31 Oct
|
IQVIA
|
Kirkland
The Regional Clinical Compliance Lead is responsible for leading, developing, and managing a team of Clinical Compliance professionals supporting country
- and site-level oversight. operational and strategic accountability to ensure consistent, high-quality execution of risk-based compliance This role plays a critical role in building team capability, driving performance, and ensuring alignment with global compliance strategies while fostering a culture of quality, accountability, and continuous improvement. Serve as the primary point of contact for the RCC country compliance managers team regarding:
- Oversee preparation, execution, and follow-up activities for inspections Provide leadership support during high-impact audits and inspections. Ensure consistent and high-quality execution of risk-based compliance activities across countries and studies. Monitor key performance indicators (KPIs), quality metrics, and compliance trends across the team. Identify systemic risks, recurring issues, and areas for improvement. Ensure timely escalation to Head RCC EMEA and effective resolution of critical compliance issues. Drive accountability for CAPA quality and effectiveness. Provide oversight and quality review of: Remote Compliance Activities Risk identification and mitigation strategies Site-level compliance assessments Resource & Capacity Management Manage and oversee the budget, resource allocation and workload balancing across the team based on study portfolio and risk profile. Ensure appropriate resourcing for high-risk studies, sites, and compliance activities. Partner with senior leadership on workforce planning and capability needs. Ensure alignment between local execution and global expectations by partnering with:
RCC Process Excellence and Risk Surveillance Quality Assurance teams regulatory guidelines High attention to detail and quality orientation Excellent communication and stakeholder management skills Excellent English written and verbal communication and interpersonal skills Set clear performance expectations and conduct regular performance reviews (goal setting, mid-year, year-end). Foster a culture of quality, accountability, continuous improvement and psychological safety. Drive talent management, including succession planning and retention of key talent. Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline
* with minimum of 8 years of progressive experience in clinical operations roles plus minimum 6 years’ experience in a GCP compliance or equivalent role (i.e. quality) including people management experience (minimum 4 years). Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Valuable Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes. Demonstrated leadership and line management skills. Strong computer skills including Microsoft Office applications. Ability to travel within the region/country. Ability to establish and maintain effective working relationships with co-workers, managers and clients. Fluent in English. 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. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.
📌 Associate Director Quality Management (Kirkland)
🏢 IQVIA
📍 Kirkland