Documentation & Strategy Team Lead• Lead a team of 3; team responsibilities include digital data & IT, Veeva system, documentation & training.• Implemented a continuous improvement tool (Supplier-Input-Process-Output) to identify team metrics. • Monitor team performance using metrics. For Fiscal Year July 1st 2023-Jun 30th 2024; 149 Documents created, 710 bulk document imports completed, 702/702 Veeva quality checks and 828/906 approval tasks completed, 85/85 workday training items posted, 16/18 change controls closed, 364/364 Veeva support items completed, 16 Veeva system changes implemented, 83/85 metadata field value updates closed, 6/6 instructor led training sessions led, 90 Veeva users were supported to create 2877 documents, 5/5 QA newsletters posted, 13/15 investigations closed, 23/27 GMP resolutions closed, 64/64 documents archived. All customer demands and compliance requirements met.• Achievements: Implementation of the GMP QMS, validation and implementation of Veeva Vault Quality Docs (VVQD) & LIMS LabVantage, continuous improvement within the QMS Program, recruitment of 10 QA staff.Continuous Improvement & Change Management• Performed analytical data deep dives using 632 electronic documents to identify compliance gaps. A simple input-process-output (IPO) created to inform stakeholders, drive alignment and influence decisions.GxP External Suppliers Audit Program Lead• Provide project management support (includes 64 external suppliers).• Co-auditor; 3 audits completed in 2024, draft Audit Reports, Agendas/Questionnaires.• Facilitate GLP/GMP monthly Audit Meetings & CAPA Tracking. Quality liaison with Key Leaders• Collaborate with leads: Vector Core, Translational Core, Immunology Core, Program for Comparative Medicine, Lab Operations, Pathology, Project Management.• Collaborates with Penn Medicine Academic Computing Services (PMACS) • Collaborate with legal strategy teams to ensure necessary supplier legal documents are in place

Designed the GMP QA Strategy• Included Objectives, Goals, KPI’s to enable the GMP QA Transition Plan implementation (Six Step Strategy approach with 15 associated tools/templates)• Introduced a KPI dashboard (RAG) updates during QA Team Meetings.• Co-designed the GMP QA Organization, Job Descriptions and conducted Interviews.GMP QMS• Lead the GMP QA Transition Team (n =5) & bi-weekly meetings (7 months), through development of the Transition Plan to establish a GMP QMS. • Partnered with Consultants to implement Veeva Vault Quality Docs.• Monitored the implementation of 309 GMP QMS Document using a Master Document Register Index (MDR) and aligned documents to a Risk Assessment • Authored, reviewed, approved 66 QMS documents; critical to enable Veeva Vault QualityDocs ImplementationMonitored compliance• Led the GMP QA Risk Assessment design and implementation and collaborated with Vector Core Leadership to facilitate their GMP QA Risk Assessment implementation: 34 GMP QA Risks, and 156 Risk Mitigation Action Items aligned to the GTP Quality Manual.• GMP QA Risk and Mitigation Action Owner for 14/34 Risks.Implemented and led the GMP Training program • Across multiple processes; Document Management, Training, Archive, and multiple systems (SharePoint/knowledge link/Veeva vault QualityDocs).• Created multiple documents: Training Files, Job Descriptions, Curriculum, Matrix Tool, Notification and Completion, Proficiencies, and Annual Training Review.Stakeholder collaboration & Quality liaison • Provided QA Support/facilitation for a series of meetings: CMC Regulatory, GTP QA Vector Alignment, Transition of Analytical to Discovery Labs, Information Management Systems, Program Review Meetings, GMP QA Meetings, and Data Integrity Committee Meetings, Senior Leadership Team Meetings.• Managed the FDA Audit Backroom Request Tracker Log (62 requests) for a 5-day FDA Inspection focused on the quality system.

