Quality Assurance Manager – GxP Systems – 5018 URA 

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Quality Assurance Manager – GXP Systems for a 12 months contract role based in Basel area.

 Main Responsibilities:

  • Facilitate the GxP document/QA process management system adoption within organisation worldwide, and monitor they are properly followed in the affiliates and departments
  • Manage the incoming requests for QS Documents framework modification, and make decision on integration in the organisation worldwide quality framework
  • Oversee the GxP compliance decision of the QS Document lifecycle, including periodic reviews, translations, and training issuance periods
  • Evaluate and implement modifications on the training matrix, based on organizational modifications or organisation departmental needs, whether at headquarter or at affiliates: identify impact on learner roles, curricula and training requirement, and decide whether the implementation does not compromise the entire organisation training matrix strategy and consistency
  • Manage the training assignment discussion and implementation with line managers and document owners for ensuring the overall compliance of the organisation training framework and compliance objectives
  • Identify, evaluate employee or groups needs for specific GxP courses, either at headquarter or at affiliates, and develop/coordinate development of training package, accordingly, including content, format, storage and maintenance modalities, related quizzes or any other training aspect
  • Organize, and drive training and onboarding activities of the new employees, Veeva experts and any group requiring a training on QA GxP systems
  • Coordinate the Veeva expert network:
  • Organize regular team meetings for collecting feedbacks and sharing knowledge on expert’s activities
  • Identify systemic issues raised by the expert and proposes solution for enabling improvement of expert’s activities
  • Identify needs for additional experts or activities relevant for experts, proposes solutions and implement them as required
  • In collaboration with the QA GxP Quality and Regulation Intelligence leader:
  • Support the organisation QS Document architecture for headquarter and affiliates: identify and implement as agreed any governance, method or processes needed for ensuring the consistency of the procedural structure is preserved across organisatoin, and for ensuring the contents of QS Documents are not overlapping
  • Organize and coordinate with local QA and local experts the QS Document structure for organisation affiliates, as well as identify the need for additional local supports
  • In collaboration with QA systems Business Owner(s) and QA continuous improvement and performance manager:
  • Obtain and monitor user feedback and contribute to optimizing the service
  •  analyze the problems of end-users and finding appropriate solutions in collaboration with GIS / technical
  • prepare regular statistics on Quality Management System activities user support and feedback
  • own and maintain some of the QS Documents, including user manuals, describing QA owned GxP systems processes and activities, and related documentations (including training material, user manuals etc…)
  • Support the business owner and the system owner for the business/technical aspects of the validation and operations of QA owned GxP systems, as needed
  • Support the GxP systems team during regulatory inspections or internal audits with regard to applicable QA and Quality Management computerized system(s) content and processes

 Qualifications and Experience:

  •  Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
  •  Minimum 6 years experience in quality systems, training and/or processes oversight, and including minimum 3 years experience in QA in pharmaceutical industry
  • Proven tracks in procedural architecture and training management structure oversight in strongly regulated context (pharma ideally, directly on GxP projects)
  • Very good knowledge of GxP regulated environments and requirements
  • Good understanding of ICH Q10 and quality systems in GxP environment
  • Strong communication skills, able to understand problems and present improvement and monitoring solutions to business stakeholders
  • Strong influencing skills for partnering with affiliates for implementing and maintaining robust centrally managed processes
  •  Ability to prepare documents and communications in a clear and concise style, impactful for business stakeholders as well as technical ones
  • Independent, and hands-on working style, team player, highly self-motivated, proactive and change oriented
  • Experienced in giving presentations and standing in front of an audience
  • Experienced in and capable of dealing with people of different cultures, educational backgrounds, and computer knowledge
  • Ability to put oneself in the position of a GxP system user, and, based on this, to shape training, answer users’ inquiries accordingly and emphasize the benefits of GxP systems
  • Fluent in English (written and spoken), French and/or German is a plus
  • Ability to work under pressure and prioritize tasks
  •  Ability to independently deal with complex and difficult situations