Director, Product Quality Lead

BeOne Medicines Ltd.; San Mateo (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

BeOne Medicines Ltd. seeks a Product Quality Lead to drive global quality initiatives across platforms and molecule-level governance. You will lead risk assessments, investigations, and change controls while partnering with R&D, CMC, and regulatory teams to embed quality in development and lifecycle management.

The role requires advanced leadership, experience with QRM frameworks, and proven ability to mentor teams. Travel up to 20% may be required as part of global quality governance activities.

Qualifications

• Bachelor’s degree in a regulated field with 8+ years of relevant experience.
• Master’s degree preferred with 10+ years in quality sciences or related domains.
• Experience leading quality investigations, risk management and new tech adoption.

Responsibilities

• Represent the Quality Organization at platform and governance forums.
• Function as SME for quality risk assessment, investigations, and change control.
• Lead Product Quality Network teams across late-phase programs.
• Collaborate with R&D, manufacturing (CMC) and regulatory teams on quality in development
• Advise on CMC strategies and risk management for commercialization
• Drive quality performance monitoring and continuous improvement
• Lead cross-functional teams to strengthen quality systems
• Develop and implement QRM frameworks aligned with ICH Q9
• Support regulatory inspections and audits
• Mentor and develop quality staff and SME networks
• Stay abreast of emerging scientific trends and their impact on BeOne BeiGene products

Skills

Leadership

Quality investigations

Risk management

Cross-functional collaboration

Mentoring & training

Education

Bachelor's degree

Master's degree

Tools

Mintab

JMP

Tableau

SciLab

Job description

General Description:

The Product Quality Lead, as part of the Quality Sciences and Knowledge Management organization, will play a critical role in advancing global quality initiatives, ensuring the highest standards of product quality, and fostering expertise in emerging quality technologies. This position will contribute to quality risk management, knowledge-sharing strategies, and the development of technical training programs to strengthen compliance, operational excellence, and innovation. The PQL will support cross-functional collaboration, drive process improvements and enhance the organization's approach to quality governance.

This individual will collaborate across functions and sites to drive continuous improvement, ensure regulatory compliance, and build a robust knowledge‑sharing and risk management culture.

• Represent the Quality Organization at platform level through participation in molecule level governance meetings and forums.

• Serve as a Subject Matter Expert (SME) and Facilitator for quality risk assessment, investigations, change control, and resolution of complex quality issues including review of regulatory CMC submission content

• Manage Product Quality Network teams responsible for deliverables for multiple late‑phase clinical or commercial programs

• Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management.

• Advise on CMC strategies and quality risk management for commercialization including strategies for in process controls, specifications, stability, and comparability

• Contribute to product quality performance monitoring, identifying trends and driving improvements.

• Lead or participate in cross‑functional teams to improve quality systems and address systemic challenges.

• Support the development and implementation of Quality Risk Management (QRM) frameworks, ensuring compliance with regulatory requirements (e.g., ICH Q9).

• Support regulatory inspections and audits, ensuring alignment with global quality standards and best practices.

• Actively mentoring new and existing team members to develop core Product Quality skills and leadership skills

• Understanding and responding to the impact of emerging scientific/technical trends and their implications for BeOne / BeiGene Products.

• Perform other related responsibilities as assigned.

Education/Experience Required:

• Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).

• Master’s degree and 10+ years experience preferred

Supervisory Responsibilities:

• 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

• Experience in statistical modeling software (Mintab, JMP, Tableau, SciLab

Other Qualifications :

• 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 (e.g., FDA, EMA), and risk management frameworks (e.g., ICH Q9).

• Strong leadership and problem‑solving skills, with the ability to manage complexity and ambiguity.

• Experience in developing and delivering global training programs ad fostering SME networks.

• Proficiency in quality tools and methodologies (e.g., root cause analysis, Lean, Six Sigma).

• Ability to communicate complex information clearly and effectively across business functions

Travel: Up to 20%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.