Senior Director, Global R&D Audits & Inspections Readiness

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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