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IT Project Quality Manager/ Business analyst -CSV

Company: Infosys
Location: Basking Ridge
Posted on: June 23, 2022

Job Description:

Infosys Limited's Domain Consulting Group is seeking a CSV Business analyst professional with Pharma/med device experience. As a Principal Consultant, you will be a key player in our Risk Management, Audit Services and Compliance Solutions practice. You will need to gain an understanding of an organization's objectives, regulatory and risk management environment, and the diverse needs of their critical stakeholders. You will be leading an entire account and assist with the overall management of the validation activities across multiple projects and geographies. You will also support knowledge transfer with the objective of providing value-adding consulting solutions that enable our clients to meet the changing needs of the global regulatory landscape.Required Qualifications:

  • Candidate must be located within commuting distance of New York/New Jersey/Connecticut/Massachusetts area or anywhere in East Coast or be willing to relocate to the area. This position may require travel within the US.
  • Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
  • At least 11 years of Information Technology experience.
  • Minimum 10+ years' experience in Computer Systems Validation, IT Regulatory Compliance area with Pharma/Med Devices clients
  • Experience in leading large Managed Validation Services with clients across geographies
  • Excellent knowledge of Sales and Marketing processes, systems and products and data in Global Pharmaceutical organizations
  • Knowledge of FDA 21 CFR Parts 211 and 820, Health Canada regulations, ISO 9001, ISO 13485 are required
  • Quality experience including regulatory inspections and IT Compliance Audit support is required
  • Knowledge of IT architecture and IT solution development in an FDA regulated environment
  • Experience in performing assessments to evaluate IT controls, security, SOD, and potential for optimization as well as implementation and/or configuration of ERP products
  • Have a broad understanding of the system architecture, data flow, and key financial and operational processes within a pharmaceutical, life sciences, CRO, or medical device organization.Preferred Qualifications:
    • Professional compliance certifications like CISA, CRISC, CISSP, ASQ, etc.
    • Knowledge of Agile/Scrum as required for Validation (Certifications like PSM, SAFe Scaled Agilist, PMI ACP would be an added advantage)
    • Project Management Skills
    • Understanding of Computer System Validation Processes as relevant to sales and marketing
    • Knowledge & Exposure to other areas of Pharmaceutical business areas would be an added advantage.The job entails sitting as well as working at a computer for extended periods of time. Should be able to communicate by telephone, email or face to face.

      About Us
      Infosys is a global leader in next-generation digital services and consulting. We enable clients in 50 countries to navigate their digital transformation.
      With over three decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.

      To learn more about Infosys and see our ideas in action please visit us at

      EOE/Minority/Female/Veteran/Disabled/Sexual Orientation/Gender Identity/National Origin

Keywords: Infosys, Newark , IT Project Quality Manager/ Business analyst -CSV, Professions , Basking Ridge, New Jersey

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