B.A., Physiology @
University of Minnesota-Twin Cities
A highly experienced Quality & Operations Executive who has demonstrated the ability to lead diverse teams of professionals to new levels of success in a variety of highly competitive industries, cutting-edge markets, and fast-paced environments. Accomplished Quality Management professional with 20+ years of progressive experience and a record of significant contribution in areas of quality operations, QA/QC,
A highly experienced Quality & Operations Executive who has demonstrated the ability to lead diverse teams of professionals to new levels of success in a variety of highly competitive industries, cutting-edge markets, and fast-paced environments. Accomplished Quality Management professional with 20+ years of progressive experience and a record of significant contribution in areas of quality operations, QA/QC, compliance management, quality systems, post market surveillance, project management, validation, and customer relationship management. Proven track record of a balanced quality approach; focused on compliance while driving operational efficiencies. Extensive experience working with regulators and customers globally.
• Aligning Resources with Strategic Plan
• Operational Efficiency by Building High Performance Teams
• Product Lifecycle Management
• QA Processes, CAPA, QA Auditing
• cGMP, cGLP and cGCP
• Quality and Business Process Mapping
• Organizational Development
• Building Competency through Process Improvement
• Fiscal Management
Vice President, Manufacturing Quality, Medical Care Solutions @ From January 2015 to Present (1 year) Greater Minneapolis-St. Paul AreaVice President, Quality Assurance - Peripheral Vascular @ From August 2014 to Present (1 year 5 months) Greater Minneapolis-St. Paul AreaDirector Quality Operations @ • Leads the Quality initiatives for multiple sites. This includes overseeing all Quality Operations/Assurance functions and Site Quality Review Team (SQRT); planning, implementing and achieving site and global quality objectives; interfacing with global regulatory agencies; leading and developing a diverse team of talented and engaged colleagues to assure Quality Standards are met; and interfacing with diverse stakeholders (internal and external) across the organization.
• Develop colleagues to create a strong, knowledgeable quality team to support the initiatives of the sites and the business. Creates a high achieving team with goals and values aligned with other teams and operations.
• Achieves compliance and business results through partnerships between Quality and Operations and other site/cross site functions.
• Manages overall assurance and disposition of products produced at the sites.
• Approves quality and production quality assurance reports and investigations.
Review key quality and regulatory documentation and implement appropriate actions.
• Leads and engages SQRT to ensure sites regulatory compliance.
• Coordinates development of area training plans of Quality Operations colleagues.
• Develops and maintains lean organizational structure to accomplish key quality initiatives.
• Develop departmental budget and assure achievement of financial performance of department recognizing its impact to the sites.
• Analyzes inspection findings, determining significance of issues and formulating action plans to mitigate issues and institute quality improvement plans
• Delivers on key quality metrics and ensuring they are defined, measured, and achieved and trending/issues were escalated through given internal reporting systems
• Identifies and implements significant improvements in line with Business Plans and Strategic Objectives to create more effective process design/implementation, productivity improvements, and document management From August 2012 to August 2014 (2 years 1 month) Principle @ • Developed an on-going Lifecycle Management (LCM) plan for pre and post market support. Successfully oversaw the start-up, development and institutionalization of this plan across several business units resulting in increased operational efficiency, improved QA processes and customer satisfaction
• Established processes to provide R&D with recommended changes and product requirements for improved reliability.
• Process mapped post market support activities in order to analyze repair and return data to define opportunities for increased product reliability. This included preparing summary reports of product returns based on product line, failure mode, and manufacture date.
• Identified new approach to develop and implement a compliant, effective and efficient QMS that met FDA, ISO, MDD and other International requirements for approval of a Class III implantable cardiac device
• Oversaw the strategic management and operational oversight of product portfolios and management operations in order to provide streamlined operations, reduced operating costs and greater profitability
• Interfaced with global partners within highly matrixed environments to develop and maintain organizational strategies, operational efficiencies and proposals for increasing innovations, efficiency and operating margins
• Directed/oversaw national quality team to assure completion of Quality Systems remediation projects.
