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.
