Clinical Research Quality & Compliance Lead

OneOncology; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

OneOncology is seeking a Manager, Research Quality to lead quality programs across the OneR network, ensuring regulatory compliance and governance of CAPA, audits, and vendor qualification to uphold top-tier clinical research standards.

The role partners with cross-functional teams to drive continuous improvement and supports sponsor/CRO inspections. Travel ~25% is required for site visits and audits.

Qualifications

• Experience in clinical research quality assurance and regulatory compliance.
• Experience supporting FDA inspections.
• Professional certification in clinical research or quality assurance preferred.

Responsibilities

• Advance the quality management system for the network.
• Monitor KPI health of quality operations.
• Lead CAPA program including investigations and effectiveness.
• Oversee vendor qualification and regulatory risk assessments.
• Prepare sites for sponsor/CRO audits and regulatory inspections.

Skills

GCP knowledge

FDA regulations

ICH guidelines

Quality management

Audits & inspections

Regulatory compliance

Cross-functional collaboration

Analytical thinking

Education

Bachelor's degree

Advanced degree in a relevant scientific discipline

Tools

Microsoft Office

EDC systems

Electronic regulatory binders

CTMS

Job description

OneOncology is seeking a Manager, Research Quality to lead quality programs across the OneR network, ensuring regulatory compliance and governance of CAPA, audits, and vendor qualification to uphold top-tier clinical research standards.

The role partners with cross-functional teams to drive continuous improvement and supports sponsor/CRO inspections. Travel ~25% is required for site visits and audits.