Quality Assurance Director
Actalent, Indianapolis, IN, United States
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.
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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.
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