Director, Systems Compliance - Onsite in Aliso Viejo, CA

Role: Lead strategy, governance, and execution of compliance, validation, and risk management for enterprise technology systems in a biopharma setting. Responsibilities: oversee compliance programs across regulated applications, cloud environments, infrastructure, and cybersecurity; develop IT governance frameworks, policies, and validation activities; ensure systems meet FDA, GxP, ISO, SOX, and data integrity standards; support technology lifecycle management, audit readiness, and risk assessments; collaborate with IT, Quality, Regulatory, and business leaders; lead audit and inspection activities; implement modern validation and digital quality initiatives; build and lead a high-performing compliance team. Requirements: Bachelor's degree in Engineering, Computer Science, or Life Sciences; 12+ years in IT compliance, validation, or quality within regulated environments; 5+ years leadership experience managing validation and compliance teams; expertise supporting GxP-regulated systems and global regulatory standards; experience with audits, inspections, validation programs, and remediation. Preferred: advanced degrees or certifications in Quality, Validation, or IT. High-Value: extensive GxP and regulatory compliance experience, validation leadership, audit and inspection management, enterprise systems, cloud platforms, cybersecurity, digital transformation; full-time onsite at Aliso Viejo, CA, with relocation and benefits.