Director of IT Compliance & System Validation

Glaukos Corporation; Aliso Viejo (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Relocation assistance

Excellent compensation and benefits

Job summary

Glaukos Corporation is seeking a Director, IT Systems Compliance & Governance to lead strategy, governance, and execution of compliance programs across enterprise platforms. The role ensures FDA/GxP, ISO, and data integrity compliance for Quality, Manufacturing, Regulatory, and Corporate functions, partnering with IT, Cybersecurity, Quality, and Regulatory Affairs.

This onsite role at our Aliso Viejo, CA headquarters offers autonomy, leadership of a high-performing team, and opportunities to

Qualifications

• Bachelor's degree and 12+ years of experience in Computer System Validation, Quality Systems, Information Technology Compliance, or a related regulated environment.
• Minimum 5+ years of leadership experience managing validation, compliance, or quality teams in the medical device, pharmaceutical, biotechnology, or life sciences industry.
• Demonstrated expertise supporting GxP-regulated computerized systems and global regulatory compliance requirements.
• Experience leading regulatory inspections, compliance audits, validation programs, and remediation initiatives across multiple business functions.
• Proven ability to influence senior leadership and drive enterprise-wide compliance strategies in a highly regulated environment.

Responsibilities

• Lead the enterprise IT compliance and Computer System Validation (CSV) program for regulated applications, cloud platforms, infrastructure, and digital technologies.
• Establish and maintain IT governance frameworks, policies, standards, and procedures related to system compliance, validation, cybersecurity, data integrity, and technology risk management.
• Direct system lifecycle governance activities including risk assessments, validation planning, change control oversight, testing strategies, implementation reviews, and compliance approvals.
• Ensure enterprise technology environments operate in compliance with applicable FDA, GxP, ISO, SOX (where applicable), data integrity, privacy, cybersecurity, and global regulatory requirements.
• Provide strategic oversight of compliance activities supporting new technology implementations, cloud migrations, ERP deployments, infrastructure upgrades, integrations, automation initiatives, and system retirements.
• Partner with IT Architecture, Infrastructure, Enterprise Applications, Cybersecurity, Quality, Regulatory Affairs, and business leaders to align technology strategies with compliance requirements and operational objectives.
• Lead technology-focused audit and inspection activities, including internal audits, supplier assessments, regulatory inspections, and remediation programs.
• Establish and monitor key compliance, cybersecurity, operational, and system performance metrics to support executive decision-making and enterprise risk management.
• Oversee technology risk assessments and remediation activities related to regulated systems, cybersecurity controls, third-party platforms, and critical business applications.
• Drive adoption of modern validation methodologies, risk-based compliance approaches, automation tools, and digital quality initiatives to improve efficiency and effectiveness.
• Build, develop, and lead a high-performing team of IT compliance, validation, and governance professionals while fostering a culture of accountability, security, innovation, and continuous improvement.
• Serve as a key advisor to executive leadership on technology governance, compliance risks, cybersecurity preparedness, and regulatory impacts associated with enterprise systems and digital transformation efforts.

Skills

IT compliance

CSV / Computer System Validation

Regulatory compliance

Cybersecurity

Governance

Risk management

Audit readiness

Leadership

Education

Bachelor's degree in Engineering

Bachelor's degree in Computer Science

Bachelor's degree in Information Systems

Job description

Glaukos Corporation is seeking a Director, IT Systems Compliance & Governance to lead strategy, governance, and execution of compliance programs across enterprise platforms. The role ensures FDA/GxP, ISO, and data integrity compliance for Quality, Manufacturing, Regulatory, and Corporate functions, partnering with IT, Cybersecurity, Quality, and Regulatory Affairs.

This onsite role at our Aliso Viejo, CA headquarters offers autonomy, leadership of a high-performing team, and opportunities to