Kristin Ortlieb
Vice President, Quality & Training @ProPharma
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WORK HISTORY
Vice President, Quality & Training @ProPharma
Philadelphia, PA, US
Responsible for strategic and functional leadership of the Global Quality Assurance, and Training & Development functions in support of regulatory/health authority compliance, service quality, continuous improvement, and quality system compliance across portfolio of services. Establish and maintain harmonized quality-related systems, processes, and governance mechanisms across the organization. Oversee employee onboarding training program and employee development to support various functional areas and leadership development.Manage and continuously improve the infrastructure required to perform the core activities of the Quality Management System (eQMS), including complaints and deviations, CAPAs, investigations, change control, validations, internal & external audit and inspections, supplier management program and customer inquiries and questionnaires. Ensure that adequate training systems are in place and integrated across all sites. Ensure the provision of training and support to facilitate the delivery of high-quality services to clients and promote professional development. Ensure global data privacy requirements are met across client programs through adherence with GDPR, HIPAA, CCPA, PIPEDA, and PIPL, among others.Lead the coordination, tracking and trending & drive closure of audit report responses, CAPAs, and deviations. Participate in development of corrective action plans and oversee the CAPA program. Manage and continuously improve the deviation handling process through maintenance of requirements, processes, and procedures, including requirements for root cause and impact analysis, and investigations as applicable. Maintain a state of continuous inspection readiness of the eQMS, including regular administration of internal and vendor audits to ensure compliance with relevant standards and regulations. Lead the process for hosting third-party audits.
EDUCATION
Penn State University
Communications, Telecommunications Management
Villanova University
Lean Six Sigma Sensei
Villanova University
Six Sigma Green Belt Certificate
Villanova University
Lean Six Sigma Certificate
ABOUT KRISTIN ORTLIEB
An innovative, results-driven, and enterprising leader with in-depth experience in quality assurance, process improvement, health authority regulations and compliance, contact center operations, forecasting, P&L, client/vendor relations, and strategic planning. Reputed as a change agent with the ability to analyze issues, devise continuous process improvements, and incorporate business process initiatives to increase efficiency, streamline operations, and decrease aggregate expenses with limited resources. Additional proven aptitude in content development, systems management, disaster recovery/business continuity, and account/program management. A broad-minded and adaptable leader who empowers an organization to develop highly efficient workflow processes, increase revenue, and improve client and employee satisfaction while achieving business objectives.
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