Role Summary
The Senior Director, IT Compliance and Privacy ensures all technology operations meet regulatory, legal, and corporate governance requirements while enabling business agility. This role leads a team responsible for SOX ITGC, GxP validation, data privacy (GDPR, HIPAA), and comprehensive risk management across the technology portfolio.
Responsibilities
- Regulatory Compliance Leadership
- Lead quarterly Sarbanes-Oxley IT General Controls testing across all financial systems, coordinate audit evidence preparation, and manage external auditor interactions
- Oversee pharmaceutical system validation processes, ensuring compliance with FDA requirements and supporting regulatory inspections and audit preparation
- Maintain comprehensive compliance programs for all public company IT obligations and regulatory reporting requirements
- Conduct enterprise-wide IT compliance risk assessments and develop mitigation strategies across the technology landscape
- Data Privacy & Governance
- Implement and maintain comprehensive data privacy programs covering GDPR, HIPAA, and state privacy regulations
- Establish enterprise data classification, handling procedures, and governance frameworks across clinical, commercial, and corporate data
- Conduct privacy reviews for all new technology implementations and system changes
- Parter with Cybersecurity lead on data breach response coordination across IT pillars and business units, ensuring proper regulatory notification and remediation
- Cross-Pillar Integration
- Review all technology decisions for regulatory impact before implementation, embedding compliance checkpoints into standard IT workflows
- Translate complex regulatory requirements into practical IT policies, procedures, and training programs
- Manage internal and external audit activities, coordinating evidence gathering across Business Technology, Infrastructure, and Security teams
- Interface with external auditors, regulators, compliance consultants, and legal counsel on IT-related matters
- Team Leadership & Development
- Direct IT Compliance and Privacy & Data Governance teams, providing strategic guidance and professional development
- Develop and deliver compliance training programs tailored to specific IT roles and business functions
- Continuously improve compliance processes to balance regulatory requirements with business agility and operational efficiency
- Manage escalation of significant compliance risks to CIO and executive leadership
Qualifications
- Bachelors in IT, Computer Science, or related field; advanced degree or JD preferred with 10+ years of IT compliance experience with 5+ years in leadership roles or equivalent experience
- Pharmaceutical, biotechnology, or regulated life sciences industry experience required
- Proven track record managing compliance for technology portfolios in public company environments
- Extensive experience with Sarbanes-Oxley IT General Controls testing, documentation, and audit support
- Deep knowledge of pharmaceutical validation requirements, FDA regulations (21 CFR Part 11), and quality management systems
- Expert-level understanding of GDPR, HIPAA, CCPA, and other privacy regulations with hands-on implementation experience
- Strong background in IT risk assessment methodologies, business continuity planning, and compliance program management
- Understanding of enterprise applications, databases, cloud platforms, and integration architectures from a compliance perspective
- Experience coordinating internal and external audits, evidence collection, and remediation planning
- Proven ability to translate regulatory requirements into practical business processes and technical controls
- Exceptional skills in communicating complex compliance requirements to technical and business audiences
- Experience leading cross-functional compliance initiatives in matrix organizations
- Proven ability to influence without authority across business units and IT teams
- Experience managing relationships with external auditors, consultants, and regulatory bodies
- Travel: 10%
Preferred Qualifications
- CISA, CRISC, CIPP, CIPM, or other relevant compliance and privacy certifications
- Knowledge of ISO 27001, NIST frameworks, and life sciences industry best practices
- Familiarity with evolving privacy laws, AI governance requirements, and digital health regulations