São Paulo, Brazil \| Full time \| Home\-based \| 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 \- Company and study\-specific procedures \- General compliance\-related queries • 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. *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: \- Remote Compliance Activities \- Risk identification and mitigation strategies \- Site\-level compliance assessments \- Drive standardization and harmonization of processes across the team. *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 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 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 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).** • Experience in oncology global trials is preferred. • Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience. • Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes. • Excellent organizational, in