Essential Functions

• Check compliance with GCP and relevant regulatory requirements

• Conduct monitor clinical trial processes for quality assurance

• Maintain Standard Operating Procedures

• Review regulatory and quality-related document for clinical trials

• Implement and oversee Corrective and Preventive Actions

• Support regulatory inspection and sponsor audits

•Plan and execute Quality Management activities, including risk identification and assessment through data review and quality control processes.
• Provide support in risk mitigation, planning corrective/preventive actions, and guiding continuous improvement initiatives.
•  Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.  
• Work closely with relevant business teams and stakeholders to maintain 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 ensure successful delivery.
• Compliance Support & Non-Compliance Management.
• Provide expert advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
• Collaborate with teams to manage non-compliance, quality issues, and assist in planning corrective/preventive actions in accordance with SOPs.
• Communicate any quality issues to the assigned business line and Quality Assurance according to SOPs.
• Collaboration with Quality Assurance & Regulatory Support.
• Work closely with Quality Assurance and business staff in case of suspected misconduct, as required by applicable SOPs.
• Provide assistance during audits and regulatory inspections, supporting operational teams as agreed with Quality Management.
•Reporting & Continuous Improvement.
• Prepare and deliver periodic reports to stakeholders on quality-related matters, risk assessments, and specific quality improvement initiatives.
• Upon agreement with the Line Manager, perform any additional reasonable tasks as required by the role.
Qualifications & Skills:
• Strong knowledge of Good Clinical Practice (GCP) and Quality Management Systems.
• Experience in risk identification, assessment, and mitigation within clinical trials.
• Excellent communication and collaboration skills, with the ability to engage stakeholders at all levels.
• Strong problem-solving skills, with the ability to address quality issues effectively and support corrective/preventive actions.
• Experience supporting teams during audits and regulatory inspections is a plus.

• Ability to prepare detailed reports on quality metrics and improvement initiatives.

Qualifications
• Bachelor's Degree  

• Minimum of 1 year of experience in quality assurance or regulatory compliance in the CRO or pharmaceutical.

• Experience in internal/external audits and quality management

• Strong communication and documentation skills.
• Sound working knowledge of medical terminology, IQVIA Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP),, applicable regulatory requirements, quality management processes. Knowledge of National and International Regulations and Drug Development processes.
• Knowledge of Pharmaceutical industry operations.
• Good judgment and decision-making skills.
• Good influencing and negotiation skills.
• Excellent problem solving skills.
• Ability to lead and motivate a clinical team. Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.

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 https://jobs.iqvia.com