Developed an LLC business model for Quriosity, LLC, with a mission statement "Consult - Innovate - Improve". The intent was to design and package consulting services for pharmaceutical companies, that provide innovative ways of improving business processes and continuous improvement. These services were designed to focus on four specific categories:1. Creating a successful quality culture, 2. Driving quality improvements, 3. Effective leadership & 4. Driving performance.Registered Quriosity, LLC in the state of Pennsylvania in April 2020.Developed & published the website: http://www.quriosityconsulting.com (refer to this website for more detail on the four services provided by Quriosity, LLC).

Designed, implemented and continuously improved the Quality Strategy and Strategic Workforce Planning process. Facilitated the Product Quality Pharma R&D (PQPRD) Leadership Team (LT) – seven team members, and Pre-Clinical Quality Assurance (PCQA) LT - seven team members. Led the Deviation Mastery Core Team - ten team members, and Capability Framework Team - six team members. Led Continuous Improvement initiatives. • Developed and implemented a Senior Leadership Six-Step Strategy process successfully for three years. • Facilitated >120 hrs of Leadership Team Meetings which involved Strategic Workforce Planning, Capability Framework sessions and, bi-weekly review of departmental objectives using Visual Factory tools and Key Performance Indicator (KPI) Score Cards. Meeting outputs were communicated within bi-weekly departmental Highlights aligned to R&D’s Strategic Priorities. This initiative contributed to improved departmental engagement survey scores that increased from 60 to 80%. • Led the Deviation Mastery Team that transformed the Deviation Mastery Training Package from paper to electronic. Continuously improved the Deviation Program to improve quality and compliance, and optimized BLI resource. • Led the Implementation of the Global Quality Assurance (GQA) Model for Capabilities, Competencies, and Proficiency aligned with the R&D Model. Incorporated innovative ways for implementation across GQA. Supported Senior Leadership Teams in building key capabilities and provided input on behalf of PCQA towards the GQA Capability Framework Model. • Led the following Continuous Improvement initiatives: o Explored Data Analytics that determined previously unidentified relationships within the quality systems. o Introduced a Continuous Process Improvement program aligned with the GSK Internal Control Framework Maturity Model. o Developed a process to evaluate Good Manufacturing Practice (GMP) Quality Practices against ICH Q10 expectations.

Led the Pre-Clinical Quality Assurance (PCQA) Leadership Team (LT) Strategy Evolution - seven team members. Designed and facilitated PCQA LT Strategic Workforce Planning sessions. Led the Global Quality and Assurance (GQA) Extended Quality Culture Team - six team members. Organized Global Quality Culture Events. Led PCQA LT Communications. Designed and implemented PCQA Development Day Offerings. • Continuously improved the process of delivering the PCQA Strategy and incorporated data trending and monitoring. Facilitated regular reviews of High-Level Scorecards, Key Performance Indicators (KPI’s) and Metrics that provided visibility of how the department delivered on objectives and generated valuable team discussions. This approach improved the way PCQA LT delivered on goals, objectives, and Strategic Workforce Planning through improved coordination, alignment and focus. • Led the GQA Extended Quality Culture Team and, a team member/major contributor to the Core R&D “Do the Right Thing” Quality Culture Team. Organized and delivered inspiring unique R&D Global events to promote an improved culture of quality: o Quality of Artistry (Live Performance at the piano by Dr. Katelyn Bouska, a Doctor of Music and University Professor emphasizing: “The Right Notes, at the Right Time, in the Right Way”, followed by a panel discussion. o A Quality Carol (Live Broadcast Panel Discussion: “A review of quality challenges in the Past and Present and how to continuously improve quality in the Future). • Pioneered new ways of communicating for the PCQA Leadership Team (LT): Introduced a modernized design for the PCQA Website Platform, published 20+ Newsletters, Highlights, and Articles (Story Telling, Interviews, Reflection Articles & Videos). • Co-ordinated and communicated a series of Development Day Offerings for all six PCQA Business Lines and designed PCQA-Quality Futures Development Day Offering as a Team Building experience.

