Clinical FSP Quality Manager
IQVIA
full-time
Posted on:
Location Type: Hybrid
Location: Mexico City • 🇲🇽 Mexico
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- 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.
Requirements
- 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, 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.
- Fluent in English.
- Ability to travel within the region/country.
Benefits
- High organizational, interpersonal, and communication skills.
- Good judgement and decision-making skills.
- Strong influencing and negotiation skills.
- Up to 80% travel - domestic/regional travel to Latin America/Potential to North America
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality ManagementRisk ManagementData ReviewQuality ControlCorrective ActionsPreventive ActionsGood Clinical Practice (GCP)Standard Operating Procedures (SOPs)Medical TerminologyRegulatory Requirements
Soft skills
CommunicationCollaborationProblem SolvingAdvisory SkillsStakeholder EngagementPlanningExecutionSupportEffectiveness EnhancementFocus on Quality
Certifications
Bachelor's Degree