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QA Senior Specialist, External Manufacturing @Bavarian Nordic A/S

[Hiring] QA Senior Specialist, External Manufacturing @Bavarian Nordic A/S

Apr 05, 2025 - Bavarian Nordic A/S is hiring a remote QA Senior Specialist, External Manufacturing. đź’¸ Salary: unspecified. đź“ŤLocation: Denmark.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

This role involves setting Quality direction and having Quality oversight at Contract Manufacturing Organizations (CMOs), taking ownership, working independently, and continuously learning and growing.

You will join an experienced team of 8 Specialists/Senior Specialists with a flexible work culture. The main responsibilities are:

  • QA-responsible person for the Combination Product/Device process (the process is owned by MSAT)
  • Quality oversight of production and activities at the CMO with primary stakeholders
  • Maintain and develop specialized knowledge within the field of responsibility
  • Ensure timely review and QA-approval of CMO documents i.e. Change Controls, Deviations, Process Performance Qualification (PPQs), and any other CMO-related documents
  • QA-responsible person for technical transfer and improvement projects

Qualifications

  • M.Sc. degree in pharmacy, chemistry, engineering, or similar
  • +10 years of experience in a pharmaceutical organization
  • Up-to-date knowledge of GxP requirements i.e. Deviations and Change Control handling, Annual Product Review (APR), Validations, and PPQ
  • Knowledge of Combination Product/Device process, Drug Substance, Drug Product production, Secondary Packaging, CMO handling, technical transfer
  • Proficient in English. Danish is a plus

Requirements

  • Highly accountable and confident professional
  • Thrives in a fast-paced, ever-changing environment
  • Excels at working both independently and in teams
  • Strong communication, adaptability, and a collaborative mindset
  • Comfortable making decisions and standing firm with stakeholders to ensure compliance
  • Keen eye for detail and a commitment to quality

Benefits

  • Be part of a team that directly contributes to global health by manufacturing and developing life-saving vaccines
  • Work within a global department, managing CMOs, technical transfers, and commercial processes ensuring the highest standards are met across our worldwide operations
  • Your work here has a visible and significant impact, ensuring the safety and well-being of millions
  • Personal and professional development and training in processes
  • Vibrant staff club that offers a variety of diverse, fun, and exciting events
  • Charging stations for electric vehicles at our facilities in Kvistgaard
  • Convenient bus route (70E) from Humlebæk Station directly to our Kvistgaard facilities

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đź“Ť Be aware of the location restriction for this remote position: Denmark
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Back to Remote jobs  >   QA
QA Senior Specialist, External Manufacturing @Bavarian Nordic A/S
QA
Salary đź’¸ unspecified
Remote Location
Denmark
Job Type full-time
Posted Apr 05, 2025
Apply for this position Unlock 54,899 Remote Jobs
️
đź“Ť Be aware of the location restriction for this remote position: Denmark
‼ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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