Director, Clinical Quality Assurance

Role Summary

Director, Clinical Quality Assurance (CQA) is responsible for establishing, implementing, and maintaining quality systems and risk-management practices to ensure clinical trials are conducted in compliance with ICH-GCP, regulatory requirements, internal SOPs, and industry best practices. This role provides quality management and oversight of clinical trials, the clinical audit program, and portfolio-wide risks, partnering with cross-functional teams to proactively improve quality and trial execution. The position reports to the Head of Quality and is remote/full-time, with periodic on-site visits preferred.

Responsibilities

• Quality Oversight & Compliance
  • Develop, implement, and maintain the Clinical Quality Management System (CQMS) to support inspection readiness and regulatory compliance.
  • Provide GCP compliance oversight to all clinical programs, including CROs, clinical sites, vendors, and internal teams.
  • Review clinical documentation (protocols, monitoring plans, TMF, vendor deliverables, etc.) to ensure compliance and quality.
  • Serve as a subject matter expert (SME) for GCP and clinical quality best practices.
• Audit & Inspection Readiness
  • Plan, execute, and report on internal and external audits (e.g., sites, vendors, TMF, system audits).
  • Track and support resolution of audit findings and CAPAs.
  • Lead preparation for regulatory inspections (FDA, EMA, MHRA, etc.).
  • Facilitate mock inspections, training, and inspection logistics.
• Risk Management
  • Lead clinical risk assessments using quality-by-design (QbD) and risk-based quality management (RBQM) principles.
  • Identify systemic risks across the clinical trial portfolio and implement risk mitigation strategies.
  • Monitor key quality indicators (KQIs), KPIs, deviations, and other signals to detect emerging risks.
  • Partner with Clinical Operations and Data Management to evaluate and escalate risks proactively.
• Vendor & Site Oversight
  • Evaluate and qualify CROs and key service providers from a quality perspective.
  • Perform vendor audits when needed and oversee vendor risk assessments.
  • Partner with Clinical Operations to ensure oversight plans are robust and followed.
• Training & Continuous Improvement
  • Conduct GCP and quality training for clinical staff, CROs, and investigators.
  • Develop and maintain SOPs, work instructions, guidance documents, and quality tools.
  • Lead quality improvement initiatives and support continuous process optimization.
  • Foster a culture of quality, compliance, and proactive risk management throughout the organization.
• Documentation & Reporting
  • Prepare clear, concise reports summarizing audit outcomes, risk assessments, and quality metrics.
  • Ensure timely and accurate documentation in the Trial Master File (TMF).
  • Present quality trends, risks, and recommendations to management and cross-functional teams.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
• 5–10+ years of experience in clinical research, with a minimum of 3 years in Quality Assurance or Clinical Compliance.
• Deep knowledge of ICH-GCP, FDA, EMA, and other global clinical regulatory requirements.
• Experience conducting clinical site, vendor, and/or system audits.
• Strong understanding of risk-based monitoring and QbD principles.
• Excellent communication, problem-solving, and relationship-building skills.

Skills

• Analytical and strategic thinking to identify and address quality risks.
• Attention to detail and strong documentation habits.
• Diplomacy and collaboration, working effectively across functions.
• Proactive problem-solving with a continuous improvement mindset.
• Ability to manage multiple priorities in a fast-paced environment.

Education

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.