Principal Clinical Quality Assurance Specialist

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.