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Job Title: Senior Master Data Management (MDM) & Data Governance Consultant
Location: Sanford, NC
Contract only for W2 Candidates
Required Skills
•15+ years of experience in MDM, Data Governance, and Data Integrity
•Proven delivery in regulatory-compliant data integrity (FDA, EMA, PMDA)
•Hands-on experience with GxP data integrity principles (ALCOA+)
•Strong experience designing data governance from scratch
•Experience supporting greenfield site implementations
•Deep understanding of ERP–MES–LIMS–QMS master data integration
•Experience with federated master data models
Technology used: Microsoft D365 ERP, Azure Integration Services (AIS), Veeva Vault Quality, LabVantage (LIMS / ELN / LES), POMSnet Aquila (MES), ValGenesis (VLMS), CMMS platforms
•Location: Sanford, NC (On-site presence expected, with flexibility for remote work to candidates nearby states)
Required:
Mandatory Experience:
- 15+ years of experience in MDM, Data Governance, and Data Integrity.
- Proven delivery in regulated Life Sciences environments (FDA, EMA, and 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).
Responsibilities:
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, and PMDA).
- Support Azure Integration Services–based data interfaces between critical systems.
- Deliver a scalable MDM template reusable for future sites.
Scope of Responsibilities:
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, and VLMS.
- Design the MDM operating model including governance, ownership, and escalation mechanisms.
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.
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.
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.
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.
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.