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Clinical Quality Assurance Expert

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Location München, Bayern Salary Verhandelbar
Sector Life Sciences Type Temporary

Für einen pharmazeutischen Kunden in München bin ich derzeit auf der Suche nach einem Experten für den Bereich "klinische Qualiätssicherung"

Start: Zeitnah
Umfang: Vollzeit
Anstellung: Befristete Festanstellung über Progressive
Ort: München

GCP support for clinical teams and Global Medical Affairs, as well as support of inspection readiness activities for a US subission in preparation

Support and deputize Head Global Clinical Development QA - Biosimilar Programs, as assigned, with strategic Quality oversight on the entire Clinical Trial Process for the clinical development business areas under responsibility, including late phase clinical development activities, in order to ensure compliance with Health Authorities' requirements,
the internal standards and to ensure pa-tients' safety, rights, well-being, and data integrity

As a team member, provide CQA expertise and Quality support to the Clinical Trial Teams (CTTs) and to International Clinical Teams (ICT),
Global Program Teams (GPTs), as assigned, and collab-orate with other Quality functions in order to ensure that programs and Quality initiatives
meet defined expectations

For Late Phase/Non-Interventional Studies, provide CQA expertise and guidance to Global Clinical Development organization as well as to Global Medical Affairs and local Affiliates. Collaborate with other QA functions and business units involved in post-marketing clinical activities in order to ensure that post market programs, and Clinical Quality initiatives driven by the business meet defined expectations


IDEAL BACKGROUND:

Bachelor Degree in Life Sciences, Pharmacy or Medicines
Fluent in English, knowledge of other languages (e.g., German) a plus but not required

*Minimum 6 years of experience in regulated activities (GCP/PV), clinical development and/or QA positions
*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
*Two or more years' experience in managing projects
*Ability to effectively interact with and present to senior management, as well as to external audiences and inspectors
*Strong skills in GCP, quality and/or clinical development. Experience in Late Phase Clinical Development desirable
*Experience with managing Authority inspections desirable
*Auditing Experience desirable
*Strong interpersonal, communication, negotiation, and problem solving skills

Wenn Sie Interesse haben und mehr erfahren möchten, dann freue ich mich sehr von Ihnen zu hören.

Viele Grüße aus München,

Ines Steiner

i.steiner(at)progressive.de

Dieser Geschäftszweig der SThree GmbH betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.