수평: Mid-Senior level

직업 종류: Full-time

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작업 내용

Job Description

What  You’ll  Do  
  • Accountable for management of Quality operations activities with key/critical CMOs
  • Perform functions and make decision consistent with cGMPs, Good Distribution Practices (GDP) and Biogen's quality governance.
  • Ensure that the CMOs maintain quality systems that are in the state of compliance and aligned with Biogen expectations
  • Ensure appropriate corrective and preventive actions are defined, implemented and that their effectiveness is assessed.
  • Participate to technology transfer, scale-up or improvements projects through validation and on-site presence
  • Identify and timely communicate to the management any supply risk or risk of batch rejection
  • Prepare and manage Quality management Review and Quality agreement
  • Solves technical and operational problems in field of expertise based on existing policies, procedures and solutions.
  • Identify any compliance gap in Biogen processes and identify appropriate stakeholder to fix the issue Identify and drive opportunities of improvement/standardization in the purpose of continuous improvement of the system/process used
Who You  Are  

Qualifications

Being a seasoned quality assurance representative (preferably with experience in Gene Therapy and exposure to CMOs) you strive for process improvement and change status quo. You are an excellent communicator and are passionate to work in a cross-functional team with focus on compliance and patients.

Required Skills  
  • Strong quality mind-set
  • Strong communication skills.
  • Ability to work in an international matrix environment.
  • Negotiation skills
  • Ability to clearly articulate complex situation into resolution by providing path forward to the upper management
  • Strives for high level of autonomy with strong organizational skills to meet commitments.
  • Compassionate team player
  • Well-versed in managing relationships/building and maintaining network
  • At ease picking up new IT solutions swiftly
About This Role  

Additional Information

The main purpose of this job is to remotely provide Quality oversight to activities at external manufacturing and testing organisations (i.e. CMO). As such the position holder is the Relationship Manager for all Quality matters related to that CMO with focus on manufacturing and testing activities of clinical products associated with all product stages (API, Drug Substance, Drug Product and Packaging) and with primary focus on two modalities i.e. Gene Therapy and Oligonucleotides. Therefore, it is expected that this CMO Quality Lead manages compliant and un-interrupted supply of clinical products while working within a cross-functional team. This position is opened in the Global External Quality department and reports to the Head of External Quality Emergent Technology in Baar, Switzerland.
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마감 시간: 04-05-2024

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