Quality Assurance Principal Specialist

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Regular Full-Time Admin Support Worker Woodbury, NY, Woodbury, NY, US

10 days ago Requisition

BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens, including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research, aiming to improve patient outcomes by coupling comprehensive clinical data with donor samples. As the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes.

By combining our technical expertise, exceptional customer service and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science.

The Quality Assurance Principal Specialist serves as a senior Quality leader responsible for the oversight, effectiveness, compliance, and continuous improvement of the organization's Quality Management System (QMS). This role provides independent Quality oversight to ensure products, processes, facilities, and quality systems consistently meet regulatory requirements, industry standards, customer expectations, and internal quality objectives.

The position is responsible for driving Compliance and Regulatory Excellence, maintaining a state of audit and inspection readiness, and ensuring the effectiveness of key quality systems including Management Review, Deviations, CAPA, Change Control, Customer Complaints, Nonconforming Materials, Internal Audits, Validation oversight, and Document Control. The Quality Assurance Principal Specialist applies risk-based decision-making principles to identify, assess, and mitigate quality and compliance risks while partnering across the organization to drive sustainable quality improvements.

As a Quality subject matter expert, this role analyzes quality performance metrics and trends, leads quality investigations, facilitates root cause analyses, and ensures effective implementation of corrective and preventive actions that support product quality, patient/customer safety, and operational excellence. This position serves as a trusted advisor to Operations, Manufacturing, Laboratory, Technical, and Regulatory functions and plays a key role in fostering a proactive culture of quality, compliance, accountability, and continuous improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities include, but are not limited to, the following:

• Provide leadership and oversight for assigned Quality Management System (QMS) processes to ensure system effectiveness, compliance, and continuous improvement.
• Drive initiatives that improve quality system performance, operational excellence, compliance effectiveness, and risk reduction across assigned sites and business units.
• Monitor QMS health and performance through management reviews, quality metrics, audit results, CAPA effectiveness, and compliance trend analysis.
• Serve as a Quality subject matter expert and advocate for quality principles throughout the organization.

• Lead Quality Management Reviews for assigned sites and business units, ensuring comprehensive assessment of quality system effectiveness, compliance status, quality objectives, customer feedback, audit outcomes, quality risks, and improvement opportunities.
• Present quality system performance, compliance risks, emerging trends, and strategic recommendations to management.
• Ensure management review action items are documented, assigned, tracked, and completed in a timely manner.

• Ensure compliance with GMP, GLP, GDP, FDA, EMA, ISO, USP, USDA, and other applicable regulatory…