CMO Quality Lead

Biogen

View: 177

Update day: 26-03-2024

Location: Baar Zug ZG

Category: Pharmaceutical / Chemical / Biotech

Industry: Pharmaceutique et biotechnologie

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Job content

Job Description


What You’ll Do

  • Accountable for management of Quality operations activities with key/critical CMOs
  • Prepare and manage Quality management Review, Annual Product Review performance and Quality agreement
  • 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
  • Solve 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 Identify and drive opportunities of improvement/standardization in the purpose of continuous improvement of the system/process used

Qualifications


Who You Are

Being a seasoned quality assurance representative 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

  • Minimum Bachelor’s degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
  • You have a minimum of 5 years of experience in pharmaceutical or biotechnology industries
  • Strong communication and negotiation skills.
  • Ability to work in an international matrix environment.
  • Ability to clearly articulate complex situation into resolution by providing path forward to the upper management
  • High level of autonomy with strong organizational skills to meet commitments.
  • Strong quality mind-set
  • Compassionate team player
  • Well-versed in managing relationships/building and maintaining network
  • At ease picking up new IT solutions swiftly

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 assembly, labeling and packaging activities of parenteral as well as pharmaceutical products. Therefore, it is expected that this CMO Quality Lead manages compliant and un-interumpted supply of commercial products to patients while working within a cross-functional team. This position is opened in the Global External Quality department and reports to the Head Quality Packaging in Baar, Switzerland.

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Deadline: 10-05-2024

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