Senior Director, Global R&D Audits & Inspections Readiness

BeiGene

1d•$207,800 - $277,800•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Computer Science, Information Technology, Bioengineering, Lifecycle Sciences, or a related field.
12+ years of experience in IT compliance, quality assurance, or software engineering within the pharmaceutical, biotech, or medical device industry.
5+ years of experience directly leading or orchestrating audit/inspection readiness activities, mock audits, or live health authority inspections (FDA, EMA, MHRA, etc.).
Proven experience working inside modern software engineering environments, explicitly embedding GxP compliance within Agile/Scrum methodologies and automated CI/CD pipelines.
Deep, authoritative understanding of global regulations and guidelines, specifically FDA 21 CFR Part 11, EMA Annex 11, and GAMP 5 principles.
Strong working knowledge of standard Computer Systems Validation (CSV) workflows paired with practical experience implementing modern Computer Software Assurance (CSA) risk-based testing practices.
Good understanding of data integrity frameworks (ALCOA+) and healthcare privacy regulations (HIPAA, GDPR) as they apply to research, tech, and clinical data repositories.
Business relationship management acumen and demonstrable success as a change agent leading or contributing to significant transformational initiatives in organizations.
Accomplished in building and development of people and teams, comfortable working with a broad cross section of people in direct and matrixed relationships
Proficient in various project management disciplines (i.e., Agile, Scrum, Kanban, Lean etc.)

Nice To Haves

An advanced degree is a plus.
Certified Quality Auditor (CQA) or Certified Manager of Quality/Organizational Excellence (CMQ/OE)
Certified Information Systems Auditor (CISA)
Agile/Scrum certifications (Certified ScrumMaster, Product Owner) indicating an understanding of modern dev workflows.

Responsibilities

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.
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.
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.
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.
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, balancing agile development velocity with rigorous regulatory alignment.
Lead, mentor, and manage a high-performing GRDTS team dedicated to the inspections & audit readiness.
Foster a culture of innovation, accountability and drive professional development.
Liaise with vendors, Enterprise IT partners, audit, and compliance to coordinate system implementation and change activities.
Ensure the team is trained in and embeds CSV, compliance, and health authority requirements into operational activities.
Collaborate with the broader GTS (Enterprise IT) organization, Quality & Security functions.
Collaborate with other teams on standards and best practices.
Engage with peers to define, sponsor, and execute continuous improvements.
Lead, mentor, and manage a high-performing GRDTS team dedicated to the Development function.