KAREENA PARRIS
Tucson,AZ
Summary
Quality Systems Executive with extensive experience in developing and managing quality management systems across pharmaceutical and medical device sectors. Achieved zero nonconformities during audits, effectively leading cross-functional teams and ensuring compliance with FDA and ISO standards.
Overview
18
18
years of professional experience
Work History
Senior Director, Quality Systems/Auditing
Becton Dickinson & Co
Sparks, MD
03.2025 - 04.2026
- Led the MDSAP Surveillance audit, achieving zero nonconformities and reinforcing a 100% compliance record
- Led QMS separation and harmonization activities during divestiture of Diagnostics Solutions business unit, coordinating with acquisition team to ensure seamless transition while maintaining stringent quality and regulatory standards
- Resolved Form 483 findings by restructuring complaint handling and medical device reporting practices
- Led development of a complaint handling intake process utilizing AI capabilities to enhance customer experience, compliance, and patient safety
- Collaborated with the FDA’s MDR policy group to advocate for updates to Form 3500A and the MDR Guidance for malfunction reporting
- Developed and validated requirements for a new data analytics tool ensuring 21 CFR Part 11 compliance with AI capabilities
- Enhanced management review process by implementing actionable metrics to drive informed decision-making
- Championed BD’s global 'Inspire Quality' program, streamlining operations through simplification initiatives and fostering a culture of continuous improvement
Senior Director/QMS Strategy and Governance
Roche Diagnostics
Global Remote, AZ
06.2020 - 10.2024
- Co-inventor for a global quality management system (US patent pending), implementing a modular QMS across sites and product classifications
- Global Process Owner for Management Responsibility and QMS Governance
- Developed and presented quarterly management review reports with quality metrics and KPIs to executive leadership, enhancing decision-making processes
- Led and supported successful ISO certifications and regulatory inspections, achieving zero critical findings
- Established comprehensive audit program for internal operations and supplier quality, ensuring compliance and fostering continuous improvement initiatives
- Developed global quality policies to ensure compliance with FDA, ISO, and international requirements
- Managed quality budget and resources to meet operational targets while ensuring compliance with regulatory standards
Senior Director/Head of Diagnostics Quality System
Roche Diagnostics
Global Remote, AZ
12.2017 - 06.2020
- Managed cross-functional quality teams to enhance global document control, CAPA, and training systems
- Led Management Review process, focusing on metrics collection, trend analysis, and effectiveness monitoring for informed decision-making
- Developed standardized quality processes, ensuring consistent application across multiple sites
- Established electronic solutions for streamlined quality system management and reporting
- Supported successful regulatory inspections and third-party audits
Senior Director/Head of Quality
Roche Diagnostics Hematology
Boston, MA
11.2014 - 12.2017
- Implemented a comprehensive quality management system compliant with FDA and ISO requirements, achieving ISO 13485 certification
- Led successful regulatory inspections, achieving zero major findings
- Managed supplier quality program, conducting audits and establishing quality agreements to ensure compliance and supplier accountability
- Developed quality metrics program with monthly reports to site leadership, enhancing visibility into quality performance
- Established document control and training management systems to streamline processes and ensure regulatory compliance
Director- Design Control Quality (R&D QA)
Roche Tissue Diagnostics
Tucson, AZ
04.2012 - 11.2014
- Developed and implemented comprehensive quality strategies for complex development programs, enhancing compliance and product integrity
- Led cross-functional teams to implement quality systems aligned with regulatory requirements
- Managed successful regulatory inspections and partner audits
- Oversaw design control lifecycle processes for oncology product development and successful launches
- Recognized for 28% design change process efficiency
Senior Manager Quality Control Laboratories
Roche Diabetes Care
Indianapolis, IN
03.2009 - 04.2012
- Led team of 50+ scientists in analytical chemistry and quality control, fostering collaboration and innovation
- Collaborated with NIST to develop breakthrough analytical methods, enhancing laboratory capabilities and scientific reputation
