Director, Global Product Quality & Risk

BeOne Medicines Ltd.; United States; On-site; USD 172,000 - 232,000; Full time

Benefits offered by this job

Medical benefits

Retirement plan (401k)

Paid time off

Wellness program

Job summary

BeOne Medicines Ltd. seeks a Product Quality Lead to advance global quality initiatives and strengthen risk management and knowledge sharing across sites. You will guide governance, drive continuous improvement, and develop training programs to elevate compliance and operational excellence.

The role requires leading investigations, implementing new technologies, and partnering with diverse teams to ensure top-tier product quality in a regulated environment.

Qualifications

• Bachelor's degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (pharma/biotech/medical devices).
• Master's degree and 10+ years experience preferred.
• 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
• Advanced degree in life sciences, quality management, or related field.
• Extensive experience in leading quality investigations, quality risk management, and implementing new technologies.
• Expertise in quality systems, regulatory requirements (FDA, EMA), and risk management frameworks (ICH Q9).
• Strong leadership and problem-solving skills, with the ability to manage complexity and ambiguity.
• Experience in developing and delivering global training programs and fostering SME networks.
• Proficiency in quality tools and methodologies (root cause analysis, Lean, Six Sigma).
• Ability to communicate complex information clearly and effectively across business functions

Responsibilities

• Lead quality initiatives within Quality Sciences and Knowledge Management.
• Advance global quality programs and knowledge-sharing strategies.
• Drive regulatory compliance, risk management, and continuous improvement.
• Develop technical training programs and strengthen SME networks.
• Collaborate across sites to foster governance and operational excellence.

Skills

Leadership

Problem-solving

Communication

Cross-functional collaboration

Analytical thinking

Quality governance

Education

Bachelor's degree

Master's degree

Tools

Mintab

JMP

Tableau

SciLab

MS Office

Job description

BeOne Medicines Ltd. seeks a Product Quality Lead to advance global quality initiatives and strengthen risk management and knowledge sharing across sites. You will guide governance, drive continuous improvement, and develop training programs to elevate compliance and operational excellence.

The role requires leading investigations, implementing new technologies, and partnering with diverse teams to ensure top-tier product quality in a regulated environment.