BeOne Medicines

BeOne Medicines

Senior Director, Global R&D Audits & Inspections Readiness

Remote (US) · Director

Sponsorship not specifiedDetected 9 hours ago
Cloud PlatformsCI/CDDevOpsMachine LearningComplianceAgileAuditingLogisticsHIPAAFDA RegulatoryMedical DevicesResearchLeadershipCommunicationCollaborationProblem SolvingMentoringGxPCertified ScrumMaster

About the role

  • 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.

Responsibilities

  • Lead, mentor, and manage a high-performing GRDTS team dedicated to the Development function.
  • 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.
  • Proactive Continuous Quality Drive: Commitment to keeping all data repositories, systems, and platforms in a state of "perpetual readiness".
  • Continuous Validation Execution Playbooks: Documented delta-validation strategies and automated compliance frameworks built for CI/CD pipelines to support iterative feature releases.
  • 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.
  • Vendor & SaaS GxP Assessment Reports: Detailed compliance scorecards, audit notes, and risk ratings generated from evaluating third-party software and cloud infrastructure 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.
  • Liaise with vendors, Enterprise IT partners, audit, and compliance to coordinate system implementation and change activities.

Requirements

  • Conduct regular gap assessments against new regulatory guidance and advise leadership on required strategic adjustments.
  • 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 di

Nice to have

  • Bachelor's degree in Computer Science, Information Technology, Bioengineering, Lifecycle Sciences, or a related field.
  • An advanced degree is a plus.

Benefits

  • 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.
  • Ensure the team is trained in and embeds CSV, compliance, and health authority requirements into operational activities.
  • 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.
  • Exceptional poise and strategic thinking when managing live health authority inspections, guiding engineering SMEs on interview techniques and precise communication protocols.
  • 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.).
  • Good understanding of data integrity frameworks (ALCOA+) and healthcare privacy regulations (HIPAA, GDPR) as they apply to research, tech, and clinical data repositories.

Company info

  • At BeOne we believe that access to life-changing medicine sees no borders.

Visa & Work Authorization

  • Engage with peers to define, sponsor, and execute continuous improvements
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This listing is sourced directly from BeOne Medicines's careers page and normalized into a canonical job model.