Associate Director, Quality Management (Clinical Research)

About the role

This Associate Director, Quality Management role is assigned to designated delivery units, countries, sponsors, business units and specific tasks as defined by the line manager. It contributes to developing and implementing quality improvement initiatives and advises stakeholders on quality control, risk assessment, risk management and corrective and preventive actions. The role is based in Athens.

Key responsibilities

• Support the development and implementation of the 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.
• Advise teams on Good Clinical Practice (GCP) compliance and help manage non-compliance and quality issues, informing the business line and Quality Assurance as required by SOPs.
• Assist in planning corrective and preventive actions 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.
• Manage staff in line with organizational policies: plan, assign and direct work, appraise performance, guide professional development, reward and discipline employees, handle employee relations and approve HR actions.
• Provide support during audits and regulatory inspections, and perform other reasonable tasks agreed with the Head of the business line.

Required profile

• Bachelor's or Master's degree in Medical or Life Sciences (or equivalent experience); PhD preferred.
• At least 12 years of experience in clinical trial processes (design, planning, conduct, analysis, reporting) and regulatory environment.
• At least 5 years of extensive GCP experience and extensive experience with Quality Management Systems.
• Leadership and line management skills, with the ability to lead and motivate a clinical team.
• Fluent in English and able to travel within the region or country.

Required skills

• Extensive experience with Quality Management Systems and GCP.
• Strong organizational, interpersonal and communication skills, judgment and decision-making, and problem-solving skills.
• Influencing and negotiation skills, and ability to work in a matrix environment.
• Strong computer skills, including Microsoft Office.

The potential base pay range is EUR 44,200 to EUR 94,100 per year, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.