Systems, Engineer IV - eQMS DD&T

Overview

Lead the eQMS (electronic Quality Management System) product for DD&T, owning the product vision, roadmap, budget and day-to-day operations of Veeva Vault QMS and related quality applications across global GxP environments.

What you'll do

• Provide Veeva Vault QMS technical leadership for Deviation, CAPA, Change Control and Complaints across global, multi-site GxP environments.
• Own GxP/CSV validation strategy and execution for SaaS quality platforms (21 CFR Part 11, EU Annex 11, data integrity/ALCOA+, audit and inspection readiness).
• Oversee and manage product budgets, including invoices from service providers, CAPEX, prepaid OPEX and OPEX within the eQMS domain, global purchasing (PLAY requests and SoW negotiations), SPOT application management and yearly MRP management.
• Engage and align business stakeholders and DD&T on current plans, strategies and future opportunities, providing product recommendations to build a pipeline of meaningful releases.
• Develop and communicate the product vision, strategy and roadmap for eQMS, aligning key stakeholder capability and feature needs.
• Lead and manage the product life cycle, translating pipeline products into agile development projects and working with development teams on new releases.
• Own end-to-end solution engineering and release, from requirements through process/design authority, configuration/build, test/UAT oversight, deployment and hypercare.
• Drive advanced workflow and lifecycle design and optimization, including routing, approval matrices, e-signature steps, timers/SLAs, escalations and exception handling.
• Oversee integration architecture and delivery for interfaces, including API/middleware coordination and data integrity controls.
• Govern platform administration and configuration, including object/field model, forms/templates, controlled vocabularies, security/roles, audit trails, e-signatures and configuration standards.
• Lead regulated SDLC and change control, including impact assessments, release documentation, controlled deployments, validated-state maintenance and periodic review support.
• Prioritize the product backlog to keep agile teams unblocked and aligned, and lead research to identify articulated and non-articulated product needs.
• Monitor product portfolios and business composition, adjusting roadmaps to optimize performance and effectiveness, and own sustainability of the end-to-end customer experience.
• Estimate workload and timelines for multiple professionals and monitor capacity to deliver the most value to product users.
• Oversee daily operations of technical support services, including applications, analytics and device management.
• Lead major incident and problem management for quality-critical services, including severity triage, RCA facilitation, CAPA ownership/support, vendor escalation and on-call readiness.
• Review performance and operational metrics to recommend architecture and automation improvements, and assess and manage operational risk and policy compliance.
• Manage IT vendors and service level agreements (SLAs and SoWs), addressing complaints and enhancing code quality.
• Plan and prioritize application maintenance and updates with minimal service disruption, and provide onboarding and training for L1/L2/L3 support teams, including external service providers.
• Manage senior stakeholder relationships and enablement across QA process owners, site SMEs, IT and vendors, including training strategy, adoption metrics and continuous improvement roadmap.
• Apply strong financial acumen to vendor contracts, payments and financial oversight.

What you'll need

• Bachelor's degree or equivalent in a scientific discipline, computer science or business administration.
• 5 years or more of relevant professional experience in research or development business lines, IT service delivery or a related area.
• Professional in-depth knowledge of product management in the pharmaceutical industry.
• Experience in stakeholder relationship management.
• Influential in orchestrating key stakeholders and product teams to turn product vision into reality.
• Excellent oral and written communication skills, business acumen and enterprise knowledge.
• Extensive experience in design or in implementing solutions or products, and preferably experience in quality improvement.
• Understanding of design thinking, with the ability to explain and convince stakeholders.
• Experience working with virtual/agile teams in different locations, aligning different work, culture and communication styles.
• Detailed knowledge of internal finance and planning applications: PLAY, DAS, SPOT, Apptio, etc.
• Advanced proficiency in Microsoft Office 365, Active Directory, Mac OS, Microsoft Windows 10, Information Technology Infrastructure Library, Local Area Networks, Wide Area Networks and issue tracking.

Nice to have

• Master's degree.
• Experience in managing people.
• Experience with regulated systems, with a good level of understanding of system validation.
• Experience in Agile Scrum delivery.
• Accomplished practitioner of design thinking, with a proven track record of developing and exploiting deep customer insights.
• Experience with the design and development of pharmaceutical life science products.
• Ability to think counterproductively and out of the box and convince stakeholders.

Details

• Location: Bangalore, India (Bengaluru).
• Full-time, regular employee position.
• Management level D2; reports to the eQMS DD&T Lead.
• Travel required up to 5%, domestic and international.
• Geographic scope: Global.