Job Description :
Role : Compliance TrackWise Business Analyst, Information Technology Quality
Rate: $55/hr
USC,GC,EAD-GC or H1B
Location: Durham, NC
Duration: 6+ Months
Overview :
Senior Business Analyst (BA) to deliver high-quality requirements in a project. This Senior BA will follow Biogen PO&T IT methodologies for project governance, leverage BA tools & techniques to capture business and functional requirements, and use approved corporate documentation templates for SDLC documentation. Projects span the Quality Assurance, Quality Control and Patient Services applications. The focus of the position is, but not limited to, the day to day management of, and the long strategy for the TrackWise application.
The individual will :
Work in a team and serve as tactical IT liaison to the business through building and fostering a partnership.
Demonstrate strong understanding of the business area and its supporting technology as well as broad understanding of overall business unit.
Ensure solution delivery meets business needs and expectations through business requirements gathering process.
Gather and validate business needs to translate into requirements for technical team.
Work with technical teams to develop technical requirements and solutions.
Is accountable for projects throughout entire lifecycle; depending on scale and complexity may need input or guidance on critical decisions.
Be proactive in identifying solutions or opportunities that can help improve Business processes.
Be point of contact for business focused application questions and be able to identify and leverage resources across IT.
Model and enhance business process diagrams and other related models to capture business operations change requirements within defined opportunities or projects, modeling both current and future state.
Document or map business processes targeted for change via approved projects, both current and future state. Determine and document the impact of process changes for the process owner.
Define the needed business cases with project team and process owner, defining business outcomes, including current baseline and future target metrics, such as leading and lagging indicators, and linking to strategic key performance indicators (KPIs Document business requirements for system enhancements and collaborate with IT to ensure effective development and testing needed for successful solution deployment.
Business partnership and technology expertise
The ideal candidate will have demonstrated experience in laboratory, quality, and business process and systems leadership as it relates to compliance with regulatory and corporate expectations and guidelines.
The ideal candidate will be able to demonstrate a successful track record of assessing systems against corporate and regulatory requirements and driving change to ensure compliance in a GxP environment.
The ideal candidate will possess a fundamental understanding of the TrackWise application, hardware, and supported processes utilized in a GxP biopharmaceutical company.
The ideal candidate will be able to demonstrate a successful track record developing processes, SOP’s, systems to support applications and equipment in a GxP environment.
Provide recommendations to address and resolve business issues, improve business processes and leverage opportunities.
Demonstrate strong understanding of data integrity, quality, and change management processes in a GxP, regulated environment.
Strong understanding of the Quality, Mfg, Regulatory and/or Supply Chain business areas and their supporting technology as well as broad understanding of overall business units a plus.
Be point of contact for business focused application questions and be able to identify and leverage resources across IT.
Impact :
In collaboration with the business customer, utilizes broad business knowledge to proactively search for strategic technological solutions.
Exerts some influence on the overall objectives and long-range goals of the business area.
Builds and manages peer and management-level business relationship through achievement of results, accountable to schedule, and allocation of resources and meeting customer needs.
Scope :
Collaborates cross functionally to driver initiatives to a successful conclusion.
Decision Making :
Identifies and recommends process improvements.
Demonstrates ability to identify issues, independently resolves routine issues, escalates more complex issues to a higher level.
Knowledge :
In depth knowledge of business functional area with strong understanding of business unit (Or if new to business area, shows strong learning agility to achieve in depth knowledge
Understands the technology offerings applicable to the business when assisting in the design of solutions.
Has knowledge of and utilizes software lifecycle methodologies.
Qualifications Minimum Requirements:
B.S. degree (in science, engineering or business), with related business discipline experience. M.B.A. or other advanced degree in business or social sciences is a plus.
Multiple years of process improvement experience (depending on skill level — more time for advanced skills and commensurate salary), especially experience that leverages technology as part of the solution.
Hands-on experience with process modeling, analysis and simulation tools.
Experience working on projects using a variety of process redesign methods (such as business process re-engineering, value chain analysis, Lean Six Sigma or total quality management
Track record of working on projects that delivered different types of business outcomes: revenue growth and customer satisfaction, for example, not just process efficiency or cost reduction.
Manufacturing experience with knowledge of GMPs, GDPs.
Good interpersonal, verbal and written communication, including good presentations.
Strong analytical and conceptual skills.
More interested in business results than personal preferences, and in group rather than individual achievement.
Ability to work within high-performing virtual teams and highly collaborative.
Builds excellent relationships with key internal and external customers based on trust and confidence.
Minimum travel both domestically and internationally.
Supplement the Vendor management team focused on driving value and mitigating risk in vendor contracts and relationships.
Execute best practices and processes for managing technology suppliers and vendors, with focus on performance of Hardware, Software and Software as a Service provider.
Work with IT and business partners to identify licensing and contract structure options, negotiate and support agreement execution against strict timelines.
Support vendor lifecycle activities as required – renewals, cost optimizations, growth.
Identify opportunities to optimize vendor execution and relationships in support of organizational goals.