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

R1575806

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 explicit 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 environment

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

📌 Associate Director Quality Management (Quebec City)
🏢 IQVIA
📍 Quebec City