Full Time

AD/SM of QA for Viral Clearance Study for GZ Bio-island

Posted 1 month ago
Application ends: November 15, 2021
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Job Description

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

POSITION DESCRIPTION

  • The successful candidate will play a key role in building and leading the QA/QC function within the Research Support organization at BeiGene’s Bio-Island Innovation Center. The responsibilities of this position will include direct supervision of GLP operations and drives on-time execution of project delivery for clients on QA perspective

Responsibilities

  • Build the quality assurance system for the biosafety unit with CNAS and GLP standard requirement. Lead the cross functional team to ensure ISO9001, SGS and CMA certification.
  • Set up the QA system including standards and SOPs to ensure successful submission and approval of IND/NDA/BLA by regulatory authorities to support small and biological drug development. Drive on time delivery of QA reports with quality and speed. Provide final regulatory required QA documents to support client’s IND/BLA filing (NMPA, FDA, EU, etc).
  • Work closely with the clients to give appropriate solutions for their viral clearance validation process or drug development from QA perspective.
  • Lead the QA/QC group to work with scientists for projects and develop various tests. Supervisor QC staff to identify assays problems and oversees trouble shooting or improvement of these assays when deviation occurs.
  • Lead team to host audit or inspection from authorities or clients. Do validation according to GxP requirements.
  • Responsible for QA training, managing and evaluating as well as coordinating, scheduling and assigning work within QA/QC team and maintaining standards.
  • Perform routine housekeeping checks on a daily, weekly and monthly basis, to ensure high standards of regulatory compliance.
  • Stay current with the latest quality and regulation developments, maintain an international perspective.
  • Responsible for adherence to health and safety procedures and general use of the facility.

Qualifications

Qualification Required:

  • At least 8 years experiences in pharmaceutical field, validation or quality assurance aspect.
  • Excellent audit knowledge and PM experience during auditing or be audited.
  • Master with GMP or GLP regulations and has rich experience and knowledge with approved success record of IND/BLA filing (China, EU, USA).
  • Familiar with a variety of biologics drug purification processes is a plus: such as Low PH, affinity, cation and anion chromatographic separation, depth filtration, virus filtration, ultrafiltration, ultracentrifugation, and other impurity clearance steps.
  • Proven team leader with rich experience of effiency.
  • Ability to manage multiple projects/ initiatives in a fast-paced environment.
  • Excellent interpersonal, communication and presentation skills. Ability to effectively collaborate with internal and external partners and drive towards scientific goals in a dynamic, cross-functional matrix environment.
  • Well written documents, record and presentation.

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