Quality Assurance Principal Specialist

BioIVT•Baltimore, MD

About The Position

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.

Requirements

Bachelor's degree in Biological Sciences, Chemistry, Microbiology, Engineering, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.
Minimum of 7-10 years of progressive experience in Quality Assurance, Quality Control, Manufacturing, or Operations within pharmaceutical, biotechnology, biologics, cell therapy, medical device, or other regulated industries.
Demonstrated experience managing and improving regulated Quality Management Systems.
Experience with quality investigations, CAPA, deviation management, change control, customer complaints, internal auditing, and regulatory compliance programs.
Working knowledge of GMP, GLP, GDP, FDA, EMA, ISO, and related quality and regulatory requirements.
Strong knowledge of Quality Management Systems (QMS) and quality risk management principles.
Demonstrated expertise in compliance management, inspection readiness, and regulatory expectations.
Advanced proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Access.
Experience utilizing electronic Quality Management Systems, document control systems, and quality software platforms.
Excellent analytical skills with the ability to interpret complex quality data and identify meaningful trends and risks.
Strong technical writing skills, including authoring and reviewing procedures, investigations, CAPAs, reports, and audit documentation.
Exceptional verbal, written, presentation, and facilitation skills.
Proven ability to influence cross-functional teams and drive quality-focused decision-making.
Strong organizational skills, attention to detail, and commitment to Good Documentation Practices.
Experience conducting internal audits and supporting regulatory and customer inspections.
Extensive knowledge of manufacturing, laboratory, testing, validation, and quality assurance processes.

Nice To Haves

ASQ certifications (CQE, CQA, CMQ/OE) preferred.
Proficiency with MasterControl strongly preferred.

Responsibilities

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 and industry requirements.
Interpret and apply regulatory requirements, quality standards, and industry best practices to support compliant operations.
Provide independent Quality oversight and approval of quality records, investigations, deviations, change controls, and associated quality documentation.
Support regulatory inspections, customer audits, accreditation assessments, and third-party audits while ensuring timely and effective responses to observations.
Serve as an active member of Deviation Review Boards, Change Control Review Boards, Material Review Boards, and Quality Review Boards.
Evaluate proposed changes, deviations, investigations, and quality events using risk-based quality management principles.
Assess potential impacts to product quality, patient/customer safety, regulatory compliance, process performance, and business operations.
Manage Customer Complaints, Deviations, Corrective and Preventive Actions (CAPA), and Nonconforming Material programs.
Lead and facilitate root cause investigations utilizing structured problem-solving and risk assessment methodologies.
Ensure CAPAs are timely, effective, sustainable, and focused on preventing recurrence of quality issues.
Monitor CAPA effectiveness and identify systemic opportunities for corrective and preventive improvement.
Collect, trend, analyze, and interpret quality data to identify emerging risks, recurring issues, adverse trends, and opportunities for improvement.
Develop and maintain Quality Key Performance Indicators (KPIs) and dashboards that measure Quality System effectiveness and organizational performance.
Prepare and present monthly, quarterly, and annual quality reports summarizing compliance performance, quality metrics, audit outcomes, complaint trends, CAPA effectiveness, and quality risks.
Utilize statistical analysis and data-driven decision-making tools to support quality improvements and management review activities.
Provide Quality oversight and support for validation and verification activities as applicable.
Review validation protocols, reports, and associated records to ensure compliance with applicable quality and regulatory requirements.
Partner with site leadership to maintain a continuous state of inspection readiness.
Support product disposition and release activities by ensuring products meet established quality, regulatory, and customer requirements.
Review quality-impacting documentation and provide risk-based recommendations regarding product release decisions when required.
Plan, conduct, and lead risk-based internal audits of facilities, quality systems, laboratories, manufacturing operations, suppliers, and support functions.
Assess compliance with regulatory requirements, company policies, quality standards, and documented procedures.
Prepare detailed audit reports and communicate findings to management and stakeholders.
Coordinate and verify corrective actions resulting from audit findings and effectiveness checks.
Drive continuous audit readiness by proactively identifying and addressing quality and compliance gaps.
Serve as MasterControl Document Control Administrator for assigned sites and Corporate Quality functions.
Ensure quality documents, procedures, forms, records, and controlled documentation are accurate, compliant, current, and properly maintained.
Act as a subject matter expert for electronic Quality Management Systems (eQMS) and document control processes.
Deliver training and guidance on document management, Good Documentation Practices, and Quality System requirements.
Identify opportunities to streamline and improve document control and quality system workflows.
Participate in regular cross-functional meetings to review product quality, compliance trends, quality events, and operational performance.
Provide Quality guidance and oversight to laboratory, manufacturing, operational, and support functions.
Promote a proactive quality culture emphasizing compliance, accountability, quality ownership, risk awareness, and continuous improvement.
Mentor and train employees on quality systems, regulatory requirements, quality risk management, and best practices.
Support the development and maintenance of quality and safety standards throughout the organization.