Manager, Supplier Quality

Provide quality and technical guidance on product and manufacturing related issues

  • Assist in the implementation of the Biogen Idec quality system in the Hillerød facility
  • Oversee activities related to the review and approval of validation activities protocols.
  • Support the daily function and process improvement of validation activities
  • Review and edit process/ methods/ regulatory reports
  • Provide quality and technical oversight of partnerships and critical suppliers
  • Supply quality support to development activities in the international region
  • Act as liaison between disposition groups and contract manufacturers
  • Author and review sections of the Annual Product Reviews
  • Serve as required on multifunctional Biogen Idec committees and teams as required
  • Compile and report product trending and metric data
  • Assure quality oversight and participation for critical investigations, specification management change control, technology transfer and method
  • Provide support for Regulatory Inspections, as required.
  • Assist in the performance and facilitation of internal and external audits of quality areas and suppliers for GMP compliance


  • Proven ability to lead multi disciplinary teams
  • Solid grounding in quality systems and knowledge of cGMP regulations
  • Experience of validation of both manufacturing and analytical equipment and instrumentation,
  • Knowledge of the validation of manufacturing control systems and applicable regulations
  • Excellent oral and written communication skills in English
  • Knowledge of office automation ‘Word, Excel, Lotus Notes etc
  • Good organisational skills


Bachelors degree in a relevant scientific discipline with a minimum of 10years technical experience in the biotech or pharmaceutical industry.