Associate Director Quality Management
New
I
IQVIAClinical research
United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Languages
- Fluent in English.
- Experience
- Minimum of 8 years of progressive experience in clinical operations roles plus minimum 6 years’ experience in a GCP compliance or equivalent role (i.e. quality), including people management experience (minimum 4 years).
- Required Skills
- People ManagementMicrosoft Office
Requirements
- Hold a bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical, or healthcare discipline.
- Have a minimum of 8 years of progressive experience in clinical operations roles.
- Have a minimum of 6 years’ experience in a GCP compliance or equivalent quality role.
- Have a minimum of 4 years of people management experience.
- Bring a thorough understanding of clinical trial processes, ICH-GCP, and associated regulatory guidelines.
- Have sound working knowledge of ICH, Good Clinical Practice, SOPs, applicable regulatory requirements, and quality management processes.
- Demonstrate leadership, line management, and the ability to lead and motivate a clinical team.
- Demonstrate organizational, interpersonal, communication, problem-solving, judgment, and decision-making skills.
- Be fluent in English, written and verbal.
- Have strong computer skills, including Microsoft Office applications.
- Be able to work in a matrix environment and manage multiple priorities.
- Be able to travel within the region or country.
- Experience in oncology global trials is preferred.
Responsibilities
- Serve as the primary point of contact for the country compliance managers team on GCP requirements, company and study-specific procedures, and compliance queries.
- Provide guidance on regulations and internal standards to support consistent compliant practices.
- Oversee preparation, execution, and follow-up for inspections, and provide leadership support during high-impact audits and inspections.
- Monitor KPIs, quality metrics, and compliance trends; identify systemic risks and areas for improvement.
- Ensure timely escalation and resolution of critical compliance issues and drive CAPA quality and effectiveness.
- Review remote compliance activities, risk identification and mitigation strategies, and site-level compliance assessments.
- Manage budget, resource allocation, and workload balancing across the team.
- Translate global compliance strategies into team objectives and partner with clinical compliance, clinical operations, and quality assurance teams.
- Lead, coach, and develop the team, including setting performance expectations, conducting reviews, and addressing skill gaps.
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