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DEDebiopharm

Pharmaceutical Quality (pQM) Specialist(m/w/x)

Lausanne
Full-timeOn-siteExperienced

Quality oversight for cancer and infectious disease therapies, including CDMO Quality Agreements and batch record review. 3-5 years GMP operations experience required. Equal-Pay certified workplace, inclusive culture.

Requirements

  • University degree in Pharmaceutical Sciences, Chemistry, Life Sciences, or related field
  • 3-5 years experience in GMP operations (pharmaceutical development, QA/QC, CDMO)
  • Solid understanding of EU GMP, ICH guidelines, and quality system elements
  • Experience with deviations, CAPA, and batch record review (advantageous)
  • Strong analytical and organizational skills
  • Ability to work autonomously and within cross-functional teams
  • Great ability to build and maintain strong working relationships
  • Ability to influence cross-functional stakeholders for quality compliance and project alignment
  • Fluent in English
  • Fluent in French

Tasks

  • Contribute to Quality Agreements with CDMOs
  • Represent pQM in assigned development projects
  • Manage pharmaceutical quality documentation lifecycle
  • Oversee archiving and verification of Batch Record Review files
  • Support management of deviations, CAPAs, change controls, and OOS/OOT events
  • Ensure inspection readiness with internal teams and CDMOs
  • Support quality risk management activities
  • Draft SOPs for continuous improvement
  • Coordinate GMP training
  • Analyze quality KPIs for data-driven decisions

Work Experience

  • 3 - 5 years

Education

  • Bachelor's degree

Languages

  • EnglishFluent
  • FrenchFluent

Benefits

Other Benefits

  • Equal-Pay certified workplace

Informal Culture

  • Inclusive and respectful workplace

Purpose-Driven Work

  • Culture that values people, purpose, and performance

Startup Environment

  • Opportunity to grow, share, and shape the future of healthcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Debiopharm and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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