Associate Director, Clinical QA - GCP/GVP (Hybrid)

SystImmune, Inc.; Princeton (NJ); Híbrido; USD 150.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental/vision

STD/LTD

401(k) match

Vesting 5 years

PTO 15 days

Paid holidays

Descripción de la vacante

SystImmune, Inc. is seeking an Associate Director of Clinical Quality Assurance to provide strategic leadership for GCP/GVP programs across development.

You will collaborate with Clinical Operations, Drug Safety, Regulatory Affairs, and external vendors to ensure a robust quality system, proactive risk management, and inspection readiness. Ideal candidates have 8+ years in Clinical Quality Assurance, strong experience with audits and regulatory inspections, and a track record in oncology

Formación

• Bachelor's degree in Life Sciences or related field.
• 8+ years in Clinical Quality Assurance, Clinical Research, Pharmacovigilance, or related functions.
• Minimum 5 years of direct GCP Quality Assurance experience.
• Experience leading GCP audits, vendor audits, and inspection readiness programs.
• Experience supporting regulatory authority inspections (FDA, EMA, MHRA, PMDA, NMPA, or equivalent).
• Experience in oncology clinical development preferred.

Responsabilidades

• Provide strategic leadership for Clinical Quality programs to ensure GCP/GVP compliance.
• Partner with Clinical Operations, Drug Safety, Regulatory Affairs, Biostatistics, and vendors to implement quality systems.
• Lead audit programs and oversee internal, external, and CRO audits.
• Coordinate inspection readiness and assist during regulatory inspections.
• Oversee CAPA investigations and drive timely, effective corrective actions.
• Lead SOP development and training for GCP, GVP, and Clinical Quality.

Conocimientos

GCP/GVP oversight

Quality management

Audit programs

Regulatory compliance

Vendor management

Educación

Bachelor in Life Sciences

Herramientas

QMS software

Descripción del empleo

SystImmune, Inc. is seeking an Associate Director of Clinical Quality Assurance to provide strategic leadership for GCP/GVP programs across development.

You will collaborate with Clinical Operations, Drug Safety, Regulatory Affairs, and external vendors to ensure a robust quality system, proactive risk management, and inspection readiness. Ideal candidates have 8+ years in Clinical Quality Assurance, strong experience with audits and regulatory inspections, and a track record in oncology