ERP Quality Manager

Basel Area
07 Dec 2018
04 Feb 2019
Contract Type

Main Responsibilities

  • Support the overall Project Management Team in the planning and implementing of an ERP (Enterprise Resource Planning)-system (SAP) for streamlining and harmonising the manufacturing-, release- and supply processes of medicinal products;
  • Ensuring the Quality compliance of the ERP-system and its interfaces to other IT-systems and the underlying processes;
  • QA role during the development, risk assessment, validation, implementation and maintenance of Quality relevant process workflows according to ERP project plans
  • Collaboration with quality team members and other process stream leaders to drive alignment and process standardisation;
  • Support the roll-out of the ERP-system to the different manufacturing sites;
  • Managing, maintaining and controlling the quality aspects of SAP in the post go-live phase
  • Provide input of quality process design and integration with other systems and processes (e.g. LIMS);
  • Identify and monitor the quality related project risks and initiate preventive and corrective actions;
  • Monitor that quality related business benefits included in the SAP business case are delivered
  • Conduct IT vendor, contractor and supplier audits;
  • Support the integration of the projects into the global IT landscape;
  • Presentation of the projects to the Steering Committees;
  • Write, review or approve related manuals and procedures;
  • Support agency inspections and customer audits as needed;
  • Coordination, planning and optimisation of resources and budget

Qualifications and Experience:

  • Higher degree (Bachelors or Masters) in a technical field (Science, Business Administration, Engineering) or proven work experience;
  • Experience in Project Management;
  • Good understanding of laws and guidelines such as GMP, GDP, GAMP5;
  • In-depth understanding of business processes from launch of the production order to the final release;
  • Excellent change management skills;
  • Demonstrated ability to successfully collaborate and negotiate across different sites, functions and management levels;
  • Good knowledge of IT system landscape within a manufacturing and QC-environment;
  • Work experience in different areas as Manufacturing, Quality, Supply Chain, etc.
    Knowledge of (pharmaceutical) quality systems, business processes and IT-Systems (e.g. LIMS)
  • Experience with Operational Excellence and/or Business Process Management methodologies;
  • Experience with the harmonisation and simplification of business processes across multiple sites
  • Experience with SAP planning system would be an advantage;
  • Lean Six Sigma green or yellow belt certification would be an advantage;
  • Fluency in English and German (both spoken and written);
  • Knowledge of French would be an advantage;
  • Availability to travel;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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