Site Quality & Compliance Lead: Training & CAPA

Magnit; United States; Sur place; USD 140 000 - 200 000; Plein temps

Résumé du poste

Magnit is seeking a Site Quality and Compliance Lead to drive quality and ensure compliance with FDA/ICH/GCP across Phase I-IV trials, Expanded Access Programs, Registries and Survey trials within Clinical Development Operations. The role includes developing training programs and coordinating quality activities across CD&O.

You will lead inspection readiness, CAPA development, risk mitigation, and collaboration with Legal, Med/RA, and cross-functional partners to address findings and drive

Qualifications

• Current knowledge of FDA, ICH, GCP regulations.
• Bachelor’s degree in life sciences preferred.
• Experience in clinical development operations quality activities.
• Ability to work with cross-functional teams.

Responsabilités

• Drive quality activities and inspection readiness across CD&O.
• Develop and deliver just-in-time training within US CDO.
• Lead CAPA and risk mitigation for trial findings.
• Collaborate with Legal, Med/RA and cross-functional partners.
• Report quality metrics and support onboarding and process improvements.

Connaissances

Regulatory knowledge

Project management

Quality assurance

Communication

Formation

Bachelor's Degree (Life Sciences preferred)

Description du poste

Magnit is seeking a Site Quality and Compliance Lead to drive quality and ensure compliance with FDA/ICH/GCP across Phase I-IV trials, Expanded Access Programs, Registries and Survey trials within Clinical Development Operations. The role includes developing training programs and coordinating quality activities across CD&O.

You will lead inspection readiness, CAPA development, risk mitigation, and collaboration with Legal, Med/RA, and cross-functional partners to address findings and drive