Quality Assurance Director

Job Title: Quality Assurance Director

Job Description

The Quality Assurance Director will lead the Quality Assurance organization at the Indiana University School of Medicine and provide strategic quality support across various areas of Indiana University, including Cell and Gene Therapy Manufacturing, Gene Therapy Testing Laboratory, IU Genetics Biobank, and more. This role is integral in supporting quality improvement strategies and ensuring compliance with applicable regulations and standards.

Responsibilities

• Provide quality leadership support and interact closely with leadership and departments across IUSM and IU Health.
• Serve on committees to offer QA expertise and ensure regulatory compliance.
• Develop and conduct QA educational programs for staff and leadership to enhance quality culture.
• Ensure establishment and monitoring of quality management systems tailored to area needs.
• Focus on continual quality improvement by using metrics and management reviews.
• Ensure compliance with state and federal regulations, including FDA, ICH, and FACT guidelines.
• Provide staffing support, coaching, mentoring, and conduct performance reviews.
• Monitor employee workloads and manage hiring based on area needs.
• Develop compliance plans consistent with federal, state, and local regulations.
• Oversee office management, recruit and train employees to maintain regulatory knowledge.
• Develop and conduct training programs on research integrity matters.

Essential Skills

• Proficient communication and negotiation skills
• Ability to work independently with minimal supervision
• Excellent organizational and time management skills
• Analytical and problem-solving skills
• Leadership and management abilities
• Friendly and service-oriented approach

Additional Skills & Qualifications

• Bachelor's degree in business, law, health administration, medical technology, life sciences, or engineering
• Master's degree in a related discipline preferred
• 8 years of experience in clinical research, compliance, or project management
• 5 years of supervisory experience in life sciences or Quality Assurance preferred
• Clinical Research Coordinator, Associate, or Professional Certification preferred
• Experience in strategic quality planning and external client interactions during audits

Work Environment

This role offers a hybrid work environment with responsibilities onsite at IUSM facilities and the flexibility to work remotely as needed. The schedule is Monday to Friday, from 8 am to 5 pm. Initially, more onsite presence may be required to familiarize with the facilities and meet teams.

Job Type & Location

This is a Contract to Hire position based out of Indianapolis, IN.

Pay and Benefits

The pay range for this position is $64.90 - $64.90/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Indianapolis, IN.

Application Deadline

This position is anticipated to close on Apr 7, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

#J-18808-Ljbffr