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Job: IT Systems Business Analyst, Seqirus, Holly Springs, NC


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General Information

(3665026)

Job title: IT Systems Business Analyst
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Job location: Holly Springs, NC  27539 United States
Requisition code: R-051128
Date posted: 10/06/2017
Compensation:
Job category:IT
Employment type:Full time
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Job Description


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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.



Overview:
The purpose of the IT Applications Specialist role is to maintain and support all applications installed in the local Data Centre (system owner) and provide technical escalation, where required to the global support team. Key responsibilities include technical support of local applications for Manufacturing and Lab operations, providing support to projects as required, working with the global applications team to ensure alignment to the application frame works and ensuring the systems are maintained in line with the IT Quality Management System (IT QMS). This individual will apply proven technical, communication and problem-solving skills to maintain and support the local (regional) systems.

Accountabilities:
Participate in the creation and implementation of local IT Application Strategies that are aligned with global application strategy and provide input on application roadmaps to support the strategic direction.

• Work closely with business functional leadership to identify and agree future needs
• Produce clear coherent application roadmaps that are aligned to both function and business goals.
• Work with QC and Quality business units and IT to streamline application landscape, reducing local point solutions

Drive and 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 application requirements
• Define and deliver practical, workable, pragmatic and cost-effective application solutions to stakeholders’ business requirements.
• Manage all projects using the approved lifecycle with controls and documentation as defined by the PMO.
• Transition all projects to live with a smooth and methodical cut-over (with a rollback plan in place).
• Ensure all application documentation is kept up to date, safely stored, appropriately secured and organised

Management and development of all local applications, 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 all local applications are available for business use according to agreed SLA
• Manage 3rd party and vendor resources as required for application support
• Ensure systems 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.
• Ensure systems performance and capacity is (at least) adequate for the business needs.
• Ensure systems comply with defined global standards, the group IT security policy, IT business continuity plan and quality management framework.
• Apply appropriate best practice to all aspects of IT service delivery, in line with Seqirus standards
• Be the technical SME in relation to the local applications
Drive and 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 application requirements
• Define and deliver practical, workable, pragmatic and cost-effective application solutions to stakeholders’ business requirements.
• Working with the Project Managers, manage all projects using the approved lifecycle with controls and documentation as defined by the PMO.
• Transition all projects to live with a smooth and methodical cut-over (with a rollback plan in place).
• Ensure all application documentation is kept up to date, safely stored, appropriately secured and organised
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Job Requirements


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Requirements:

Essential:
• Bachelor’s or Master’s Degree in Computer Science, Information Systems, Business Administration, or other related field or equivalent practical experience.
• Experience working in pharmaceutical / biotech industry
• Experience of project management methodologies (such as PRINCE 2 or PMI)
• Experience of a highly regulated IT environment or good documentation culture, including formal change management processes.
• Broad understanding of technical application/system support

Technical Knowledge specific to this IT functional area includes:
• Quality business process knowledge
• GAMP, GxP, EMA and FDA regulations (including 21 CFR Part 11)

Preferred / Desired:
• Technical knowledge of integrating and operating Enterprise Applications architectures
• Biotech industry experience and GAMP training / qualifications.
• Operating with outsourced service providers in an international context
• Practical experience of FDA / MHRA audits
• R&D systems knowledge
• Laboratory Information Management systems (Preferred: Labware)
• Scientific Data Management/Instrument Management, HPLC Management systems
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