Director, IT Compliance & Validation Leadership

Glaukos Corporation; Aliso Viejo (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

Glaukos Corporation in California seeks a Director, IT Systems Compliance to lead strategy, governance, and execution of compliance programs across enterprise platforms and regulated systems. You will drive FDA/GxP, ISO, and data integrity initiatives, partner with IT, Quality, Regulatory Affairs, and business leaders, and lead a high-performing team to enable secure, compliant digital transformation.

You will oversee validation, cybersecurity controls, risk management, and audit readiness for

Qualifications

• Bachelor's degree and 12+ years of experience in computer system validation, quality systems, or regulated IT compliance.
• Minimum 5+ years leadership experience managing validation, compliance, or quality teams in medical device, pharma, biotech, or life sciences.
• Demonstrated expertise supporting GxP-regulated systems and global regulatory requirements.
• Experience leading regulatory inspections, audits, validation programs, and remediation initiatives.
• Ability to influence senior leadership and drive enterprise-wide compliance strategies.

Responsibilities

• Lead enterprise IT compliance and CSV programs for regulated applications, cloud platforms, and infrastructure.
• Establish and maintain IT governance, policies, standards, and procedures for compliance, validation, cybersecurity, and risk management.
• Direct system lifecycle governance activities including risk assessments, validation planning, and change control oversight.
• Ensure environments comply with FDA, GxP, ISO, SOX where applicable, data integrity, privacy, and cybersecurity.
• Provide strategic oversight of compliance for new tech implementations, cloud migrations, ERP deployments, and integrations.
• Partner with IT, Cybersecurity, Quality, Regulatory Affairs, and business leaders to align tech strategies with compliance requirements.
• Lead technology-focused audits, regulatory inspections, and remediation programs.
• Monitor key compliance and system performance metrics for executive decision making and risk management.
• Oversee risk assessments and remediation for regulated systems and third-party platforms.
• Promote modern validation methodologies, risk-based compliance, automation tools, and digital quality initiatives.
• Build and lead a high-performing IT compliance, validation, and governance team.

Skills

IT Compliance

CSV (Computer System Validation)

Regulatory Compliance

Cybersecurity

Leadership

Education

Bachelor's degree in Engineering/CS/IS

Advanced degree / certifications preferred

Job description

Glaukos Corporation in California seeks a Director, IT Systems Compliance to lead strategy, governance, and execution of compliance programs across enterprise platforms and regulated systems. You will drive FDA/GxP, ISO, and data integrity initiatives, partner with IT, Quality, Regulatory Affairs, and business leaders, and lead a high-performing team to enable secure, compliant digital transformation.

You will oversee validation, cybersecurity controls, risk management, and audit readiness for