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Job: TrackWise Application Lead, Seqirus, Holly Springs, NC
TrackWise Application Lead
Holly Springs, NC 27539 United States
Built on 100 years of experience in influenza, Seqirus is a new global company with an exciting future. It was created in 2015 when parent company CSL Limited acquired the Novartis Influenza Vaccine business and combined it with its own longstanding influenza vaccine operations. Seqirus is currently the world’s second largest influenza vaccine company and a major partner in the prevention and control of influenza globally. It is a reliable supplier of influenza vaccine for Northern and Southern Hemisphere markets and a transcontinental partner in pandemic preparedness and response.
Seqirus operates state-of-the-art production facilities in the US, UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and commercial operations in more than 20 countries. In Australia and the Asia Pacific region, Seqirus is a leading provider of in-licensed vaccines and specialty pharmaceuticals. It also manufactures and markets diagnostics for immunhaemotology laboratories and is the sole supplier of a unique range of products made in the national interest for the Australian Government, including antivenoms and Q fever vaccine. Seqirus’ parent company CSL is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovative medicines. It operates in over 30 countries with more than 16,000 employees.
This is role is in the Seqirus IT organization to support all of the Global IT activities and operations associated with the TrackWise application. Key responsibilities include support for the TrackWise application and planning/resource management to support key business projects. This individual will apply proven communication and problem-solving skills to guide and assist the business on opportunities and issues related to the design, development, and deployment of TrackWise Quality Systems.
• Participate in the creation and implementation of global IT TrackWise Quality Systems that are aligned with corporate business strategy and develop strategic application roadmaps to support the strategic direction.
• Work closely with business functional units to identify and agree future TrackWise Business needs
• Contribute to application roadmaps that are aligned to both function and business goals
• Work with business units and IT to streamline TrackWise application landscape, reducing local point solutions
• Support change through effective project delivery. Define requirements, present business cases, deliver global IT projects to expectations and a strong commercial focus.
• Align closely with business colleagues to define and priorities TrackWise application requirements
• Define and deliver practical, workable, pragmatic and cost-effective TrackWise solutions to stakeholders’ business requirements.
• Ensure all application documentation is kept up to date, safely stored, appropriately secured and organised
• Management and development of TrackWise System, delivering continuous improvement for the organisation. Regularly and critically review processes and procedures with a view to improving quality, simplicity, efficiency and/or effectiveness across all areas of responsibility and the business.
• Ensure TrackWise System is available for business use according to agreed SLA
• Manage 3rd party and vendor resources as required for application support
• Ensure TrackWise system and application data have complete and proven recovery mechanisms (backups/restore/archival)
• Ensure systems have an appropriate level of resilience depending on its business use
• Apply appropriate best practice to all aspects of IT service delivery, in line with Seqirus standards
• Bachelor’s Degree in Computer Science, Information Systems, Business Administration, or other related field.
• Minimum 5 years’ experience in a similar role.
• Experience working in pharmaceutical / biotech industry
• Experience of a highly regulated IT environment or good documentation culture, including formal change management processes.
Preferred / Desired Experience:
• Specific application experience relevant to the Quality business domain and their associated processes; such as Quality Compliance Management systems, including Change Management, Audit Management, Product Technical Complaints, CAPA and Deviation Management (Preferred: TrackWise)
• Technical Knowledge specific to this IT functional area such as GAMP, GxP, EMA and FDA regulations (including 21 CFR Part 11)
• Technical knowledge of integrating and operating Enterprise Applications architectures such as SAP and LIMS
• Biotech industry experience and GAMP training / qualifications.
• Operating with outsourced service providers in an international context
• Practical experience of FDA / MHRA audits
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