[Hiring] Senior Manager, Global R&D Audits & Inspections Readiness @BeiGene

Role Description

The Senior Manager, Global R&D Audits & Inspections Readiness is an execution-focused role responsible for helping maintain a continuous state of regulatory compliance and inspection readiness for R&D technology solutions. Reporting to the Senior Director, this role translates audit readiness strategy, validation-by-design principles, regulatory expectations, and quality standards into practical day-to-day execution across assigned systems, products, vendors, and readiness activities.

The role partners closely with software engineering, product owners, Quality, Compliance, Enterprise IT, Security, vendors, and R&D stakeholders to embed GxP compliance, computerized systems validation (CSV), Computer Software Assurance (CSA), and data integrity expectations into Agile / Scrum delivery, automated testing, CI/CD practices, system lifecycle documentation, and operational support activities.

A successful candidate brings practical GxP compliance, CSV / CSA, audit readiness, and technology delivery experience, with the ability to coordinate detailed execution across multiple stakeholders. The role requires strong documentation discipline, risk-based thinking, inspection composure, and the ability to translate regulatory and quality expectations into clear technical actions for engineering and product teams.

Qualifications

• Bachelor’s degree in Computer Science, Information Technology, Bioengineering, Life Sciences, Quality, Regulatory, or a related field. An advanced degree is a plus.
• 7+ years of experience in IT compliance, quality assurance, software engineering, systems validation, audit readiness, or related technology quality roles within the pharmaceutical, biotech, or medical device industry.
• 3+ years of experience supporting audit / inspection readiness activities, mock audits, regulatory inspections, vendor audits, validation programs, CAPA execution, or compliance remediation.
• Practical experience embedding GxP compliance into Agile / Scrum delivery, system lifecycle practices, validation documentation, test evidence management, and/or DevOps / CI/CD workflows.

Requirements

• Strong working knowledge of FDA 21 CFR Part 11, EMA Annex 11, GAMP 5 principles, CSV, CSA, data integrity expectations such as ALCOA+, and relevant privacy / security considerations such as HIPAA and GDPR.
• Ability to apply risk-based testing, delta validation, change impact assessment, requirements traceability, evidence review, vendor compliance assessment, and inspection readiness practices.
• Familiarity with modern software delivery, cloud / SaaS platforms, externally sourced systems, AI/ML technology considerations, and regulated R&D data environments.

Benefits

• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and participation in the Employee Stock Purchase Plan.
• Annual bonus plan for Non-Commercial roles and incentive compensation plan for Commercial roles.

Salary Range

$147,800.00 - $192,800.00 annually. Actual compensation packages are determined by several factors unique to each candidate.

Company Description

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.