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 Specialist, External Supply Quality (ESQ), Clinical Product Quality supports quality operations at Contract Manufacturing Organisations (CMOs). The role is responsible to review and approve GxP documentation generated before, during and after manufacturing, testing, primary packaging as well as releasing of drug substances, drug products (including their intermediates) as well as finished goods manufactured and tested at Contract Manufacturing Organisations (CMOs), in collaboration with CMC teams and Clinical Supply Chain.

Essential Functions of the job:

Approve master batch records and review executed batch records associated with drug substance, drug product manufacturing, analytics, primary and secondary packaging in development scope (IMP).

Collaborate with contract manufacturing and testing sites to facilitate the manufacture, release and disposition of drug substance, drug product, intermediates and finished goods batches.

Ownership of activities within electronic quality systems including change controls, investigations, and CAPAs and interfacing with contract manufacturing and testing sites to progress activities within electronic quality systems.

Maintain batch genealogy summaries.

Collect and report data for performance metrics.

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.

Experience

Minimum 3 years of experience in Quality function of pharmaceuticals or biotechnology industry.

Education Required: 

Degree in science, laboratory, engineering or a related field, bachelor’s degree.

Other Qualifications:  

Understanding of Quality best practices, including familiarity with Quality Systems Regulations and GxPs.

Strong knowledge of Good Manufacturing Practices (GMP)

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 

Oral and written proficiency in English required. 

Experienced interfacing with external manufacturing, packaging, and testing vendors is a plus

Computer Skills:   PC literate with MS Office skills, including Teams, PowerPoint, Outlook, Word, Excel.

Travel: Occasionally, as required

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 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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

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.