Global Clinical Quality Delivery Manager

IQVIA Inc

Barcelona

On-site

EUR 70,000 - 90,000

Full time

5 days ago
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Job summary

IQVIA Inc is seeking an experienced Quality Management professional to define and execute global quality plans across designated units and lines of business. The role focuses on improving compliance with ICH, GCP, SOPs, and KPIs, collaborating with global teams to ensure quality in delivery and readiness for audits.

The candidate should bring a minimum of eight years' experience in clinical trial processes, strong regulatory knowledge, and excellent problem solving.

Qualifications

  • Expert knowledge of and experience in ( minimum of 8 years ) processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principles and concepts as well as regulatory environment).
  • Knowledge of National and International Regulations and Drug Development processes.
  • Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
  • Excellent problem solving skills.
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
  • Fluent in English.

Responsibilities

  • Adopt and implement the global Quality Management Plan within the scope of the assignment.
  • Plan and execute the Quality Management activities.
  • Risk identification and assessment through data review and quality control processes.
  • Provide support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement.
  • 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, support in planning corrective/preventive actions, as applicable according to SOPs.
  • Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
  • Inform Quality Management, 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 with the business lines, as required by the applicable SOPs.
  • Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
  • Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
  • Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.

Skills

Clinical trial design
Regulatory knowledge
Quality management
GCP compliance
English proficiency

Job description

IQVIA Inc is seeking an experienced Quality Management professional to define and execute global quality plans across designated units and lines of business. The role focuses on improving compliance with ICH, GCP, SOPs, and KPIs, collaborating with global teams to ensure quality in delivery and readiness for audits.

The candidate should bring a minimum of eight years' experience in clinical trial processes, strong regulatory knowledge, and excellent problem solving.

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