CSV Global Manager

Piper Companies is seeking a CSV Global Manager for a clinical-stage biotech innovator in gene-edited cancer immunotherapies. The CSV Manager will be responsible for leading global CSV and software assurance for enterprise systems, ensuring GxP compliance while managing multi-site projects and implementing risk-based validation strategies. This position is located in Raleigh, NC.

Responsibilities of the CSV Global Manager:

• Lead global CSV program, ensuring GMP and regulatory compliance across lifecycle documentation.
• Execute validation for enterprise systems (Oracle ERP, HCM, Supply Chain, EPM; SAP optional).
• Standardize processes and apply CSA/risk-based validation strategies.
• Manage projects and stakeholders across Paris and Raleigh, collaborating with C-suite and cross-functional teams.
• Support future initiatives (EQMS, CMMS) and maintain validated systems.

Qualifications for the CSV Global Manager:

• 4+ years CSV experience in pharma/biotech.
• Expertise in Oracle ERP or SAP; knowledge of EQMS, CMMS, LIMS is a plus.
• Skilled in protocol development, risk assessments, and CSA principles.
• Strong understanding of GMP vs. non-GMP requirements; excellent communication and leadership for global program management.

Compensation for the CSV Global Manager:

• Salary Range: Starting at $135,000/year
• Comprehensive Benefits: Sick leave if required by law, medical, dental, vision, 401K

This job opens for applications on 11/10/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: CSV, Computer System Validation, CSA, Risk-Based Validation, GMP Compliance, Oracle ERP, SAP, HCM, Supply Chain, EPM, EQMS, CMMS, LIMS, Validation Lifecycle, Protocol Development, Functional Risk Assessment, Global Program Management, Pharma, Biotech, Quality Systems, Regulatory Compliance, Enterprise Systems, Standardization, Project Management

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