Expert for Computer System Validation and Migration

Excelya>Full-time>Expert for Computer System Validation and Migration

Job description

Created in 2014, EXCELYA is a unique model among Contract Research Organizations (CROs) in healthcare.

With nearly 800 employees and strong growth over the last 8 years, EXCELYA offers an original customer and HR approach – Excelling with care – which reintroduces the benefits of customer focus, initiative and ambition for excellence in a regulated environment where operational and scientific rigor is absolute.

With EXCELYA, pharmaceutical laboratories, biotech companies, academic research organizations and patient associations can offer a global response to their development needs in the clinical, biometrics, regulatory affairs, medical writing, data science and pharmacovigilance fields. Above all, they benefit from an unparalleled degree of intellectual and operational involvement.

‘Excelyates’ have a strong culture of Excellence. They know to take project ownerships, challenge demands, and invest their whole selves to guarantee excellence in customer service.

This is how EXCELYA has gained the confidence of European and international healthcare companies and aims to become the leading independent CRO in Europe.

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We are looking for an Expert in Computer System Validation and Migration in a GCP/GxP regulated environment. The role includes the consolidation of existing systems, migration of systems of potential new entities to be integrated in Excelya’s IT environment.

You will be responsible for the strategic planning, risk/mitigation assessment, migration, and validation.

To fill that position, you should have significant experience in working in regulated environments (ICH/GCP), CSV, and migration of systems. Preferably you should have served in an Associated Director position in a bigger CRO or Pharma. You must have project management skills, excellent communication in English, and be a highly motivated, analytical, and solution-oriented person.

 

Job tasks:

  • Overall responsibility for all regulated systems in the Excelya Group including validation, security, and migration
  • Excellent knowledge in Computerized System Validation (CSV), General Principles of Software Validation, Change Documentation in a GCP/GxP regulated environment and Risk Management/Mitigation
  • Definition of all necessary parameters for a smooth implementation, migration and validation of all regulated systems to ensure a valid system environment.
  • The professional Project Management as well as the operational planning, and strategy development together with the IT team within the Excelya Group.
  • Experience in leading a multinational team
  • Standardization, harmonization, and integration of a decentralized IT infrastructure with a view to optimizing quality, reliability, and end-user satisfaction.
  • Planning and introducing innovations and new technologies. Knowledge and experience in DIN ISO 27001.
  • Organizing and managing all major IT projects, including rollout and migration in an regulated environment. Oversee software upgrades and patches

Skills and experience

  • You have a higher technical/IT education or a comparable education with several years of experience in the management of a regulated system environment in CRO/Pharma organizations, preferably within a matrix structure.
  • In addition to high leadership skills, a natural authority and intercultural sensitivity, you bring above all a solid, know-how in IT technology (CSV, Risk/Mitigation, System Migration, cloud technologies, IT security, etc.).
  • You have a good experience in the realignment and implementation of IT strategies and have a sound knowledge of project management as well as successfully proven routine in the planning, control, and implementation of international IT projects.
  • In this context, you are familiar with the analysis, conceptual design and introduction of IT systems or their specification as well as with the definition and implementation of roadmaps based on migration strategies.
  • Your thinking and actions are entrepreneurial, you work pragmatically as well as analytically adaptively and persistently.
  • You have excellent communication and presentation skills, a structured and results-oriented way of working.
  • Excellent English skills.

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