Job OverviewThis role is typically a line manager assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by their line manager (LM). The purpose of this role is to work together with global Quality Management, Site Management, and other stakeholders in a joint effort to define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, to assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.This role coordinates and oversees staff within the scope of the assignment, provides advice, and supports staff and other relevant key stakeholders with regard to quality control, risk management, and corrective/preventive actions.Essential FunctionsAdopt and implement the global Quality Management Plan within the scope of the assignment, which includes planning and executing the Quality Management activities, risk identification and assessment through data review and quality control processes, providing support in risk mitigation, planning corrective/preventive actions, and guidance for improvement.Cooperate closely with relevant business and other stakeholders, supporting the maintenance of 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, monitoring 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 and quality issues, assisting in planning corrective/preventive actions according to Standard Operating Procedures (SOPs).Inform Quality Management, 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 applicable SOPs.May provide assistance during audits and regulatory inspections to the teams as agreed with Quality Management and as required by applicable SOPs.Act as the primary contact for Quality Assurance on quality matters at the level of the assignment, attending meetings/teleconferences.Prepare periodic reports to Head(s) of business lines on quality-related matters, risk assessments, and specific quality improvement initiatives.Manage staff in accordance with the organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues, and resolving problems. Approve actions on human resources matters.Upon agreement with the line manager, perform any other reasonable tasks as required by the role.QualificationsBachelor's Degree or equivalent qualification required.Equivalent combination of education, training, and experience.Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, and quality management processes.Knowledge of National and International Regulations and Drug Development processes.Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.Knowledge of IQVIA corporate standards and SOPs.Good organizational, interpersonal, and communication skills.Good judgement and decision-making skills.Strong influencing and negotiation skills.Strong computer skills including Microsoft Office applications.Excellent problem-solving skills.Ability to travel within the region/country.Ability to lead and motivate a clinical team.Ability to establish and maintain effective working relationships with co-workers, managers, and clients/customers.Fluent in English.Please note, this role is not eligible for UK visa sponsorship.IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA Careers.
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