• Manage an organization of 25 people across three different teams• Implemented a visual management scheduling system for all teams• Instituted Daily tier 1 meetings for all teams• Oversaw the movement of multiple pieces of equipment from the Chemistry team’s original location to a lab that was 3 times larger• Purchased and installed 6 new HPLC/UPLC systems which more than doubled the capability of the Chemistry team• Oversaw the implementation/validation of an upgrade to the Empower software system to its most current version• Implemented a new folder structure in Empower which allows for the separation of Development, Validation, and Production data generation, this structure allows for the easy retrieval of data generated by client, then method, then year.• Implemented a controlled print system for all of the data capture forms used in the lab to allow full issuance and reconciliation traceability.• Oversaw the installation/validation of a new ICP-MS triple quad system, Mastersizer 3000 system, and BioQuell sterility cabinet in the Chemistry and micro labs• Implemented a full 5S program in the QC Chemistry lab, and engaged leads to help maintain the system on a daily/weekly basis• Successfully drove improvements from yearly internal audit to reduce 4-5 major findings in 2023 down to 3-4 minor findings in 2024

• Member of the site leadership team (SLT)• Manage an organization of 125 people across nine different teams (Stability, E&L, Organics, Inorganics, Analytical research, and development (ARD), QCCA, Micro, Solid State, and Environmental Monitoring)• Added a Sr Manager of Continuous Improvement to the organization to oversee several projects in SMA that will deliver efficiency gains to different teams• Re-organized the department to drive an optimal working environment• Worked with the stability team to mange out of a backlog of over 200 lab notebooks and hire/train the needed personnel to prevent a backlog from re-occurring• Delivered positive financial results for SMA in FY Q4 2022

• Member of the sites Quality Leadership Team (QLT)• Performed multiple walkthroughs of QC and MFG areas to ensure a successful Novartis baseline audit and FDA PAI inspection of the site focusing on data integrity (DI) and Quality systems compliance• Performed self-inspections of the quality operations unit and multiple quality control testing groups including: Microbiology, QC sample management, Biochemistry, and ddPCR labs• Worked in the back room of several site audits as a Request manager ensuring:o Correct assignment of SMEs to auditor requestso Availability of the SME and documentation when needed to present to the auditoro Close out of requests once presentation to the auditor was completed• Performed multiple interview investigations for DI related investigations at the site and escalated per the site SOP when required • Co-ordinated all data integrity remediation projects on-going at the GTxNC including:o Certified as a trainer for Data Integrity Maps and Data Integrity Advanced classeso Held numerous DI Maps and DI Advanced training classes for the site to increase DI training compliance from 35% to over 95% completeo Data mapping of all critical processes at site to capture and mitigate potential DI failure pointso QC remediation activities of equipment and processes shown to have DI gapso Manufacturing remediation activities of equipment and process shown to have DI gapso Reviewed and/or approved all site relevant data maps, CAPA’s, and SOP updates• Created and manage the site’s data integrity SPOC’s (Single point of contact) to provide escalation points in all of the groups throughout the site• Provided data integrity guidance for all deviations at the site, including interviews and escalations of major data integrity issues• Provided data integrity impact assessments for applicable change controls at the site• Created Spotlight for Quality newsletter at the site to highlight/recognize people’s positive data integrity behaviors

• Co-ordinate all data integrity remediation projects on-going at the Zebulon site• Created and maintain local Technical Implementation Plan (TiP) and Continuous Improvement Framework (CIF) for data integrity initiatives• Provide site leadership team with monthly project updates• Participate in Monthly meetings with other site leads to discuss projects and best practices • Perform Data Integrity (DI) assessments on lab and production equipment (Legacy and New)• Performed Audit Trail Review Determinations (ATRD) on lab, production, and IT systems and equipment• Construct and provide monthly communication packages to the site about data integrity issues from around the network and global industry• Revised SOP’s, created training modules, and forms to include relevant DI information• Enhanced lab training program across all 3 value streams to add clarity and documentation for data integrity (ALCOA+) and audit trail review as part of the routine testing and peer review processes.• Work with manufacturing equipment to mitigate risks associated with generic accounts on equipment.

• Manage day to day activities of 15 analysts/senior scientists under USFDA, ICH and EMA regulations as well as ROW regulations.• Review and approve Laboratory investigations, CAPA’s and CAPA effectiveness.• Successfully implemented GlaxoSmithKline Production System (GPS) into the Oral Dose (OD) stability area o Sample testing on time completion rate increased from an average of 65% to averaging above 95%.o Increased testing on-time rate from 95% to over 99% thru problem solving and GEMBA’s with team memberso Drive continuous improvement in GPS knowledge and abilities of all current team members thru GEMBA’s and process confirmations.o Leader and manager of multiple continuous improvement projects for 5S (Sort, Store, Shine, Standardize, and Sustain) to revisit all areas of Oral Dose to review and optimize the areas.• Coached 2 senior scientists to improve their abilities in writing laboratory investigations and CAPA’s.• SME for computer data systems, chromatography, and lab investigations during regulatory audits. Recognized as an SME for method transfers and technical expertise with regards to lab systems and the LIFT systems during internal and external audits.• Conduct and participate in company audits at all levels (level 1: self inspection, level 2: local audit group, level 3: global GSK audit group, and level 4: global regulatory agencies) • Conduct midyear and end of year performance development planning (PDP’s) for all direct reports to ensure individual performance and development opportunities align with site goals and individual career goals

• Successfully completed a four month secondment as the acting Solid Dose supervisor with no compliance/audit observations or loss in productivity.• Liaised with LabVantage visitors to identify issues with Sapphire (LIFT) software so that appropriate code drop fixes could be developed. • Co-ordinate and approve investigations of any atypical and/or OOS (out-of-specification) results generated by the analysts.• Provided technical expertise for the launch of the last two Zebulon launch products. (Horizant and Potiga)• Have received a person performance evaluation of Outstanding from 2009-2013 (4 years).• Provide necessary information during FDA/MEA audits of the QC lab.• Co-chairman of a multisite group designed to implement the next generation of automated laboratory equipment.• DEA certification to work with controlled substances• Participate in site EIT reviews using lean sigma skills to determine the root cause for OOS/atypical results• Generate Annual Data Reports for the FDA and other regulatory agencies• Developed, validated and implemented TOC (total organic carbon) cleaning methods for over a dozen different compounds, which reduced the manufacturing/ packaging down time from 4 days to a day and a half.• Developed and validated a set of generic HPLC parameters and conditions that allowed for the analysis of over a dozen compounds on a single HPLC system without the need to change mobile phases or columns. This resulted in a 50% reduction in HPLC swab sample results turnaround time.• Participated in multiple method transfers from sites located in both the US and the UK.• Perform statistical analysis of the data generated for all method development and method transfer projects.• Participated in Dissolution Kaizen event in the US/UK to determine the root cause of low dissolution results.

• Oversaw the implementation of the pesticide testing area.• Transferred the USDA testing methods in to allow the company to begin basic pesticide testing. • Authored and reviewed the company’s quality policy.• Ensured that testing was conducted in a manner consistent with ISO-9000 guidelines. • Participated in two ISO-9000 audits of the pesticide area which resulted in no critical or major observations• Developed several new methods which expanded the testing capability of the site from 23 compounds to over 100 compounds• Performed onsite audit of second pesticide lab be established at the Brazil site in South America.