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Quality Leader/Manager PDMA Switzerland - Oferta z Jobs.pl

Badania i Rozwój » Specjalista ds. badań i rozwoju

  • Województwozagranica
  • Miejscowośćinne
  • AdresSwitzerland,
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Quality Leader/Manager PDMA Switzerland

Nr ref.: /JOBS.pl

  • Job Title : Quality Leader PDMA Objectives and Scope of Position:• To provide Global Product Development Medical Affairs (PDMA) staff with compliance supportto ensure that all medical affairs activities are conducted in accordance to the clients SOPs, guidelines and policies and all international (ICH, GCP) & Health Authority regulations• To provide Quality Management support to PDMA and the Affiliates, and deliver a qualityoversight plan and metrics ensuring that Medical Affairs activities are executed efficiently,effectively and in compliance with regulations• To support the sharing of 'best practice' learnings within PDMA and the Medical NetworkSummary of Main Responsibilities:Training & Induction Programs• Ensure PDMA staff are trained on the clients Controlled Documents and international regulations(ICH GCP) or Health Authorities requirements• Co-ordinate the Learning Management system for PDMA and maintain PDMA Training Gridfor Controlled Documents for relevant functions and external vendors• Support the functional induction and orientation program for new PDMA staffQuality Management• Implement Quality Management processes to improve the accuracy or timelines of itsoutput, or to meet established standards (e.g. compliance checks)• Develop and maintain PDMA quality standards & metrics for key medical affairs activities• Active review of audit reports, propose and monitor action plans (CAPAs) to improvemedical affairs standards & processes• Member of Quality networks• Inspection Readiness support for PDMACompliance support• Provide compliance support by answering questions or providing advice on ICH GCP, SOPs,regulations and guidelines and bring issues to the attention of PDMA Leadership Teammembers as appropriate.• Play an active role in the preparation and review of Controlled Documents &processes/working guidelines• Work proactively as a member of global and regional Compliance & Training networks tomaintain and improve consistency across the organization, and sharing of best practices• In collaboration with other Global Functions develop and maintain metrics to ensureAffiliates medical complianceCommunication• Promote cross-functional and Affiliates communicationCompliance• Is responsible for acting in line with legal, regulatory and company standards and codes ofpractice (e.g. The Clients Code of Conduct, applicable directives, guidelines and SOPs)• Completes all required training modules as a priorityProfessional and Technical Requirements:• University degree preferably in life sciences /biology/medicine or other healthcare discipline


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