Fractional GCP Quality & QbD Consultant (Risk-Based)

Penfield Search Partners Ltd; Boston (MA); Hybrid; USD 120,000 - 180,000; Part time

Job summary

Penfield Search Partners Ltd in Boston area seeks an experienced GCP Quality / QbD Consultant to provide fractional support for clinical quality, risk assessment, and risk-based quality management across a clinical development program.

This strategic governance role focuses on proactive risk identification, assessment, and mitigation, not traditional medical writing, with onsite workshops and cross-functional collaboration.

Qualifications

• Strong background in Clinical Quality Assurance with extensive knowledge of Good Clinical Practice (GCP).
• Hands-on experience with Quality by Design (QbD) methodologies and risk-based quality management within clinical development.
• Demonstrated success facilitating cross-functional workshops and building consensus among diverse stakeholders.
• Excellent documentation skills with the ability to convert complex discussions into clear, structured quality and risk management deliverables.
• Experience supporting clinical quality governance and risk management within biotechnology, pharmaceutical, or CRO environments is preferred.

Responsibilities

• Lead and support QbD risk management activities across clinical development programs.
• Facilitate cross-functional workshops focused on clinical quality, critical-to-quality factors, and risk-based decision making.
• Identify, assess, and prioritize clinical trial risks while partnering with stakeholders to develop practical mitigation strategies.
• Translate workshop discussions and stakeholder input into well-organized quality documentation, including risk assessments, mitigation plans, and supporting governance materials.
• Apply Good Clinical Practice (GCP) principles and risk-based quality management methodologies to strengthen clinical trial oversight and execution.
• Support quality governance activities that promote proactive risk management, study quality, and inspection readiness.
• Collaborate effectively with Clinical Operations, Quality, and other cross-functional teams to drive alignment and consistency across the development program.

Skills

GCP knowledge

QbD methodologies

Risk-based quality management

Cross-functional facilitation

Documentation skills

Stakeholder management

Communication

Organizational skills

Job description

Penfield Search Partners Ltd in Boston area seeks an experienced GCP Quality / QbD Consultant to provide fractional support for clinical quality, risk assessment, and risk-based quality management across a clinical development program.

This strategic governance role focuses on proactive risk identification, assessment, and mitigation, not traditional medical writing, with onsite workshops and cross-functional collaboration.