Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
Job Description
Job ID:
319339 Department
SCHOOL WIDE RESEARCH
(IN-RESW-IUINA) 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. Qualifications Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.
EDUCATION
Required Bachelor's degree (preferably in business, law, health administration, medical technology, life sciences, or engineering). Preferred Master's degree in a related discipline.
WORK EXPERIENCE
Required 8 years of experience in clinical research, conduct, compliance, and/or project management with progressive responsibility. Preferred 5 years of industrial, clinical, and/or Quality Assurance work experience. 5 years of supervisory experience in life sciences and/or Quality Assurance.
LICENSES AND CERTIFICATES
Preferred Clinical Research Coordinator Certification Upon Date of Hire. Clinical Research Associate Certification Upon Date of Hire. Clinical Research Professional Certification Upon Date of Hire. SKILLS Required Proficient written and verbal communication skills. Effective negotiation skills. Ability to perform work independently with minimal supervision. Excellent organizational skills. Ability to work within tight time frames and meet strict deadlines. Demonstrates time management and priority setting skills. Demonstrates analytical skills. Demonstrates problem solving skills. Maintains composure under pressure. Ability to lead/manage others. Friendly and service-oriented. Preferred Knowledge of Quality Management Systems, Quality Assurance, and associated regulations and guidelines. Experience in strategic quality planning. Strong supervisory skills. Experience in leading external interactions with clients during audits and/or federal agencies (e.g., FDA) during inspections and discussions. Demonstrates strong decision making and teamwork skills. Working Conditions / Demands This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation. Work Location Indianapolis, Indiana Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including: Comprehensive medical and dental insurance Health savings account with generous IU contributions Healthcare and dependent care flexible spending accounts Basic group life insurance paid by IU Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance Base retirement plan with generous IU contributions, subject to vesting Voluntary supplemental retirement plan options Tuition subsidy for employees and family members taking IU courses 10 paid holidays plus a paid winter break each year Generous paid time off plans Paid leave for new parents and IU-sponsored volunteer events Employee assistance program (EAP) Learn more about our benefits by reviewing the IU Benefit Programs Brochure .
Job Classification Career Level:
Strategic FLSA:
Exempt Job Function:
Research Job Family:
Research Compliance Click here to learn more about Indiana University's Job Framework. Equal Employment Opportunity Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information .
