Vice President, Global Operations Quality for Alora Pharmaceuticals family of companies, with quality oversight of Alliant Packaging in Alpharetta, GA, Osmotica Pharmaceuticals in Marietta, GA, Trigen Laboratories in Tampa, FL, Vertical Pharmaceuticals in Sayreville, NJ, and Sovereign Pharmaceuticals in Fort Worth, TX. Reporting to me are the site quality directors of each manufacturing location, as well as the Head of Third Party Quality (CMO oversight), and Associate Director, Quality Process Excellence. Provide strategy and guidance to implement, manage, and improve quality programs per 21 CFR 210, 211 and ICH Q9 / Q10. Champion quality operations improvement processes to ensure product quality and adherence to CGMPs. Hire and manage quality operations leadership, define expectations, and coordinate priorities across multiple projects and site activities. The activities of my role and my team include:· Re-organized corporate quality structure and site leadership teams to streamline quality processes· Implemented corporate quality policies that apply to the entire network to ensure global compliance· Won new drug product business for Osmotica/Trigen sites due to reliable deliveries and product quality· Currently implementing MasterControl QMS for Sovereign and Alliant sites to improve event quality· Currently supporting implementation of SAP for improved product management and process optimization· Implemented batch record review certification program to ensure high quality review across the network· Implemented on-time quality review for product release throughout the network for reliable deliveries· Created position and hired the Associate Director, Quality Process Excellence to lead lean improvements· Quality Process Excellence activities currently involve 5S improvements and tracking quality initiatives

Site Quality Director for the Osmotica Pharmaceuticals Marietta, GA site. The site focuses on laser-drilled solid oral dose products, both NDA and ANDA. Responsible for quality oversight of manufacturing, packaging, laboratory, warehouse, validation, facilities, and pharmaceutical development. Manage three direct reports including Associate Director, Quality Operations, Associate Director, Quality Compliance, and Associate Director, Validation Compliance. The activities of my role and my team included:· Assessed risk in GMP activities using ICH Q9 principles and per 21 CFR 210, 211 and ICH Q10 guidance· Maintained no 483 observations (No Action Indicated) from FDA since 2019· Achieved 0 missed shipments, 0 backorders, and 0 recalls as a site since 2017· Implemented Veeva Vault, Compliance Wire, MasterControl, and AuditUtopia since 2018· Established Quality policies / procedures following regulations, guidance, and industry standards· Reduced deviations by 40% since 2017 by implementing appropriate corrective actions· Performed supplier quality management activities and implementing quality agreements· Evaluated quality events for potential FDA Field Alerts when applicable· Led FDA inspections and other quality inspections by external auditors

Ensured site compliance with 21 CFR Parts 210 & 211.Implemented Quality Systems (ICH Q10)Wrote, reviewed, and approved procedures and protocols for the site.Reviewed engineering changes and equipment qualifications.Created risk-based approach to quality programs.Provided quality oversight of laboratory, manufacturing, and packaging operations.Set up vendor quality management and raw material management programs.Implemented investigation, CAPA, and non-conformance processes.Initiated systems-based internal auditing.Designed customer complaint, investigation, and trending program.

Tablets Site QC Senior Manager• Manage site QC activities with 92 team members. Team consists of laboratory operations for Finished Products and Stability, Raw Materials, and Process Validation. Site Quality Materials included in QC team, performing sampling and raw material release. Site Quality Components is also included in the QC team, performing sampling, testing, and release of packaging components.• Guide leadership team of 9 including: manager of raw materials and quality materials, supervisor of raw materials, supervisor of components, supervisor of quality materials, 3 supervisors of finished products and stability, supervisor of process validation, and supervisor of laboratory infrastructure.• Laboratory tests approximately 7000 samples per year (35,000 analyses).• Reduced laboratory investigation error rate by 58% in 2014 versus 2013.• Reduced laboratory investigation error rate by 42% in 2015 versus 2014.• Reduced turn around time for finished product and raw material samples by >50%.• Improved RFT by analysis from 92% to 99%.• Implemented 5-year instrument replacement plan (currently in year 3) with 40% equipment replaced to improve operational efficiency. Another 20% to install in 2016.• Manage annual laboratory operations budget of approximately $2 million, salary budget of $4.5 million, and annual CapEx budget of ~$1 million.• Guide a team of chemists responsible for supplemental method validation activities.• Validation team performs 4-6 new product launches or transfers per year. Team also performs scale-up and alternate supplier validations.

