effective local QMS and inspection-ready records.
• Act as regulatory/technical contact for Swissmedic and health authority inspections.
• Ensure proper labeling, segregation, and packaging compliance.
• Approve test reports and technical documentation for finished products.
• Lead self-inspections, GDP training, and CAPA programs.
• Oversee supplier qualification and 3PL oversight.

Kenntnisse

Quality Assurance

GDP compliance

Regulatory affairs

Cross-functional teamwork

Ausbildung

University degree in Life Sciences

Tools

Veeva eQMS

Quality Management Systems

Jobbeschreibung

Rhythm Pharmaceuticals Inc. seeks an experienced Quality leader to serve as the Responsible Person (RP) for Switzerland under the MPLO.

You will maintain the local QMS, act as Swissmedic contact, ensure compliant labeling and packaging, and oversee GDP activities across the Swiss market and global operations. The role requires a university life sciences degree, 8+ years in QA/GDP, and fluency in English with German or French preferred for regulatory interactions.