Associate Director Quality Management

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 t