8 May, 2019

Associate Director of Computerised Systems Quality Assurance

This role provides leadership, compliance oversight and independent Quality review to ensure all GxP and Data Integrity, regulations for IT are met by various business departments within the Ergomed Group, which includes but is not limited to IT and Safety Database team.
This role provides assurance to the business through risk-based audit planning that processes related to new IT systems implementation, changes to existing computerised systems, as well as data and records controls are compliant and fit for purpose. Also that the implementation and periodic review of effective and efficient Computer Validation and Infrastructure Qualification processes are in place.

Key Accountabilities
  • Ensures regulatory compliance by approving and periodic auditing of computer and Infrastructure deliverables for GxP Business Systems such as ARISg, AGInquirer, SAGE, Master Control, SharePoint, and any other future Computerised Systems implemented.
  • Plans and conducts Computer Systems Supplier Audits to meet business project schedules
  • Audits current computer systems suppliers as per risk based Quality Audit Schedule
  • Audits business processes related to Computer Systems Validation (CSV) to ensure Ergomed Group polices and standards are maintained.
  • Acts as subject matter expert on CSV/IT quality processes when required.
  • Act as Liaison between IT and Business Quality functions on all aspects of computer systems quality.

Qualifications and Skills
  • Significant experience in an IT Quality and /or Computer Systems Validation (CSV) role in a GxP-regulated pharmaceutical sector environment.
  • Experience in IT Quality audits.
  • Experience in a line management role leading and directing a team in an international matrixed environment
  • Specific experience of the Quality Management and CSV aspects of IT application implementation and of change controls, IT applications’ life-cycle management and operations specifically GxP and/or 21 CFR part 11 regulated environments.
  • Experience of quality management process such as ISO9001 and ISO27001.
  • Practical experience of interfacing with FDA, MHRA & other global regulatory agencies with a demonstrated knowledge of GAMP 5, GxP, SOX, and data privacy regulations and guidelines and of data governance from the perspective of pharmaceutical regulatory authorities
  • Analytical, written and oral communication skills with the ability to translate technical terms and GxP computerized system risks into business language.
  • Strong team player
  • Ability to think strategically and to work collaboratively using risk-based, proactive approaches to problem-solving
  • Good / Strong English language skills (written and spoken)
  • Proven communication skills are essential in this role.

Our Offer
  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth
  • Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
  • Friendly working environment with several social events per year

If you would like to be considered for this opportunity, please send your application via email to careers@primevigilance.com enclosing your English CV.

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Thank you for your application. Unfortunately, because of the volume of applications we receive, we are not able to give status updates, but if you are invited for an interview, we will contact you directly.

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