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 GVP Quality Lead, is responsible for supporting the Director GVP Quality in implementing and maintaining a balanced, proactive, global approach to GVP Quality Assurance. This position will be primarily responsible for ensuring PV activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards, procedures and practices.

Essential Functions of the job:

Conduct and support quality assurance (QA) activities related to applicable PV regulatory requirements, guidelines, laws and internally established standards, procedures and practices for all phases of drug developmentParticipate and support as member of the GVP QA team to enhance performance and maintain accountability for the implementation of QA systemsDevelop/improve and manage quality systems and processes to include:Conducting/managing routine/for cause audit of vendors, partner, internal audits etc.Supporting the activities related to the vendor management process training, SOPs, etc.Maintaining Key QA systems, such as investigations, Significant Quality Events (SQEs), Deviations, CAPAs, AuditsDeveloping and managing Integrated Quality Management Risk plansConducting/managing review of key PV documentsDeveloping quality metrics and measures to drive assessment and continuous improvementManagement and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriateCoordinate and/or administer GCP/GVP training, as neededParticipate in the review of metrics (i.e. deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends and the need for process improvementsCoordinate and support PV inspection readiness activities and contribute to regulatory health authority inspections conduct and managementExpert knowledge of GVP requirementsSuperb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environmentExercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for complianceStrong global knowledge and understanding of international PV regulations applicable to the conduct of clinical trials and pharmacovigilance operationsParticipate and represent R&D Quality in meetings and discussions, as neededOther duties as assigned

Qualifications:  

Bachelor’s degree, preferably in ScienceExpert knowledge of GVPs and GCP requirementsAbility to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factorsPromote continuous improvements in quality systems and department infrastructure; assist with creation / revision of appropriate SOPsProven ability in driving quality process improvement initiativesStrong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operationsExcellent English oral & written

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.