Lorna A. Bienvenue
Dighton,MA
Summary
Diligent Project Lead with background in leading diverse project teams to successful outcomes. Managed multiple high-profile projects, ensuring timely delivery and stakeholder satisfaction. Demonstrated capability in strategic planning and team coordination.
Overview
11
11
years of professional experience
Work History
Quality Systems Specialist
Johnson & Johnson MedTech / Abiomed, Inc.
08.2023 - Current
- Oversee numerous Quality Management Systems (QMS)
- Responsible for working with Abiomed site managers and employees to Integrate into Johnson & Johnson’s Key Performance Indicators (KPIs) and metrics reporting
- Facilitate daily/weekly meetings with subject matter experts (SMEs) to drive actionable results with escalation as needed
- Develop and administer communication, and deployment strategies for next phase integration activities (with deadlines)
- Develop and maintain strong relationships with cross-functional teams to ensure alignment and monitor effectiveness
- Lead and execute lifecycle workflow for Monthly, Quarterly and Bi-Annual Data Review Boards
- (Zero missed or late)
- Engage with all levels of the organization including the Office of the President
- Establish targets and triggers with Sr
- Management and cross functional teams for better controls of manufacturing and supplier performance
- Analyze and monitor key performance indicators (KPIs) to track and report on the effectiveness of quality control measures, contributing to continuous improvement initiatives
- Provide guidance and training to department, site owners and managers
- Assign actions to owners for remediation activities per recommendation during Data Review Board
- Follow-up and track progress for on time closure
- Create presentations and slide decks, compile meeting minutes, execute delegation forms and store in repository for traceability and audits
- Maintain a robust document control system, ensuring the accuracy and accessibility of quality-related documents
- Update Standard Operating Procedures (SOPs) and Work Instructions
- Contribute to the development of risk management activities, ensuring that potential quality risks are identified and mitigated
- Developed comprehensive quality assurance plans, ensuring compliance with industry standards and regulations.
- Created detailed reports analyzing trends in product performance, identifying areas for enhancement or improvement.
- Implemented effective corrective action plans based on thorough data analysis and investigation findings.
- Managed risk assessments to identify potential hazards and implement corrective actions for continuous improvement.
- Collaborated with other departments to facilitate successful project completion.
- Trained and mentored junior engineers, providing guidance and direction.
- Developed and implemented procedures to verify compliance with engineering standards.
- Analyzed and interpreted data to identify trends and recommend improvements.
- Collaborated with cross-functional teams to design, develop, and implement customized integration strategies for clients.
- Delivered quality results across multiple projects simultaneously by employing effective time management skills and attention to detail.
- Developed robust documentation outlining integration procedures, contributing to knowledge sharing among team members.
- Mentored junior consultants within the organization on effective techniques for successful execution of complex projects.
- Established strong working relationships with clients through clear communication and timely responses to inquiries.
- Oversaw successful integrations from start-to-finish while adhering strictly to budgetary constraints set forth by clients or stakeholders.
- Provided comprehensive training to clients on the use of integrated systems, ensuring smooth transitions and minimal disruptions.
- Led workshops for clients on best practices in system integration, fostering long-term relationships built on trust and expertise.
- Served as liaison between clients and internal technical teams, ensuring seamless communication throughout each project''s lifecycle.
- Analyzed client requirements to determine optimal integration solutions that aligned with their business objectives.
- Provided exceptional customer support during post-integration stages when adjustments or modifications were required.
- Proved successful working within tight deadlines and a fast-paced environment.
- Created proofs of concept for innovative new solutions.
- Collaborated with cross-functional teams to develop robust processes, ensuring compliance with industry standards.
- Mentored junior team members on best practices in quality systems management, contributing to their professional growth.
- Participated in regulatory inspections to demonstrate compliance with applicable standards and regulations.
- Conducted regular audits to maintain adherence to established quality management system requirements.
- Served as liaison between manufacturing and engineering departments, facilitating communication on product specifications and requirements.
- Provided training on quality systems procedures, fostering a culture of continuous improvement within the organization.
- Streamlined quality systems documentation for increased efficiency and ease of access.
- Analyzed data trends for identification of recurring issues, leading efforts in finding long-term solutions.
- Established a strong working relationship with external auditors, streamlining assessment processes while addressing any gaps in compliance.
- Enhanced product quality by implementing innovative process improvements and quality control measures.
- Implemented risk-based thinking strategies for proactive identification and mitigation of potential issues.
