Head of Product Quality & Regulatory Risk

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

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. is seeking a Product Quality Lead to advance global quality initiatives and strengthen knowledge management across platforms.

You will drive quality governance, risk management practices, and cross-functional collaboration to enhance product quality and regulatory compliance. The role involves leading SMEs, coordinating with R&D, manufacturing, and regulatory teams, and mentoring team members to build critical Product Quality capabilities.

Qualifications

• Bachelor’s degree in a regulated industry with extensive quality science or quality systems experience.
• Master’s degree preferred with 10+ years in related field.

Responsibilities

• Represent the Quality Organization at platform level and governance meetings.
• Serve as SME for quality risk assessment, investigations, change control, and complex issue resolution including CMC submissions.
• Lead Product Quality Network teams supporting late-phase clinical or commercial programs.
• Collaborate with R&D, manufacturing (CMC) and regulatory teams to embed quality in development and lifecycle.
• Advise on CMC strategies and quality risk management for commercialization, including in-process controls and specifications.
• Monitor product quality performance, identify trends, and drive improvements.
• Mentor and develop team members to build core Product Quality skills.

Skills

Quality risk management

Cross-functional collaboration

Leadership

Quality investigations

Regulatory compliance

Education

Bachelor's degree

Master's degree

Tools

Mintab

JMP

Tableau

SciLab

Job description

BeOne Medicines Ltd. is seeking a Product Quality Lead to advance global quality initiatives and strengthen knowledge management across platforms.

You will drive quality governance, risk management practices, and cross-functional collaboration to enhance product quality and regulatory compliance. The role involves leading SMEs, coordinating with R&D, manufacturing, and regulatory teams, and mentoring team members to build critical Product Quality capabilities.