IT Quality & Change Management Specialist
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Allerød
What we Offer
IT is in transformation. We are developing the IT organization, enhancing IT services, standardizing and consolidating our systems, and optimizing our IT infrastructure. All to secure effective IT services in the future, provide better systems and faster development, and pave our way to the emerging digital business models in our industry.
Over 300 IT professionals at our sites around the world do their best to take us through this transformation, and to minimize risks and disruption in a close partnership with our business entities.
We are looking for an IT Quality & Change Management Specialist to help us.
Your Responsibilities
As our new IT Quality & Change Management Specialist, you will be responsible for ensuring compliance with a variety of regulatory requirements and internal IT quality assurance & change management objectives. You will report to our Information Security Officer and become part of a global team of skilled and dedicated colleagues.
More specifically you will work on the following:
You
We are looking for an experienced quality and change management professional, preferably with experience from IT, and from an international environment with global exposure. The ideal candidate is a responsible, organized, meticulous person with high sense of urgency in problem solving.
Experience:
Personal Competencies:
Join Us
Please submit your application as soon as possible. We will screen and invite candidates for interviews on an ongoing basis. If you have any questions about the position, please contact: Kristoffer Baadsgaard on +45 25 48 10 41.
IT is in transformation. We are developing the IT organization, enhancing IT services, standardizing and consolidating our systems, and optimizing our IT infrastructure. All to secure effective IT services in the future, provide better systems and faster development, and pave our way to the emerging digital business models in our industry.
Over 300 IT professionals at our sites around the world do their best to take us through this transformation, and to minimize risks and disruption in a close partnership with our business entities.
We are looking for an IT Quality & Change Management Specialist to help us.
Your Responsibilities
As our new IT Quality & Change Management Specialist, you will be responsible for ensuring compliance with a variety of regulatory requirements and internal IT quality assurance & change management objectives. You will report to our Information Security Officer and become part of a global team of skilled and dedicated colleagues.
More specifically you will work on the following:
- Manage validation and related maintenance activities of key systems to provide evidence for compliance and continuous compliance, in accordance with FDA 21 CFR Part 820 and Part 11, ISO 13485, GAMP 5, the internal WS Audiology quality management requirements, and other relevant compliance guidelines
- The tasks can range from validation deliverables of smaller interfaces and changes, to complicated ERP and infrastructure projects.
- Prepare and provide status report information and documentation with the help of various stakeholders to meet periodic external and regulatory audit requirements (e.g. FDA, TÜV, GMP, ISO, etc.)
- Manage the change request review and approval process with technical teams and business stakeholders to ensure that all impacted IT systems, infrastructure, and other relevant teams are aware of proposed change and engaged with the review/approval process
- Provide support and guidance to aid in successful execution of IT Change/Release Management
- Monitor and govern compliance with the Change/Release Management process by enforcing relevant processes and procedures
- Conduct IT compliance assessment on systems, infrastructure, procedures and instructions
- Ensure requirements and architecture designs undergo reviews to proactively validate appropriate applicability, accuracy, feasibility, usability, clarity, and testability
- Participate in project work on software validation, process validation
- Define and maintain IT Quality and Change/Release Management policy, processes, initiatives, and related documentations as part of the overall IT and QMS compliance frameworkEnsure that the IT Quality and Change/Release Management processes are well integrated with other service processes such as incident, problem, configuration, and asset management.
You
We are looking for an experienced quality and change management professional, preferably with experience from IT, and from an international environment with global exposure. The ideal candidate is a responsible, organized, meticulous person with high sense of urgency in problem solving.
Experience:
- Experienced in Quality Assurance, Validation, and Change/Release Management
- Good understanding of IT applications, technologies, and operations
- Able to identify and clearly articulate the needs and benefits of quality assurance and change management control
- FDA 21 CFR Part 820 and Part 11, ISO 13485, GAMP5, GxP standards and regulatory requirements related to testing and validation within the life science and medical devices industry is an advantage
Personal Competencies:
- Structured approach to tasks and processes, and a distinct sense of quality and detail
- Bias towards action and results delivery which are critical in a highly performance-oriented environment; passion for quality and efficiency
- Excellent analytical skills, ability to make sound and logical judgements
- Capable of taking a risk based approached based on sound argumentation
- Comfortable in a global organization with multicultural people, working with people from diverse cultural background and cross-border teams
Join Us
Please submit your application as soon as possible. We will screen and invite candidates for interviews on an ongoing basis. If you have any questions about the position, please contact: Kristoffer Baadsgaard on +45 25 48 10 41.
Information og data
Denne ledige stilling har jobtypen "IT-chef", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i Allerød.
Jobbet er oprettet på vores service den 22.8.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- IT-chef
- Allerød
- Lørdag den 14. september 2019
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