- Monitored staff organization and suggested improvements to daily functionality.
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
Quality Assurance Manager
HERO Health, Inc.
02.2023 - 06.2023
- Responsible for developing and maintaining compliance of the Quality Management System
- Oversight and direct the Quality Assurance team to compliance of standards and regulatory requirements for release of next generation product evolution
- Facilitated a Gap Assessment of their Quality Systems
- Remediated validation gaps and other criteria
- Created a strategy for tighter compliance to Training, Document Controls, CGMP, Audit and CAPA processes
- Created and implemented a transition plan of a new Quality Management System (Greenlight Guru)
- Risk Assessments to impact of change: including Labeling with Software and Hardware customer notification updates and releases
- Reviewed adverse events for reporting to FDA, created Medical Device Reports and e-Submitted to the FDA with zero (0) late reportable events
- Developed and Implemented procedures and specification with cross functional teams
- Supported Engineering, R&D and Manufacturing for design changes, Design History Reviews, Design Inputs/Outputs, Verification and Validation, with ownership of severity matrix and HHE evaluations
- Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals.
- Investigated customer complaints and performed corrective actions to resolve quality issues.
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
- Established robust quality documentation systems that ensured traceability throughout the entire production lifecycle.
- Conducted risk assessments to identify and mitigate potential quality issues.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Created and maintained quality management systems to align with industry standards.
- Championed continuous improvement initiatives, consistently seeking ways to optimize operations for better results.
- Collaborated with cross-functional teams to develop and implement process and system improvements.
- Oversaw transition to new quality management system, ensuring minimal disruption to operations.
Project Manager, Regulatory Affairs
Smith and Nephew, Inc.
08.2021 - 02.2023
- Project Manager for Global Operations Strategic Manufacturing Transfer projects
- 30 projects for internal and external manufacturing changes that impact global product registrations to supported growth and ensured compliant commercial and distribution operations (focus on EU, Malaysia; Singapore; Thailand; LATAM, regions)
- Project kick-off 2021 through close in 2024
- Partnered with business analysts, commercial and distribution organization to define project scope, objectives, and deliverables while managing expectations throughout the project’s lifecycle
- Monitored project progress regularly through status meetings and reports, identifying potential risks and developed contingency plans and implemented risk mitigation strategies
- Facilitated effective communication among team members by conducting regular meetings and providing clear instructions on tasks and responsibilities
- Developed detailed project documentation such as charters, work breakdown structures (WBS), risk assessments, and communication plans
- Evaluated and managed change requests for their impact on scope, timeliness, and resources
- Proposed necessary adjustments
- Assessed manufacturing changes for impact ensuring compliance with current design and development of devices in alignment with the EU Medical Device Regulations (MDR 2017/745 and regulatory)
- Oversight of global license and registration updates, and global documentation requirements based on country and regional laws as applicable
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for large projects.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Delivered exceptional customer satisfaction by proactively addressing client concerns and meeting or exceeding expectations throughout the engagement process.
- Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
- Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.
- Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Monitored project performance to identify areas of improvement and make adjustments.
- Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
- Provided detailed project status updates to stakeholders and executive management.
- Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
- Managed projects from procurement to commission.
- Provided detailed technical and operational direction in project challenges, consistently meeting deliverables according to deadlines.
- Prepared detailed reports on project status for stakeholders, ensuring transparency and alignment with objectives.
- Effectively managed scope creep by establishing clear boundaries on requested changes while keeping projects aligned with original objectives and budgets.
- Implemented continuous improvement initiatives to optimize project outcomes while maintaining costeffectiveness.
- Mentored junior team members in project management best practices to enhance their skills and contribute to better overall performance.
- Fostered a culture of innovation and creativity within the project team, leading to improved problem-solving capabilities and enhanced outcomes.
- Proved successful working within tight deadlines and a fast-paced environment.
- Optimized project schedules, identifying critical path tasks and reallocating resources to maintain momentum.
- Achieved high levels of team engagement and morale by promoting collaborative and inclusive work environment.
- Ensured projects aligned with strategic objectives, working closely with senior management to refine project goals.
- Completed projects within tight deadlines, coordinating team efforts and prioritizing tasks effectively.
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
- Reported regularly to managers on project budget, progress, and technical problems.
Quality Assurance Engineer, Supplier Quality Global Shared Svcs
Smith and Nephew, Inc.
