R&D Quality Risk Manager – Clinical Trials Leader

Planet Pharma; Princeton (NJ); On-site; USD 62,000 - 76,000; Full time

Job summary

Planet Pharma seeks an experienced R&D Quality Risk Manager to oversee quality risk management for clinical trials within a GCP framework. Collaborate with internal R&D teams and CROs to ensure compliance and drive improvements across PV, data management, and regulatory affairs.

The role emphasizes metrics tracking, ICH-aligned risk controls, and CAPA implementation, with opportunities to mentor junior staff and travel up to 10% as needed.

Qualifications

• 6+ years in a GCP-regulated R&D/pharma environment.
• Experience with risk management in clinical trials and QA systems.
• Familiarity with FDA/EMA/MHRA regulations.

Responsibilities

• Lead quality risk management activities for R&D trials.
• Support Drug Safety, PV, CV and GLP areas as needed.
• Develop and implement risk-based quality control measures and metrics.
• Coach junior staff in QRM practices and regulatory expectations.

Skills

Quality Risk Management

GCP compliance

Regulatory affairs

CAPA & root cause analysis

Project coordination

Cross-functional collaboration

SOPs & process improvement

Education

Bachelor's or Master’s degree

Tools

Clinical Trial Management systems

eTMF

eCRFs

Microsoft Office

Job description

Planet Pharma seeks an experienced R&D Quality Risk Manager to oversee quality risk management for clinical trials within a GCP framework. Collaborate with internal R&D teams and CROs to ensure compliance and drive improvements across PV, data management, and regulatory affairs.

The role emphasizes metrics tracking, ICH-aligned risk controls, and CAPA implementation, with opportunities to mentor junior staff and travel up to 10% as needed.