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BeiGene
About us
BeiGene 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 BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).
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.
Job Description:
General Description:
Oversight of Clinical Operations-specific CAPAs (internal to Clinical Operations departments and studies, and those associated with CAPAs due to vendor/partner/distributor oversight)
Clinical Operations department representative for support of internal and external audits and inspections
Support for Clinical Operations department for the preparation, conduct, and development of responses to health authority inspections of BeiGene's studies and operational activities
Reference point for strategic ICH-GCP queries
Coordinator for Clinical Operation audit responses with internal and external partners/vendors
Essential Functions of the job:
Tracks and performs trend analyses from internal and external audits and provides updates to APAC Management and presentations to Clinical Study Managers (CSMs) (as appropriate); communicates any critical compliance risks noted to APAC Management.
Be the GCP Subject Matter Expert for APAC region, excl Greater China.
Develops and performs training for Clinical Operations teams to assist with inspection readiness and responses to CAPAs following audits and inspections as applicable.
Performs reviews of Site Compliance Visit reports, reviews issues and compiles trending reports for APAC Clinical Operations.
Performs Site Compliance Visits.
Works with CSMs to assist with inspection/audit inspection readiness plans and study inspection readiness.
Collaborates closely with Clinical Operations team in APAC to ensure consistent approach to compliance oversight & CAPA tracking/closure.
Manages Clinical Operations corrective and/or preventative actions (CAPA) management plans to ensure compliance with applicable regulations, guidelines, and BeiGene policies/agreements.
Facilitates risk mitigation and escalates inadequate Clinical Operation audit responses to APAC Management.
Contributes to the development of process improvement initiatives that enhance compliance
Supports Clinical Operations regulatory inspections (MFDS, FDA, EMA, CFDA, PMDA etc.).
Ensures Clinical Operations audit report responses and CAPA plans are developed and completed within timelines as mandated by BeiGene QA policies & procedures.
Be the primary point of contact as Clinical Compliance lead for assigned compounds at regional level and support the execution of Global Clinical Compliance Strategy at Regional level. Including Issue Management and Inspection Readiness activities.
Qualification Required:
Education Required:
Bachelor's degree or higher in a scientific or healthcare discipline preferred.
Other Qualifications:
Bachelor's degree or higher in a scientific or healthcare discipline preferred.
10 years or above of progressive experience in within the biotech, pharmaceutical sector or CRO industry
3 years or above of Quality Compliance or Quality Assurance experience (Senior Manager level)
Documented training, knowledge, and application of current Regulations, GCP and ICH guidelines in clinical trials required
Regulatory authority inspection experience preferred. Especially, PMDA experience.
Strong written and verbal communication skills
Travel: Up to 30%
What We Offer To Our Valued Employees
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.
BeiGene 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 BeiGene’s global operation, job applicants’ data will be stored in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (https://www.beigene.com/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) BeiGene’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) BeiGene’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.
