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Regulatory Business Analyst/Life Sciences with QMS platforms Complaint Mgt.

Company: InfoWays
Location: Jersey City
Posted on: November 19, 2020

Job Description:

Business Analyst (from Life Sciences) Beginning to end of global project (Shaping to implementation) Coordinate with business lead to shape project demand, conduct processdatatechnical assessments, coordinate with IT teams on solutions, costs, design, delivery. Quality, CAPA, Complaint processes QMS platforms Complaint Mgt TrackWise Regulatory experience 10-15 Year experience in Life Sciences Industry in Quality function with expertise in QMS platforms such as TrackWise Serve as a point person and will work with a team of business partners to conduct analysis, prepare appropriate solution direction, and deliver the work. Collaborate with internal and external experts to ensure that business priorities are shaped, prioritized, and delivered. Reports to Lead Business Partner, Quality. Develop a deep knowledge of the Quality Function, including key driver goals, short- and long-term roadmaps, key projects, and personnel Identify and define new opportunities to leverage technology andor process re-design to advance business strategies that directly contribute to driving revenue growth, cost optimization andor risk mitigation and compliance. Work with other IT business partner teams and external partner teams to define, document, analyze and prioritize existing and emerging business requirements Complete the projectsimprovementsdeliverables needed to implement technology, processes, or services to meet business requirements including the documentation, testing and implementation Execute projects and report progress, including consistent and effective communication, change management impact analysis, readiness and effectiveness, cutover and go-live support. This includes managing escalation and mitigating risk Measure and communicate value realized on a periodic basis through defined and agreed upon metrics and supporting analysis QUALIFICATIONS EXPERIENCE 10-15 years of experience in a business including work in a technology function with focus in Quality Experience delivering technology and workplace solutions in a Medical Device or Pharmaceutical regulated environment with solid knowledge of relevant QualityRegulatory standards (i.e. cGxP, CFR Part 11, etc.) Must be a leader who can influence stakeholders in written and oral communications EDUCATION Bachelorrsquos degree in technology, business or a related field is strongly preferred. Masterrsquos degree highly desirable. Educational certificate or training in a process methodology is a plus.

Keywords: InfoWays, Jersey City , Regulatory Business Analyst/Life Sciences with QMS platforms Complaint Mgt., Other , Jersey City, New Jersey

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