The individual will be responsible for ensuring that IT operates with the leanest CSV and project management processes commensurate with being a regulated pharmaceutical company and ensuring that IT change delivers benefit to the company quickly. The individual will be expected to foster collaborative relationships with Global Quality and Norgine PMO ensuring that IT Governance is consistent with the requirements of these functions while always looking for opportunities for improvement. In addition the individual will lead the initiative to further develop appropriate portfolio management practices across the IT project portfolio, with particular emphasis on resource and financial forecasting and management.
IT Project Portfolio Management
- Delivery and ownership of the IT Project Portfolio within agreed timescales and budget. This includes the creation, prioritisation, budgeting and delivery of the IT project portfolio.
- Develop and champion the MECHANO project methodology across Norgine IT and provide support to any other business function that utilises the process
- Provide professional guidance to IT project managers in all aspects of project management and ensure that skill levels are appropriate to the complexity of the projects managed.
- Maintain overall responsibility for the IT PMO.
- Manage the Computer System Validation of relevant IT systems
- Ensure that all IT systems are compliant with the appropriate pharmaceutical industry and financial regulations and that audits/inspections result in no major findings.
- Develop and manage the IT processes and procedures around the introduction of all levels of change to production systems.
- Develop and manage the IT Quality Management system.
- Develop and champion a risk management culture across IT and maintain the IT risk register in line with Norgine corporate standards
- Provide Norgine Quality Council with relevant and appropriate metrics that enable decision to be made regarding the risks to patient safety, product quality and data integrity emanating from Norgine computer systems
- Provide appropriate metrics to assure management that the IT change management activities are under control and are implemented so as to minimise the risk of disruption to business operation
- Manage the staffing of the IT Governance function to ensure that the appropriate level of support is provided to the IT community and associated business functions
- Ensure that the appropriate level of resource is assigned to Business As Usual and project activities across the IT function.
- Represent IT on the Norgine Governance Committee, ensuring that appropriate consideration is given to IT related issues.
- Accurately manage forecast and budget for allocated costs centres, ensuring that IT delivers value for money.
Overall objectives and responsibilities
- Provide a single point of contact regarding portfolio, programme, project and change management in IT.
- Provide scrutiny, oversight and challenge across Norgine IT’s portfolio of change
- Provide Computer Systems Validation oversight to ensure that Norgine’s IT systems comply with all relevant regulatory expectations. This applies to traditional systems hosted internally or ‘in the cloud’ as well as apps and bots.
- Ensure that IT Quality Management System is maintained so that SOPs and work instructions are regularly reviewed and updated to reflect practice
- Provide assurance that all IT functions are performing as expected and comply with the relevant Standard Operating Procedures and Working Instructions
- Provide leadership within the IT function to ensure that external audits and inspections result in no major findings
- Ensure that the IT project portfolio is delivered on time, within budget, with agreed scope and quality. This includes tracking progress against schedule and cost and reporting on any differences to the agreed plan.
- Ensure that risks to Norgine emanating from IT systems and infrastructure are captured and prioritised appropriately. Where the risk is significant this must be escalated according to prescribed processes
- This role involves the management of the IT Governance team located across multiple Norgine sites.
- The annual IT project budget is typically in excess of €3M and a total IT budget in the region of €15M
- The IT team is approximately 70 people spread across 8 sites
- Objectives and priorities are established with and reviewed by the IT Director
- As a member of the ITLT this role has a shared accountability for the effective delivery of services to the business
- Accountable for the maintenance of the IT Quality System, MECHANO, risk register
- This role reports to the IT Director and participates as a member of the IT Leadership team.
- The role also has a relationship with the IT Steering Committee, the Norgine Quality Council and the Norgine Governance Committee
- The role must establish a working relationship with the Global Quality function with regard to the maintenance of the validated state of computer systems
Knowledge and Skills
- A proven track record in IT Quality and project management.
- A working knowledge of Computer Systems Validation in the pharmaceutical industry
- A working knowledge of risk management practice
- A working knowledge of the principles of annual budgeting
- Able to demonstrate process improvement techniques knowledge
- Proficient in at least one project management tool, e.g. Microsoft Project, Primavera
- Proficient in Microsoft Office applications
- Able to communicate at all levels of the business
- Experience of a multi-site environment and its cross-cultural implications
- Able to work on own initiative or as part of a team