Harless Lewis
Sandy Springs,GA
Summary
Results-driven Business Excellence Leader with 20+ years of experience in Project Management and Quality & Regulatory. Proven expertise in executing large-scale business integration projects and cultivating strategic partnerships. Skilled in LEAN continuous improvement initiatives and driving audit readiness.
Experienced thought leader driving strategic direction and cultural shifts. Excel in fostering innovation, operational excellence, and sustainable process improvements. Strong background in coaching, mentoring, and developing high-performing teams.
Overview
13
13
years of professional experience
Work History
Director
Quality Management System
04.2022 - Current
- Formulate and implement the Business’ long-range quality, regulatory and compliance policy
- Create Q&R awareness level as determined within the organization
- Enforces (a simplified) quality systems and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting
- Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction
- Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
- Collaborated with senior leadership to set long-term objectives for the company.
- Facilitated collaboration between teams by encouraging open communication channels.
- Assessed employee performance against established benchmarks or targets.
- Directed the organization's daily operations, ensuring compliance with applicable laws and regulations.
- Trained team members on new processes and tools related to continuous improvement projects.
Sr. Quality Integrations/PMO Leader
04.2021 - 04.2022
- Responsible for the integration of businesses and business groups into the North American market.
- Focused on synergy identification and development, establishment and tracking of performance measures across each Quality function, and end-to-end process design and integration.
- Developed and implemented a global standard way of working and operational processes for quality integrations and alignment with other regions.
- Responsible for managing complex Change Management and communications, as well as Transition of Service Providers for major clients.
- Led cross-functional teams through assessments for business-to-region integrations.
- Managed reviews and updates of Intra-Company Quality Agreements between Philips businesses and the North America Region.
- Developed strategic plans and operations models for cross-functional groups.
Q&R Post Market Surveillance Project Manager
08.2019 - 04.2021
- Developed and managed project management program, project portfolio funnel.
- Provided quantifiable measurement of progression of organizations' projects.
- Developed, operationalized, and communicated project plans and status.
- Managed multiple complex projects/initiatives, ensuring execution was in line with the business strategy.
- Established and led organizations' PMO, equipped with standardized processes, tools, and playbook with defined interfaces with other functions.
- Defined the portfolio of programs/projects and their goals, in consultation with management and relevant stakeholders, as input to the performing organization to manage the project pipeline, budgets, and risks, and appointed the Program/Project Managers in agreement with general or business management.
Vigilance Reporting Specialist
Philips, PROS Business Unit
02.2017 - 07.2019
- Ensured timely complaint investigation and medical device reporting.
- Assessed complaints against reporting requirements and facilitated any required further investigation.
- Wrote and submitted medical device reports (MDRs) and/or regulatory reporting.
- Managed Q&R projects such as EU MDR implementation and readiness, Complaint Triage, Complaint Coding, Complaint Intake, and Post Market Surveillance Analysis and Trending.
Supervisor, Frontline Operations
Philips Healthcare
06.2015 - 02.2017
- Oversaw the hiring and development of a team of 50+ employees, recommending promotions and completing performance reviews.
- Managed Frontline Operations for optimal productivity.
- Played a key role in resolving escalations by partnering with FSEs and RSMs.
- Efficiently researched and resolved issues to aid field organizations and customers.
Sr. Quality Analyst
Philips Service Record Review Team
01.2013 - 06.2015
- Contributed toward optimizing production processes by providing insights through in-depth analysis of quality data.
- Developed advanced knowledge of complaint review and coding in alignment with Business Unit standards.
- Managed development and implementation of comprehensive strategic training plans.
Regional Field Project Manager
Advantor Systems
09.2011 - 03.2012
- Prepared and oversaw correspondence, including MS Project schedules, project status reports, daily work logs etc.
- Consistently met 3M revenue requirements by directing activities of Advantor Systems employees and subcontractor employees at multiple locations
- Developed plans for optimizing efficiency and minimizing costs on field projects.
Education
Associate of Business -
Strayer University
01.2009
Certified Technical Trainer (CTT) -
Lean Leader Certified -
Skills
- Operational Efficiency Enhancement
- Cross-Functional Team Management
- Project Integration Management
- Program/Project Management
- Data-Driven Business Insights
- Adaptation Strategies
- Strategic Planning
- Customer Support Management
- Complaint Handling/Management
- Post Market Surveillance Management
- Regulatory Reporting
- LEAN Leadership and Implementation
- Quality Assurance Management
- Collaborative Negotiation Expertise
- Strategic Relationship Building
- Effective Conflict Resolution
- Strategic Problem Resolution
Military history
United States Air Force, 1990 – 2002, Security Forces Specialist, Resource Protection Manager, Supply Chain Operations Manager
Timeline
Director
Quality Management System
04.2022 - Current
Sr. Quality Integrations/PMO Leader
04.2021 - 04.2022
Q&R Post Market Surveillance Project Manager
08.2019 - 04.2021
Vigilance Reporting Specialist
Philips, PROS Business Unit
02.2017 - 07.2019
Supervisor, Frontline Operations
Philips Healthcare
06.2015 - 02.2017
Sr. Quality Analyst
Philips Service Record Review Team
01.2013 - 06.2015
Regional Field Project Manager
Advantor Systems
09.2011 - 03.2012
Associate of Business -
Strayer University
Certified Technical Trainer (CTT) -
Lean Leader Certified -
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