CSV Global Manager

ZP Group•Raleigh, NC

30d•$135,000•Hybrid

About The Position

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.

Requirements

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

Responsibilities

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