Project Manager - CAPA Remediation

Position Summary:
Seeking an experienced contract professional to lead CAPA remediation initiatives focused on Item Master, Part Information Records (PIRs), Approved Supplier Lists (ASLs), Design and Purchasing controls for vendor and material master data.

This role partners across Procurement, Quality, Regulatory, Engineering, Manufacturing, Supply Chain and IT to implement compliant, sustainable people, process and technology improvements supporting ISO 13485, GxP and SOX requirements.

Key Responsibilities:
Lead procurement CAPA remediation from planning through implementation.
Drive governance for Item Master, PIRs, ASLs, and material qualification.
Support CAPA remediation efforts related to process and purchasing controls, engineering specifications through purchasing controls
Partner cross-functionally to redesign workflows, gather requirements and implement scalable digital solutions.
Support procurement technology roadmap, system implementations, testing, validation and change management.
Develop procedures, training, KPIs, executive reporting and continuous improvement plans.
Ensure compliance with ISO 13485, FDA/GxP, SOX and Quality Management System requirements.

Qualifications:
Bachelor's degree in Supply Chain, Engineering, Business or related field; MBA/PMP preferred.
5+ years leading procurement, supply chain, master data or transformation projects in regulated manufacturing.
Experience with supplier onboarding, vendor/material master governance, CAPA remediation and ERP implementations.
Knowledge of SAP S/4HANA, SAP MDG, Oracle, Ariba, Dynamics or similar platforms.

Preferred Skills:
Power BI, Excel, Power Query and analytics expertise.
Project management (Agile/Waterfall), Smartsheet or MS Project.
Lean Six Sigma, validation (IQ/OQ/PQ/UAT), stakeholder management and executive communication.

Success Measures:
Completion of CAPA milestones, improved master data quality, successful adoption of
standardized workflows, regulatory compliance and measurable operational improvements.