12.2018 - 08.2021
- Strategy and Integration
- Contract negotiation and execution: Global EU MDR Remediation of Critical Suppliers
- >700 Quality Agreements completed over 1.5 years and prior to deadline
- Created strategy for timely assessment and negotiation
- Subject matter expert for Supplier Quality Agreement (SQA) negotiations with external Global Economic Operators to ensure compliance to FDA and EU MDR 2017/745 regulations, ISO 9001 Quality Management Standards
- Partner with Procurement to mitigate risk and ensure supplier compliance to Smith and Nephew’s Quality Management System, it’s processes and standards for their Sports Medicine, Wound, Orthopedics and Robotics franchises
- Totaling >$200M revenue
- Collaborate with Legal Counsel (internal and external) to review and provide insight and feedback for quality compliance content related to Distribution Agreements, Supplier Quality Agreements, and Corporate Agreements
- Improvement program execution: 5 Year Review Process of suppliers, Data Review of KPIs and Metrics, Creation of the Approved Supplier List Data Warehouse, Authorized Signatory Roles
- Managed Site Acquisition Integration activities, related to process and training
- Trained and advised Quality Engineers and site Managers on QA/QC procedures and processes
- Maintained Global Quality Plan for Supplier Remediation EU MDR deadline 2019-2021; Zero non-conformities or findings: 100% completion to closure by June 2021
- Supplier Onboarding activities including risk assessment
- Change controls and updates to procedures/work instructions
- Lead monthly metrics reviews, compile Quality Management Review reports, analyze and escalate issues
- Brexit readiness rollout RFI, phase one
- Managed inputs of the Global Supplier Audit Schedule to drive compliance to schedule adherence
- Support BSI and Corporate Audits
- Maintain healthy cross functional relationships with Leadership and Management (Global Compliance, Procurement, Regulatory, EU MDR Team, Legal Counsel, Global Systems, and Global Site Management)
- Committee Member: Smith and Nephew Life Award, Presenter Quarterly Showcase, Unity Community Member, Enrolled in Leadership Training Elevate
- Enhanced supplier performance by conducting thorough audits and implementing corrective action plans.
- Established strong relationships with key stakeholders within the supplier base, fostering trust and collaboration toward shared goals of excellence in product quality and service delivery.
- Coordinated regular supplier meetings to review performance metrics and drive continuous improvement efforts across the supply chain.
- Negotiated favorable contract terms with suppliers, ensuring cost-effective procurement while maintaining high quality standards.
- Developed robust supplier evaluation criteria to ensure selection of high-quality vendors, reducing the risk of substandard materials or services.
- Championed a culture of accountability among suppliers by regularly reviewing compliance documentation and enforcing strict adherence to contractual obligations.
- Streamlined communication between suppliers and internal teams, resulting in timely resolution of issues and increased efficiency.
- Trained new employees on company-specific supplier quality requirements and procedures, supporting their successful integration into the team''s operations.
- Conducted comprehensive supplier assessments, identifying areas for improvement and providing recommendations for enhanced performance.
- Reported problems and concerns to management.
- Managed a diverse portfolio of suppliers, ensuring adherence to strict industry standards and regulations.
- Fostered long-term partnerships with high-performing suppliers, contributing to overall business growth strategies.
- Championed a culture of quality within the organization by promoting best practices in supplier management techniques.
- Provided timely feedback to suppliers on their performance, fostering an environment of transparency and collaboration.
- Streamlined communication channels between suppliers and internal departments to facilitate issue resolution quickly and efficiently.
- Maintained accurate records of supplier evaluations, certifications, and performance metrics for easy reference.
- Collaborated with cross-functional teams to address supplier-related concerns and implement corrective actions.
- Established clear expectations for suppliers through detailed specifications and requirements documentation.
- Conducted thorough risk assessments for potential new suppliers, mitigating potential issues before onboarding.
- Developed strong relationships with suppliers through regular communication and site visits.
- Established and tracked quality department goals and objectives.
Regulatory Compliance Representative / Regulatory Affairs Specialist
Insulet Corporation
01.2017 - 12.2018
- Labeling Responsibilities: Review, approve, control, and implement new and revised labeling, advertising and publications in accordance with 21 CFR Part 820; including vendor controls
- >400 annually
- Worked with Legal Counsel for Vendor Business Associate Agreements (BAAs) and onboarding
- Project Management for Global rebranding with deadline driven results
- Change controls, traceability, metrics, and reporting
- Support to Risk Management activities for OUS compliance
- Verification activities IFU, Kit drawings
- Reviewed and approved engineering change requests for labeling changes to ensure compliance with FDA and international government regulations
- Controlled non-conforming materials and documentation, CAPA responsibilities
- Project Management: New PLM system implementation for commercial labeling
- Trained US, Canada and UK teams to Procedure and Process workflows for labeling and compliance
- Wrote, reviewed, and edited Standard Operating Procedures, Forms and Methods
- Support to FDA and third-party audits (Front and Backroom activities)
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Recommended improvements to processes.
