Global R&D Audit & Inspection Readiness Lead

BeiGene; United States; Remote; USD 148,000 - 193,000; Full time

Job summary

BeOne seeks a Senior Manager, Global R&D Audits & Inspections Readiness to drive regulatory compliance across R&D technology solutions. You will coordinate validation, audit readiness, and vendor compliance while partnering with software engineering, Quality, Compliance, and Enterprise IT teams.

You will translate regulatory expectations (FDA/EMA/GxP) into actionable SDLC controls, lead inspection readiness activities, and guide SME preparations to support audits and CAPA remediation.

Qualifications

• Bachelor’s degree related to IT, quality, or life sciences.
• 7+ years in IT compliance, quality assurance, or validation in pharma/biotech.
• 3+ years supporting audit/inspection readiness, mock audits, or regulatory inspections.
• Practical experience embedding GxP in Agile/Scrum, SDLC, validation, and DevOps/CI-CD workflows.
• Willingness to travel as required.

Responsibilities

• Lead audit readiness and inspection coordination for R&D IT systems.
• Oversee validation documents (URS, FS, risk assessments, evidence) and release readiness.
• Manage externally sourced systems, vendor compliance, and CSA/CSV activities.
• Translate regulatory expectations into concrete SDLC actions for engineering teams.
• Promote a quality-first culture with emphasis on data integrity and security.

Skills

GxP compliance

CSV/CSA

Audit readiness

Regulatory translation

Agile / Scrum

Documentation discipline

Risk-based thinking

Inspection readiness

Cross-functional collaboration

Education

Bachelor's degree in Computer Science, Information Technology, Bioengineering, Life Sciences, Quality, Regulatory, or related field

Advanced degree is a plus

Job description

BeOne seeks a Senior Manager, Global R&D Audits & Inspections Readiness to drive regulatory compliance across R&D technology solutions. You will coordinate validation, audit readiness, and vendor compliance while partnering with software engineering, Quality, Compliance, and Enterprise IT teams.

You will translate regulatory expectations (FDA/EMA/GxP) into actionable SDLC controls, lead inspection readiness activities, and guide SME preparations to support audits and CAPA remediation.