EXECUTIVE DIRECTOR, IT COMPLIANCE

Summary

The Executive Director of IT Compliance will be tasked with ensuring that Ionis complies with relevant regulatory and industry standards in the development and commercialization of products on a global scale. A key aspect of this role involves the development and design of IT controls that align with regulatory requirements and industry benchmarks, such as CSA, SOX, NIST, and ISO. The ideal candidate will possess a robust background in IT GxP and SOX compliance, coupled with a strong interest in utilizing digital tools to mitigate risks and automate controls whenever feasible.

In this position, collaboration with various departments—including Internal Audit, Quality Assurance, Clinical, Manufacturing, Regulatory, Finance, and internal IT functions supporting GxP and SOX applications—will be essential. The candidate will be responsible for ensuring that controls are effectively implemented, continuously monitored to protect the organization's technology and data, and integrated into broader data privacy and regulatory compliance frameworks. This position can be fully onsite, hybrid or remote. For remote working, the expectation includes travel (25%) to Carlsbad, CA (HQ).

Responsibilities

• Establish and maintain the IT compliance program aligned with organizational risks, global regulations, and evolving compliance standards.
• Assist in the creation of SOPs, training materials, and work instructions, ensuring compliance education is embedded across IT and business functions.
• Serve as the point of contact for internal and external audits, regulatory inspections, and ongoing compliance assessments.
• Oversee SAP SOX ITGC ownership and IT change management processes, ensuring alignment with IT risk and compliance controls.
• Drive continuous improvement of quality systems, risk-based compliance frameworks, and validation processes to ensure regulatory adherence and efficiency.
• Collaborate with cross-functional teams to develop and implement IT Compliance strategies, including:
  • Quality & Compliance Policy and Procedure Management
  • Software Lifecycle Management and Software Quality Assurance
  • Audit Preparation and Support
  • Third-Party and Vendor Quality Management (ensuring compliance with external regulatory requirements)
• Conduct compliance risk assessments and root cause analyses to identify and address deficiencies in alignment with global regulatory expectations.
• Develop templates for validation documentation and support electronic system applications to improve audit readiness.
• Implement data-driven compliance monitoring, reporting tools for analysis, trending, and KPI metrics to track compliance program effectiveness.
• Partner with the Data Privacy Officer to define and integrate privacy compliance requirements into IT governance, ensuring alignment with evolving data protection laws (GDPR, CSL, etc.).
• Attract and retain talent while promoting diversity, compliance expertise, and staff development.
• Manage operating budgets and project expenditure with financial discipline, ensuring compliance-related investments align with business priorities.

Requirements

• Bachelor’s Degree required (Master’s a plus) in a related field.
• At least 10 years of experience in the life sciences industry with a strong compliance background.
• Domain Expertise: Quality, Clinical, Regulatory, Manufacturing, PV/Safety, Finance.
• Regulation Expertise: GMPs, 21 CFR Part 11, Good Automated Manufacturing Practice (GAMP5), GCP / GLP, Good Automated Laboratory Practice (GALP), General Data Protection Regulations (GDPR), CSL, and Sarbanes-Oxley (SOX).
• Technical Expertise: Veeva Development Cloud, SAP S4/HANA, SAP GRC, and compliance automation tools.
• Strong internal control management, including IT General Controls (ITGC), IT Access Controls, and IT compliance frameworks.
• Strong hands-on, end-to-end CSV/CSA experience, managing project controls, and applying risk-based compliance approaches across all project lifecycle phases (from requirements gathering to release management).
• Solid understanding of data integrity risks, validation frameworks, and compliance monitoring activities.
• Experience in regulatory inspections, audit management, and compliance reporting.
• Ability to manage complex projects and timelines in a matrix team environment while ensuring continuous regulatory adherence.
• Ability to independently identify compliance risks, escalate when necessary, and drive proactive risk mitigation efforts.
• Excellent verbal and written communication skills across all levels of the organization, with the ability to translate compliance requirements into clear, actionable strategies.

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003545

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $200,995 to $268,140

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.