KIM VAN HOUTEN
Trenton,NJ
Summary
Senior Quality Assurance Leader experienced in leading Quality Management Systems and regulatory compliance initiatives within pharmaceutical and biologics environments. Achieved operational excellence through development of quality strategies, management of complex quality events, and fostering cross-functional collaboration to enhance compliance and drive continuous improvement. Focused on building high-performing teams and advancing inspection readiness to optimize quality systems and maintain compliance with industry standards.
Overview
1
1
Certification
19
19
years of professional experience
Work History
SR. SUPERVISOR, QA TECHNICAL OPERATIONS
ProBio, Inc.
Hopewell, NJ
03.2025 - Current
- Led Quality Technical Operations and Supplier Quality activities supporting GMP manufacturing operations within a regulated cell and gene therapy/CDMO environment.
- Provide strategic oversight of supplier qualification, supplier performance monitoring, and quality risk management programs.
- Govern material disposition decisions and quality assessments to support uninterrupted manufacturing operations.
- Partner with site leadership, Manufacturing, QC, Validation, Engineering, and Supply Chain to ensure inspection readiness and continuous compliance.
- Direct investigations, deviations, nonconformances, and CAPAs, ensuring robust root cause analysis and sustainable corrective actions.
- Establish and monitor quality metrics, supplier scorecards, and KPI trends to drive data-based quality improvements.
- Review and approve validation documentation, SOPs, specifications, quality agreements, and controlled documents.
- Lead supplier and internal audits while driving timely remediation of audit observations and compliance gaps.
QUALITY COMPLAINTS MANAGER
PCI Pharma Services
Philadelphia, PA
10.2020 - 03.2025
- Led a team responsible for complaint investigations, technical writing, CAPA implementation, and quality event management.
- Oversaw complaint trends, KPIs, and effectiveness metrics to identify systemic issues and drive continuous improvement.
- Collaborated with domestic and international clients to investigate complex product quality concerns and maintain customer confidence.
- Strengthened Quality Management System effectiveness through oversight of APQRs, internal audits, CAPAs, and change controls.
- Managed the site complaint handling program supporting commercial pharmaceutical and biotech manufacturing operations.
- Supported multiple regulatory inspections and client audits with successful outcomes.
QUALITY ASSURANCE MANAGER
CSL Plasma
Philadelphia, PA
12.2013 - 10.2020
- Led site quality assurance activities and served as the primary representative during supplier, customer, and regulatory audits, ensuring ongoing compliance with FDA, GMP, and applicable regulatory requirements.
- Directed audit observation management, CAPA development, effectiveness verification, and timely closure of commitments to maintain inspection readiness and strengthen quality system performance.
- Led complex quality investigations, deviation assessments, and root cause analyses, implementing effective corrective and preventive actions to improve product quality and operational reliability.
- Developed and monitored quality metrics, trend analyses, and risk indicators to identify improvement opportunities, reduce compliance risk, and support data-driven decision making.
- Oversaw preparation, review, and submission of regulatory reports, including Viral Marker Testing documentation, BPDRs (Biological Product Deviation Reports), and FARs, ensuring accuracy, completeness, and regulatory compliance.
- Partnered cross-functionally with Operations, Manufacturing, and Quality teams to enhance processes, improve efficiency, and maintain GMP compliance across all activities.
- Provided strategic oversight of the Quality Management System (QMS), including deviations, CAPAs, change controls, training, and quality event management to support a culture of continuous improvement.
- Identified compliance gaps and quality system deficiencies, driving remediation plans and sustainable corrective actions to improve overall site performance.
- Utilized risk-based decision-making principles to support business objectives while maintaining the highest standards of product quality and patient safety.
QUALITY ASSURANCE MANAGER
Gulf Medical Services
Pensacola, FL
12.2010 - 12.2013
- Audited and requested medical records, ensuring thoroughness and compliance with regulatory standards.
- Assessed medical documentation to verify accuracy and compliance with healthcare regulations.
- Analyzed healthcare records, assessing quality of services and identifying areas for improvement.
- Oversaw admission and discharge data collection, ensuring completeness and accuracy.
- Training oversight includes instructor led training on documentation requirements to improve data quality and compliance.
- Monitored filing processes, safeguarding confidentiality and ensuring adherence to policy requirements.
ASSISTANT OPERATIONS MANAGER
Genesco
Pensacola, FL
08.2009 - 10.2010
- Managed daily operational performance, monitoring financial metrics, budget targets, labor costs, and inventory controls to drive profitability and achieve business goals.
- Executed operational strategies and promotional campaigns, aligning implementation with organizational objectives to enhance overall effectiveness.
- Identified operational inefficiencies and implemented process improvements that enhanced productivity, customer service performance, and financial results.
- Analyzed operational reports and performance metrics to identify trends and risks, developing actionable plans that bolstered business performance.
- Managed company assets, inventory, cash handling, and facility operations, ensuring compliance with policies and enhancing loss prevention measures.
- Recruited, trained, coached, and developed team members, improving employee performance, engagement, and overall operational effectiveness.
- Ensured compliance with company procedures, regulatory requirements, and workplace safety standards while supporting day-to-day business operations.
ASSISTANT CLINIC ADMINISTRATOR
Massage Envy
Pensacola, FL
07.2007 - 09.2009
- Directed clinic operations, establishing effective workflows and standardized processes to maintain operational consistency, customer satisfaction, and regulatory compliance.
- Monitored financial performance through reporting, payroll administration, and budget oversight, ensuring accuracy, accountability, and alignment with operational goals.
- Oversaw inventory management processes, including forecasting, stock control, reconciliation, and supply availability to ensure uninterrupted operations.
- Led onboarding and training programs to ensure personnel competency, procedural compliance, and adherence to established quality and service standards.
- Analyzed operational reports and performance metrics to identify trends and inform data-driven decision-making.
- Maintained oversight of records, documentation practices, and administrative controls to ensure accuracy, consistency, and adherence to organizational requirements.
- Monitored operational processes and resource utilization to enhance compliance and mitigate risks.
Education
Bachelor of Science - Sports Medicine / Athletic Training
University of West Florida
Pensacola, FL05-2013
Associate of Science - Pre-Med
Hillsborough Community College
Brandon, FL05-2009
Skills
- Quality Management Systems (QMS)
- GMP/GDP/GxP Compliance
- FDA & Regulatory Inspections
- Audit Management
- CAPA Management
- Deviation & Investigation Management
- Change Control
- Supplier Quality Management
- Quality Risk Management
- Material Disposition & Product Release
- Validation Oversight
- Batch Record Review
- Complaint Management
- KPI & Quality Metrics Management
- Continuous Improvement
- Serialization
- Cross-Functional Collaboration
- Team Leadership & Development
- Data Integrity
Certification
- ISO 9001 Internal Auditing
Affiliations
- US Soccer Referee
- US Coaching License - D
Timeline
SR. SUPERVISOR, QA TECHNICAL OPERATIONS
ProBio, Inc.
03.2025 - Current
QUALITY COMPLAINTS MANAGER
PCI Pharma Services
10.2020 - 03.2025
QUALITY ASSURANCE MANAGER
CSL Plasma
12.2013 - 10.2020
QUALITY ASSURANCE MANAGER
Gulf Medical Services
12.2010 - 12.2013
ASSISTANT OPERATIONS MANAGER
Genesco
08.2009 - 10.2010
ASSISTANT CLINIC ADMINISTRATOR
Massage Envy
07.2007 - 09.2009
Bachelor of Science - Sports Medicine / Athletic Training
University of West Florida
Associate of Science - Pre-Med
Hillsborough Community College