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 position will report to the Senior Director, Head of Quality, New Markets. The Director, Cluster Quality lead, New Markets, will provide GMP/GDP expertise in the assigned region and supervise the affiliate setup, commercial launch, post marketing quality activities (complaint, recall etc.), distribution of IMPs and commercial products within assigned region for BeiGene (mainly MENA region & surrounding countries >15 countries) and ensure the compliant affiliate setup, structure, interdependencies and supply with medicinal products and Quality oversight of all Distributors in the assigned region. The incumbent will ensure that clinical and commercial products are supplied to these markets in accordance with regulatory expectations and applicable quality standards.

Essential Functions of the job:

Ensure that the affiliate Quality Management System complies with relevant national and international guidelines and internal policies/global standards/SOPs are met.Collaborates with Distributors in the assigned territory and ensures their onboarding and qualification.Act as single point of contact for Distributors in the assigned territory.Manages Quality Agreements, Deviations, Temperature Excursions, Change Controls and CAPAs for their assigned territoryAssess and revise, as needed, SOPs and identify opportunities to streamline systems and processes. Create and maintain required documents and records in the QMS system.Actively contribute to establish and review Global Quality Standards to ensure compliance with local law requirements.Point of Quality contact for all operational Quality topics for Commercial and Investigational Medicinal Products for MENA region and assigned territory.In country/region product disposition as necessary and collaborate for batch disposition of finished products with Responsible Persons/Qualified Persons as required.Oversee product complaint handling in the assigned territory.Support the Head of Quality New Markets the launch setup.Ensure that all quality processes are compliant, sustainable and meet Health Authorities expectations.Participate in Due Diligence activities.Support internal audit and Health Authority Inspections.Support functions and SMEs to maintain and improve the inspection readiness process/mock audits.Advise and support agreements (e.g. Quality Distribution, Service, Master, Collaboration) regarding content, implementation, review and updates.Support regulatory filings, as needed.

Experience & Qualifications:

Bachelors Degree in science. Masters degree preferred. More than 10 years pharmaceutical or biotechnology industry experience.Extensive GMP and GDP experience in a quality and manufacturing function.Quality experience as RP/QP or acting as Regional Quality HeadFrench & Arabic language skills is an assetKnowledge of setting up QMS in AffiliatesWorked in commercial environment, technical development and clinical environment experience is an asset as well as regional experience in Middle East North Africa region.

Core Knowledge and Skill Requirements:

In-depth knowledge of GMPs and GDPs.Experience working with Distributors or Logistic ProvidersIn- depth knowledge of QMS set up in Affiliates  In-depth knowledge of Quality principles, concepts, industry practices and standards.Working Knowledge and experience with local and regional pharmaceutical regulations and experience in working with different regulatory authorities.Excellent verbal, written and interpersonal communication skills.Ability to work independently with scientific/technical personnel.Experience with regulatory compliance inspections.Apply principles of logical and scientific thinking to a wide range of intellectual and practical problems.Must possess strong presentation skills to speak effectively before groups; ability to respond.Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.Strong Project Management Skill Set.

Supervisory Responsibilities:  

MENA region and surrounding countries

Computer Skills:   

PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio)Veeva Vault Quality Docs; Veeva Vault Quality Suite; Veeva Submissions; SAPUL ComplianceWire; UL LearnShare

Travel: 

May travel approximately 25 %

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.