Validation Lead | Remote
Validation Lead
Work Location: King of Prussia (Remote)
Job Description
• 15+ years of experience in Pharma IT and SAP environments.
• Strong knowledge of CSV, GxP, and regulatory frameworks.
• Proven leadership in quality assurance and validation.
• Validation Oversight: Author and approve key validation deliverables (e.g., Deliverable Scaling Assessment, CRs, lifecycle documents, test artifacts).
• Strategic Quality Leadership: Define validation strategies with SMEs; assess impact on product quality and data integrity.
• Risk & Compliance Management: Lead and contribute to risk assessments (GxP, cybersecurity, data privacy); ensure validated state and operational compliance.
• Team Guidance & Mentorship: Advise teams on SOPs, CSV processes, and regulatory standards; foster quality culture and process excellence.
Audit & Supplier Engagement: Support internal/external audits; lead audit activities for GxP systems; perform supplier assessments
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