Clinical FSP Quality Manager

About the role

This is an individual contributor role for a Clinical FSP Quality Manager at IQVIA in Athens. The person works with global and regional Quality Management teams, functional teams and other stakeholders to define, carry out and adopt the global Quality Plan, and helps staff improve compliance with ICH, GCP, SOPs, KPIs and regulatory requirements. The role advises and supports clinical staff on quality control, risk management and corrective and preventive actions.

Key responsibilities

• Adopt and implement the global Quality Management Plan, including planning and executing quality activities, identifying risks through data review and quality control, and supporting risk mitigation and corrective/preventive actions.
• Help the assigned business line and staff improve their effectiveness, and cooperate with stakeholders to keep quality at the heart of project delivery.
• Contribute to a Delivery Unit/Sponsor-specific Quality Management plan and Risk Management Program, and monitor its implementation.
• Advise teams on GCP compliance and help manage non-compliance and quality issues, following SOPs.
• Report quality issues to Quality Management, the business line and Quality Assurance, and act as the primary contact for Quality Assurance on quality matters, attending meetings and teleconferences.
• Prepare periodic reports on quality matters, risk assessments and quality improvement initiatives.
• Support teams during audits and regulatory inspections, and handle suspected misconduct cases as required by SOPs.

Required profile

• Bachelor's degree or equivalent qualification.
• At least 7 years of overall working experience.
• At least 3 years of extensive experience in a Good Clinical Practice (GCP) environment.
• Knowledge of clinical research organization (CRO) or pharmaceutical industry operations.
• Fluent in English; able to travel within the region or country.

Required skills

• Knowledge of national and international regulations and drug development processes.
• Good organizational, interpersonal and communication skills, and excellent problem-solving skills.
• Ability to lead and motivate a clinical team and build effective working relationships with colleagues, managers and clients.

The stated base pay range is EUR 34,400 to EUR 66,200 per year, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.