Senior Digital Health Technology Auditor - Berlin, Deutschland - Bayer

Bayer
Bayer
Geprüftes Unternehmen
Berlin, Deutschland

vor 1 Monat

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Senior Digital Health Technology Auditor M/F/d

YOUR TASKS AND RESPONSIBILITIES


The purpose of this position is to contribute to drive for business quality and efficiency by increasing compliance with GxP and IT regulations (Bayer internal and external) while focusing on a risk-based approach for all relevant digital health technology system, service provider and supplier audit activities.

This will be achieved through the conduct of cross divisional, regional and local digital health technology audits in Bayer Pharmaceuticals / Consumer Health (PH/CH) R&D, Pharmacovigilance (PV), Medical Affairs (MA) and Radiology including digital health technology service provider and supplier audits to provide management with independent information on digital health technology systems and services' compliance, digital health technology supplier reliability and data integrity.

In addition, corresponding activities will ensure that business risks are known and considered in a systematic and appropriate manner during digital health technology lifecycle.


Main tasks:


  • Manage digital health technology system, service and supplier audits by ensuring timely completion of the following audit activities:
  • Design of detailed digital health technology audit plans for specific assigned processes.
  • Development of all relevant tools necessary for the collection of audit data in line with the approved audit plans.
  • Conduct of the audits in compliance with the approved audit plans.
  • Reporting of audit results.
  • Communication of digital health technology audit results to all relevant personnel within Bayer R&D, MA, PV, and Radiology. This includes all members of Development Managing Committee and/or other functions covered by the audit, e.g., Enabling Functions.
  • Follow up of audits. This includes the assessment of corrective and preventive actions finally decided by responsible parties, which should lead to a better performance of the processes covered in terms of compliance and/or efficiency.
  • Lead cross functional global audit teams where digital health technology systems, services and suppliers are in focus by assisting in the development of the audit plans, developing tools for conducting such audits, conducting the audit, and reporting the results.
  • Participate in the development and maintenance of the strategic planning for digital health technology system, service and supplier audits in line with the business needs of Bayer PH R&D, PV, MA, Radiology.
  • Through digital health technology system, service and supplier audits, support providing management of R&D, MA, PV and Radiology with results of independent assessments of the performance of the regulated digital health technology systems, services and suppliers in use within PH R&D, PV, MA, Radiology.
  • Support providing management with information on the effectiveness of the corrective actions implemented to facilitate senior management s decision making regarding business needs for improvement initiatives.
  • Support Health Authority inspections conducted at Bayer R&D, MA, PV, and Radiology by providing resources and functional expertise. Provide interpretation and guidance for internal and external customers on quality related regulations / guidelines (e.g., FDA, ICH, EMA, etc.) and company procedures and policies, proactively maintaining cognizance of current digital health technology system and service standards.
  • Support the development and refinement of the Global Quality System by participating in SOP authorship or review teams.

WHO YOU ARE

  • Master's degree in information technologies, informatics, biomedical science, or equivalent education
  • Longterm working experience in the pharmaceutical industry, esp. in IT system and service quality management related activities and preferably a proven record in Research & Development auditing activities
  • Previous experience with tasks assigned to Lead Auditors in digital health technology / IT audits (development of standards and tools, conduct, reporting and follow up of such audits)
  • Previous experience in quality management, risk management, digitalization initiatives
  • Acquired people management skills
  • Ability to assimilate large amounts of data efficiently, exercise sound judgement, and maintain composure to effectively handle sensitive issues
  • Professionalism, strong stakeholder management, and a
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