Associate Director of Clinical Quality

i-Pharm Consulting; New Jersey; Presencial; USD 170.000 - 230.000; Jornada completa

Descripción de la vacante

i‑Pharm Consulting seeks an experienced Associate Director of Clinical Quality to oversee quality and compliance of outsourced clinical trials. The role requires developing and maintaining clinical quality systems and ensuring ongoing regulatory readiness.

Responsibilities include auditing sites and vendors, managing GCP compliance issues, and ensuring FDA inspection readiness across US sites, with occasional travel to NJ HQ.

Formación

• 7+ years of Clinical Quality experience in the pharmaceutical or biotech industry.
• Experience leading GCP inspections and audits.
• Ability to travel to New Jersey HQ and other sites across the US.

Responsabilidades

• Auditing sites and vendors.
• Managing GCP compliance issues.
• Ensuring FDA inspection readiness.

Conocimientos

Clinical Quality

GCP audits

FDA inspections

Descripción del empleo

An industry leading Commercial Stage Biotech company is seeking an experienced Associate Director of Clinical Quality to oversee the quality and compliance of the company's outsourced clinical trials. They will be expected to have a strong background developing and maintaining clinical quality systems.

Responsibilities

• Auditing sites and vendors
• Managing GCP compliance issues
• Ensuring FDA inspection readiness

Qualifications

• 7+ years of Clinical Quality experience in the Pharmaceutical or Biotech industry
• Experience leading GCP inspections and audits
• Ability to occasionally travel to New Jersey HQ and other clinical sites across the US