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Dir, Connected Devices Quality and Compliance

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Primary Location: Vienna, Austria Additonal Locations: Barcelona, Spain,ESP; Berlin, Germany,DEU; Bratislava, Slovakia,SVK; Budapest, Hungary,HUN; Dublin, Ireland,IRL; Durham, NC,USA; Frankfurt, Germany,DEU; Leeds, United Kingdom,GBR; London, United Kingdom,GBR; Madrid, Spain,ESP; Milan, Italy,ITA; Oeiras, Portugal,PRT; Paris, France,FRA; Prague, Czech Republic,CZE; Reading, United Kingdom,GBR; Rome, Italy,ITA; Warsaw, Poland,POL Full time R1332576

Job description


Connected Devices is one of the most dynamic and interesting areas within the Clinical Research industry. The identification, strategy and management of various devices and their data ingestion modalities in order to meet the endpoint goals of our customers is ever challenging and exciting.  This highly visible business unit is closely connected to other trial delivery teams within IQVIA.  We work closely with technology partners and our sponsor partners to help speed therapies to market in a global network. We seek highly motivated and accountable people looking for opportunities to impact the business and be part of the solution. At IQVIA, we look at individuals with a focus on continuous learning and career development


We are looking for an experienced clinical operations leader who is passionate about technology and committed to driving quality and compliance including regulatory initiatives. Our thought leader will not only assist audits and inspection but will also redesign and own our global quality and compliance framework and scale that up to our quickly evolving business. The candidate will partner with internal and external teams to support an agile regulatory approach for connected devices in clinical trials across all major geographical regions.

Responsibilities

  • Establish and maintain strong working relationships with internal and/or external customer team leads and counterparts, as assigned
  • Provide actionable insights to customer counterparts, QA Leadership and Senior Management
  • Drive quality improvements and efficiencies along with risk mitigation based on QA data analyses, operational performance data, knowledge of process management, changing regulations and customer expectations
  • Provide consultation and support concerning compliance with regulations and appropriate controls, quality measures and risk assessment and mitigation in the development of improved or new service offerings across the business
  • Lead and project manage internal QA quality improvement initiatives
  • Plan, schedule, conduct, report and close audit activities
  • Assist in enhancement and establishment of quality assurance and control policy and risk identification and mitigation by providing consultation and recommendations to regional and Global QA Leadership
  • Serve as author for QA Standard Operating Procedures (SOPs), especially focusing on cross-functional connected devices processes from study build to execution
  • Participate in or lead teams for special projects as assigned. Teams may be cross functional
  • Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
  • Host customer audits and/or regulatory inspections participate in review of corrective action plans and effectiveness checks.
  • Recommend process and systems for audit, write systems audit plans and oversee the delivery of these audits, review the Corrective and preventive actions (CAPAs) and ensure appropriate follow up
  • Oversee documentation, reporting, and closure of significant compliance issues
  • Conduct trend analysis of audit results and provide QA management with initial root cause analysis
  • Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections
  • Support regulatory strategy and oversight for connected devices with regional elements
  • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.

Experience / Requirements

  • Typically requires a minimum of 7 - 10 years of prior relevant experience. including 4 or more years of project management or related experience in a key CRO/Pharmaceutical/healthcare operational function e.g., data management, clinical operations, laboratory, pre-clinical
  • Leadership level track record of active engagement in audits and inspections
  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics
  • Strong influencing and negotiation skills
  • Good team leadership skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

Preference

  • Minimum of 4 years of experience in functions with a focus on quality, compliance or regulatory strategy
  • Minimum of 4 years of experience in functions related to technology applications in highly regulated environments

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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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