Associate Director IT Compliance

The Associate Director, IT Compliance is responsible for organising, leading and continuously improving Novotech’s IT Compliance function across a global CRO environment. The role provides leadership for IT governance, compliance assurance, audit readiness, vendor and sponsor audit responses, ISMS governance, ISO/IEC 27001:2022 certification activities, and regulatory compliance guidance for GxP computerised systems.

This role acts as a key interface between IT, Information Security, Quality Assurance, Legal, Privacy, Business Operations, system owners, sponsors, vendors and external auditors. The successful candidate will ensure that Novotech’s IT practices, systems, documentation and control evidence remain inspection-ready and aligned with applicable regulatory, contractual, quality and information security requirements.

The role requires a pragmatic compliance leader who can interpret regulatory obligations, translate them into practical IT controls and documentation, and guide business and technology teams through audit, certification, risk management and continuous improvement activities.

• Lead, organise and manage the global IT Compliance function, ensuring clear priorities, operating cadence, responsibilities, documentation standards and service expectations.
• Act as the primary IT Compliance lead for technology governance, IT control assurance, IT audit readiness and regulatory support.

• Manage and coordinate IT responses to vendor, sponsor, client and regulatory audits involving IT systems, IT practices, information security controls and data privacy controls.
• Manage and coordinate vendor, sponsor, client and regulatory reviews in relation to emerging AI and Machine Learning capabilities, as well as participate in strategy discussions related to AI

• Manage and maintain Information Security Management System records, registers, evidence repositories and governance documentation.
• Support the ongoing operation, monitoring and continual improvement of Novotech’s ISMS.

• Provide guidance to IT, Quality Assurance, system owners and business process owners on regulatory compliance expectations for GxP computerised systems.
• Support interpretation and practical application of relevant regulatory and industry expectations, including GxP, computerised system validation, data integrity, 21 CFR Part 11, EU Annex 11 and GAMP 5-aligned risk-based validation principles.

• Lead or support technology risk assessments for new and existing systems, vendors, services and IT processes.
• Identify control gaps, compliance risks and documentation deficiencies, and work with accountable owners to define appropriate remediation or risk treatment plans.

• Support supplier and vendor compliance assessments for technology vendors, cloud service providers, SaaS platforms and GxP-relevant suppliers.
• Review supplier control evidence such as ISO certifications, SOC reports, validation documentation, security questionnaires, privacy documentation and contractual compliance requirements.

• Own or contribute to IT Compliance policies, SOPs, work instructions, templates, guidance materials and evidence packs.
• Translate complex regulatory, security and quality requirements into practical, business-friendly guidance.

• Effective operation of the global IT Compliance function.
• Timely, accurate and defensible IT responses to vendor, sponsor, client and regulatory audits.
• Maintained and audit-ready ISMS records, evidence, registers and governance artefacts.
• Successful support for ISO/IEC 27001:2022 certification, surveillance and recertification activities.
• Clear compliance guidance for GxP systems, SaaS platforms, cloud services and technology projects.
• Improved audit evidence reuse, response consistency and inspection readiness.
• Well-maintained IT Compliance SOPs, work instructions, templates and control…