Introduction

 

Internal job advertisement 

Department: 

Location: Frankfurt

 

Global Quality Business Process Manager (m/f/d)
Frankfurt, Germany

  • Frankfurt
  • ASAP
  • Full-time
  • Permanent

Your Tasks

  • Global Quality Business Partner focused on the Quality Management of IT System implementation projects and for the Life Cycle Management of Corporate GxP IT Applications.
  • Subject Matter Expert within the CordenPharma network regarding compliance with 21CFR Part11, GMP Annex 11 and GAMP5.
  • Development of Design Requirements followed by Validation and Testing strategies in a GxP environment for new Electronic Business solutions.
  • Evolvement and continuous optimization of the Global Validation and Lifecycle approach and its presentation to regulatory authorities and external / internal customers during inspections and audits.
  • Supervision of cross-functional teams within the CordenPharma network during execution of new and ongoing Validation and Qualification activities for Computerized Systems. 
  • Close collaboration with CordenPharma Site Quality and IT teams for locally implemented electronic systems and support cost-efficient solutions.
  • Review and implementation of IT quality-related processes, standards and systems.
  • Execution of internal and external audits and responsibility for supplier management of IT service providers.

Your Profile

  • Master’s degree in IT, Pharmaceuticals, Engineering, Life Sciences or a similar field.
  • Profound knowledge of FDA- / EU-Guidelines, including computer system validation, quality risk management and data integrity.
  • Long-term professional QA experience in supporting IT applications in a global GxP environment throughout the whole lifecyle of an application, preferred in a CDMO business.
  • Confident handling with electronic systems, ideally to be familiar with Trackwise, Labvantage, SAP, eCTD Manager.
  • Fluent communication in English.
  • Excellent interpersonal and communication skills.
  • Highly self-motivated with “Can do” mentality and a strong sense of ownership.
  • Flexibility and willingness to travel (< 10%).

 

Please note that this role can be filled at any of Corden Pharma's European sites. 

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