Clinical FSP Quality Manager
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Job Location:
Mexico City - Mexico
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Overview
This 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
Bachelors Degree Bachelors 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.
Strong computer skills including Microsoft Office applications.
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
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
