Senior GCP QA Lead for Clinical Trials

Planet Pharma; Cambridge (MA); On-site; USD 142,000 - 178,000; Full time

Job summary

Planet Pharma seeks an experienced Quality Assurance leader to provide expert GCP oversight for clinical trials, ensuring protocol compliance, site oversight, data integrity, and TMF quality. You will drive the quality program and partner with regulatory teams to sustain inspection readiness.

You will lead investigations of deviations, develop risk-based QA processes, oversee CRO/vendor quality, and contribute to SOPs and CAPA plans. Strong writing and cross-functional influence are essential.

Qualifications

• Advanced degree in a scientific or healthcare field.
• 12+ years in pharma/biotech with clinical quality oversight.
• 8+ years in direct GCP quality, global Phase II–III oversight.
• Deep knowledge of ICH-GCP, FDA, EMA, PMDA regulations.
• Experience with biologics programs and inspection readiness.

Responsibilities

• Provide expert GCP quality oversight for trials and trial master file quality.
• Support implementation of clinical quality strategy aligned with regulatory expectations.
• Lead investigations of GCP deviations and quality issues with root cause analysis.
• Oversee CRO/vendor quality oversight with metrics and escalation processes.
• Collaborate with study teams to mitigate quality risks in design, execution, and submission readiness.
• Lead hands-on GCP audits, TMF quality reviews, and inspection readiness activities.
• Develop GCP quality metrics, dashboards, and trend reports for proactive risk management.
• Author and review GCP-related SOPs, QA plans, CAPA, and controlled documents.

Skills

GCP compliance

Quality Assurance

Regulatory affairs

Clinical Operations

Audit oversight

Education

BS/MS in science/healthcare

Tools

TMF quality systems

CRO oversight

GCP audits

Clinical data integrity

Job description

Planet Pharma seeks an experienced Quality Assurance leader to provide expert GCP oversight for clinical trials, ensuring protocol compliance, site oversight, data integrity, and TMF quality. You will drive the quality program and partner with regulatory teams to sustain inspection readiness.

You will lead investigations of deviations, develop risk-based QA processes, oversee CRO/vendor quality, and contribute to SOPs and CAPA plans. Strong writing and cross-functional influence are essential.