- Maintained detailed records of all regulatory activities, enabling quick access during inspections or audits.
- Prepared and submitted regulatory file applications and supporting documentation.
- Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
- Maintained and archived regulatory paperwork.
- Reviewed advertising materials before release to verify claims were supported by scientific evidence, minimizing potential legal risks.
- Wrote or updated standard operating procedures, work instructions or policies.
- Coordinated recall or market withdrawal activities as necessary.
Sr. Regulatory Affairs Operations Coordinator
Medtronic (Covidien)
01.2014 - 12.2015
- Supported Director Regulatory Affairs Surgical Innovations, the VP Quality Assurance, and the Associate General Counsel
- Support auditing processes and 483 activities (TUV, BSI, FDA) (Documentation retrieval, logistics)
- Research FDA and Federal Register proposed guidance’s and regulations
- Complete Applications for Certificates to Foreign Government (CECATS) Medical Device Export Certificate
- Maintain valid product requirements
- Process document legalization and Apostil services (Washington Consular Services)
- Register and renew memberships, passports, and visa applications
- Process Medical Device User Fee Registration (MDUFMA)
- 510(k) support, Process annual license registrations for manufacturing sites
- Maintain Regulatory records, files and, digital media/e-files
- Coordinate annual panel discussions, logistics and presentations with FDA (e.g., Advamed, Food and Drug Law Institute, others)
- Facilitate Business Unit Quarterly Town Hall meetings
- Created PowerPoint presentations
- Reduced financial inconsistencies while assessing and verifying billing invoices and expense reports.
- Reduced operational risks while organizing data to forecast performance trends.
Education
Bachelor of Science - Business Management: Leadership
Roger Williams University
Bristol, Rhode Island05.2010
Project Management -
UMass Amherst
04.2024
Certified Dental Assistant -
UMass Amherst
05.2014
Associate’s degree - Business Administration
Bristol Community College
Fall River, Massachusetts05.1996
Skills
- Agile (Doc Control)
- Greenlight Guru (QMS)
- SAP
- EtQ Instinct
- Windchill
- Prism
- Pilgrim (complaints)
- Microsoft Office Suite
- Microsoft Word
- Excel
- One Note
- PowerPoint
- Access
- Outlook
- Publisher
- SharePoint
- FileMaker Pro
- PeopleSoft
- DocVault
- Qlik (KPIs)
- Compliance wire
- SmartSolve
- Pilgrim
- AX
- Master Control
- Salesforce
- FDA e-Sub/Government/ Fast Lane portals
- Veeva Vault (PLM)
- Visio
- Workday
- Wrike PM
- Concur (T&E)
- Effective communication
- Manage, lead, provide guidance at and above my level
Knowledge And Experience
- Quality Management Systems
- Quality Assurance
- Quality Compliance
- Supplier Quality
- People Manager
- Records Management/Change Controls
- Key Performance Indicators (KPI’s) and Metrics
- FDA CFRs
- ISO 13485, 9001, 14971
- MDD & MDR
- CGMP
- CAPA
- FDA Audit Front/Back Room
- Audit Support
- CoAs, DoC’s, LTFs, Global Declaration Documents
- Six Sigma (DMAIC)
Timeline
Quality Systems Specialist
Johnson & Johnson MedTech / Abiomed, Inc.
08.2023 - Current
Quality Assurance Manager
HERO Health, Inc.
02.2023 - 06.2023
Project Manager, Regulatory Affairs
Smith and Nephew, Inc.
08.2021 - 02.2023
Quality Assurance Engineer, Supplier Quality Global Shared Svcs
Smith and Nephew, Inc.
12.2018 - 08.2021
Regulatory Compliance Representative / Regulatory Affairs Specialist
Insulet Corporation
01.2017 - 12.2018
Sr. Regulatory Affairs Operations Coordinator
Medtronic (Covidien)
01.2014 - 12.2015
Project Management -
UMass Amherst
Certified Dental Assistant -
UMass Amherst
Bachelor of Science - Business Management: Leadership
Roger Williams University
Associate’s degree - Business Administration
Bristol Community College
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