Kim Mourino
Carteret,NJ
Summary
Dynamic compliance leader with extensive experience at Bristol Myers Squibb, driving global quality initiatives and enhancing clinical supply chain operations. Expert in GxP principles and CAPA processes, fostering cross-functional collaboration to optimize outcomes. Proven track record in training program design and regulatory compliance, ensuring organizational excellence and operational efficiency.
Overview
12
12
years of professional experience
Work History
Global Audits, Training & Development, Inspection Readiness
Bristol Myers Squibb
New Brunswick, NJ
01.2022 - Current
- Lead global compliance initiatives to ensure adherence to quality management systems (QMS) and GxP regulations, supporting clinical trial operations
- Spearhead audit and training programs, delivering comprehensive curricula to meet regulatory expectations and enhance organizational compliance readiness
- Provide guidance on CAPA, deviation management, and change control processes, ensuring continuous improvement and operational efficiency across functions
- Manage stakeholder collaboration across global teams to optimize compliance and quality outcomes in clinical supply chain operations
Senior Manager, Global Product Quality Complaints
Bristol Myers Squibb
New Brunswick, NJ
01.2019 - 01.2022
- Oversaw global complaint handling and quality processes, ensuring timely and compliant resolution of patient and product quality issues
- Led quality risk management initiatives, including CAPA, root cause analysis, and corrective actions to ensure compliance with regulatory requirements
- Managed documentation control, including reporting deviations and ensuring compliance with GMP and other regulatory guidelines
- Worked closely with internal and external teams to optimize complaint management and product integrity processes
Manager, Global Complaint Vigilance
Johnson & Johnson Consumer
Skillman, NJ
01.2013 - 01.2019
- Managed quality compliance for product complaints, including leading audits, inspections, and overseeing corrective actions in adherence to GxP principles
- Led and executed internal audits and training to ensure compliance with regulatory frameworks and industry standards
- Directed investigations and risk management activities related to product complaints, including safety risk cases and product recalls
Education
Master of Business Administration (MBA) - Healthcare and Hospital Management
Long Island University
Bachelor of Science - Business Administration, Management
Long Island University
Skills
- Global Clinical Supply Compliance
- GxP and ALCOA Principles
- Deviation Management and CAPA
- Risk Management & Compliance
- Clinical Supply Chain Operations
- Audits, Inspections, and Change Controls
- Documentation Administration & Control
- Cross-Functional Stakeholder Management
- Training & Development Program Design
- Environmental Health & Safety (EHS)
- Quality and Process Excellence
- Regulatory Compliance (US CFR, EU Eudralex)
Systems Proficiency
- Microsoft Excel, Word, PowerPoint, Project
- SAP, Trackwise, Veeva (Audits/Complaints/Deviations)
- ELMS SuccessFactors Administration
- Redica (Compliance Documentation)
Timeline
Global Audits, Training & Development, Inspection Readiness
Bristol Myers Squibb
01.2022 - Current
Senior Manager, Global Product Quality Complaints
Bristol Myers Squibb
01.2019 - 01.2022
Manager, Global Complaint Vigilance
Johnson & Johnson Consumer
01.2013 - 01.2019
Master of Business Administration (MBA) - Healthcare and Hospital Management
Long Island University
Bachelor of Science - Business Administration, Management
Long Island University
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