Director of Quality & Compliance

Director of Quality & Compliance

Location: Winter Park, Florida, USA

Work Arrangement: Hybrid

Employment Type: Full-time

Industry: Clinical Research / Clinical Trials

About the Opportunity

We are partnering with a growing clinical research organisation to appoint a Director of Quality & Compliance to lead and strengthen its quality, regulatory and compliance functions across a multi-site clinical research network.

This is a senior leadership opportunity for an experienced quality professional with a strong background in Good Clinical Practice (GCP), clinical research compliance, audit management and quality systems. The successful candidate will play a pivotal role in maintaining regulatory standards, driving continuous improvement and ensuring consistent quality oversight across clinical research operations.

Reporting directly to the Chief Executive Officer, with a dotted-line relationship to the Chief Medical Officer on medical and research participant-protection matters, this individual will work closely with executive leadership to support operational excellence and the organisation's continued growth.

The position is based in Winter Park, Florida, with a hybrid working arrangement and regular travel to clinical research sites as required.

Key Responsibilities

Quality Assurance & Quality Management Systems

• Lead the development, implementation and continuous improvement of the organisation's Quality Management System (QMS).
• Establish and maintain quality policies, procedures, standards and controls across the clinical research network.
• Drive a culture of quality, accountability and continuous improvement across all sites and functions.
• Oversee quality metrics, identify trends and implement appropriate corrective and preventive actions (CAPAs).

Audit Management & Inspection Readiness

• Develop and oversee risk-based internal and external audit programmes.
• Lead audit preparation, execution, reporting, follow-up and remediation activities.
• Ensure ongoing inspection readiness and compliance with applicable regulatory requirements and GCP standards.
• Manage audit findings, deviations, non-conformances and CAPAs through to effective resolution.

Regulatory Compliance & Participant Protection

• Provide oversight of clinical research compliance, ensuring appropriate processes and controls are in place.
• Partner with executive and medical leadership on significant quality risks, regulatory issues and participant-safety escalations.
• Support the consistent application of clinical research standards and regulatory requirements across the network.
• Identify compliance gaps and proactively implement risk-mitigation strategies.

Leadership & Cross-Functional Collaboration

• Lead and develop the Quality Assurance, Quality Control, Regulatory Affairs and EDC functions through direct-reporting leaders.
• Work closely with operational and clinical leadership to embed quality into day-to-day research activities.
• Provide strategic quality and compliance guidance to the CEO and wider leadership team.
• Support the development of scalable processes and governance structures as the organisation grows.

Required Experience & Qualifications

• Significant experience in quality assurance, quality compliance or quality leadership within clinical research.
• Strong working knowledge of ICH-GCP and applicable clinical research regulatory requirements.
• Demonstrable experience developing, implementing or improving Quality Management Systems.
• Proven experience managing risk-based audits, inspection readiness, audit findings and CAPA programmes.
• Experience leading teams and overseeing multiple quality or compliance functions.
• Strong stakeholder-management skills, with the ability to influence senior leadership and operational teams.
• A proactive, solutions-oriented approach to risk management, problem-solving and continuous improvement.
• Willingness and ability to travel regularly to clinical research sites as required.

Preferred Background

• Experience within a clinical site network, multi-site clinical research organisation, site management organisation or comparable clinical research environment.
• Experience supporting multiple research sites and standardising quality processes across geographically dispersed operations.
• Previous responsibility for regulatory inspections, sponsor/CRO audits or significant compliance remediation initiatives.
• Experience building or scaling quality functions within a growing organisation.

Location & Working Arrangements

This is a hybrid position based in Winter Park, Florida, with regular travel to clinical research sites for quality oversight, audits and inspections.

How to Apply

If you are an experienced clinical research quality leader looking for an opportunity to shape quality standards, strengthen compliance infrastructure and contribute at executive level, we would welcome your application.

Apply directly through LinkedIn or contact the recruitment team for a confidential discussion about the opportunity.