ID EXISTS
POS 3885
Status 5
DJM 1

Clinical QA Program Lead

Beschreibung: For one of our Swiss Pharma clients we are seeking temporary support as: Clinical QA Program Lead (M/F/*)
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Tasks:
  • Provide strategic Quality oversight on the entire Clinical Trial Process (CTP) for the clinical trials under responsibility in order to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to patients’ safety, rights and well-being.
  • Based on risk analysis, take critical decisions together with internal stakeholders, ensuring clinical trials have no delays whilst maintaining high quality level data.
  • Dispense QA expertise and guidance to the Global Clinical Teams (GCT) and collaborate with other QA functions in order to ensure that high priority programs, Quality initiatives driven by the business meet defined expectations.
  • Takes full ownership of the quality aspects of the assigned clinical trials
  • Lead/ participate in due diligence efforts for assigned programs.
  • Drive a culture of quality in Global Drug Development by close business collaborating to positively impact the business and implementing the Strategy, Mission and Vision of Global Development QA (GDQ).
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Qualification:
  • Start: 01.09.2020 // Duration: 6 months // 40 h/week onsite
  • Degree in Life Sciences, Pharmacy or Medicines. Advanced degree a plus.
  • 7+ years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions
  • Experience in Clinical QA, GCP, Clinical Studies Development, across Therapeutic Areas, big pharma, mid-sized or CRO experience
  • 3+ years’ experience in managing projects.
  • Clinical Auditing experience is a plus
  • Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
  • Ability to work independently and in a global/matrix environment.
  • Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors
  • Strong skills in GCP, quality and/or clinical development
  • Business Fluency in English
Bemerkungen: WANTED: Clinical QA Program Lead (M/F/*). Please contact +41 71 577 27 41 or msp@k-recruiting.com Skills: Auditor, Clinical Development / Study Design, Clinical Operations, Clinical Project/Study Management, CRO Experience, Drug Developement, Drug Safety / Pharmacovigilance, English, GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), Pharma, Project management (Professionals, IPMA, PMI, Prince 2), QA (Quality Assurance)
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Interesse geweckt?
Auf geht's!
Beginn: 01.09.2020
Laufzeit: 6 months
Einsatzort: Basel, Switzerland
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