Director, Systems Compliance - Onsite in Aliso Viejo, CA

Director, Systems Compliance

How You'll Contribute:

The Director, IT Systems Compliance & Governance is responsible for leading the strategy, governance, and execution of compliance, validation, and risk management programs for enterprise technology platforms and regulated computerized systems across the organization. This role ensures that business-critical applications, cloud environments, infrastructure, cybersecurity controls, and digital platforms supporting Quality, Manufacturing, Clinical, Regulatory, and Corporate functions operate in compliance with applicable regulations, industry standards, and internal technology policies. The Director provides strategic leadership for IT compliance, system validation, technology governance, audit readiness, cybersecurity compliance, and data integrity programs. This position partners closely with Information Technology, Cybersecurity, Quality, Regulatory Affairs, and business leaders to ensure enterprise systems are secure, reliable, scalable, and compliant throughout their lifecycle. The role operates with significant autonomy and serves as a trusted advisor on technology risk, compliance strategy, and digital transformation initiatives.

What You'll Do:

• 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.

How You'll Get There:

• 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.
• Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related discipline required.
• Advanced degree and/or relevant certifications in Quality, Compliance, Validation, or Information Technology preferred.
• This role works full-time onsite at our worldwide headquarters in Aliso Viejo, CA.
• Relocation is available along with excellent compensation and benefits!

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