- Optimized laboratory operations, achieving a 35% increase in throughput while maintaining compliance
- Managed laboratory operations, focusing on method validation, stability testing, and environmental monitoring to ensure compliance and quality standards
Senior Manager Quality Control Laboratories
Roche Centralized Diagnostics
Indianapolis, IN
01.2008 - 03.2009
- Managed quality systems for clinical chemistry, immunoassay, and drugs of abuse manufacturing, ensuring compliance and effectiveness of the stability program
- Collaborated with R&D to validate test methods, ensuring compliance with FDA Warning Letter requirements
- Facilitated transfer of product and testing programs to sister site in Mannheim, ensuring seamless continuity of operations
Education
MS - Regulatory and Quality Compliance
Purdue University
West Lafayette, INBA - Psychology
Saginaw Valley State University
Saginaw, MISkills
- Quality Systems Leadership
- Regulatory compliance
- 21 CFR Part 820 (QMSR)
- 21 CFR Part 210/211 and 11
- ISO 9000/9001
- ISO 13485
- IVDR/MDR
- MDSAP
- Audit Management
- Audit programs
- Supplier Quality Audits
- Manufacturing Operations Audits
- Due Diligence Audits
- CAPA
- Document Control
- Change Control
- Risk Assessment
- Risk Mitigation
- Quality management
- Process optimization
- Data analytics
- Analytical expertise
- Execution
- Strategic management
- Project management
- Strategic planning
- Change management
- Continuous improvement
- Team management
- Quality teams
- Cross-functional teamwork
- Cross-department collaboration
- Stakeholder Management
- Influencing stakeholders
- Collaborative leadership
- Change leadership
- Innovation management
- Coaching and guidance
- Team building
- Communication proficiency
- Communication Skills
- Communication skills
- Conflict Resolution
- Issue resolution
- Training
- Presentation Skills
- Analytical reasoning
- Collaborative workplace
- Merger & Acquisitions (QMS Transition)
Soft Skills And Leadership Competencies
- Global Team Leadership, Empowerment, and Development
- Organizational and Presentation Skills
- Strategic, Creative, Innovative Planning and Execution
- Change Management and Transformation
- Cross-functional Collaboration and Stakeholder Management
- Risk Assessment, Mitigation, and Judgement
- Analytical and Problem-Solving
- High Emotional Intelligence
- Strong Conflict Resolution and Communication Skills
Core Qualifications
Deep understanding and practical application of FDA QMSR, ISO 9000/9001, ISO 13485, IVDR/MDR, and international standards, including MDSAP countries, Proven track record of successfully implementing and managing quality systems across multiple facilities and functions, Expertise in developing and presenting quality metrics and KPIs for executive management review, Demonstrated ability to establish standardized quality processes, ensuring regulatory compliance and operational efficiency, Led comprehensive internal and external audit programs, consistently achieving successful outcomes in regulatory inspections, Expertise in conducting audits across various areas, including supplier quality, manufacturing operations, and quality systems, Successfully led Due Diligence audits for new mergers and acquisitions (M&A), Proven ability to build, lead, and manage high-performing quality teams, delivering consistent results in compliance, cost reduction, and operational excellence, Adept at fostering a collaborative and effective team environment, promoting employee development and engagement, Successfully implemented e-solutions for quality systems, including document control, change control, CAPA, and training, driving efficiency and compliance, Proficient in leading and managing change initiatives within quality systems, ensuring smooth transitions and positive outcomes
Professional Development
- Member of American Society of Quality and Regulatory Affairs Professionals Society
- Executive Leadership Program - Roche Horizons, London Business School
- Genentech/Roche Business Acumen Course - Advanced Talent Development
Timeline
Senior Director, Quality Systems/Auditing
Becton Dickinson & Co
03.2025 - 04.2026
Senior Director/QMS Strategy and Governance
Roche Diagnostics
06.2020 - 10.2024
Senior Director/Head of Diagnostics Quality System
Roche Diagnostics
12.2017 - 06.2020
Senior Director/Head of Quality
Roche Diagnostics Hematology
11.2014 - 12.2017
Director- Design Control Quality (R&D QA)
Roche Tissue Diagnostics
04.2012 - 11.2014
Senior Manager Quality Control Laboratories
Roche Diabetes Care
03.2009 - 04.2012
Senior Manager Quality Control Laboratories
Roche Centralized Diagnostics
01.2008 - 03.2009
MS - Regulatory and Quality Compliance
Purdue University
BA - Psychology
Saginaw Valley State University