Quality Assurance Director (Quality Control Leader)

Department Information

The Quality Assurance (QA) Director is responsible for leading the Indiana University School of Medicine (IUSM) Quality Assurance organization and for supporting various areas across Indiana University (IU) including Cell and Gene Therapy Manufacturing, Gene Therapy Testing Laboratory, IU Genetics Biobank, Laboratory Animal Resource Center, Biospecimen Management Core, and Clinical Research Center. Additionally, the Quality Director is responsible for providing strategic quality support to broad-reaching initiatives such as the Quality and Compliance Workstream as part of the IU Health Clinical Research Council and to Indiana's Clinical Translational Science Institute.

Job Summary

Department-Specific Responsibilities

• Provides quality leadership support.
• Interacts closely with leadership and departments across IUSM and IU Health to understand strategies, feedback, and future needs in order to partner with them in establishing and implementing quality improvement strategies.
• Serves on committees to provide QA expertise and recommendations, to ensure regulatory compliance, and further continuous quality improvement across areas.
• Develops and conducts QA educational programs for organizations (staff and leadership) and committees to further QA understanding and improve Quality culture.
• Provides strategic quality management system support.
• Ensures the establishment, implementation, and monitoring of fit-for-purpose quality management systems based on area needs. This includes establishing risk-based quality strategies, quality plans, quality standards and procedures, training, best practice sharing, and quality monitoring.
• Ensures each area is focused on continual quality improvement to increase the effectiveness of work processes and systems. This includes the use of metrics and management reviews to drive area quality performance.
• Ensures area compliance with applicable state and federal regulations as well as accrediting organizational standards, as appropriate. This includes regulations and guidelines from the United States Food and Drug Administration (FDA), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Foundation for the Accreditation of Cellular Therapy (FACT), etc.
• Provides staffing support.
• Provides coaching, mentoring, and feedback to direct reports including conducting performance reviews, regular 1-on-1 meetings, and career coaching discussions.
• Works with area leadership to understand area needs, strategic objectives, and feedback on QA employees.
• Monitors employee workloads and hires new staff based on area needs.
• Establishes development plans with employees to further their growth in QA knowledge, interpersonal skills, and leadership abilities.
• Creates an open environment for the QA organization and the areas being supported.

General Responsibilities

• Directs and leads oversight of research compliance.
• Develops, manages, and implements compliance plans for the IU research community consistent with the requirements of federal, state, and local regulations and statutes, as well as compliance policies of the University.
• Oversees an office and manages, recruits, trains, and staffs employees that maintain the working knowledge to consistently apply complex federal regulations and University policies to satisfy regulatory requirements.
• Develops and conducts training programs and conferences regarding research integrity matters related to the responsible conduct of research for committee members, faculty investigators, administrators, and staff.
• Provides detailed summary reports of compliance concerns to school, department, and division leadership.
• Serves on committees to provide advice and make recommendations to members and committee chairs, university counsel, senior administrators, faculty investigators, and other affiliated institutions.