Veeva Quality Lead

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