Associate Director Quality Management

Job Title: Associate Director Quality Management

Job Location: Reading, Berkshire, United Kingdom

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: 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 improv...