Senior Quality Specialist

About

Description

This role is assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to carry out and adopt the global Quality Plan according to the specific needs defined by the scope of the assignment, to assist the assigned business line staff in improving compliance withrelevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines. Contribute to the development and be responsible for the implementation of specific quality improvement initiatives as agreed with the management and the relevant Head(s) of assigned business lines. Provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.

Responsibilities

• • 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

Qualifications

• Bachelor's Degree
• Equivalent combination of education, training, and experience
• Sound working knowledge of medical terminology, IQVIA standard operating procedures (SOPs), 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
• Knowledge of IQVIA corporate standards and SOPs

Application instructions:

• Click on the application Link and Fill in the form