Location: New Jersey - Onsite/Hybrid
Industry: Pharmaceutical / Life Sciences
Duration: Initial 6-month contract with potential extension
Role Overview:
We are seeking an experienced GxP/CSV Validation & Program Lead for a critical clinical/drug safety data initiative. This is a client-facing role responsible for GxP/CSV validation, quality documentation, project management, stakeholder management, and vendor coordination. The individual will work closely with Drug Safety, Digital Quality, CSV/Validation, Data & Analytics teams, and external vendors.
Key Responsibilities:
Lead GxP/CSV validation activities for a regulated data and analytics platform. Work closely with Digital Quality and CSV teams on validation strategy, requirements, testing, traceability, approvals, and compliance. Develop and manage validation plans, requirements/specifications, traceability, test evidence, UAT, deviations, and release documentation. Manage project milestones, risks, dependencies, deliverables, and stakeholder communication. Coordinate across Drug Safety, Quality, validation, architecture, data engineering, analytics, and external vendor teams. Drive requirements, validation, testing, issue resolution, approvals, and production readiness. Ensure project documentation and deliverables meet applicable GxP and organizational quality requirements.
Required Qualifications:
7+ years of experience in pharmaceutical/life sciences environments. Strong hands-on GxP/CSV validation experience. Strong experience with validation documentation and regulated SDLC processes. Experience working with Digital Quality / Quality Assurance teams. Strong project/program management and vendor coordination experience. Excellent client-facing communication and stakeholder-management skills. Preferred Experience with Drug Safety/Pharmacovigilance, clinical data, Oracle Argus Safety, Snowflake/cloud data platforms, data migration, reconciliation, and analytics is highly desirable. Mandatory skills: GxP/CSV Validation | Validation Documentation/SDLC | Digital Quality/QA | Project & Vendor Management
