Global Product Quality Lead & Risk Champion

Regulatory Jobs; United States; Remote; USD 172,000 - 232,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Product Quality Lead to advance global quality initiatives within the Quality Sciences and Knowledge Management organization.

The role drives quality risk management, knowledge-sharing, and training programs to strengthen compliance, operations, and innovation. You will collaborate across functions and sites, lead quality investigations, change control, and CMC strategy discussions, mentoring teams while promoting a robust risk-management culture.

Qualifications

• Bachelor’s degree in a life sciences, quality or related field.
• Master’s degree preferred with 10+ years of experience.
• Extensive experience in leading quality investigations, risk management, and implementing new technologies.

Responsibilities

• Represent the Quality Organization at platform level through governance meetings.
• Serve as SME for quality risk assessment, investigations, change control, and CMC review.
• Manage Product Quality Network teams for late-phase programs.
• Collaborate with R&D, manufacturing (CMC) and regulatory to embed quality in development and lifecycle management.
• Advise on CMC strategies and quality risk management for commercialization.
• Contribute to product quality performance monitoring and trend improvements.
• Lead or participate in cross-functional teams to improve quality systems.
• Develop and implement Quality Risk Management frameworks ensuring regulatory compliance.
• Support regulatory inspections and audits.
• Mentor team members to develop core Product Quality skills and leadership.

Skills

Quality leadership

Quality risk assessment

Regulatory knowledge

Cross-functional collaboration

Process improvement

Quality systems

Mentoring

Education

Bachelor’s degree in Life Sciences/Quality

Master’s degree preferred

Tools

Mintab

JMP

Tableau

SciLab

Excel

Job description

BeOne Medicines Ltd. is seeking a Product Quality Lead to advance global quality initiatives within the Quality Sciences and Knowledge Management organization.

The role drives quality risk management, knowledge-sharing, and training programs to strengthen compliance, operations, and innovation. You will collaborate across functions and sites, lead quality investigations, change control, and CMC strategy discussions, mentoring teams while promoting a robust risk-management culture.