King Of Prussia, PA
Industry: Medical Devices & Diagnostics•
11 - 15 years
Posted 333 days ago
1. Accountable for the provision of Manufacturing and Quality applications and supporting processes that meet the strategic needs of the Manufacturing and Quality business function. This includes accountability for the Operational support and maintenance strategies and implementation of those strategies. Operations shall ensure: the planning and prioritization of system enhancements; change and release management; maintenance management; and appropriately resourced support (skills and availability) to meet the needs of a global customer base.
The Manufacturing and Quality Applications, include but are not limited to the following:
• Laboratory Information Management Systems (e.g. Labware, Sample Manager).
• Scientific Data Management Systems (e.g. NuGenesis)
• Quality Systems (e.g. Trackwise, Smartsolve and Learning Management Systems e.g. Plateau)
2. Partners closely with key Manufacturing and Quality Business stakeholders, the global IT Leadership Team, and Enterprise Architecture to ensure the development of the Manufacturing & Quality Applications strategic roadmap. The application roadmap will incorporate and consider Business input regarding Manufacturing & Quality strategy, required functionality that is aligned with the business strategy, and technology standards.
3. Ensure that team members (including temporary staff) are trained and comply with the appropriate regulatory guidelines (e.g. cGMP), and conduct their work according to IT policies and procedures, including the IT Quality Management System.
4. Responsible for the human resource development of the IT Manufacturing and Quality team. Human resource development shall include skills and competency assessments, development and career planning, coaching, and performance monitoring and appraisal on a continual basis.
5. Responsible for resource management to ensure that appropriate resources are planned and assigned to Operations and Projects to meet the support and strategic needs of the Business. This involves assessing operational and project requirements and estimating the resources necessary to accomplish specific operational or project activities; projecting the availability of application resources for project activities (supply) and, in conjunction with the IT planning group, assigning resources to projects as indicated in the IT Project Portfolio (demand). In the case of a shared resource (i.e. assigned to different applications or application groups) coordination with other managers is required to ensure availability and maximize utilization. This includes the provision of appropriate Subject Matter Experts to support Regulatory Authority inspections as needed.
6. Responsible for supporting the gathering and assessment of Business demands on a continual basis. This involves assisting the Business to identify opportunities for ITinvestment that are aligned with IT Strategy and helping the Manufacturing and Quality customer to develop supporting business cases; ensuring the demand gathering activities are conducted in coordination with the IT Business Liaison; and following the demand gathering process and schedule that is coordinated by the IT Planning team.
7. Provide oversight and direction in Steering Committees, as required, to ensure project scope, cost, schedule, delivery, and quality adhere to the strategic needs of CSL. Provide leadership and oversight of project roles undertaken by the IT Manufacturing and Quality team.
8. Maintain a working knowledge of functionally relevant applications. The functionally relevant applications includes the Manufacturing and Quality applications in use within CSL , understanding key integration points to other systems and other standard business applications (e.g SAP, BPCS) and also the current technologies and best practices related to the Manufacturing and Quality functional area, in general. Provide technical and process leadership, propose and assess design solutions, evaluate vendor technology and consider industry trends and future requirements as defined in the application roadmap.
9. Manage the local site operational budget (OPEX) as Cost Centre owner. Budget management is conducted according to the Bern site annual budgeting process, involving periodic forecasting activities, on-going expense management (ensuring compliance with delegation of authority limits), and project cost tracking and capital recovery process as appropriate. As necessary, provide assistance with capital expenditure proposals and cost estimates for IT projects. Allow for IT Functional operational costs (outside of IT Manufacturing and Quality) as identified by otherIT Functional managers.
10. Responsible for fulfilling the role of IT Supplier Relationship Manager (IT SRM) as defined by Global Sourcing. This involves managing vendor relationships of the identified business critical suppliers and may include negotiation and selection activities, establishing Service Level Agreements (SLAs), monitoring and reviewing performance and contract management.
11. Accountable for fulfilling the duties of System Owner for the Manufacturing and Quality applications and ensuring that application information is captured and is current, in accordance with the IT Quality Management System. System Owner accountability includes management of information regarding: configuration, licenses, GxP relevance and Validation status. ; and ensuring that applications are maintained as ‘inspection ready’.
12. Accountable for ensuring that the Manufacturing and Quality applications are maintained as ‘inspection ready’ and to support periodic and adhoc audits conducted by Regulatory Authorities and other third parties (e.g. PWC, E&Y). This may involve the investigation, coordination and delivery of appropriate actions in response to audit results.
BS/MS or equivalent, preferably in IT, science or engineering. MBA desirable.
Min. 10 years experience working within IT in a leadership role including global team leadership experience.
Demonstrates strong skills in the areas of
Demonstrates ability to strongly uphold CSL Core Values of innovation, superior performance, collaboration, customer focus and integrity.
Strong skills in the areas of Project Management, Requirements Gathering and Testing & Validation, and Presentation delivery