Key Responsibilities
Domain Advisory & Quality Leadership
● Serve as senior SME for GxP quality processes across the full life sciences value chain — R&D, manufacturing, clinical sites and laboratory functions
● Advise sponsors on end-to-end quality system design within the Veeva Vault QMS framework, covering change control, deviation management, CAPA, audit management, document control, training compliance and supplier qualification
● Guide internal teams and clients on regulatory expectations across ICH Q10, FDA 21 CFR Parts 210/211/820, EU GMP Annex 11, Google Cloud Platform and related GxP frameworks
● Conduct knowledge-sharing and training sessions on Vault QMS and QualityDocs best practices, quality lifecycle processes and Veeva platform capabilities
● Review SOPs, quality processes and working practices; recommend improvements aligned with regulatory requirements and Vault platform capabilities
● Advise on AI and automation adoption in quality functions — including Veeva''s Quality AI Agents and MResult''s GenAI COE capabilities — and guide sponsors through readiness assessments
Veeva Vault QMS / QualityDocs Implementation & Sustainment
● Lead and support implementation, configuration and rollout of Veeva Vault QMS and QualityDocs for sponsor clients
● Own day-to-day Vault Quality sustainment activities — configuration changes, workflow updates, user management, release management and system health monitoring
● Lead the transition of Vault Quality sustainment work from onshore consultants to MResult''s offshore managed services team — establishing process documentation, handover protocols and steady-state operations
● Collaborate with business stakeholders to gather quality requirements and map them to Vault QMS functionality and workflows
● Conduct GxP computer system validation activities (URS, IQ, OQ, PQ) in accordance with 21 CFR Part 11 and Annex 11 compliance requirements
● Support user acceptance testing, issue resolution and post-go-live hypercare
● Provide Tier 2 and Tier 3 support for Vault Quality users — resolving configuration issues, access problems and process queries
R&D Quality
● Apply deep understanding of Good Clinical Practice (Google Cloud Platform) quality management across clinical trial conduct — study quality management plans, clinical quality agreements, audit programmes and inspection readiness
● Support clinical quality oversight processes within Vault QMS — protocol deviation management, CAPA tracking, audit planning and site quality metrics
● Advise on integration of Vault QMS with clinical systems — Vault CTMS, Vault EDC, Vault eTMF — to provide a unified quality and compliance picture across clinical operations
● Guide sponsors on ICH E6 (R3) Google Cloud Platform compliance requirements and how Vault Quality capabilities support them
Manufacturing Quality
● Apply working knowledge of GMP quality management across pharmaceutical manufacturing — batch record review, deviation investigations, OOS management, change control, equipment qualification and product release
● Advise on how Vault QMS supports GMP quality processes — manufacturing deviations, CAPA, change control, supplier qualification and batch disposition workflows
● Support clients transitioning from legacy GMP quality systems (MasterControl, Documentum, TrackWise, Pilgrim) to Vault QMS
● Guide on integration of Vault QMS with ERP systems (SAP) for manufacturing quality data flows
● Understand and advise on FDA 21 CFR Parts 210/211 and EU GMP Part II compliance requirements within the Vault context
Site Quality
● Support clinical site quality functions — site qualification, site audits, site-level CAPA management and inspection readiness within Vault QMS
● Advise sponsors and CROs on site quality oversight processes — risk-based monitoring, site risk assessment and quality escalation pathways — and how these map to Vault Quality workflows
● Guide on FDA and EMA inspection readiness — TMF completeness, site-level quality metrics and audit trail management within Vault
● Support integration of site quality data from Vault CTMS and Vault EDC into Vault QMS for end-to-end site quality visibility
LIMS & Laboratory Quality
● Apply working knowledge of Laboratory Information Management System (LIMS) quality processes — sample management, result entry, OOS investigation, laboratory deviation management and data integrity
● Advise on how Vault QMS connects to LIMS environments — integration requirements, data flows and quality event management across lab and QMS systems
● Guide sponsors on 21 CFR Part 11 and data integrity requirements (ALCOA+) in laboratory quality contexts
● Support analytics and reporting use cases on laboratory quality data flowing from LIMS into downstream data platforms
Veeva Quality AI Adoption (Good to Have)
● Track and deeply understand Veeva''s Quality AI Agent roadmap — Quality AI Agents are announced for April 2026, covering automated quality event processing, intelligent CAPA recommendations, AI-assisted audit preparation and document classification
