Validation Lead

Hiring: Validation Lead – Global Development

Location: Remote (Tokyo, Japan)

Contract Opportunity

Industry: Biotechnology / Pharmaceutical

We are seeking an experienced Validation Lead with 5+ years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), and GxP Compliance within pharmaceutical or biotechnology environments.

Key Skills:

• Computer System Validation (CSV) & Computer Software Assurance (CSA)

• FDA 21 CFR Part 11, EU Annex 11 & GAMP 5

• Data Integrity (ALCOA+)

• Risk-Based Validation & CSA Transformation

• Validation Plans, URS, FRS, IQ/OQ/PQ, Traceability Matrix & VSR

• SDLC & GxP Compliance

• Audit & Inspection Readiness

• Change Control, Risk Assessments & CAPA

• Cross-Functional Project Leadership

Systems Experience:

• Veeva Vault (Strongly Preferred)

• CTMS

• eTMF

• Pharmacovigilance / Safety Systems

• Regulatory Publishing Platforms

• Biometrics & Statistical Computing Environments

Preferred Experience:

• Global Development, Clinical Development, R&D Systems

• Cloud-Based Platforms & Infrastructure Qualification

• Validation Automation Tools

• Agile Environment Experience