Specialist, Product Analyst- Quality

Overview

Specialist, Product Analyst – Quality drives solution design, implementation and continuous improvement of QMS tools, aligned to Quality business processes, with a focus on Veeva Vault Quality.

What you'll do

• Apply a structured approach to discover, document and manage business process, user and stakeholder needs, including opportunity statements, use cases, insights and requirements.
• Gather insight into user journey, behavior, motivation and pain points, and expose unarticulated problems and unmet needs.
• Document business process, business and user needs as problem statements to make up the backlog.
• Facilitate the "how" with the Development team and gain expertise in the business area.
• Manage business analysis per agreed priority backlog items in JIRA.
• Participate in impact assessment activities, review proposed changes and ensure impact is understood.
• Deliver product enhancements through the agreed backlog process so Quality solutions evolve 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, identifying stakeholders and establishing governance.
• Act as a bridge between Business SMEs, technical teams and non-technical stakeholders, communicating delivery status, solution health, risks and issues.
• Conduct product status meetings and present updates to stakeholders and senior management.
• Evaluate delivery performance and implement continuous improvement practices.
• Understand technical aspects and business process impacts to make informed decisions, including the QMS business processes, technology stack, architecture and potential technical challenges.
• Work closely with the Product Owner to prioritize and refine the product backlog.
• Identify potential risks, develop mitigation strategies and proactively address issues that could impact project success.

What you'll need

• Bachelor's Degree in Computer Science, Engineering, MIS, or Science, or in a related field.
• 3+ 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 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 such as Veeva Vault Quality and TrackWise.
• Proven experience 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.

Nice to have

• Veeva certifications (Veeva Vault, Vault Quality Suite, QMS), with completed Certified Vault Training kept up to date.

Details

• Location: Hyderabad, India (Hitec City Raidurg).
• Flexible work arrangement: Hybrid.
• Employee status: Regular.