Senior Director, Clinical Quality Assurance & Compliance

Regulatory Jobs; San Diego (CA); Presencial; USD 180.000 - 270.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equity-based compensation

401(k) with Company Match

Medical, Dental, Vision

Descripción de la vacante

ADARx Pharmaceuticals, located in San Diego, seeks a Director of Clinical Quality Assurance to lead GCP compliance across all programs. You will build a robust, risk-based quality framework and partner with Clinical Operations, Regulatory, and study teams to ensure submission readiness and inspection success.

You will oversee audits of CROs and vendors, drive CAPA actions, and guide investigations of deviations and quality events while promoting a culture of continuous improvement.

Formación

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree preferred.
• Extensive experience leading GCP quality programs and regulatory submissions.
• Strong knowledge of global GCP regulations and guidance.

Responsabilidades

• Develop and execute the Clinical QA strategy aligned with development goals.
• Lead risk-based quality systems, SOPs, and policies for trials and submissions.
• Oversee audits of sites, CROs, vendors; drive CAPA implementation.
• Ensure inspection readiness for regulatory authorities and audits.
• Collaborate with Clinical Ops, Regulatory, Biostatistics, and study teams.

Conocimientos

GCP compliance

Audit leadership

CAPA management

Regulatory inspections

Cross-functional collaboration

Strategic leadership

Educación

Bachelor’s degree in life sciences

Advanced degree preferred

Descripción del empleo

ADARx Pharmaceuticals, located in San Diego, seeks a Director of Clinical Quality Assurance to lead GCP compliance across all programs. You will build a robust, risk-based quality framework and partner with Clinical Operations, Regulatory, and study teams to ensure submission readiness and inspection success.

You will oversee audits of CROs and vendors, drive CAPA actions, and guide investigations of deviations and quality events while promoting a culture of continuous improvement.