SITE OPERATIONS MANAGER (IT)
The Site Operations Manager will be responsible for the day to day management of IT operations within Ireland, incorporating Cork and Dublin. A key responsibility will be ensuring the highest levels of IT compliance within the department.
Based in Cork the successful candidate will report into the Assoc Director, Business IT Operations.
The successful candidate will be responsible for delivering key systems support such as management of IT helpdesk and internal assignment tickets; infrastructure in Cork/Dublin and International Data Centre; and computer systems validation (CSV) activities.
The successful candidate will be required to have excellent project management skills and proven experience with established project management methodologies. Formal training in project management would be a distinct advantage. The individual will be required to project manage new infrastructure and system introductions at the site. This will include project support for major business applications, HQ systems and any local approved IT projects that are necessary for the successful operation of the Ireland business.
This individual should have 5+ years experience working in a pharmaceutical GMP facility and will be responsible for Computer System Validation activities for the IT department and development of a CSV lifecycle framework that can be deployed globally.
The successful candidate will be responsible for ensuring that the IT department is fully prepared for regulatory inspections by Irish Medicines Board (IMB), US Food & Drug Administration (FDA) and other regulatory bodies that may audit the facility.
Participation in global IT operational groups will be encouraged.
Authority and Decision-making:
- Manage day to day IT Operations of a modern pharmaceutical plant with a high reliance on IT technologies that support the business
- Ensure highest quality IT compliance within the department incl. metric reporting to Snr. Management team. This will include SOP development and compliance.
- Monitor the status of IT related change orders, change controls, issue reports and CAPAs to completion.
- Manage CSV activities for new system introductions, upgrades or enhancements. This will also involve writing computer validation documentation following GAMP 5.
- Deliver key system support including management of the IT helpdesk and internal assignment tickets; infrastructure in Cork/Dublin and the on-site data centre for the International region.
- Responsible for successful introduction of new business applications, HQ systems and locally approved IT projects.
- Proactively identify and propose systems improvements.
- Develop manage and implement project plans and budgets.
- Develop and manage process and systems improvements.
- Develop and maintain knowledge of issues, software & technologies for key business groups.
- Manage relationships with suppliers ensuring appropriate service levels within budget.
- Undertake ad hoc project work and other management tasks as required in a lean IT organisation.
- Fulfill the role of IT training coordinator.
The IT Site Operations Manager will be given the autonomy and freedom to develop IT operations within Cork and Dublin. They will however work very closely with Assoc Director, Business IT Operations on receiving direction on prioritization of activities.
- The successful candidate will use his/her skills and judgment to contribute to the achievement of the goals and objectives of the Ireland business and the global IT organisation.
- The successful candidate will be required to work closely with Corporate IT Quality team.
Profile and Competency:
As well as being able to demonstrate the relevant IT skills and competencies required to successfully deliver the tasks outlined above the following are requirements for this role:
- A good educational background, preferably with graduate or equivalent qualifications with solid IT and business experience in a multinational company.
- A working knowledge of a Project Management Methodology; e.g. PMBoK or Prince2 would be advantageous.
- Proven experience managing an IT team within the Pharmaceutical industry.
- A working knowledge of key business processes is essential, with some knowledge of ERP systems, document management solutions, and business analytics.
- Ability to develop and manage an IT budget for a project.
- Proven track record in people management. Individual must be a strong communicator and have excellent technical writing skills.
- Self starter with demonstrable drive, energy, tenacity and focus on delivery.