Associate Director Of Clinical Quality Assurance

Job DetailExperience Level Associate DirectorDegree Type Bachelor of Science (BS)Employment Full TimeWorking Type HybridJob Reference 0000018346Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful clinical quality assurance initiatives ensuring GCP compliance excellence. Collaborate across teams to drive operational improvements and regulatory readiness. Hybrid work model offers flexibility and professional growth opportunities.Job DescriptionAssociate Director Of Clinical Quality Assurance OverviewLead clinical quality assurance initiatives, ensuring compliance with GCP regulations and fostering excellence in clinical trial practices.Develop and implement strategies to enhance operational quality and maintain regulatory adherence.Collaborate with cross-functional teams to drive continuous improvement in clinical quality processes.Provide expert guidance and training on GCP compliance to clinical investigators and staff.Support regulatory inspections, ensuring clinical programs are audit-ready and compliant.Manage audit schedules, tracking systems, and metrics to monitor quality assurance activities effectively.Contribute to the development of corrective action plans, addressing audit findings proactively.Engage in a hybrid work model, combining onsite collaboration with remote flexibility.Associate Director Of Clinical Quality Assurance Key Responsibilities & DutiesConduct and oversee GCP audits of clinical sites, vendors, and internal systems to ensure compliance.Develop and execute study-specific audit plans, coordinating with auditors and clinical teams.Review audit reports, ensuring alignment with SOPs and regulatory standards.Collaborate with clinical teams to resolve audit findings and implement quality improvements.Provide training and mentorship on GCP compliance and regulatory requirements.Assist in regulatory inspections, preparing documentation and ensuring readiness.Maintain tracking databases for audit activities, providing metrics and insights to management.Ensure vendor performance aligns with GCP standards, addressing compliance issues effectively.Associate Director Of Clinical Quality Assurance Job RequirementsBachelor’s degree in Nursing, Health Science, or a related field is required.Minimum of 10 years of experience in GCP auditing or compliance roles.Proficiency in US and ICH GCP regulations and guidelines is essential.Knowledge of clinical safety and trial management systems such as ARISg and TrialWorks.Strong interpersonal, oral, and written communication skills to engage effectively.Ability to manage competing deadlines and perform under pressure.Experience with tracking databases like TrackWise and LIMS is preferred.Demonstrated ability to work independently and collaboratively within team environments.