Quality Systems & Compliance Manager

06.08. | Temporary | 100%

Quality Systems & Compliance Manager

Kelly scientific is looking for a Quality Systems & Compliance Manager for a maternity leave for a 6-month period.

The position

Establish, design and oversee Quality Systems and compliance of a pharmaceutical manufacturing site under current GMP and corporate guidelines.

Your tasks / duties


  • Follow Corporate Guidelines implementation
  • Coordinate a continuous inspection readiness program
  • Manage the Supplier Qualification Assurance (QAA, risk assessment) and supplier deviations
  • Approve packaging and QC specifications
  • Ensure manufacturing site regulation compliance :
  • QA documentation review (SOP's protocols, reports...)
  • RA requests management


  • Manage internal and external audits.
  • Lead auditor in self-inspections and external audits.

Quality Systems

  • Manage CAPAs (workflow, meetings with the concerned functions, KPIs)
  • Manage change control
  • Lead the Documentation and training systems; Expresso and Success Factor business owner.
  • Coordinate and prepare Annual Product Reviews with the objective of verifying the consistency of the process
  • Propose a training program and assure a follow up. Organize GMP training for the site
  • Manage and Lead the risk analysis
  • Perform audit trail review of GMP systems

Monitoring and Communication

  • Establish Compilations, trending of GMP data and Key Performance Indicators (KPI)
  • Diligently report to head of Quality Unit any Quality Alert/issue and actively participate to resolve significant Quality issues when they arise
  • Enssure a communication flow and collaboration with Operations and other functions to assure a product life-cycle quality


  • Backup for quality documentation management and issuance of batch record
  • Backup for compliance approval of QC lab documentation (SOP, specifications, revision analytical dossier QCA & QCM, Analytical method validation documents, stability documents, LIMS modification)
  • Backup in due date extension for CAPA and Change control

Your Profile

  • Scientific university degree, Master or Bachelor
  • At least 4 years of experience in pharmaceutical industry
  • Strong Knowledge of GDP/GMP regulations
  • Fluent in English and French, both written and spoken

Your contact at Kelly Scientific
Sophie Darthenay
Engineer in Biology
Consultant Professional Staffing Life Science

Employee, 100%


Kelly Services Switzerland

Sophie Darthenay

Kelly Life Sciences

rue du Rhône 114Geneve


Human resources / Personnel services

Kelly Life Sciences

rue du Rhône 114Geneve


Human resources / Personnel services

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