CSV Global Manager

1 week ago

Raleigh, North Carolina, United States Piper Companies Full time

Piper Companies
is hiring a
CSV Global Manager
for a
hybrid permanent
position with a global biopharmaceutical company advancing next-generation cancer therapies located in
Raleigh, NC
. The
CSV Global Manager
will lead and execute global computer system validation and software assurance efforts for enterprise systems, ensuring compliance with GxP standards while managing projects and implementing risk-based validation strategies across multiple sites.

Responsibilities of the CSV Global Manager:

  • Lead and execute global CSV program, including managing validation lifecycle documentation and ensuring compliance with GMP and global standards
  • Perform hands-on validation and implementation for enterprise systems such as Oracle ERP, HCM, Supply Chain, EPM, and possibly SAP
  • Drive global standardization and compliance by building procedures, streamlining processes, and applying CSA and risk-based validation strategies
  • Manage projects and stakeholders across Paris and Raleigh sites, working with C-suite and cross-functional teams
  • Prepare for future initiatives such as EQMS validation next year, potential CMMS involvement, and maintaining validated systems

Qualifications of the CSV Global Manager:

  • Strong CSV expertise in regulated environments with a minimum of 4–5 years experience (3 years absolute minimum) in pharma or biotech
  • Technical depth with enterprise systems including Oracle ERP suite or SAP, with familiarity in EQMS, CMMS, and LIMS as a plus
  • Ability to develop and review protocols, perform functional risk assessments, and apply CSA principles for risk-based validation
  • Deep understanding of GMP versus non-GMP requirements combined with strong negotiation and soft skills to influence quality teams
  • Leadership and global program management capability to direct validation strategy and collaborate across multiple sites

Compensation for the CSV Global Manager:

  • Salary: starting at $135,000/year
  • Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday, and Sick Leave if Required by Law

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: computer system validation, CSV, computer software assurance, CSA, validation lifecycle, IQ/OQ/PQ, validation protocols, protocol development, risk-based validation, GAMP 5, 21 CFR Part 11, EU Annex 11, GMP, GxP, non-GMP, enterprise systems validation, Oracle ERP, Oracle HCM, Oracle Supply Chain, Oracle EPM, SAP, EQMS, CMMS, LIMS, ELN, SaaS validation, IaaS, PaaS, test management, protocol review, validation master plan, compliance, audit readiness, CAPA, deviation management, functional risk assessment, global validation program, pharma validation, biotech validation, regulated systems, validation lead, validation engineer, validation manager

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