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 with 12+ years, Advanced Degree with 8+ years, or PhD/PharmD/MD with 6+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices). Advanced degree in life sciences, quality management, or related field preferred.

• 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% internationally

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.