Sr Associate III, Quality Systems
Biogen
Luterbach, Switzerland
vor 4 Tg.

Job Description

  • Drive timeline activities to support the readiness of the QMS and supporting business processes for the start-up of GMP production in Solothurn.
  • Design, review and maintain Site Master File for the Solothurn site to ensure site GMP readiness as per project timeline.
  • Represent Solothurn Quality within the global quality organization to ensure local implementation of the global QMS
  • Responsible for managing the Quality Risk Register and ensure appropriate risk assessments are in place
  • Ensure site training plan and system for content / documentation are in place and maintained.
  • Qualifications

  • Bachelor’s Degree or Master degree in Life Science preferred
  • Approximately 10 plus years of experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.
  • This position will require frequent international travel during the first two years of employment (up to 30% at times), periodically thereafter.
  • Dual Language preferred with a preferences for English and German .
  • Prior experience with facility construction and start-up strongly preferred.
  • Must have proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems.
  • Demonstrated ability to work autonomously and to lead project teams in a matrix organization.
  • Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
  • Strong presentation and organizational skills
  • Demonstrated problem solving skills
  • Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
  • Candidates with experience in drug substance (or API) and drug product are preferred.
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