Quality Specialist


IQVIA is at the forefront of healthcare innovation and delivery, which why we are now currently seeking an experienced Quality Specialist to join our Sydney team on a full-time basis. As a Quality specialist you will be assigned to Delivery Units, sponsors, business lines and/or specific tasks as defined by your line manager. The purpose of the job is to carry out and adopt the Global Quality Plan according to the specific needs defined by the scope of assignment, to assist the assigned business line staff in improving compliance with relevant ICH-GCP, SOPs, applicable regulatory requirements and guidelines.

Key responsibilities:

  • Planning and executing the Quality Management activities
  • Risk identification and assessment through data review and quality control processes either remote or on site
  • 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 of Site Visits conducted by them.
  • Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of a Regional/Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.
  • Provide advice and support to operational teams within the assigned business line, including Clinical Research Associates, Line/Site Network Managers, Resource Managers and other key stakeholders on all aspects of GCP compliance.
  • Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.
  • Inform Heads of Quality Management, Heads of 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 operational teams to the extent agreed with the Head of Quality Management and as required by the applicable SOPs.
  • Prepare periodic reports to Heads of Quality Management and to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.

Key requirements

  • Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), ICH-GCP, applicable regulatory requirements, quality management processes
  • Knowledge of National and International Regulations and Drug Development processes
  • Knowledge of CRO or Pharmaceutical industry operations
  • Good organizational, interpersonal and communication skills
  • Good judgement and decision-making skills
  • Good influencing and negotiation skills
  • Strong computer skills including Microsoft Office and Clinical Trial management System (CTMS) applications
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers

At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.