• Authored Quality Agreements documenting guidelines for exception management, manufacturing process monitoring, product complaint handling and periodic product reviews From July 1996 to July 2012 (16 years 1 month) Quality Management Consultant (contract position) @ Consult on Quality Management including the establishment of a compliant, effective and efficient Quality Management System suitable for the development and delivery of Class III active implantable medical devices. From 2011 to 2011 (less than a year) Lifecycle Management, Business Strategy & Processes (contract position) @ • Developed an on-going Lifecycle Management (LCM) plan and successfully oversaw the start-up, development and institutionalization of this plan across several business units resulting in increased operational efficiency and customer satisfaction
• Spearheaded the successful business process mapping of a legacy business resulting in implementation of a business plan which re-engineered the business from a commodity to a specialty product business
• Established critical partnership with key stakeholders to drive cross functional collaboration around a revised business strategy (for an SBU) resulting in increased operational efficiencies From July 2009 to December 2010 (1 year 6 months) Vice President, Thermo Analytical Division @ Established and deployed national Quality Assurance Program Plan across 9 national laboratory locations ensuring processes, systems and procedures for regulatory compliance. Established CAPA processes and ensured process metrics were defined, agreed upon and achieved. Managed laboratories involved in analytical chemistry, microbiology, pharmaceutical chemistry, stability studies, product release testing, lot release testing and environmental monitoring. Coordinated certification by various regulatory agencies in multiple states to ensure all laboratories met established requirements.
• Drove expansion of pharmaceutical and biopharmaceutical analytical capabilities and offerings while minimizing food testing analytical capabilities.
• Led acquisition of $35M target by formulating strategic guidelines for business operations, quality operations and technical services due diligence work.
• Managed regulatory compliance and led 90% of interfacing with regulatory agencies.
• Was awarded several long-term analytical testing contracts with national companies by acting as the primary interface for interaction and communication with potential and existing clients and by ensuring client requirements were met.
• Qualified company for multi-year environmental testing service contracts by obtaining quality certifications from United States Navy and Army Corp of Engineers. From January 1994 to March 1996 (2 years 3 months) President @ Founded this state-of-the-art analytical laboratory serving chemical and air analysis needs of industrial enterprises, consulting firms, oil companies and government agencies. Ran all aspects of operations including regulatory agency communications/compliance, implementation of quality program, team leadership, and strategic planning. Coordinated all certifications by government agencies and private entities in multiple states. Drove revenues from start up to $5M annual revenues with two locations and four mobile facilities within six years. Created quality assurance program plan and developed in-depth health and safety program.
• Achieved profits immediately in 1988, meeting sales and revenue goals every quarter for six consecutive years; opened second immediately-profitable location in 1991; credited with bringing in 90% of client base – accounting for 95% of revenues
• Handled all technical issues and regulatory requirements being the main liaison between company and EPA, United States Navy, US Air Force, California DHS, Arizona DHS and other regulatory agencies.
• Won several long-term analytical testing contracts with national oil companies and environmental consultants by delivering successful proposals and presentations.
• Qualified company for multi-year environmental testing service contracts by obtaining quality certifications from United States Navy and Army Corp of Engineers. From May 1988 to January 1994 (5 years 9 months) Manager of Operations @ Founded the first mobile analytical laboratory certified by the California Department of Health Services. Provided mobile chemical analysis of soil and groundwater needs of industrial enterprises, consulting firms, oil companies and government agencies. Managed all regulatory agency communications/compliance, implementation of quality programs and team leadership. Coordinated all certifications by government agencies. Took this small service-oriented company from start up to $2M annual revenues within two years. Created quality assurance program plan for strictly mobile laboratory operations. From 1986 to 1988 (2 years)
B.S., Microbiology @ University of Minnesota-Twin Cities From 1979 to 1983 B.A., Physiology @ University of Minnesota-Twin Cities From 1979 to 1983 Lisa Newcombe-Dierl is skilled in: CAPA, Quality Assurance, Medical Devices, Strategic Planning, Cross-functional Team Leadership, Validation, FDA, Process Improvement, Quality Systems, Pharmaceuticals, Quality Management, Six Sigma, Process Development, Continuous Improvement, Consumer Goods
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