Clinical FSP - Quality Manager

Responsibilities

• Adopt and implement global Quality Management Plans, including planning and executing quality management activities
• Perform risk identification and assessment through data review and quality control processes
• Provide support in risk mitigation, planning corrective/preventive actions, and guidance for process improvement
• Contribute to the development and implementation of Sponsor-specific Quality Management plans and Risk Management Programs
• Provide advice and support to teams regarding Good Clinical Practice (GCP) compliance
• Manage non-compliance and quality issues in cooperation with relevant stakeholders and Quality Assurance
• Act as the primary contact for Quality Assurance on quality matters within the assigned scope
• Prepare periodic reports for business lines regarding quality-related matters, risk assessments, and improvement initiatives
• Assist teams during audits and regulatory inspections as required by Standard Operating Procedures (SOPs)

Requirements

• Bachelor's Degree or equivalent qualification
• Minimum of 5 years of experience in a pharmaceutical, bio-pharmaceutical, or CRO environment
• Minimum of 3 years of experience in a dedicated Quality role
• Sound working knowledge of ICH, GCP, and applicable regulatory requirements
• Knowledge of drug development processes and clinical research industry operations
• Proficiency in Microsoft Office applications
• Strong organizational, interpersonal, and communication skills
• Ability to travel within the region or country as required
• Fluency in English

About the Company

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.