In this role, you will be responsible for ensuring compliance with Swiss pharmaceutical regulations, overseeing batch releases, and maintaining the quality management system. You will act as the key quality contact for distribution in Switzerland, supporting audits and regulatory inspections. 

Start Date: 01/08/2025

Duration: Permanent 

Key Responsibilities

  • Serve as the Qualified Person and oversee batch release processes for Swiss distribution
  • Maintain, oversee, and improve the Quality Management System in alignment with GDP standards
  • Update and manage SOPs to reflect current regulations and best practices
  • Establish and monitor quality and technical agreements with suppliers and partners
  • Prepare for and coordinate regulatory inspections and audits
  • Manage CAPA processes, ensuring timely execution and documentation
  • Support deviation investigations, change controls, and audits
  • Collaborate with cross-functional teams on quality-related matters
  • If applicable, develop and maintain QMS systems linked to clinical trial activities to ensure GCP compliance

 

Job ID 41180891

Candidate Profile

  • Degree in Pharmacy, Life Sciences, or a related discipline, with eligibility to act as a Qualified Person under Swiss law
  • Minimum of 5 years of experience in pharmaceutical quality assurance, with a focus on GDP and/or GMP
  • Experience in batch release, QMS management, audits, and regulatory inspections
  • Deep understanding of Swissmedic requirements, EU GDP/GMP guidelines, and international quality standards
  • Excellent communication and interpersonal skills, with the ability to foster collaborative relationships
  • Proactive, detail-oriented, and capable of managing multiple priorities in a regulated environment
  • Languages: English (C1), French (C1), German (C1)