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, balancing agile development velocity with rigorous regulatory alignment.

• GRDTS Leadership:

• + •

Team Leadership & Talent Development:

• + 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. +

• Operational Excellence, Compliance & Governance:

• + 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. +

• Collaboration & Partnership:

• + 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.

• Supervisory Responsibilities:

• + Lead, mentor, and manage a high-performing GRDTS team dedicated to the Development function.

• Key Capabilities :

• +

Agile Validation-by-Design:

Embedding GxP compliance directly into active sprint cycles and DevOps CI/CD pipelines, translating traditional, retroactive paper-based testing into automated electronic verification. + Modernized Validation Execution (CSV to CSA): Applying risk-based Computer Software Assurance (CSA) concepts to focus testing efforts on critical-to-quality elements while streamlining delta-based validations for continuous deployments. +

Audit & Inspection Orchestration:

Directing end-to-end strategy for internal and health authority inspections (FDA, EMA, MHRA)—including managing front/back room logistics, developing technical storyboards, and rapid document retrieval. +

Technical Regulatory Interpretation:

Translating global regulations (21 CFR Part 11, Annex 11, GAMP 5) and emerging guidelines (AI/ML frameworks) into explicit "Definition of Done" engineering criteria and SDLC checkpoints. +

Quality Lifecycle Management & Remediation:

Root-cause investigation and complete lifecycle ownership of IT Corrective and Preventive Actions (CAPAs), technical gap assessments, and technology vendor audits.

• Key Competencies :

• +

Risk-Based Operational Mindset:

Focusing on product quality and data integrity (ALCOA+) rather than absolute documentation volume; using risk profiles to accelerate deployment timelines safely. +

Cross-Functional Diplomatic Agility:

Acting as a cultural bridge who can speak engineering, agile development, and rigid regulatory compliance simultaneously to win buy-in from both software engineers and traditional quality auditors. +

Composure Under Inspection Scrutiny:

Exceptional poise and strategic thinking when managing live health authority inspections, guiding engineering SMEs on interview techniques and precise communication protocols. +

Objective Third-Party Evaluation:

Unbiased technical due-diligence when auditing external SaaS providers and third-party vendors to verify compliance against internal GxP standards. +

Proactive Continuous Quality Drive:

Commitment to keeping all data repositories, systems, and platforms in a state of "perpetual readiness".

• Key Deliverables :

• Product Life-Cycle & Validation Artifacts
• +

Synchronous Validation Package:

Real-time generation of User Requirement Specifications (URS), Functional Specifications (FS), Risk Assessments, and Traceability Matrices co-authored directly inside active sprint cycles. +

Continuous Validation Execution Playbooks:

Documented delta-validation strategies and automated compliance frameworks built for CI/CD pipelines to support iterative feature releases. + GxP Definition of Done (DoD)

Criteria:

Formal documentation appending GxP technical specifications and compliance checkboxes directly to the engineering team's software release definitions.

• Inspection Readiness & Defense
• +

Technical Inspection Storyboards:

Pre-authored, visually mapped explanations of IT architectures, data flows, and automated compliance frameworks to clearly explain systems to regulatory inspectors. +

SME Audit Coaching Curricula & Protocol Guides:

Structured training materials, interview simulations, and communication protocol playbooks designed to prepare product owners and engineers for auditor interactions.

• Risk, Governance & Quality Metrics
• +

IT CAPA Files & Root-Cause Determinations:

Formally logged, thoroughly investigated, and on-time executed Corrective and Preventive Actions addressing any flagged system or process gaps. +

Vendor & SaaS GxP Assessment Reports:

Detailed compliance scorecards, audit notes, and risk ratings generated from evaluating third-party software and cloud infrastructure partners. +

Compliance KPIs & Regulatory Risk Dashboards:

Data-driven reporting structures tracking the real-time compliance posture, platform drift, and pending gaps of active platforms for executive leadership

• Qualifications & Experience
• + Bachelor's degree in Computer Science, Information Technology, Bioengineering, Lifecycle Sciences, or a related field.

An advanced degree is a plus. + 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.

• Technical & Regulatory Knowledge
• + 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.

• Preferred Certifications
• _(Possession of one or more is highly desirable)_
• + 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.

• Other Qualifications:

• + 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.)

• Travel:

• + Some travel expected as part of assigned duties

• BeOne Global Competencies:

• When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

+ Fosters Teamwork + Provides and Solicits Honest and Actionable Feedback + Self-Awareness + Acts Inclusively + Demonstrates Initiative + Entrepreneurial Mindset + Continuous Learning + Embraces Change + Results-OrientedAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.