02 Nov
|
IQVIA
|
Quebec City
Munich, Bavaria, Germany
Mexico City, Mexico
Chennai, India
Quebec, Canada
Basel, Switzerland
Warsaw, Poland
Durham, North Carolina, United States of America
Barcelona, Spain
Sofia, Bulgaria
Madrid, Spain
Tokyo, Japan
Bratislava, Slovakia
Buenos Aires, Argentina
Athens, Greece
Beijing, China
Reading, Berkshire, United Kingdom
Mumbai, India
São Paulo, Brazil
Full time
R
General Description: The Regional Clinical Compliance Lead is responsible for leading, developing, and managing a team of Clinical
Compliance professionals supporting country- and site-level oversight. This role combines people leadership with
operational and strategic accountability to ensure consistent, high-quality execution of risk-based compliance
activities.
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.
Essential Functions Serve as the primary point of contact for the RCC country compliance managers team regarding: - GCP requirements
Provide expert guidance and interpretation of regulations and internal standards to ensure consistent and compliant practices.
Oversee preparation, execution, and follow-up activities for inspections
Provide leadership support during high-impact audits and inspections.
Ensure consistent application of lessons learned across the team.
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: Company and study-specific procedures
General compliance-related queries
Operational Oversight & Execution Excellence 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: Company and study-specific procedures
General compliance-related queries
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.
Strategic Alignment & Cross-Functional Partnership Translate global compliance strategies into clear team-level objectives and actions.
Ensure alignment between local execution and global expectations by partnering with:
RCC Inspection and Audit Lead
RCC Process Excellence and Risk Surveillance
Global Clinical Compliance
Clinical Operations leadership
Quality Assurance teams
Represent the function in governance forums and cross-functional discussions.
Core Competencies, Knowledge and Skill Requirements: Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines
Analytical and problem-solving skills
High attention to detail and quality orientation
Excellent communication and stakeholder management skills
Communication & Interpersonal Skills: Excellent English written and verbal communication and interpersonal skills
Excellent organizational skills and ability to prioritize and multi-task
Ability to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced setting
Supervisory Responsibilities: Lead, coach, and develop a team of Regional Clinical Compliance professionals across multiple countries.
Set clear performance expectations and conduct regular performance reviews (goal setting, mid-year, year-end).
Build organizational capability by identifying skill gaps and implementing targeted development plans.
Foster a culture of quality, accountability, continuous improvement, and psychological safety.
Drive talent management, including succession planning and retention of key talent.
Promote an inclusive, collaborative, and high-performing team environment aligned with company values.
Encourage feedback, innovation, and continuous learning.
Model ethical behavior and reinforce a compliance mindset across the team
Qualifications Bachelor’s degree (BS/BA or equi
📌 Associate Director Quality Management (Quebec City)
🏢 IQVIA
📍 Quebec City