Clinical Fsp Quality Manager

hace 2 semanas

Xico, México Iqvia A tiempo completo

Job OverviewThis role is an individual contributor 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 work together with operations, global or regional Quality Management team(s), functional teams, customer and other stakeholders in a joint effort to adopt the Quality Plan, Standard Operating Procedures (SOPs), improving compliance to International Council for Harmonization (ICH), Good Clinical Practice (GCP), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.This role provides advice and supports clinical staff and other relevant key stakeholders with regard to **risk identification/management, proactive quality control and corrective/preventive actions upon issues arise.**Essential Functions- 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.- Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.); Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.;**Qualifications**- Bachelor's Degree Bachelor's Degree or equivalent qualification.- Quality Management experience within CRO/Pharmaceutical industry- Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), Council for Harmonisation (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, 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.- Fluent in English.- Ability to travel within the region/country.| Up to 80% travel - domestic/regional travel to Latin America/Potential to North America- Good organizational, interpersonal and communication skills.- Good judgement and decision-making skills.- Strong influencing and negotiation skills.

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