Principal Clinical Quality Assurance Specialist

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

Target PR Range: 103-129/hr DOE

Position Responsibilities:

• Provide expert GCP quality oversight for clinical trials, including protocol compliance, investigator site oversight, trial master file quality, data integrity, and clinical study documentation.
• Support the implementation of clinical quality strategy, and evaluation of current GCP quality management processes aligned with global regulatory expectations.
• Lead investigation and resolution of GCP deviations, audit observations, and quality issues to ensure appropriate root cause analysis and, effective corrective actions
• Support CRO and clinical vendor quality oversight, including performance metrics monitoring, quality issue escalation, and continuous improvement initiatives.
• Partner with clinical, regulatory, and operations teams to identify, assess, and mitigate quality risks associated with study design, trial execution, vendor performance, data integrity, protocol compliance, and submission readiness.
• Execute hands-on GCP audit activities, including TMF quality reviews and assessment of key internal clinical trial activities and documentation as well as supporting GCP inspection readiness activities
• Develop and maintain GCP quality metrics, dashboards, and trend reports to support proactive risk management and quality visibility.
• Author, review, and contribute to GCP-related SOPs, policies, quality plans, audit reports, CAPA plans, and other controlled documents.

Candidate Requirements:

• BS/MS degree in a scientific, healthcare, or related discipline.
• 12+ years of experience in the pharmaceutical/biotech industry, with significant hands-on experience in Clinical Quality Assurance, Clinical Operations, or GCP compliance.
• 8+ years of direct GCP quality experience, including oversight of Phase II-III clinical trials in a global setting.
• Deep knowledge of ICH-GCP, ICH E6(R3), FDA, EMA, PMDA, and other global clinical trial regulations and expectations.
• Demonstrated experience with biologics clinical development programs; experience with registration-enabling studies and inspection readiness strongly preferred.
• Strong hands-on experience with CRO/vendor oversight, investigator site audits, TMF quality, clinical systems, data integrity assessments, and risk-based quality management.
• Demonstrated ability to design and implement fit-for-purpose GCP quality processes, audit programs, quality metrics, and compliance frameworks in an outsourced biotech model.
• Excellent technical writing capability, strong judgment, and the ability to influence cross-functional leaders and external partners.
• Highly proactive and detail-oriented with the ability to manage multiple priorities and execute effectively in a fast-paced environment.
• Strong communication and interpersonal skills with a commitment to quality, patient safety, and continuous improvement.