CSV Lead - MS Dynamics ERP

 CSV Lead

Industry: Pharmaceutical / Biotechnology / Life Sciences

Position Summary

We are seeking an experienced Microsoft Dynamics ERP CSV Lead to lead Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for Microsoft Dynamics 365 or an equivalent ERP platform within a regulated pharmaceutical manufacturing environment.

The CSV Lead will provide validation oversight across supply chain, manufacturing, finance, and quality business processes. The role will work closely with Quality Assurance, IT, business process owners, system integrators, and vendors to ensure that the ERP system is implemented, tested, and maintained in compliance with GxP requirements, 21 CFR Part 11, EU Annex 11, GAMP 5, and data-integrity principles.

ERP Module Scope

Supply Chain Management

* Procurement and Sourcing
* Vendor and Supplier Management
* Product Information Management
* Inventory Management
* Warehouse Management
* Transportation Management
* Landed Cost Management
* Master Planning and Material Requirements Planning (MRP)
* Demand Planning
* Sales Order and Distribution Management
* Asset Management
* Vendor Collaboration
* Batch, Lot, and Serial Number Traceability

Manufacturing

* Production Control
* Discrete Manufacturing
* Process and Batch Manufacturing
* Lean Manufacturing
* Bills of Materials (BOM)
* Formulas and Recipes
* Routes and Operations
* Production Orders and Batch Orders
* Production Planning and Scheduling
* Capacity and Resource Planning
* Shop-Floor and Manufacturing Execution
* Production Costing
* Batch Attributes, Potency, and Shelf-Life Management
* Co-products and By-products

Finance

* General Ledger
* Accounts Payable
* Accounts Receivable
* Credit and Collections
* Cash and Bank Management
* Fixed Assets
* Budgeting and Budget Control
* Cost Accounting
* Inventory Costing
* Tax Management
* Expense Management
* Financial Reporting
* Intercompany Accounting
* Financial Consolidation
* Period-End and Year-End Close

Quality Management

* Quality Planning and Quality Associations
* Incoming, In-Process, and Finished-Product Inspection
* Quality Orders
* Test Groups, Test Methods, Test Variables, and Test Instruments
* Sampling Plans and Acceptable Quality Levels
* Material Status and Inventory Blocking
* Quarantine Management
* Nonconformance Management
* Correction and Disposition Management
* Corrective and Preventive Action
* Certificate of Analysis
* Supplier and Vendor Quality
* Production Quality Control
* Batch and Lot Traceability
* Quality Trending and KPI Reporting

Key Responsibilities

* Lead end-to-end CSV and CSA activities for Microsoft Dynamics 365 ERP implementation, upgrades, integrations, releases, and controlled system changes.
* Develop and maintain the ERP validation strategy in accordance with GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and internal quality procedures.
* Provide validation oversight across supply chain, manufacturing, finance, and quality modules.
* Author, review, and approve validation deliverables, including GxP assessments, validation plans, user requirements, functional and configuration specifications, risk assessments, test plans, test scripts, traceability matrices, and validation summary reports.
* Apply risk-based CSA principles to determine the appropriate level of testing and documentation based on patient safety, product quality, data integrity, and business-process criticality.
* Facilitate requirements and risk-assessment workshops with business process owners, IT, Quality Assurance, system integrators, and vendors.
* Ensure complete traceability between business requirements, functional specifications, configuration elements, identified risks, test cases, deviations, and objective evidence.
* Provide validation oversight for integrations between Dynamics 365 and MES, LIMS, QMS, WMS, serialization, laboratory, reporting, banking, and other enterprise systems.
* Lead validation activities for data migration, including data mapping, cleansing, transformation, reconciliation, verification, and migration reports.
* Assess role-based security, segregation of duties, user access, audit trails, electronic records, electronic signatures, interfaces, reports, and automated workflows.
* Review test scripts and executed evidence for accuracy, completeness, traceability, and compliance with good documentation practices.
* Manage test deviations and defects, including investigation, impact assessment, corrective action, retesting, and closure.
* Support system integration testing, user acceptance testing, regression testing, performance testing, and release-readiness assessments.
* Participate in cutover planning, production deployment, go-live readiness, and post-implementation hypercare.
* Support change controls, periodic reviews, backup and restoration testing, disaster recovery testing, and continued validated-state activities.
* Track validation progress, risks, dependencies, issues, and deliverable status and communicate them to project and Quality leadership.
* Provide guidance and mentorship to validation analysts, testers, business users, and project team members.
* Support internal audits, client audits, and regulatory inspections by presenting the ERP validation strategy and supporting documentation.

Required Qualifications

* Bachelor’s degree in Computer Science, Engineering, Information Systems, Life Sciences, or a related discipline.
* Minimum of 8 years of CSV, CSA, IT Quality, or ERP validation experience in the pharmaceutical, biotechnology, medical-device, or another regulated industry.
* Demonstrated experience leading validation activities for Microsoft Dynamics 365 or an equivalent ERP platform such as SAP S/4HANA, Oracle ERP Cloud, or JD Edwards.
* Experience validating supply chain, manufacturing, finance, and quality processes within an ERP environment.
* Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, data integrity, and applicable GxP requirements.
* Experience authoring and reviewing validation lifecycle documentation and risk-based testing strategies.
* Experience with ERP data migration, system integrations, role-based security, audit trails, electronic records, and electronic signatures.
* Strong leadership, technical writing, stakeholder management, communication, and problem-solving skills.
* Ability to work onsite in Sanford, North Carolina.

Preferred Qualifications

* Direct experience with Microsoft Dynamics 365 Finance and Supply Chain Management.
* Experience supporting pharmaceutical process or batch manufacturing operations.
* Knowledge of GMP material management, warehouse operations, production planning, batch execution, inventory controls, and quality-release processes.
* Experience with Azure DevOps, Jira, HP ALM, ValGenesis, Kneat, or similar validation and test-management tools.
* Experience supporting large-scale ERP implementations using Agile, Waterfall, or hybrid methodologies.
* Previous experience as an ERP CSV Lead, Validation Lead, or IT Quality Lead.