Senior Manager Quality, Australia New Zealand

2 weeks ago

Sydney, New South Wales, Australia BeiGene, Ltd. Full time

Senior Manager Quality, Australia New Zealand page is loaded Senior Manager Quality, Australia New Zealand Apply locations Australia - Home Office Sydney time type Full time posted on Posted 2 Days Ago job requisition id R24649 Bei Gene 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.


Job Description:

About Bei Gene:
Bei Gene (

NASDAQ:
BGNE;

HKEX:
06160;

SHA:

is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide.

With a broad portfolio of more than 40 clinical trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030.

Bei Gene is a headquarter-less company by design, with a growing global team of over 10,000 colleagues across five continents.


About the Position:

General Description:
Ensurecompliantanduninterruptedsupplyof Bei Genecommercialproductsortheimportproductsfrom collaboration partners in accordance with Bei Gene's quality management system and Australia/New Zealandcountries'regulatory authorityexpectations .

Provide qualityoversightof third-party vendors in Australia/New Zealand, clinical GMP quality activity and the management of temperature excursions, product complaints and deviations.


Essential Functionsofthejob:

  • Ensurelocalactivities(AU/NZ)comply GDP(Good Distribution Practice) orrelevantc Gx Pand Bei Gene's Quality Management System.
  • In country disposition / release activities for Australia/NZ and provide support as back up toother APACcountries as required.
  • Develop,update,andmaintainlocalqualityprocedures andprovideinputinto APACprocessand proceduresas required.
  • Complaint,deviation, clinical and commercialtemperatureexcursionhandlingaccordingthe Bei Gene QMSandas per regulatoryrequirements
  • Supportthemanagementof commercial/clinicalproductrecalls,counterfeits, andproducttamperingaccording tothe Bei Gene QMSandtheregulatory requirements.
  • Quality oversight of 3rd party providers within the commercial and clinical supply chain– includingqualification,audits,qualityagreements,monitoringactivity,participatein KPIandbusinessreviews andidentifycompliancetrendsthatrequireimprovement.
  • Participate/respondtoauditsandself-assessmentsforresponsiblecountriesincludingconductas requiredself-assessments for other APACregions.
  • Managementoftemperaturesensitiveproductsincludingqualitysupportfor lanequalifications,shipperqualification,temperatureexcursionassessments,transportvalidation
  • Completetherelevantqualityactivityand/or assessmentrequiredforchangecontrolparticularlywithnew productintroductions/lifecyclechanges/distributionreadiness.
  • Gx Ptrainingcontentdeliveryfor Australia andother APAC countriesasrequired.
  • Actasdelegate/backuptothe Country Leadasrequiredforcriticalsystems.
  • Contributeandparticipateintheregional/globalmanagementreviewassubjectmatter expertforsystems withinremit.
  • Subject Matterexpertandnetworkrepresentativefor APACregionandprovidesystemsupporttotheregionas requiredincludingdeviations.
  • Provideonsiteinspectionsupportincountryasrequiredbythe GMPcomplianceteam.
  • Providequalityoversightforcommercialprograms–e.g.,patientsupportprograms Core Competencies, Knowledge, and Skill Requirements Life sciences or equivalent tertiary degree or direct relevant experience to complete required responsibilities.

Minimum of 10 years' experience in pharmaceutical/biological pharmaceutical company Minimum of 5 years' experience in quality management of imported commercial/clinical medicines.

Experience in complaint handling and temperature excursion management Experience in oversight the drug wholesaler and distributors Knowledge and understanding of the current PIC/s Guide to GMP for Medicinal Products, US and EU Good Manufacturing Practices (GMP), and International Conference on Harmonization (ICH) guidelines.

Experience with regulatory compliance inspections Experience with cold chain distribution and working with vendors throughout the supply chain.
Communication & Interpersonal Skills Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.
Excellent time management and prioritization skills Proven success working on collaborative projects with supply chain, regulatory, commercial operations.
Good written and verbal communication skills, interpersonal skills, and technical writing skills.
Ability to manage stakeholders and escalate issues as appropriately.

Successful at working from home across multiple time zones on an ongoing basis Significant Contacts Interacts with all levels of Bei Gene employees; CMOs, 3 rd party logistics, wholesalers, customers.


Qualification Required:
REQUIREMENTSExperience10+ years of experience in pharmaceutical industry5+ years of experience in quality role Strong knowledge and experience with GMP and GDP regulations Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems Demonstrated understanding of the commercial product lifecycle Highly regarded Project management experience Experience in APAC regional support Audit experience Project management experience Line management experience Veeva platform capabilities Supply chain experience including understanding of wholesale supply mechanisms

Supervisory Responsibilities:
Dependentonexperience What we offer to our valued employees: Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant and performance-based annual equity plan)

In-house and external learning and development opportunities Fantastic benefits program and keep improvingPlus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear:
Cancer has no borders and neither do we.
Bei Gene is proud to be an

Equal Opportunity Employer:
We are proud to be an equal opportunity employer and we value diversity.

Bei Gene 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.

Bei Gene 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 Bei Gene is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations.

Due to Bei Gene's global operation, job applicants' data will be stored overseas with adequate protection.

Besides, job applicants' data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in Bei Gene.

For further details, please refer to Bei Gene's Job Applicant Privacy Policy ( ).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) Bei Gene's Job Applicant Privacy Policy as well as the relevant privacy terms.

If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) Bei Gene's Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.

About Us Bei Gene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.

With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.

We are committed to radically improving access to medicines for far more patients who need them.

Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.

S.

To learn more about Bei Gene, please visit and follow us on Linked In and X (formerly known as Twitter).

To Mainland China Candidates For more information, please visit the link to explore job opportunities in China Mainland.
At Bei Gene, how we work is just as important as the work we do.
Below are our Values that determine the decisions we make and how we do things.
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