Principal Clinical Quality Assurance Specialist

Our client, a leading Contract Research Organization (CRO), is seeking a Principal Clinical Quality Assurance Specialist to join their team. The Principal Quality Assurance Specialist is a seasoned Clinical QA professional responsible for conducting GCP audits, supporting regulatory inspections, as well as strengthening compliance and quality systems across the organization. This role partners closely with the VP of Quality Assurance and serves as a key quality resource, leading audit activities and supporting process improvement initiatives in a clinical research environment.

The ideal candidate will demonstrate strong attention to detail, proactive problem-solving skills, and a collaborative mindset, which will align successfully within the organization.

Job Title: Principal Clinical Quality Assurance Specialist

Location: Bethesda, MD (Remote)

Salary: $120,000 - $150,000

Travel: Up to 25%

• Verify compliance with GCP regulations, SOPs, and applicable quality standards.

• Conducts audits of clinical sites, vendors, and suppliers.

• Lead and support external audits at investigator sites and vendor facilities.

• Provide ongoing support for the Quality Management System (QMS).

• Lead CAPA investigations and continuous process improvement initiatives.

• Review clinical quality management plans and provide consultative quality support.

• Train and mentor junior staff on quality processes and regulatory requirements.

• Support regulatory authority inspections and inspection readiness activities.

• Participate in business development activities as needed.

• Strong knowledge of current GCP regulations, FDA requirements, and ICH guidelines.

• Experience conducting GCP clinical site audits and vendor audits.

• Experience supporting regulatory authority inspections.

• Experience working within Quality Systems in a CRO environment.

• Demonstrated experience managing audit findings, CAPAs, and quality improvement activities.

• Strong written and verbal communication skills.

• Proficiency in Microsoft Office.

• Ability to travel domestically and occasionally internationally for audit activities.

• Opportunity to contribute to impactful clinical research projects.

• Flexible remote work environment supporting work-life balance.

• Engagement with a dynamic and innovative team.

• Chance to develop and refine your expertise in clinical quality assurance.

• Supportive organizational culture committed to professional growth.

• Medical and Prescription Drug Plans

• Dental Plan

• Vision Plan

• Health Savings Account

• Health Flexible Spending Account

• Dependent Care Flexible Spending Account

• Supplemental Life Insurance

• Short Term and Long Term Disability Insurance

• Business Travel Insurance

• 401(k), Plus Match

• Weekly Pay

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