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Quality Manager - Digital Therapeutic Solutions (7040)

Posted on Jul 13, 2020 by iET SA

Basel, Switzerland
IT
Immediate Start
Annual Salary
Contract/Project


Quality Manager - Digital Therapeutic Solutions | Basel City | 6 months

For a project at our client's site, a pharmaceutical company based in Basel, we are looking for a Quality Manager - Digital Therapeutic Solutions.

Your Qualifications:
  • Many years experience as Senior Quality Manager with focus on Digital Applications

  • Well versed in writing, reviewing and approving deliverables (eg procedures, records, third party work, contractors, clinical trial material, components) and related tools (eg IT, document systems, training tools, facility validation) to ensure GMP compliance.

  • Experience in 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
  • Familiar with improving the overall quality of mobile software, including peer reviews, software hazard analysis, requirements traceability, defect tracking, software metrics, configuration management as well as software tool validations
  • Making sure that software quality assurance endeavors are life cycle oriented during product requirements development and continuing throughout its lifetime
  • 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
  • Fluent in English, good skills in German
Your Responsibilities:
  • Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise in the area of Digital therapeutic solutions to Line Unit and other QA Units in area of responsibility
  • Write, review, decide on approval and/or release of GMP-relevant deliverables and or/related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables
  • Manage project-related activities such as TRD digital product portfolio, development of new tools, processes, quality initiatives, quality manual implementation, quality plans, quality risk assessments, training activities, qualification, and facility upgrade activities
  • Support project management functions as a project team member
  • Provide support to TRD line functions in GMP related topics as per area of responsibility
  • Comply with internal and external guidelines regarding quality and safety (quality manual, regulatory cGMP guidelines, health authority guidance, SOPs, etc.)
  • Delegation/deputizes for peers within the same area of responsibility or Quality Manager

Off to new destinations! Apply now directly or contact our team.




Reference: 910246327

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