Regional Clinical Compliance Lead

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 of the Job

• Compliance Subject Matter Expert and Strategic lead for RCC Study and site compliance team
• 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
• Computer Skills
• PC literacy required; MS Office skills (Outlook, Word, Excel, Power Point)
• Travel
• Up to 10-20% travel
• Salary Range Switzerland: 156,200.00 CHF - 195,200.00 CHF
• Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer.

Be One does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.

All employment is decided on the basis of qualifications, merit, and business need.

#J-18808-Ljbffr