Senior Quality Specialist at IQVIA

IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services,...

 

Senior Quality Specialist

  • Job TypeFull Time
  • QualificationBA/BSc/HND
  • Experience3 years
  • LocationNairobi
  • Job FieldMedical / Healthcare 

Essential Functions

  • Adopt and implement the global Quality Management Plan within the scope of the assignment; this will include:
  • Planning and executing the Quality Management activities;
  • Risk identification and assessment through data review and quality control processes;
  • Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement;
  • Supporting the assigned business line management and staff to enhance effectiveness.
  • Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
  • Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.
  • Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
  • Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to SOPs.;
  • Inform the assigned business line and Quality Assurance of quality issues according to SOPs.
  • Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
  • May provide assistance during audits and regulatory inspections to the teams to the extent agreed, as required by the applicable SOPs.
  • Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
  • Upon agreement the line manager: Perform any other reasonable tasks as required by the role.

Qualifications

  • Bachelor's Degree
  • At least 3 years relevant experience in Quality Management (not in the manufacturing industry)
  • Sound working knowledge of medical terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
  • Knowledge of National and International Regulations and Drug Development processes.
  • Knowledge Pharmaceutical industry operations.
  • Good organizational, interpersonal and communication skills. Good judgement and decision-making skills.
  • Strong influencing and negotiation skills.
  • Strong computer skills including Microsoft Office applications.
  • Excellent problem solving skills.
  • Ability to travel within the region/country.
  • Ability to lead and motivate a team.
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.

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Method of Application

Interested and qualified? Go to IQVIA on jobs.iqvia.com to apply

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