Shire Regenerative Medicine's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
Responsible for Shire Regenerative Medicine global business process development and business systems integrations (both commercial and clinical) which includes business process design, execution, control and communication. Includes responsibility for Class 'A' assessments, business process improvements, and Operations Excellence processes and techniques.
Education and Experience Requirements
- Lead multiple, concurrent SRM efforts and Teams in the development, design, execution and articulation of robust SRM business processes, systems for Manufacturing, Supply Chain, Quality (QC, QA, Regulatory), Facility Services / Engineering and partner support Groups (Finance, HR, IT). Plays a key role to establish methods for managing the robust integration of these business systems and processes. Leads major initiatives or other special projects that span multiple business system communities.
- Provide leadership, coordination, direction and project management for the SRM 'Class A' Business Process Improvement initiatives including development of SRM business process gap analyses (current vs. future state); development of business process remediation activities; 'enterprise' coordination of stakeholders; creation of a 'quality' and 'right the first time' culture; proactive efforts to support collaboration and participation; facilitation and synchronization of inter-plant and inter-site group activities; efficient utilization of shared resources between plants and sites; recommend and implement end-to-end business process design and improvements. Support cross training by providing opportunities and information.
- Help embody the culture of Class 'A' into the SRM team. Use Class 'A' tools and develop SRM-specific process design artifacts (SIPOC, RACI, process flowcharts, value stream analyses). Recommend and improve operational metrics and SRM performance dashboards.
- Lead, guide, direct and provide expert knowledge on all SRM MES activities and projects. Assure effective systems, data and interfaces are developed / applied sufficient to install and operate a robust SRM Production MES tool.
- Perform all formal business process project management activities including creating project plan, subsidiary plans, budgets, and resource needs. Effectively coordinate resources with cross-functional teams and SRM Project Management to ensure key projects are is delivered within budget and timelines.
- Identify and execute robust synergies between multiple business processes, key projects and initiatives. Make information available for quality improvements and decision-making and enhance both procedural and process controls.
- Partner with all stakeholders to apply and teach Lean OE principles / techniques for operations improvement efforts.
- Develop effective collaborations for cross-functional communications, procedures and information sharing between business Groups necessary to implement and sustain fully integrated, multi-functional business processes. Develop and implement Service Level Agreements with key partners and customers.
- Install mechanisms for 'enterprise thinking' and robust 'end-to-end' process analysis.
- Analyze, recommend and execute integrations to internal information and batch reporting systems (QAD, LIMS, MES, SAP, and legacy) and to Shire Corporate systems sufficient to enable global information exchange. Represent SRM site interests and processes with Corporate initiatives.
- Help establish / improve product transfer business processes.
- Perform SRM activities when assigned such as system validation, revalidation, compliant change management, security access, maintenance of functionality, 24 hour system support, and all other responsibilities as required for efficient production operations and as outlined in relevant Standard Operating Procedures (SOP's).
- Develop and communicate future business process design strategy and direction for SRM plants and CMO operations.
- Act as standing member of relevant / assigned cross-functional Teams.
- Stays abreast of internal and external business developments, opportunities and challenges as to their potential influence and impact on the relevant line functions and associated business systems.
Shire is an Equal Opportunity and Affirmative Action Employer.
- Minimum BS / BA degree (Informatics, life sciences, engineering, business or finance disciplines preferred)
- 10 or more years' professional experience working with Business Systems and Information Technology gained within the biotechnology / pharmaceutical industry (manufacturing, supply chain, strategic planning, project and process management). Multidisciplinary experience strongly preferred.
- Heavy technical experience / training in industry standard business systems (ERP / SAP / QAD, MES, DCS, LIMS, EDMS / Trackwise, WMS).
- 6 or more years' heavy people management experience. Has proven abilities to effectively lead, organize and prioritize work of others.
- Experience in Oliver Wight Class 'A' Assessment process.
- Experience and / or certifications in Lean/Six Sigma / Operations Excellence.
- Has a successful, overall performance record to meet or exceed quantitative and qualitative goals and targets. Demonstration of sound business judgment and effective decisions.
Shire plc (Shire) is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its...