Cheryl Nowlan
Mundelein,IL
Summary
Accomplished in leading quality assurance and regulatory compliance at Abbott, I've spearheaded strategic initiatives across global sites, enhancing operational efficiency by 30% and slashing audit findings by half. My leadership fosters organizational growth and stakeholder engagement, blending strategic planning with a commitment to leadership development.
Knowledgeable in all aspects of Operations and Quality with proven background in senior leadership roles, driving strategic initiatives and fostering organizational growth. Successfully led cross-functional teams to achieve key business objectives, enhancing operational efficiency and stakeholder satisfaction. Demonstrated expertise in project management and strategic planning.
Overview
32
32
years of professional experience
1
1
Certification
Work History
Sr. Director Quality Assurance
Abbott Toxicology
10.2023 - Current
- Directed cross-functional teams across 10 Sites worldwide to achieve project goals and meet organizational objectives.
- Enhanced division compliance profile by reducing audit findings by 50% and enhancing audit finding ratings
- Spearheaded organizational change and Quality System initiatives to improve efficiency and effectiveness.
- Enhanced team performance by mentoring leaders and promoting professional development.
- Led strategic initiatives to drive operational success and business growth across multiple departments.
Site Director Quality Assurance
Abbott Hematology
02.2019 - 12.2023
- Developed strategic plans for site growth, resulting in increased revenue and profitability.
- Obtained Regulatory clearance in multiple geographies for a highly complex Hematology analyzer and high volume track system.
- Managed a team of professionals, ensuring high-quality performance and adherence to company standards.
- Maintained compliance with regulatory requirements while continuously seeking opportunities for process improvement based on best practices.
- Cultivated a culture of excellence by setting clear expectations for team members while providing support for their professional development goals boosting employee retention rates.
Sr. Manager Reg Compliance, OPS & Supplier QA
Abbott Structural Heart
07.2017 - 03.2019
- Enhanced team productivity by implementing strategic plans, metrics and Quality System enhancement to ensure continuous improvement in the supply base.
- Developed comprehensive business strategies for achieving organizational growth and sustainability to support construction of a new Clean Room and a new manufacturing Site.
- Improved operational efficiency with streamlined processes and innovative solutions resulting in a 30% improvement.
- Led high-performance teams, ensuring successful project delivery and performance excellence.
Sr. Manager Design Quality
Abbott Diabetes Care
08.2015 - 07.2017
- Led team of Quality Engineers through new product development activities for hardware, software and chemistry devices used to manage diabetes to achieve organizational goals and increase revenue.
- Implemented strategic initiatives for enhancing operational efficiency and streamlining processes to scale up manufacturing 800K units to more than 20 million units per year to support worldwide product launches.
- Developed comprehensive plans to align novel innovative projects with company objectives with timely delivery and increased team productivity.
Sr. Manager Design Quality Assurance
Abbott Hematology
03.2012 - 08.2015
- Leads the R&D QA organization ensuring quality and compliance are achieved for new product development for Hematology medical devices including hardware, software and reagents.
- Implemented electronic solutions for Design Control activities, documentation and change control across >400 personnel.
- Managed and motivated employees to be productive and engaged in work while accomplishing multiple tasks within established timeframes.
Manager Quality Assurance
Abbott Global Pharmaceutical Operations
05.2011 - 05.2012
- Improved team performance by implementing effective training programs and fostering a collaborative work environment.
- Developed strategic plans for enhancing operational efficiency and achieving business goals regarding global stability monitoring for a pharmaceutical portfolio of >300 products.
- Optimized resource allocation, spearheading project initiatives to meet deadlines consistently through implementation of the Electronic Common Technical Document for Regulatory filing.
- Implemented new processes to streamline operations and enhanced workflows to reduce bottlenecks through alignment of Stability Monitoring programs for pharmaceuticals throughout the EMEA and LAC regions.
Sr. Project Manager
Abbott Diagnostics
08.2003 - 05.2011
- Maintained schedules to meet key milestones at every project phase resulting in relaunch of > 250 diagnostic products.
- Presented regular status reports to executive leadership, providing insights into progress made toward achieving key milestones.
- Adapted quickly to unexpected challenges or obstacles encountered during project execution, devising creative solutions without compromising objectives to ensure Regulatory compliance and consistent supply of product.
Technical Product Specialist
Abbott Diagnostics
10.1996 - 08.2003
- Identified areas for cost reduction in production processes without compromising on quality or functionality standards resulting in cost savings > $1 Million annually.
- Streamlined communication between departments, facilitating smooth product launches and updates.
- Developed comprehensive user guides for customer support team to ensure customer satisfaction.
- Implemented technical solutions for improved customer satisfaction, via software solutions or reformulations addressing various client needs.
- Optimized product performance with diligent troubleshooting and root cause analysis.
Research and Development Technician
Abbott Transfusion Medicine
02.1993 - 10.1996
- Designed experiments to test hypotheses, generating valuable data for further analysis and development efforts.
- Improved prototype designs through meticulous attention to detail and rigorous testing procedures.
- Collaborated with Clinical Affairs for Beta testing on retrovirus products.
- Presented research findings to stakeholders, effectively communicating complex data and insights for informed decision making.
Education
Bachelor of Science - Medical Technology
Purdue University
West Lafayette, IN05-1992
Skills
- Strategic planning
- Leadership development
- Organizational growth
- Project management
- Change management
- Operational efficiency
- Stakeholder engagement
- Decision-making
- Resource allocation
Certification
ASCP Medical Technology
Timeline
Sr. Director Quality Assurance
Abbott Toxicology
10.2023 - Current
Site Director Quality Assurance
Abbott Hematology
02.2019 - 12.2023
Sr. Manager Reg Compliance, OPS & Supplier QA
Abbott Structural Heart
07.2017 - 03.2019
Sr. Manager Design Quality
Abbott Diabetes Care
08.2015 - 07.2017
Sr. Manager Design Quality Assurance
Abbott Hematology
03.2012 - 08.2015
Manager Quality Assurance
Abbott Global Pharmaceutical Operations
05.2011 - 05.2012
Sr. Project Manager
Abbott Diagnostics
08.2003 - 05.2011
Technical Product Specialist
Abbott Diagnostics
10.1996 - 08.2003
Research and Development Technician
Abbott Transfusion Medicine
02.1993 - 10.1996
ASCP Medical Technology
Bachelor of Science - Medical Technology
Purdue University
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