Led the Pre-Clinical Quality Assurance (PCQA) Strategy Evolution. Facilitated the PCQA Leadership Team (LT) – seven team members. Co-Chaired the PCQA Communications Team - six team members. Team member of the Quality Management System (QMS) Steering Team. • Led the PCQA Strategy Evolution to define “Current State” and proposed an alternative and innovative approach to driving the “Future State” using a Six-Step Strategy Process. This involved GSK Accelerated Delivery Program (ADP) Facilitation that incorporated Lean Sigma Tools: Capability Heat Maps, Current & Future State Maps, Visual Factory, Dashboards, and Key Performance Indicator (KPI) Metrics. The approach was implemented in 2016 and successfully delivered the strategy for PCQA throughout 2019 for all six business lines: Quality Futures, PCQA Operations, Site Services QA & Good Manufacturing Practice (GMP) Audit Team, Biopharm QA, External QA and, Data Integrity & Good Laboratory Practice (GLP) QA. This process was monitored and continuously improved. • Facilitated > 50 hours of PCQA LT meetings through Video Teleconference & Face to Face Meetings that delivered Strategy, Strategic Workforce Planning (SWP), and PCQA LT Agendas. Defined strategic intent, goals, and objectives. • Led and designed the PCQA Communication Team Strategy for 2017 that improved communication, engagement, and transparency. • Reviewed the QMS Process using ADP Tools to identify UDE’s (Undesirable Events) and suggested recommendations for improvement to the QMS Steering Team (seventeen team members across R&D & GMS). All recommendations were endorsed and implemented.

Technical Risk Assessment (TRA) Lead/Risk Assessment Facilitator. • Facilitated R&D Drug Development Project Teams to conduct rigorous risk assessments that supported the development and maintenance of a robust and effective control strategy. • Ensured effective risk communications were produced to support the definition of the control strategy both internally and externally.

Drove the Product Development (PD) & Investigational Material Supply (IMS) Quality Continuous Improvement (CI) Projects. Implemented and managed communication platforms for PD Initiatives. Led the Quality Culture Team across PD, IMS, and Global Quality & Compliance (GQC) – twelve team members. Led the PD Community of Practice Team (CoP)- eight team members, and CI Team - six team members. • Led the following Continuous Improvement projects: o Analyzed and improved PD Compliance high-level Metrics for overdue Quality Investigations, Customer Complaints, CAPA, and GMP deviation status. o Trended Compliance Metrics that reduced the backlog of overdue control documents. o Harmonized the former Pharmaceutical Development and Chemical Development business line SOP review tools to successfully implement a new platform: iReview. o Worked as part of the Platform Technology and Science (PTS) Implementation team to successfully roll out the new Risk Management System. Silver Award o Developed a Key Performance Indicator (KPI) Traffic Light/Score Card system that successfully measured metrics across the PD Six Performance Categories: Quality, Projects, People, Technology, Environmental Health & Safety and, Business & Planning. o Performed a deep dive analysis of PD deviations. This work triggered Quality Council endorsement of the new Deviation Mastery Program. Silver Award • Led the Quality Culture Team that successfully created and implemented the first departmental score cards for PD Quality Culture. The Quality Culture Score cards included KPI’s for Risk Management, Story telling, Visible Quality and Positive Reinforcement. • Improved Communication Platforms: Led the CI Team who designed the CI Website: a Knowledge Share repository with accessible Lean Sigma Tools, Green Belt Projects, Best Practices and Training materials. • Led the CoP Team to deliver Global Yellow Belt training and Trained Root Cause Analysis Workshops. Silver Award

