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Contact: Lauren Scutero - lscutero@penfieldsearch.com
No 3rd party candidates

Location: Boston, MA

Our client is seeking an experienced GCP Quality / Quality by Design (QbD) Consultant to provide fractional support for clinical quality, risk assessment, and risk-based quality management across a clinical development program. This is a strategic clinical quality and governance role focused on ensuring study quality through proactive risk identification, assessment, and mitigation—not a traditional medical writing position.

The consultant will partner closely with cross-functional stakeholders to facilitate Quality by Design (QbD) activities, guide risk-based quality discussions, and develop clear, structured documentation that supports clinical trial quality and regulatory expectations. Candidates located in the Boston area with availability for occasional onsite workshops and working sessions are strongly preferred.

Key Responsibilities

• Lead and support Quality by Design (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.

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.
• Strong communication, organizational, and stakeholder management skills.
• Experience supporting clinical quality governance and risk management within biotechnology, pharmaceutical, or CRO environments is required.