Head of Clinical Compliance & Quality Assurance

Charter Research, LLC; Orlando (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Charter Research, LLC, based in Florida and Illinois, seeks a Compliance Director to lead the Compliance Team. You will ensure ALCOA-C data collection and adherence to ICH GCP, FDA guidance, and Charter SOPs across sites in Orlando.

You will design and monitor QA standards, audits, CAPA, and regulatory reporting, guiding senior leadership and maintaining inspection readiness for FDA and sponsors.

Qualifications

• 3+ years in clinical research compliance and quality assurance.
• Experience leading internal and sponsor audits and inspections.
• Proven ability to develop and implement company-wide compliance plans.

Responsibilities

• Develop, implement, and maintain QA standards ensuring data integrity and patient safety.
• Design compliance plans, risk analyses, and key initiatives.
• Ensure inspection readiness across all sites and coordinate FDA inspections.
• Oversee audits and CAPA tracking across studies and processes.
• Lead day-to-day quality control, deviation tracking, and regulatory reporting.
• Manage version-controlled documents (SOPs, WI, forms) and keep them up to date.
• Provide guidance to senior leadership on regulatory affairs.
• Prepare CAPA plans and reports addressing gaps for compliance.
• Report compliance issues to IRBs, sponsors, and CROs as required.

Skills

Regulatory compliance leadership

Audit management

Data integrity

Quality assurance

FDA inspections

GCP/ICH knowledge

Risk analysis

Policy development

Team leadership

Education

Bachelor’s degree

Master’s degree preferred

Clinical research certifications (ACRP/SOCRA)

Job description

Charter Research, LLC, based in Florida and Illinois, seeks a Compliance Director to lead the Compliance Team. You will ensure ALCOA-C data collection and adherence to ICH GCP, FDA guidance, and Charter SOPs across sites in Orlando.

You will design and monitor QA standards, audits, CAPA, and regulatory reporting, guiding senior leadership and maintaining inspection readiness for FDA and sponsors.