Director, Clinical Quality (GCP) – Remote (U.S.)

Posted by Thorough Group on behalf of our biotech client

Reports to: Head of Quality

Location: Remote (U.S.-based)

Travel: 10–25%

Position Summary

Thorough Group is supporting a fast-growing biotechnology organization in the search for a Director of Clinical Quality to lead GCP Quality Assurance activities across the company’s clinical programs. This is a high-impact role responsible for proactive quality oversight, inspection readiness, risk mitigation, and ensuring compliance with global GCP, FDA, and ICH regulations.

The Director will oversee internal and external QA operations, guide clinical teams on best practices, manage audits, and ensure submission-ready quality data to support clinical development and future regulatory filings. This position offers the opportunity to build and strengthen the company’s GCP quality infrastructure during a period of significant clinical growth.

Key Responsibilities

• Lead day-to-day GCP Quality Assurance activities across all clinical programs, ensuring compliance with corporate procedures and global regulatory requirements.
• Manage Clinical Quality staff and contractors, providing mentorship, accountability, and continuous development.
• Build strong working relationships with Clinical Development, Clinical Operations, Regulatory, and cross-functional program teams.
• Provide strategic quality insights during clinical execution and partner closely with senior leadership on QA matters.
• Lead the planning, execution, and follow-up of GCP audits (internal, vendor, CRO, investigator site, laboratory, data management).
• Oversee inspection readiness activities, including FDA BIMO preparation, documentation systems, processes, and cross-functional coordination.
• Support development, implementation, and maintenance of GCP and GLP quality systems, SOPs, and controlled documents.
• Represent Clinical Quality Assurance in program team meetings; provide guidance on GCP compliance, continuous improvement, and best practices.
• Drive quality improvements and risk mitigation strategies based on audit trends, QA metrics, and performance insights.
• Review essential clinical documents (Protocols, Study Plans, IBs, CSR sections) for accuracy, quality, and compliance.
• Maintain the internal audit program; ensure findings are investigated, root cause analyses completed, and CAPAs implemented and monitored for effectiveness.
• Support delivery and tracking of GCP training across the organization; maintain training records in the learning management system.
• Ensure consistent inspection-ready documentation across all clinical activities.
• Monitor quality metrics, KPIs, and periodic audit reporting.
• Maintain current knowledge of global GCP/GxP regulations and industry standards (FDA, EMA, ICH, ISO, AVOCA).
• Perform other quality-related duties and special projects as assigned.

Required Qualifications

• BS/MS or higher in life sciences, healthcare, or biotechnology disciplines.
• Minimum 7 years of industry experience, with 5+ years specifically in GCP-focused Clinical Quality Assurance.
• Hands-on experience in global clinical trial compliance, GCP QA systems, and inspection readiness.
• Strong understanding of GxP regulations, including FDA/EU GCP, ICH, and ISO guidelines.
• Direct experience preparing for and supporting FDA BIMO inspections (sponsor, CRO, or site).
• Experience with audit programs, clinical documentation review, and CAPA processes.
• Proficiency with Microsoft Word, Excel, PowerPoint, and workflow tools (Visio or similar).

Preferred Experience

• Direct experience in global clinical trial compliance, clinical data management or Biostatistics is a plus.
• Clinical Research certification (e.g., RQAP-GCP, CCRA, CQA) is a plus.
• Experience working in small or emerging biotech environments.

Skills & Success Factors

• Strategic thinker with hands-on execution skills; able to balance operational detail with long-term planning.
• Strong leadership, communication, and interpersonal skills; adept at influencing across levels.
• Ability to manage multiple priorities, solve problems proactively, and operate in a fast-paced, matrixed environment.
• Exceptional attention to detail with a commitment to producing high-quality deliverables.
• Strong negotiation and stakeholder management skills.
• Ability to work independently while building collaborative relationships across internal teams and external vendors.