Corporate Quality Manager QC

Reference Number: 896035-W
Type of placement: Permanent
Location: Switzerland, North East / Central

Introduction:

Our client is a global specialty pharmaceuticals company.

Corporate Quality Manager QC will join Corporate Quality Management (CQM) team,  reporting to the Head of Corporate Quality IT and maintain and improve all corporate QC IT applications and their integration in the global IT architecture (e.g. LIMS, Chromeleon and related interfaces) as a global project or program lead.

Main Responsibilities:

  • Support and manage corporate Quality Control (QC) - and if needed Quality Assurance (QA) - business process harmonisation and improvement activities
  • Support the strategy for implementation of a paperless laboratory
  • Lead a program to define, implement and review global data governance standards for global QC applications
  • Lead a program to define, implement and review global data integrity standards for global QC applications (considering aspects like audit trail review, user management review and global data review)
  • Lead and support the development, validation, implementation and maintenance of corporate IT-Systems used in QC and ensure that key user support as well as training is provided as required
  • Support the integration into the global IT landscape SAP, MES and PLM (MDM)
  • Trouble shooting and management of IT-System incidents, issues and changes, if necessary routing issues to other internal or external partners
  • Write, review or approve related manuals and procedures
  • Provide input during the global Quality audit planning cycles and execute internal and external Quality audits according to plan
  • Support the development, implementation and maintenance of the Vifor Pharma Quality System
  • Provide input for the Quality KPI Report and implement performance improvements
  • Supervise the CQM Application Manager for QC IT Systems as direct line manager
  • Support agency inspections and customer audits as needed
  • Provide input and controlling of budget

Qualifications and Experience:

  • Higher degree (Bachelor or Master) in a natural science field
  • 5 – 8 years of experience in the Pharmaceutical, Medical Device Industry and/or similar industry
  • Work experience in QC 
  • Knowledge of Pharmaceutical Quality Systems, business processes and IT-Systems used in QC (e.g. LIMS, HPLC software, Titration software)
  • Sound knowledge in informatics and programming
  • Customisation and configuration of QC systems would be beneficial
  • Experience in validation of computerised systems (CSV)
  • Knowledge of applicable legislation, industry standards and norms within the area of GxP and process automation
  • Sound knowledge in Quality Risk Management
  • Ability to lead and manage cross-functional multi-site projects and programs at corporate level
  • Experience with Operational Excellence and/or Business Process Management methodologies as well as with the harmonisation and simplification of business processes across multiple sites
  • Work experience as lead or co-auditor
  • Experience as a line manager
  • Lean Six Sigma green or yellow belt certification would be an advantage
  • Fluency in English (both spoken and written) and advanced level in German
  • Knowledge of French would be an advantage
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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