Led the Global Communication Team - ten team members. Led Continuous Improvement Initiatives. Facilitated several Matrix Teams using Lean Sigma Tools to change, improve and increase productivity for the following teams: Management & Change Control, Quality Strategy - Quality Focus Network, and People & Culture. Facilitated Root Cause Analysis sessions for project team investigations and supported internal and external audits as necessary. • Led the Product Development (PD) Global Communication Board (GCB) Team and Project across ten Global GSK sites. This initiative captured departmental news on three key aspects: People, Projects, and Quality. Introduced a web version of the GCB and published monthly PD news articles on milestones. • Led the following Continuous Improvement Initiatives: o Analyzed and improved high-level compliance Metrics for Quality Investigations & Customer Complaints, CAPA) and GMP deviations. Reported regular status updates to Senior Leadership Teams. o Monitored the Control and Guidance Document Metrics and introduced Future Forecast predictions that improved quality and compliance for all business lines. o Enabled the implementation of a Web-Based and equivalent Hard-Copy Quality Manual. Designed Visual Factory Tools that were used to track implementation progress and identified opportunities for improvement. o Facilitated the “Right First Time” Control and Guidance Document process initiative to support the PD/IMS Quality Management System (QMS). o Monitored the Management and Change Control (MaCC) Platform entries that improved quality and compliance. • Facilitated the following teams: o MaCC Team – ten team members, through implementation steps of the new process. Bronze Award. o Quality Focus Network Team – three team members, across Manufacturing, Packaging and Analytical functional areas. Successfully harmonized their metric reporting processes across all three functional areas.

Led the Value Stream Lead Team – thirteen team members, and coordinated batch release activities through Quality Assurance (QA) under Consent Decree restrictions. In partnership with QA and external 3rd Party QA group, “The Quantic Group”, developed processes within the Logistics department to improve the batch release process. • Set release targets for the site each week for batch release. • Provided metrics on batches released each week against agreed targets and communicated weekly status updates to the site leadership team. • Reviewed Value-Added Steps and Non-Value Added Steps that improved the batch release process.

Supported the site remediation plan through consultation with the external 3rd Party QA group, “The Quantic Group”. Led the investigation team - fourteen team members, through improvement activities that reduced the backlog of overdue investigations. Performed audits for Finished Product, Raw Materials, Commercial, and Microbiology Laboratories. Revised Quality Standard Operating Procedures. • Improved “Right First Time” Pass Rate for Quality Investigations. The investigation process was revised, improved and transitioned to a state of control. This work reduced the backlog of investigations by 53% within 6 months and increased RFT metrics to 70% within 9 months. Investigation timeliness and compliance both continuously improved throughout the process.

Involved in the validation and launch of the R&D Lab at Cidra GMS site. Ran the Lean Lab Program and performed analytical testing. The establishment of the PD lab in a GMS site was an important goal for PD. Having worked in PD prior to GMS, focused support to lab set up and training of the site staff in the analytical methodology for both the high throughput methods and stability methods, enabled the laboratory to perform a key function of PD• Worked as part of a team to ensure the target deadline to launch the R&D PACE lab was met.• Trained lab staff in analytical methodologies - including Dissolution, Content Uniformity, Assay and Degredation. • Conducted appropriate laboratory Investigations for both laboratory and process Investigations.• Performed stability testing, analytical method transfer, Q batch support and PAI support.• Ensured that the QC lab compiled with all cGMP's and GSK safety and quality standards.

Performed Stability Testing, Analytical Method Transfer, Quality batch Testing, Pre Approval Inspection Support, and Patent Support work for Product Line Extensions. • Contributed to the launch of Product Line Extensions through the following activities: o Supported audits for Finished Product, Raw Materials, Commercial, and Microbiology Laboratories. Conducted laboratory investigations and report writing. Silver Award • Performed research in collaboration with the Gastrointestinal Centre of Excellence of Drug Discovery (GI-CEDD) Drug Metabolism and Pharmacokinetics (DMPK).

Study Director for Pre-clinical Pharmacokinetic Studies. Safety Officer for all Drug Metabolism and Pharmacokinetics (DMPK) laboratories at GSK The Frythe Site. Study Director for Pre-clinical PK Studies. Safety Officer for all DMPK laboratories at The Frythe Site.

Research in the field of Vitamin K and Vitamin K - dependent proteins.