Target PR Range: 103-129/hr DOE

Seeking an experienced Principal Clinical Quality Assurance Specialist to provide expert guidance and hands-on support for Good Clinical Practice (GCP) quality across the company’s biologics clinical development portfolio. Reporting to the Head of Global Quality, this contract role will serve as a trusted partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and external clinical service providers. The position is accountable for supporting clinical quality strategy execution, GCP quality systems implementation, clinical quality risk management, CRO and vendor oversight, inspection readiness, quality metrics, and the development of fit-for-purpose GCP processes.

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.