Clinical FSP Quality Manager

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

• 9+ years total experience. • Clinical Operations background plus GCP/compliance experience. • Strong site oversight and risk management experience. • Oncology experience preferred. • Bachelor's Degree or equivalent qualification. • Knowledge of medical terminology, SOPs, ICH, GCP, applicable regulatory requirements, and quality management processes. • Knowledge of National and International Regulations and Drug Development processes. • Knowledge of CRO or Pharmaceutical industry operations. • Knowledge of IQVIA corporate standards and SOPs. • Good organizational, interpersonal, and communication skills. • Good judgment and decision-making skills. • Strong influencing and negotiation skills. • Strong computer skills including Microsoft Office applications. • Excellent problem-solving skills. • Ability to travel within the region/country. • Ability to lead and motivate a clinical team. • Ability to establish and maintain effective working relationships with co-workers, managers, and clients/customers. • Fluent in English.

• Conduct country and site-level compliance oversight using a risk-based approach. • Identify compliance risks, conduct site assessments, and manage CAPAs. • Support inspections and audits while serving as the local GCP expert. • Drive inspection readiness and compliance at the country level. • Plan and execute Quality Management activities, including risk identification and assessment. • Support risk mitigation and planning corrective/preventive actions. • Cooperate with business and other stakeholders to maintain focus on quality in project delivery. • Contribute to the implementation and monitoring of Delivery Unit/Sponsor specific Quality Management plans and Risk Management Programs. • Provide advice and support teams on all aspects of GCP compliance. • Manage non-compliance and quality issues, supporting planning of corrective/preventive actions according to SOPs. • Inform Quality Management, assigned business line, and Quality Assurance of quality issues as per SOPs. • Work with Quality Assurance and business staff in cases of suspected misconduct. • Assist during audits and regulatory inspections as agreed. • Act as primary contact for Quality Assurance on quality matters and attend meetings/teleconferences. • Prepare periodic reports on quality matters, risk assessments, and quality improvement initiatives. • Perform other reasonable tasks as required by the role upon agreement with the line manager.

IQVIA maintains a zero tolerance policy for candidate fraud; any false statements or omissions during recruitment will result in disqualification or termination of employment according to applicable law.