Remote QA Director, Clinical Research & Compliance

Innovative Hematology, Inc.; Indianapolis (IN); Remote; USD 120,000 - 180,000; Full time

Job summary

Innovative Hematology, Inc. (IHI) seeks a Director of Quality Assurance to lead its clinical research QA program remotely, with quarterly visits to IHI or on-site as needed.

You will oversee the QA system, audits, CAPA, and regulatory readiness, coordinating with senior leaders to ensure compliance across studies. The ideal candidate has 12+ years in clinical research, at least 5 in GCP QA leadership, and holds a Bachelor’s degree in a related field, with an MS preferred; a valid driver’s

Qualifications

• Minimum Bachelor’s degree in related field.
• MS degree or higher preferred.
• Minimum 12 years of clinical research experience with at least 5 years in GCP quality assurance leadership position.
• Valid driver’s license and insured automobile required.

Responsibilities

• Oversee and improve the clinical research QA system in collaboration with executive leadership.
• Conduct internal audits and document findings; create audit certificates as needed.
• Develop and maintain SOPs and WIs for QA and related regulatory topics.
• Lead CAPA program and internal investigations; review trends quarterly with leadership.
• Prepare and assist in FDA inspections; host inspections when requested.
• Mentor and train research staff; provide advanced training for physicians and APPs.

Skills

GCP QA leadership

Clinical research audits

Team supervision

Education

Bachelor's degree in related field

MS degree or higher

Job description

Innovative Hematology, Inc. (IHI) seeks a Director of Quality Assurance to lead its clinical research QA program remotely, with quarterly visits to IHI or on-site as needed.

You will oversee the QA system, audits, CAPA, and regulatory readiness, coordinating with senior leaders to ensure compliance across studies. The ideal candidate has 12+ years in clinical research, at least 5 in GCP QA leadership, and holds a Bachelor’s degree in a related field, with an MS preferred; a valid driver’s