Back to Job Search

Lead (m/f/x) IT Validation

  • Location: Hamburg
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 17 Tage her

  • Sector: Medizinische Technologie
  • Contact: Liana Costanza
  • Contact Email: l.costanza@sciproglobal.de
  • Start Date: ASAP
  • Expiry Date: 10 December 2022
  • Job Ref: IT_2022_11_1668083251

Hamburg - 60% remote

As a competent contact for IT Validation, you can be a great asset within the IT Assurance function in a global medical device company. You lead a cross-regional team within the Global IT Organization and oversee the development and implementation of a compliant IT validation strategy.

These tasks are waiting for you:


IT Validation

  • Expand the cross-regional validation strategy of utilizing and leveraging assistance from resources
  • Evaluate and validate third party vendors to create a collaboration to support the cross-regional validation strategy
  • Manage external vendors to ensure the conduct of software/ system validation is completed accurately to be regulatory compliant
  • Improve and oversee the IT validation and change management roadmap to ensure efficient and effective resource management against the validation activities required
  • Work closely with all Global IT functions to ensure the operation of validated environments (according to GMP and other regulatory requirements relevant)
  • Design, implement and manage all operational validation activities
  • Execute the initial Quality Gate Check when a new application is established to determine whether the software requires validation
  • Support Global IT teams on the process for the creation of IT validation documentation and requirements
  • Assist project leads in preparing the functional specifications and conducting the validation report and testing
  • Support the revalidation process in the event of a major change
  • Keep the relationship with the QARA domain to provide updates on the execution and outputs of the validation conducted for software/ systems


IT-Change-Management

  • Assess documentation created by IT Validation Leaders and IT Validation Analysts to submit to the Change Advisory Board (CAB)
  • Attend scheduled CAB sessions and provide feedback on adherence to regulatory compliance
  • Handle spot check audits to ensure projects/platforms change governance is adhered to

This completes your profile:

  • Bachelor's degree in IT, Computer Science or Engineering (or equivalent and related experience preferred)
  • Extensive knowledge of validation, preferably with a focus on the Life Science sector
  • Experience in a leadership role (functional leadership or project teams)
  • Skilled in both managing people and processes
  • Experience in quality risk management and handling GxP regulations
  • Experience in project management, particularly with regards to CSV
  • Progressive experience in a multi-national, multi-divisional technology environment with demonstrated experience in planning, forecasting, modeling, and analysis
  • Knowledgeable in Quality Systems and be considered a Subject Matter Expert (SME) in several CSV capabilities
  • Demonstrable technical communication, analytical and conceptual thinking as well as detail orientation

The position offers you:

  • Contract: full time and permanent employment
  • Holidays: 30 days per year
  • Regular training courses
  • Flexible working hours
  • Health care and medical check-ups
  • A comprehensive company pension scheme

Information about our client:

The company is a global company focusing on minimally invasive therapies for Medical Devices and Life Sciences. They encourage a collaborative environment and are looking for curious personalities to improve people's lives together.