Quality Assurance Specialist, Commercial

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne 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 position's primary purpose is to support the end-to-end manufacture and release of commercial drugs at CMOs; support Quality Assurance activities within the BeiGene Quality Management System.

Essential Functions of the job:

• Review executed batch records associated with drug substance and drug product manufacturing and testing.
• Collaborate with contract manufacturing and testing sites to facilitate the manufacture, release and disposition of drug substance and drug product.
• Ownership of activities within electronic quality systems regarding change controls, investigations, and CAPAs and interfacing with contract manufacturing and testing sites to progress activities within electronic quality systems.
• Maintain batch genealogy summaries.
• Review CMO documents as QA reviewer, like MBR/CC application/deviation/ validation related.
• Collect and report data for performance metrics and annual product review.
• Support and implement or revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes.
• Support health authority inspections and internal audits, as needed.
• Provide regular updates on project progress and escalate challenges, as needed.
• Other duties as assigned.

Qualifications:  

• Minimum 3 years of experience in Quality function of pharmaceuticals or biotechnology industry.
• Understanding of Quality best practices, including familiarity with Quality Systems Regulations and GxPs.
• Strong knowledge of Good Manufacturing Practices (GMP)
• Excellent attention to details
• Ability to effectively manage time and progress tasks to meet timeline in a fast pace/dynamic environment.
• Effective oral and written communication skills 
• Experienced working cross-department with CMC, regulatory and SC
• Experienced interfacing with external manufacturing, packaging, and testing vendors
• Experienced in supporting projects towards process improvements.

Computer Skills:   

• PC literate with MS Office skills, including PowerPoint, Word, Excel.

Travel: 

• Occasionally, as required

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, 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

We are proud to be an equal opportunity employer and we value diversity. BeOne 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.