9 days ago on hays.ch

GPS Quality Manager (m/f)

Hays (Schweiz) AG

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 Please refer to JobSuchmaschine in your application

GPS Quality Manager (m/f)

We are looking for a

GPS Quality Manager (m/f)

freelance/temporary employment for a project in Basel-City

Your Duties:

  • Implement Quality Management processes to improve the accuracy and timelines of its output, and to meet established standards (e.g. compliance checks)
  • Develop and maintain GPS quality standards & metrics for key GPS activities/identify opportunities for improvement for GPS regulated processes
  • Review audit reports, propose and monitor action plans (CAPAs), monitor and manage market research and patient support programs deviations
  • Lead and coordinate supplier quality assessment for regulated processes in GPS
  • Manage multiple stakeholders interacting with global product strategy on regulated processes
  • Execute and oversee processes contributing to safety regulatory documents (e.g. periodic benefit risk evaluation report, product risk management plans, development safety update report)
  • Prepare and review controlled documents & processes/working guidelines
  • Ensure consistency across the organization & act in line with legal, regulatory and company standards and codes of practice

Your Qualifications:

  • University degree, preferably in a life sciences/biology/medicine or other healthcare discipline
  • Profound experience in pharmacovigilance/compliance related function in pharmaceutical industry at a local, regional or global level
  • In-depth knowledge of GVP, healthcare and medical compliance, SOPs and regulatory requirements
  • Demonstrated professional experience in a global organization on improving processes in a regulated environment
  • Fluency in written and verbal English
  • Mastery of office suite tools (Microsoft, Google Suite)
  • Knowledge on controlled document environments (e.g. Touchpoint, Condor)
  • Experience in Quality Risk Management or Quality Management is of advantage
  • Strong analytical and decision making skills in a complex, fast paced and changing environment