Senior Manager Product Analyst - Quality

7 - 10 years

9 - 12 Lacs

Posted:3 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Applies a structured approach to discover, document, and manage business process, user and stakeholder needs, including opportunity statements, use cases, insights, and requirements.
  • Design, develop, and deploy UiPath RPA solutions to automate Quality Management System processes including document routing, compliance reporting, deviation management, and audit preparation workflows.
  • Build and maintain low-code applications on the Appian platform to support Quality business processes, translating complex QMS requirements into process models, SAIL interfaces, CDTs, records, and reports.
  • Integrate Appian Quality solutions with external systems including Veeva Vault Quality, TrackWise, and enterprise databases via APIs, web services, and other integration methods.
  • Gathers insight into user journey, behavior, motivation, and pain points. Exposes unarticulated problems and unmet needs.
  • Documents business process, business, and user needs in the form of problem statements to make up the backlog. Facilitates the how with the Development team.
  • Gains expertise in the business area
  • Manage business analysis per agreed priority backlog items in JIRA.
  • Participate in impact assessment activities, reviewing proposed changes and ensuring impact understood.
  • Deliver product enhancements through agreed backlog process to ensure Quality solutions evolves to meet business needs
  • Ensure Quality solutions remain compliant as a Validated Solution through verification testing, documentation, and validation efforts
  • Provide overall leadership, guidance, and management of all aspects of a given solution, including requirements gathering, enhancements delivery plan and implementation.
  • Initiate projects including defining a scope/charter, identify stakeholders, and establish governance.
  • Act as a bridge between Business SMEs, technical teams and non-technical stakeholders. Communicate delivery status, solution health, risks, and issues to all parties involved and ensure that everyone is aligned and informed.
  • Conduct product status meetings and present updates to stakeholders and senior management. Evaluate delivery performance and implement continuous improvement practices.
  • Understand the technical aspects as well as business process impacts to make informed decisions, provide guidance, and communicate effectively with the development team. This includes having a deep understanding of the QMS business processes, technology stack, architecture, and potential technical challenges.
  • Work closely with the Product Owner to prioritize and refine the product backlog, ensuring that the team focuses on delivering the most valuable features.
  • Identify potential risks and develop mitigation strategies. Proactively address issues that could impact project success.
What Should you have:
  • Minimum Level of Education Required -Bachelor s Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background on how Information Technology supports the delivery of business objectives
  • Preferred Level of Education - Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date.
  • 7+ years of experience in technical project management, with a strong understanding of project management methodologies (Agile, Scrum, Waterfall).
  • Understanding of Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management)
  • Experience in solution delivery with GMP systems
  • Experience with UiPath RPA development including bot creation, workflow orchestration, exception handling, and deployment in GxP-regulated environments with validation documentation requirements.
  • Proficiency in Appian low-code platform development including process modeling, SAIL interface design, data integration with external databases (SQL, Oracle), and API connectivity for Quality system implementations.
  • Experience with architecture, integration, interfaces, portals, and/or analytics
  • Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes
  • Knowledge and experience with QMS relevant tools like Veeva Vault Quality, Track wise
  • Proven experience in leading complex technical projects in a fast-paced environment.
  • Strong technical background with knowledge of software development, systems integration, or related areas.
  • Excellent organizational, leadership, and decision-making skills.
  • Strong analytical and problem-solving abilities.
  • Effective communication and interpersonal skills to liaise with cross-functional teams.
  • Ability to manage multiple projects simultaneously and adapt to changing priorities.

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Merck Sharp & Dohme (MSD) logo
Merck Sharp & Dohme (MSD)

Pharmaceuticals

Kenilworth

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