Associate Director Of Clinical Quality Assurance

Overview

• Lead clinical quality assurance initiatives to ensure compliance with GCP regulations and guidelines.
• Conduct audits of clinical sites, vendors, and internal systems to maintain regulatory standards.
• Oversee corrective action plans and collaborate with teams to resolve audit findings effectively.
• Provide training and guidance on GCP compliance to clinical investigators and staff.
• Manage audit schedules, tracking systems, and metrics for quality assurance activities.
• Support regulatory inspections and ensure readiness of clinical programs.
• Collaborate with cross-functional teams to enhance quality practices and continuous improvement.
• Travel up to 40% and work onsite three days per week in a hybrid model.

Key Responsibilities & Duties

• Conduct and oversee GCP audits of clinical sites, vendors, and systems.
• Develop and implement study-specific audit plans in collaboration with auditors.
• Review audit reports and ensure compliance with SOPs and regulations.
• Collaborate with clinical teams to resolve audit findings and improve practices.
• Provide training on GCP compliance and regulatory requirements.
• Assist in regulatory inspections and prepare necessary documentation.
• Maintain tracking systems for audit activities and provide metrics to management.
• Ensure vendor performance aligns with GCP standards and address issues as needed.

Job Requirements

• Bachelor’s degree in Nursing, Health Science, or related field required.
• Minimum 10 years of experience in auditing or compliance for GCP-related fields.
• Proficient in US and ICH GCP regulations and guidelines.
• Knowledge of clinical safety and trial management systems (e.g., ARISg, TrialWorks).
• Strong interpersonal, oral, and written communication skills.
• Ability to handle competing timelines and work under pressure.
• Experience with tracking databases such as TrackWise and LIMS.
• Ability to work independently and collaboratively in a team environment.