IT Risk, Compliance & Validation Lead

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The IT Risk, Compliance & Validation Lead is a senior enterprise control leadership role accountable for the governance, risk direction and independent assurance framework that enables Digital Transformation & IT to demonstrate sustained compliance with regulatory, audit, policy, internal-control and computer system validation requirements.

The role sets the strategic direction, standards, decision rights and oversight mechanisms for IT compliance and validation across Pharming's global application landscape. It governs and assures work performed by qualified external partners and application or project teams rather than routinely authoring system-level protocols, test scripts or detailed validation deliverables.

Operating with broad autonomy and delegated authority, the role determines required assurance based on risk, provides independent challenge and may prevent release, implementation or continued use where material compliance or validation requirements are not met. Acceptance of material residual risk remains with the designated accountable executive or governance forum.

The IT Risk, Compliance & Validation Lead is the principal Digital Transformation & IT representative for SOX assurance, internal and external audits and regulatory inspections. The role advises senior leaders, maintains enterprise audit readiness, directs evidence and remediation governance, and holds internal owners and external providers accountable for sustainable control outcomes.

Reporting to the Head of Enterprise Applications, the IT Risk, Compliance & Validation Lead has global accountability for IT validation governance, compliance policy, control assurance, technology risk transparency and audit readiness. The role is accountable for:

• Defining the global IT validation and compliance strategy, multi-year roadmap and annual assurance priorities.
• Establishing policies, standards, governance principles, control frameworks, exception criteria and minimum evidence requirements proportionate to risk.
• Defining and enforcing decision rights and accountability across application owners, project teams, Quality Assurance, Finance, Digital Transformation & IT and external partners.
• Determining assurance scope and rigor based on system criticality, intended use, regulatory impact, control exposure and residual risk.
• Providing independent assurance over validation and control activities and requiring remediation or additional evidence where conclusions are not adequately supported.
• Leading Digital Transformation & IT representation during SOX assurance, internal and external audits and regulatory inspections, including senior-level interviews and response governance.
• Maintaining an enterprise view of compliance health, validation status, control deficiencies, findings, exceptions, overdue remediation, trends and emerging exposure.
• Exercising delegated stop or delay authority where material validation evidence, approvals or compliance requirements are insufficient.
• Advising the Head of Enterprise Applications and governance forums on exposure, remediation priorities, investment needs and decisions on residual-risk acceptance.
• Defining and assuring the operating model, qualification, quality, performance and capacity of outsourced validation and compliance services.

The role is accountable for the quality and effectiveness of the IT compliance and validation framework. Operational validation execution remains with qualified delivery teams and partners, while final acceptance of material enterprise risk remains with designated accountable leaders and governance forums.

• Own and evolve the IT validation…