Job Description :
Hi,
Position: Compliance TrackWise Business Analyst
Duration: 6 + Months Contract
Location: Boston MA


Required Skills :
We are looking for a Senior BA / SME / Domain consultant with good experience in the Quality Systems preferably Sparta Track wise, Metric Stream etc with 15+ years of experience.

Help to source very strong profile for the below JD.

Job Description:

Compliance TrackWise Business Analyst, Information Technology Quality Overview Senior Business Analyst (BA) to deliver high-quality requirements in a project.
This Senior BA will follow Agile 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. 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:
*Experience working in the Life Sciences domain specifically in Quality and regulatory space. Have worked for major Pharmacy and Medical Device clients
*Knowledge of GxP operations: Change Management, Audit Management (both GMP and Regulatory Compliance), Incident Management, Corrective and Preventive Action (CAPA)
* 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.
* 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.
* 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.
* Provide recommendations to address and resolve business issues, improve business processes and leverage opportunities.
* 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.
* 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
* Execute best practices and processes for managing technology suppliers and vendors, with focus on performance of Hardware, Software and Software as a Service provider
             

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