Swiss Responsible Person - GDP Quality Assurance

Rhythm Pharmaceuticals, Inc

Zug

On-site

CHF 180,000 - 240,000

Full time

14 days+

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Job summary

Rhythm Pharmaceuticals, Inc. seeks an experienced Quality leader to serve as the Swiss Responsible Person (RP) for the WDL. You will own Swiss regulatory compliance, maintain the local QMS, and liaise with Swissmedic to support inspections and product disposition.

In this role you will also support global GDP operations, align processes, records, and training across Rhythm GDP markets, and drive CAPAs and continuous improvement in a fast-paced biotech environment.

Qualifications

  • University degree in life sciences and eligibility as RP under MPLO Art. 11/12.
  • 8+ years of progressive QA/GDP experience in pharma/biotech.
  • Broad knowledge of Swiss and EU GDP guidelines.
  • Excellent documentation and organizational skills.
  • Experience managing outsourced GDP activities, CMOs, and 3PL partners.

Responsibilities

  • Maintain an effective local QMS for Swiss operations.
  • Act as primary regulatory contact for Swissmedic and manage inspections.
  • Ensure proper labelling, segregation and release of medicinal products for Switzerland.
  • Approve test reports and technical documents for finished products.
  • Oversee GDP training and supplier qualification for Swiss activities.
  • Support global GDP audits, self-inspections, and CAPA processes.

Skills

GDP regulatory knowledge
Quality Assurance
Cross-functional leadership
English proficiency
German/French language

Education

University degree in Life Sciences

Tools

Veeva eQMS

Job description

Rhythm Pharmaceuticals, Inc. seeks an experienced Quality leader to serve as the Swiss Responsible Person (RP) for the WDL. You will own Swiss regulatory compliance, maintain the local QMS, and liaise with Swissmedic to support inspections and product disposition.

In this role you will also support global GDP operations, align processes, records, and training across Rhythm GDP markets, and drive CAPAs and continuous improvement in a fast-paced biotech environment.

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