Senior Director, Quality Sciences and Knowledge Management

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:
The Senior Director, Quality Sciences and Knowledge Management, is responsible for strategic direction and for leading initiatives that ensure the highest standards of product quality, foster expertise in advanced quality technologies, and enhance organizational knowledge and risk management practices. This role includes acting as the Product Quality Lead (PQL) for high-priority programs, providing Subject Matter Expertise (SME) for complex quality scenarios, enabling global training and SME support for new technologies (e.g., combination products), and serving as the Business Process Owner (BPO) for Quality Risk Management (QRM).

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.
 

Essential Functions of the job:

Product Quality Leadership

• Serve as the PQL for assigned programs, ensuring alignment between quality strategies and product lifecycle stages.

• Oversee product quality performance monitoring and proactively address quality trends and risks.

• Lead cross-functional teams in resolving product quality issues to safeguard patient safety and product integrity.
   

Subject Matter Expertise & Problem-Solving

• Act as the SME for resolving complex quality challenges, such as multisite investigations and systemic issues.

• Guide root cause analysis (RCA), Corrective and Preventive Actions (CAPA), and continuous improvement initiatives.

• Provide leadership and technical guidance in advanced quality technologies, regulatory compliance, and risk management methodologies.
   

Training & Knowledge Management

• Develop and implement global SME training programs for new technologies (e.g., combination products)

• Establish frameworks for ongoing training, competency building, and knowledge sharing.

• Collaborate with cross-functional teams to ensure quality expertise is embedded in new product development and manufacturing.
   

Quality Risk Management (QRM)

• Serve as the Business Process Owner (BPO) for QRM, ensuring compliance with industry regulations (e.g., ICH Q9, FDA, EMA).

• Lead the development of QRM tools, policies, and governance frameworks.

• Provide oversight for risk management best practices across the organization.
   

Regulatory & Compliance Leadership

• Ensure adherence to global regulatory standards and industry best practices in quality systems.

• Represent the organization during regulatory audits, inspections, and external quality engagements.

• Drive continuous improvement in quality systems, knowledge management, and compliance.

• Perform other responsibilities as assigned.

Supervisory Responsibilities:  

•  Managerial responsibilities for the team

Skills and Qualifications:   

• Bachelors degree …