CSV Global Manager
ZP Group•Raleigh, NC
35d•$135,000•Onsite
About The Position
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.
Requirements
- 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.
Responsibilities
- 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.
Benefits
- Sick leave if required by law
- Medical
- Dental
- Vision
- 401K
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Industry
Professional, Scientific, and Technical Services
Education Level
No Education Listed
Number of Employees
251-500 employees