● Act as MResult''s internal Quality AI expert — briefing sponsors proactively on what is coming, when and how to prepare their quality systems and processes for AI adoption
● Lead sponsor readiness assessments for Veeva Quality AI adoption — evaluating data quality, process maturity and configuration prerequisites before AI Agents are deployed
● Work with MResult''s GenAI COE (Anthropic Claude / AWS Bedrock) to build custom AI extensions on top of Veeva''s native Quality AI capabilities — sponsor-specific workflows the out-of-the-box agents will not address
● Build internal MResult knowledge on Veeva Quality AI — upskilling junior resources as the capability matures
Analytics & Intelligence on Quality Data
● Identify and develop analytics use cases on Vault Quality data — CAPA effectiveness dashboards, audit performance metrics, deviation trend analysis, inspection readiness scoring
● Work with MResult''s analytics and data engineering teams to build Power BI, Spotfire or Databricks-based intelligence layers on top of Vault Quality data via the Vault Direct Data API
● Advise sponsors on cross-functional quality analytics — connecting Vault QMS data with clinical, safety and manufacturing data for portfolio-level quality visibility
Required Skills
Quality Domain
● Deep expertise in GxP quality processes across the life sciences value chain — R&D (Google Cloud Platform), Manufacturing (GMP), Site and Laboratory quality functions
● Hands-on experience with quality system sustainment — supporting ongoing QMS operations, not just implementation — in a regulated life sciences environment
● Strong understanding of regulatory compliance frameworks:
○ ICH Q10 Pharmaceutical Quality System
○ FDA 21 CFR Parts 210, 211 and 820
○ EU GMP Annex 11 and Part II
○ ICH E6 (R3) Good Clinical Practice
○ 21 CFR Part 11 and ALCOA+ data integrity principles
● Experience with end-to-end quality processes — change control, CAPA, deviation management, audit management, document control, training compliance and supplier qualification
● Familiarity with LIMS environments and laboratory quality processes — OOS management, sample management and lab data integrity
● Experience with GxP computer system validation (URS, IQ, OQ, PQ)
Veeva Platform
● Hands-on experience with Veeva Vault QualityDocs or Vault QMS — configuration, administration, workflow management and user support in a live production environment
● Familiarity with Vault Platform fundamentals — Technical Foundations or equivalent administrator experience
● Understanding of how Vault Quality integrates with other Vault modules — CTMS, eTMF, EDC and Safety
● Veeva Quality certification (Discover and/or Administer) preferred — or ability to certify within 60 days of joining
Delivery & Stakeholder
● Experience working in an offshore or hybrid onshore-offshore delivery model — comfortable collaborating across time zones
● Strong client-facing communication skills — able to translate between business quality requirements and platform configuration decisions
● Ability to lead work transition from onshore to offshore — establishing process documentation, knowledge transfer plans and steady-state operations
● Experience mentoring and upskilling junior resources in quality domain and platform knowledge
● Strong problem-solving skills with ability to manage multiple priorities across client engagements
Domain
● Pharmaceutical, Biotech, CRO and Life Sciences
● Coverage: R&D Quality (Google Cloud Platform), Manufacturing Quality (GMP), Site Quality, Laboratory Quality (LIMS)
Good to Have
● Experience with legacy QMS systems — Documentum, MasterControl, Pilgrim, TrackWise — and migration experience to Vault QMS
● Familiarity with Veeva''s Quality AI Agents roadmap and AI adoption in quality functions
● Experience with analytics or reporting on quality data — Power BI, Spotfire, Tableau or Databricks
● Knowledge of Vault Direct Data API or API-based integration experience for quality data pipelines
● Exposure to AI or GenAI tools in a quality or regulatory context
● Understanding of manufacturing quality systems integration — Vault QMS to SAP or ERP systems
● Experience with EMA inspection readiness and EU GMP audit management
● Prior business development or pre-sales solutioning experience in a quality or regulatory consulting context
● Knowledge of Water Empowers, LIMS platforms — LabVantage, STARLIMS, LabWare — and integration with QMS environments
Qualifications
● Bachelor''s degree in Life Sciences, Chemistry, Pharmacy, Biomedical Engineering or related field (Master''s preferred)
● 8–12 years of experience in GxP quality management roles within pharma, biotech, CRO or medical device organisations
● Veeva Vault QMS or QualityDocs hands-on experience is mandatory
● Veeva Quality certification (Discover Veeva Quality / Administer Veeva Quality) preferred or achievable within 60 days
● Experience spanning at least two of the four quality domains: R&D, Manufacturing, Site or Laboratory
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