Quality Assurance Director
Actalent, Indianapolis, IN, United States
HIRING NOW: Clinical QA Director
**INTERVIEWS AVAILABLE THIS WEEK** Interested in this role?
Book a meeting https://talentassistant.actalentservices.com/assistant/bookings/PXdlC3b3 Job Summary
The
Quality Assurance Director
will lead the Quality Assurance (QA) organization, providing strategic quality leadership across multiple initiatives. This role supports highimpact areas including
Cell and Gene Therapy Manufacturing, the Gene Therapy Testing Laboratory, the Genetics Biobank , and other research, Biospecimen Management Core, and clinical research programs. This role is integral and plays a critical role in driving continuous quality improvement strategies, ensuring regulatory compliance with applicable regulations standers,, and fostering a strong quality culture the programs. Responsibilities Provide strategic QA leadership and partner closely with leadership and crossfunctional teams. Serve on institutional committees to provide QA expertise and ensure compliance with applicable regulatory requirements. Support external audits and inspections, including interaction with external clients and regulatory bodies. Develop, conduct, and deliver QA education and training programs for staff and leadership. Establish, implement, and monitor quality management systems tailored to departmental needs. Lead continuous quality improvement initiatives using metrics, performance indicators, and management reviews. Ensure compliance with state and federal regulations, including
FDA, ICH, and FACT
guidelines. Develop and execute compliance plans aligned with federal, state, and local requirements. Provide staffing support, including hiring, coaching, mentoring, performance management, and workload oversight. Oversee office operations, including recruiting and training staff to maintain regulatory readiness. Develop and conduct training related to research integrity and quality standards. Monitor employee workloads and manage hiring based on area needs. Develop and conduct training programs on research integrity matters. Qualifications & Essential Skills Required Bachelor's degree required (preferably in business, law, health administration, medical technology, life sciences, or engineering. 5+ years of Quality Assurance leadership experience within life science, clinical industry or academia. 8+ years of experience in research (academia/clinical), conduct, compliance, and/or project management with progressive responsibility. Supervisory leadership experience in Life Sciences and/or Quality Assurance Proven, proficient effective communication skills (written/verbal) and negotiation skills. Excellent organizational and time management skills Preferred Skills but Not Required Clinical Research Coordinator, Associate, or Professional Certification preferred Laboratory, Clinical, QA Leadership, Animal Laboratory Research, Six Sigma, Regulations and Compliance, GMP, GXP, GLP, FDA auditing and inspecting experience Experience in strategic quality planning and external client interactions during audits Ability to work independently with minimal supervision Analytical and problem-solving skills Leadership and management abilities Friendly and service-oriented approach Work Environment
This exciting opportunity offers a
hybrid work environment
with responsibilities onsite at the facilities and the flexibility to work remotely. The schedule is Monday to Friday, from 8 am to 5 pm. Initially, starting off, an onsite presence may be required to familiarize with the facilities, based off the needs, and meet with the teams. This will always be a truly hybrid remote once fully trained.
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 4, 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 .
**INTERVIEWS AVAILABLE THIS WEEK** Interested in this role?
Book a meeting https://talentassistant.actalentservices.com/assistant/bookings/PXdlC3b3 Job Summary
The
Quality Assurance Director
will lead the Quality Assurance (QA) organization, providing strategic quality leadership across multiple initiatives. This role supports highimpact areas including
Cell and Gene Therapy Manufacturing, the Gene Therapy Testing Laboratory, the Genetics Biobank , and other research, Biospecimen Management Core, and clinical research programs. This role is integral and plays a critical role in driving continuous quality improvement strategies, ensuring regulatory compliance with applicable regulations standers,, and fostering a strong quality culture the programs. Responsibilities Provide strategic QA leadership and partner closely with leadership and crossfunctional teams. Serve on institutional committees to provide QA expertise and ensure compliance with applicable regulatory requirements. Support external audits and inspections, including interaction with external clients and regulatory bodies. Develop, conduct, and deliver QA education and training programs for staff and leadership. Establish, implement, and monitor quality management systems tailored to departmental needs. Lead continuous quality improvement initiatives using metrics, performance indicators, and management reviews. Ensure compliance with state and federal regulations, including
FDA, ICH, and FACT
guidelines. Develop and execute compliance plans aligned with federal, state, and local requirements. Provide staffing support, including hiring, coaching, mentoring, performance management, and workload oversight. Oversee office operations, including recruiting and training staff to maintain regulatory readiness. Develop and conduct training related to research integrity and quality standards. Monitor employee workloads and manage hiring based on area needs. Develop and conduct training programs on research integrity matters. Qualifications & Essential Skills Required Bachelor's degree required (preferably in business, law, health administration, medical technology, life sciences, or engineering. 5+ years of Quality Assurance leadership experience within life science, clinical industry or academia. 8+ years of experience in research (academia/clinical), conduct, compliance, and/or project management with progressive responsibility. Supervisory leadership experience in Life Sciences and/or Quality Assurance Proven, proficient effective communication skills (written/verbal) and negotiation skills. Excellent organizational and time management skills Preferred Skills but Not Required Clinical Research Coordinator, Associate, or Professional Certification preferred Laboratory, Clinical, QA Leadership, Animal Laboratory Research, Six Sigma, Regulations and Compliance, GMP, GXP, GLP, FDA auditing and inspecting experience Experience in strategic quality planning and external client interactions during audits Ability to work independently with minimal supervision Analytical and problem-solving skills Leadership and management abilities Friendly and service-oriented approach Work Environment
This exciting opportunity offers a
hybrid work environment
with responsibilities onsite at the facilities and the flexibility to work remotely. The schedule is Monday to Friday, from 8 am to 5 pm. Initially, starting off, an onsite presence may be required to familiarize with the facilities, based off the needs, and meet with the teams. This will always be a truly hybrid remote once fully trained.
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 4, 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 .