The IT Lead PET is the primary Point of Contact for all IT related work for the plant manager:
Partnering with local business partners by understanding their needs, priorities, and constraints. Formulating, driving, and owning the local 5Y IT Plan in balanced alignment with the Corporate Plan. Owning all local Information Technology (IT) compliance processes in balance with Corporate: Quality, Validation, Nuclear, Pharma, Internal Audit, and external audit to ensure IT processes and solutions comply with existing and future regulations and IT policies/procedures. Managing the delivery of IT activities in the assigned scope of responsibilities.
Essential Functions
Fulfilling IT 5 year plan/objectives:
- Manage new developments/possibilities in specialized field; examining developments relevant to Business Unit.
- Identify local legal regulations that affect IS, processes, and ensure the implementation of changes.
- Propose improvements for IT PET Europe Team and local Exec Team regarding enterprise and IT strategy, policies, and procedures.
- Translate Corporate and local IT strategy, policies, and procedures to the 1-5 year plan within objectives, budget, substantiating proposals; ensuring/supporting functional business understanding.
- Detect/inventor Business Unit needs for information/IT support for locations, in alignment with IT 5 years plan’s requirements and constraints.
- Act as trusted partner to advise, align, and define IT streams to deliver the Business’ 5 year plan.
- Rely on and align with Business Relationship representatives to define the strategy and for project delivery.
- Ensure all local IT systems are available/operational in relation to Business Unit.
- Ensure development of applications and systems for Business Unit usage in alignment with global and divisional policies, procedures, and in compliance with guidelines/legislations (i.e. GNP, FDA, EMA, ANSM).
- Roll out/complete all business IT systems and Business Unit/global IT projects within agreed cost/scope/quality/time frame.
- Monitor finance and planning progress of plans, altering schedules if necessary.
- Oversee compliance within corporate IT policy.
- Purchase IT related resources, tools, and services.
Departmental Activities:
- Represent Corporate IT for the whole Business Unit.
- Ensure a smooth relationship between the business and IT departments.
- Work closely with Business Relationship representatives to ensure good relationships with the business and PET EU.
- Ensure the IT organization operates as needed within the site.
- Discuss current statuses with stakeholder departments.
- Oversee performances of work (qualitative and quantitative) and monitor progress, ensuring local recognition.
- Sign local purchase of IT resources, BAR’s, tools, and services and support/attain local approval when required.
Ensure an efficient Run/Build delivery:
- Support users within ERP application architecture with a focus on Manufacturing, QC, Supply chain, and Finance:
- Discuss process changes/improvements with managers and ensure effective implementation, including providing advice, delivering wishes/requirements with suppliers, preparing contract negotiations, managing Service Level Agreements (SLAs) with 3rd parties and internal partners, and ensuring compliance within agreed SLAs respectively.
- Rectify 2nd-line problems; investigating difficulties regarding asset management systems in conjunction with manufacturing systems and HW, in cooperation with suppliers and/or global IT.
- Name IT responsible persons in departments/sites within PET IT; preparing/managing matrixes of roles and responsibilities.
- Ensure global systems’ requirements are shared and approved by stakeholders across Curium Group before implementation.
Employees (directly managed):
- Manage, define work allocation, and work schedule a team of IT professionals.
- Coach, motivate, and ensure employees are accountable.
- Monitor job performance and conduct appraisal interviews; build career paths and succession plans.
- Ensure and track training/qualifications.
Enforce regulations, compliance, and ethical behaviour:
- Ensure/oversee compliance with prevalent legal, company Code of Conduct, procedures, and regulations regarding quality, safety, health, environment, data privacy, and GDPR.
Requirements
Must have Experience/Skills:
- Approximately 10 years’ work experience in IT.
- Higher vocational education in informatics or relevant.
- Quality: ability to manage/implement existing/new hardware and software within policy plan, supporting end-users’ HW/SW use, supporting/overseeing automation projects, managing outsourcing activities to 3rd parties.
- SHWE: ability to ensure work performance aligns with prevailing safety, health, welfare, environmental, and quality regulations.
- Knowledge:
- Of end2end Business Processes within Supply Chain, ERP, and Finance.
- Familiar with Quality Control/Laboratory systems.
- Familiar with IT industry methodologies or frameworks, and corporate IT strategies, including management techniques, ICT program and project management, and virtualization techniques.
- Understanding PCI-DSS, ISO, SSAE 16/ISAE/SOC1, or SOC 2 standards.
- Experience with compliance and/or control frameworks, i.e. 21 CFR Part11, GAMP5, GxP, and PICS.
- Able to understand GMP guidelines (annex 11), Nuclear duties, GDPR, SOX legislation focused IT requirements.
- Experience in leading and operating locally within a global organization.
- Skills:
- English and French fluent.
- Excellent analytical/diagnostic skills and ability to manage process change.
- Ability to manage and respond to unexpected situations.
- Ability to prioritize in relation to business processes.
- Effective listening skills, handling difficult customers or situations effectively with sensitivity and diplomacy.
- Ability to familiarize/adapt within the organization and its processes quickly and efficiently.
- Ability to lead/drive major transformations in organization, infrastructure, and applications areas.
- Business oriented and focused.
- Team player.