Senior Quality Manager Digital applications (SaMD)

Basel  ‐ Vor Ort
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Beschreibung

For our Major Pharmaceutical client in the Basel Area we are looking for a Senior Quality Manager in Digital applications to manage:

  • Complex projects or late phase projects in the area of Digital therapeutic solutions
  • Global initiatives
  • Complex projects (cross sites, high impact); Due diligence independently.
  • Processes to support departmental digital portfolio, projects and objectives according to agreed timelines and standards.
  • Ensure that compliance with cGMP

Experience Requirement:

  • Graduate Masters, PhD, Bachelor as a Technician (5 years' in Software as Medical Device SaMD)
  • Practical experience in ISO 13485, IEC 62304, IEC 82304, ISO 14971, MDD/MDR, GDPR, 21 CFR part 820/part 4 requirements and in Medical Mobile Applications.
  • Experience writing, Reviewing and approving deliverables to ensure GMP compliance.
  • Ensure that new products including web-based and mobile applications have been effectively and efficiently verified and validated prior to their release and that these designs meet effectively documented and implied user needs and requirements.
  • Improve the overall quality of mobile software, including peer reviews, software hazard analysis, requirements traceability, defect tracking, software metrics, configuration management and software tool validations.
  • Ensure that software quality assurance efforts are life cycle oriented during product requirements development and continuing throughout its lifetime.

Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. It is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on the website.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice on our website for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.

Start
ab sofort
Dauer
12 months
Von
Stamford Consultants AG
Eingestellt
16.07.2020
Projekt-ID:
1947130
Vertragsart
Freiberuflich
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