Global Director, Analytical Quality Lead – Small Molecules

BeiGene; United States; Remote; USD 168,000 - 228,000; Full time

Job summary

BeOne Medicines Ltd. is seeking an Analytical Technical Lead to serve as the global point of contact for analytical activities across major markets.

You will drive lifecycle management, support regulatory submissions, and ensure process harmonization to maintain compliant, high-quality products. The role requires strong leadership in GMP QC, method validation, stability trends, and data integrity, with up to 20% travel.

Qualifications

• Bachelor’s degree and 10+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility required.
• Master’s degree and 7+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility preferred.
• Doctoral Degree and 5+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility desired.

Responsibilities

• Act as the global PoC for all analytical-related matters for assigned products.
• Provide governance and technical leadership for analytical topics spanning DS, DP, and critical raw materials/reagents.
• Translate global product strategy into aligned expectations and deliverables for internal QC sites, external QC labs/CMOs, AST, and MST.
• Lead and approve strategy for analytical investigations and CAPA, including method optimization.
• Drive analytical change control impact assessments and execution plans, including method updates and revalidations.
• Own escalation management for supply-critical analytical events; align actions with Quality, Regulatory, and Supply Chain.
• Serve as global business process and knowledge owner for methods, specifications, stability, and retest/shelf life.
• Provide analytical SME leadership for global regulatory submissions and health authority interactions.

Skills

GMP QC

Analytical sciences

Technical writing

Root cause analysis

Data integrity

MS Office

Education

Bachelor’s degree

Master’s degree

Doctoral Degree

Tools

MS Office

Job description

BeOne Medicines Ltd. is seeking an Analytical Technical Lead to serve as the global point of contact for analytical activities across major markets.

You will drive lifecycle management, support regulatory submissions, and ensure process harmonization to maintain compliant, high-quality products. The role requires strong leadership in GMP QC, method validation, stability trends, and data integrity, with up to 20% travel.