Sean Williams Email and Phone Number

Quality Confidential Inc. was established in October 2017. After spending more than twenty years in regulated industry, our President, Beth Slater, decided to turn her passion for compliance into a specialized consulting firm. Her vision became Quality Confidential, a dynamic consulting organization engaging the industry’s best talent to offer customized services to pharmaceutical, biopharmaceutical, and medical device clients. Personalized project planning executed by specialized consultants is how we ensure goals are met within budget.

Completed sale of a historical commercial property in downtown Lenoir, NC- Purchased, designed, and developed a multi-use, community focused, historical building.- Collaborated with architects, contractors, building inspectors, and State/Federal historical offices.Key Achievements:• Achieved State and Federal approvals for historical building restoration and development.• Designed a unique portfolio for the sale of the commercial property.• Negotiated selling price, financing terms, and interest rate with the buyer.

Drive continuous improvement across twenty-six production lines using data-driven decision-makingand worked cross-functionally with strategic operations and sales teams to increase volume, customersatisfaction, sales, and long-term strategies for meeting customer requirements. Facilitated fifteen totwenty customer and agency audits, annually.● Managed facility ISO 9001:2015 and ISO 15378:2018 Quality Systems.● Led quality improvement initiatives and audits for maintaining compliance and operational excellence.● Maintained the strategic supplier program, conducted on-site audits and annual supplier evaluations.● Prepared and led company representation during customer, supplier, and ISO certification audits.● Key Accomplishments: ● Successful ISO 9001:2015 & ISO 15378:2018 QMS site certification audits (2021/2022/2023) ● Achieved Certificate for ISO 9001:2015 Certified Internal Auditor ● Received 2022 Global Quality Systems award for Covid-19 Vial Standardization project

Contractual position to initiate the Biopharmaceutical Technology program.● Developed and managed a rigorous curriculum focused on Title 21 of the Code of FederalRegulations and ISO 9001:2015 requirements.● Major emphasis was placed on Good Documentation Practices, Good Manufacturing Practices,process validation, quality control, quality assurance and industry regulations.● Prepared individuals for employment in pharmaceutical manufacturing and related industries.● Collaboration with NC BioWorks for continuing education for local corporate training.Key Accomplishments● Established program curriculum, course content, and instruction for students.● Procurement of equipment and materials needed to facilitate instruction.● Pre-renovation design of current facility for future cleanrooms and laboratories.

● Managed the Quality Control Chemistry Laboratory, Chemists, and Laboratory Technicians.● Ensured conformity to cGLP / cGMP guidelines & comply with FDA / customer requirements.● Reviewed and approved Standard Operating Procedures and Quality Control Test Methods.● Procured laboratory reagents, standards, equipment, and laboratory service agreements.● Initiated, reviewed and/or executed protocols and reports for lab equipment validations.● AQL inspection testing on incoming vials, stoppers, overseals, and final drug product inspection.● Raw material and finished drug product testing according to USP/EP/JP methods.● Analyses included: HPLC, UPLC/MS, GC, ICP/MS, Atomic Absorption, Karl Fischer Volumetric / Coulometric Titrations, Potentiometric Titration, Optical Rotation, FTIR / UV Spectroscopy, Liquid Particulate Monitoring, LOD, Residue on Ignition, Heavy Metals, Iron, pH, Osmolality, and TOC.● Key Accomplishments: ● Design, build-up, procurement, and installation / validation of ten (10) FDA compliant laboratories. ● Developed and maintained ICH Stability program for accelerated and routine stability studies.

Quality Assurance - Quality Systems Manager● Manage the Quality Systems of the company. ● Trend Process Deviations, Laboratory Investigations, and Incidents to ensure Quality is always maintained. ● Review/Release of all incoming raw materials and components. ● Review/Approve specifications and Certificates of Analysis. ● Review/Approve method validation/verification protocols and reports. ● Review/Approve stability protocols for new drug products and for annual commercial finished product studies. ● Research and Procure laboratory reagents, standards, equipment, and laboratory service agreements.

● R&D Chemist and Lab Manager for development and commercial production of ASTM Grade Biodiesel.● Quality Control Director: Oversee the quality of initial feedstock, chemicals & final fuel.● Release Certificate of Analysis on final fuel that meets ASTM D6751 specification.● Initiate experiments directed toward maximizing yields and reducing production costs.● Successful scale up from laboratory size reactions to production capacity.● Production Director: Initiate batches and oversee movement of fuel during processing.● Production Specialist: Keep productions flowing, solve problems, and increase output. ● Document Controller: Review, sign off and maintain documents.● Initial setup and purchase of all laboratory equipment and chemicals.● Calibrate and take care of all instruments to minimize instrument downtime.● Control all MSDS documents and update when necessary. ● Medical Responder in emergency situations.

Chemist / Lab Manager● Chemist and Lab Manager for the analysis and release of ophthalmic products and irrigation solutions. ● Ensure conformity to GLP/GMP guidelines and comply with all FDA requirements.● Write proposals, protocols, and SOP’s.● Perform instrument maintenance and calibration.● Assays include: HPIC, Heavy Metals, Iron, pH, Osmolality, TOC, and Raw materials testing per USP.● Release Certificate of Analysis on all final products.