Senior Master Data Management (MDM) & Data Governance Consultant

Job Title

Senior Master Data Management (MDM) & Data Governance Consultant – Life Sciences (GxP)

Engagement Overview

We are seeking a senior individual consultant to lead and deliver the Master Data Management (MDM) and Data Governance program for a regulated greenfield manufacturing site in the Life Sciences sector.
The site will serve as a template for future global deployments, in a context where no enterprise-wide data standards currently exist.

The consultant will be accountable for strategy, governance design, data standards, data models, and implementation enablement, working closely with IT, Quality, and Business stakeholders.
The engagement is fixed-price, with a strong on-site presence expected, supported by remote work where appropriate.

Key Objectives

• Define and implement a site-level Master Data Governance operating model
• Establish data standards, ownership, and stewardship for critical systems
• Enable regulatory-compliant data integrity (FDA, EMA, PMDA)
• Support Azure Integration Services–based data interfaces between critical systems
• Deliver a scalable MDM template reusable for future sites

Scope of Responsibilities

1. MDM Strategy & Operating Model

• Define MDM vision, scope, principles, and success metrics
• Identify in-scope master data domains and Critical Data Elements (CDEs)
• Define Systems of Record, Reference, and data flows across ERP, QMS, LIMS, ELN, LES, MES, CMMS, VLMS
• Design the MDM operating model including governance, ownership, and escalation mechanisms

2. Data Governance & Stewardship Framework

• Define and operationalize Data Owner, Data Steward, and Data Custodian roles (new to the organization)
• Establish a local data governance committee, decision rights, and escalation paths
• Develop Master Data Governance SOPs and Work Instructions
• Align governance with Quality, IT, and GxP controls

3. Data Models, Standards & Data Quality

• Develop conceptual and logical data models for all in-scope domains
• Define data standards, naming conventions, controlled vocabularies, and reference data
• Establish data quality rules, validation criteria, and lifecycle controls

4. Current-State Assessment & Gap Analysis

• Document and optimize data maps across systems and interfaces
• Assess current master data processes, controls, and data quality
• Identify data duplication, inconsistencies, and regulatory risks
• Perform gap analysis versus target MDM and governance model

5. Roadmap & Implementation Planning

• Develop a phased MDM roadmap, aligned with business and regulatory milestones
• Identify dependencies across:
• Microsoft D365 ERP (global instance, federated Product Master)
• Veeva Quality Vault (QMS)
• LabVantage (LIMS, ELN, LES)
• POMSnet Aquila (MES)
• ValGenesis (VLMS)
• CMMS
• Define change management, training, and adoption activities

6. Implementation Enablement & Delivery

(No MDM platform implementation)

• Implement approved data standards within existing systems via configuration changes
• Define site-level data lifecycle workflows per domain and system
• Develop RACI models, governance cadence, and decision forums
• Create SOPs, WIs, and training materials
• Execute targeted master data remediation (e.g. de-duplication, standardization) within agreed site scope

Key Deliverables

• MDM Strategy & Operating Model
• In-Scope Data Domains & Critical Data Elements Inventory
• Data Governance & Stewardship Framework
• Conceptual & Logical Data Models
• Current-State Assessment & Gap Analysis Report
• Phased MDM Roadmap
• Data Standards, Naming Conventions & Data Quality Rules
• Data Dictionaries for all critical systems
• Master Data Governance SOPs / Operational Procedures

Required Profile & Experience

Mandatory Experience

• 15+ years of experience in MDM, Data Governance, and Data Integrity
• Proven delivery in regulated Life Sciences environments (FDA, EMA, PMDA)
• Hands-on experience with GxP data integrity principles (ALCOA+)
• Strong experience designing data governance from scratch (no existing standards)
• Experience supporting greenfield site implementations
• Deep understanding of ERP–MES–LIMS–QMS master data integration
• Experience with federated master data models

Technology Experience (Required)

• Microsoft D365 ERP
• Azure Integration Services (AIS) – governance and interface design perspective
• Veeva Vault Quality
• LabVantage (LIMS / ELN / LES)
• POMSnet Aquila (MES)
• ValGenesis (VLMS)
• CMMS platforms

(Hands-on configuration not required, but strong functional/data understanding is mandatory)

Consulting & Leadership Skills

• Able to operate as lead individual contributor
• Strong stakeholder engagement with IT, Quality, and Site leadership
• Excellent facilitation of governance forums and design workshops
• Able to translate regulatory expectations into practical, operational data processes
• Strong documentation discipline (SOPs, data dictionaries, governance artifacts)

Engagement Model

• On-site presence expected, with flexibility for remote work
• Location: Sanford, NC

Ideal Candidate Summary

A senior, hands-on MDM & Data Governance expert with deep Life Sciences and GxP experience, capable of designing and operationalizing master data governance from zero, supporting complex system landscapes and regulated integrations, and delivering a reusable global template.