BeOne is a global biopharmaceutical company dedicated to the discovery and development of innovative drug therapies for the treatment of cancer. At BeOne we believe that access to life-changing medicine sees no borders. **General Description:** The Senior Director, Global R&D Audits & Inspections Readiness is a strategic, high-impact role responsible for ensuring our internal and external technology solutions maintain a perpetual state of regulatory compliance and inspection readiness. Bridging the gap between fast-paced software engineering and rigorous healthcare regulations, this leader will design & oversee the embedding of "Validation-by-Design" principles directly into modern Agile workflows and automated CI/CD pipelines. From orchestrating live health authority inspections and mock audits to translating global GxP and data privacy laws into actionable engineering guardrails, this individual will play a vital role in accelerating our digital delivery while safeguarding our compliance posture. A successful candidate is a seasoned GxP compliance leader with a strong foundation in computerized systems validation (CSV) and modern Computer Software Assurance (CSA) methodologies. They must possess an in-depth, practical understanding of global health authority regulations-such as FDA 21 CFR Part 11 and EMA Annex 11-alongside familiarity with data privacy and enterprise security frameworks. A proven track record of guiding engineering teams through Agile/Scrum lifecycles, and designing integrated compliance artifacts directly into CI/CD pipelines, and successfully fronting live regulatory inspections is essential. Crucially, the ideal candidate must be a skilled cross-functional collaborator who can seamlessly translate complex security and regulatory constraints into clear, actionable technical requirements for development and quality partners. Ability to manage multiple projects across different sub-functions in a global, geographically diverse environment, and building and sustaining teams in times of ambiguity are all critical success factors for this role. An ideal candidate will adapt communication cadences and problem-solving skills to accommodate stakeholders, partners, and team members, exercise diplomacy and effective influence to reach consensus, and build strong relationships. **Essential Functions of the job:** + **In-House Product Validation & Lifecycle Integration** + Partner with software engineering and QA from product conception to embed compliance into Agile/Scrum lifecycles. + Oversee the authoring of critical validation deliverables (URS, FS, Risk Assessments, Traceability Matrices) during sprint cycles to eliminate retrospective documentation. + Collaborate with DevOps to transition traditional testing into automated verification workflows within CI/CD pipelines, generating audit-ready electronic records. + Design dynamic, delta-based validation strategies for iterative feature updates to accelerate continuous deployment without bloated validation cycles. + Define clear "Definition of Done" criteria that explicitly tie software completion to updated GxP technical specifications. + **Audit & Inspection Orchestration** + Lead the planning, execution, and wrap-up of all internal, mock, and external regulatory inspections for R&D. + Create and refine technical inspection storyboards to clearly articulate architectures, data flows, and compliance posture to auditors. + Coach and prepare product owners and engineering SMEs on interview techniques, audit protocols, and precise regulatory communication. + Direct front- and back-room operations during active audits to ensure the highly coordinated, rapid retrieval of documentation. + **Externally Sourced System Compliance & Platform Readiness** + Ensure all active externally sourced R&D IT systems & platforms maintain a continuous state of compliance. + Provide authoritative guidance on Computer Systems Validation (CSV) and champion the transition to Computer Software Assurance (CSA). + Assess and audit external technology vendors and SaaS providers to ensure third-party deliverables meet internal GxP standards. + **Regulatory Intelligence & Interpretation** + Act as the primary technical expert on global regulations, including FDA 21 CFR Part 11, EMA Annex 11, HIPAA, GDPR, and emerging AI/ML frameworks. + Translate evolving regulatory guidelines into actionable engineering guardrails, technical policies, and SDLC checkpoints. + Conduct regular gap assessments against new regulatory guidance and advise leadership on required strategic adjustments. + **Risk Management, Remediation & Quality Culture** + Manage the R&D Systems related Corrective and Preventive Action (CAPA) lifecycle, ensuring root causes are identified and remediations are executed on time. + Design and track compliance KPIs and systems risks for executive leadership visibility. + Cultivate a quality-first mindset within engineering teams, balanci