Tablets Site QC Manager• Manage site QC activities with 60 team members. Team consists of laboratory operations for Finished Products, Raw Materials, and Process Validation. Site Quality Materials also included in QC team, performing sampling and raw material release.• Guide leadership team members including: manager of raw materials and quality materials, supervisor of raw materials, supervisor of quality materials, 2 supervisors of finished products, supervisor of process validation, and supervisor of laboratory infrastructure.• Manage annual QC operations expense budget of $2 million.• Initiated programs and quality expectations to drive down chemist investigation error rate by 67% in 2nd Half 2013 versus 1st Half 2013.• Implemented laboratory targets and metrics for improving quality. Developed scorecard for lab leadership team to maintain quality metrics.• Support laboratory technical services by providing resources to revise chemistry methodologies while maintaining normal laboratory operations.• Support StarLIMs implementation and use for site laboratory teams.• Improved QC training compliance rate from 66% in August 2013 to 96% in December 2013.• Directed development of new QC training curriculum and training program materials to ensure a robust chemist onboarding process and maintain existing chemist skills.• Review and approve Trackwise laboratory investigations and non-conformance reports. Provide guidance to supervisors and lead chemists through the investigative process.• Conduct cross-functional investigation team consisting of QC, laboratory technical services, and QC compliance to discuss open investigations and determine next steps.• Implemented laboratory compliance audit system to ensure chemist daily activities are within limitations of governing procedures.• Continue implementation of 6S program for improved laboratory organization and efficiency.

• Supervised QA inpsectors and provided shop-floor oversight at solid-dose manufacturing facility in Huntsville, AL. Areas of oversight included weighing raw materials, granulation, blending, compression, and film coating. Reviewed compliance with 21 CFR 210, 211.• Maintained and continuously improved quality at site while working within the value stream to attain monthly production goals of 700-800 million doses.• Worked within ops value stream to perform root cause analyses and implemented successful CAPA events. Provided deviation management and mitigation to maintain system controls. Performed product impact assessments regarding batch disposition.• Led weekly Deviation Review Board for VSO1 manufacturing to discuss next steps and track deviation progress.• Performed regular shop-floor audits and reported findings to QA and OPS management. Audits included review of personnel training and gowning, room organization, potential contamination, procedures, and master batch records.• Provided support for packaging QA as needed to determine product impact on batches from manufacturing or on line during packaging.• Became Qualified Trainer to perform personnel cGMP training as necessary on procedures, OJTs, and Qualifications.

• Team leader of four quality groups on 2nd shift: raw materials laboratory, packaging supply inspection, sample administration, and glassware managing total personnel of 15-20 analysts and technicians.• Scheduled daily activities for the raw materials lab, prioritizing critical materials needed to continue production while ensuring quality standards were met.• Allocated available resources to high priority items and delegated tasks to team to optimize productivity – worked with other lab groups to get help when needed to meet demand.• Improved quality by reducing raw material laboratory analyst-error investigations by 45% in 2011 versus 2010.• Provided communication bulletins to planners, factory groups, QA, and management regarding timelines and completion of raw material and packaging supply testing.• Reviewed GEMA documents for new and revised raw material test methods – ensured new methods matched specifications from USP, NF, EP, or FCC prior to approval.• Conducted regular audits for safety submissions and training documentation – led individuals or groups to close any gaps quickly and effectively. • Created procedures for departmental operations (scope included safety for working with hazardous materials, general test methods, and handling narcotics).• Authored and reviewed investigations and deviations in Trackwise when material testing results were out of specification.• Standardized analyst objectives and challenged team to achieve higher targets – worked with analysts’ career goals to create objectives and development plans.• Conducted interviews for new employees, hired key analysts for team, provided monthly performance discussions with employees, and delivered disciplinary actions when needed.• Implemented lab metrics and Key Performance Indicators (KPIs) that monitored laboratory processes and challenges. Some KPIs involved First Time Right, Investigation Rate per # of Materials Tested, and Schedule Attainment.

• Provided support to the Customer Service dept via Master Data changes, Product Allocation, Material Determination, DEA licensing and reporting, SAP superuser, EDI backup analyst, and team trainer.• Served as point of contact for production planners, QA, product supply management, master data, IT, display team, logistics, forecasting, and customer strategy.• Maintained UPC and CIN records in material determination table to improve fill rates and monitor transitions from PIN to PIN (saved $500k in sales in 2009).• Populated monthly limits by customer into the product allocation tables to support customer strategy and maintain Inventory Protection plan (cough/cold 2009)• Performed troubleshooting for sales orders, deliveries, and invoices as well as analyze master data issues affecting customer service and prepared formal change requests.• Acted as SAP superuser, logging TOM tickets and working with IT to resolve SAP problems and implement enhancements, also logging tickets to get additional user access to SAP.• Performed SAP Q10 and P10 testing for system improvements for cough/cold terms, split valuation, and obsolescence sales.• Led project teams to test and implement SAP upgrades for Batch Search Strategy (2008) and Prevacid Launch (2009) affecting orders, shipments, and invoicing.• Provided leadership to customer service team with product release information, processing instructions, error correction, and training documents.• Acted as EDI backup analyst, processing IDOCs out of workflow, setting up customer partnerships in SAP, and pulling raw data from GXS server.• Instructed classes for the Customer Service Reps to understand new SAP tools, new procedures, and review existing processes.• Provide performance feedback to team and management to increase team efficiency and reduce errors in order processing and delivery creation.

• Inspected raw materials and compared to company monographs and specifications. Accepted/rejected raw materials based on quality standards. • Sampled all NCH materials at site (400+) working from production and laboratory schedules.• Utilized SAP to locate raw materials, order pallets, remove material inventories, check batch receipt dates, and ensure material quarantine as necessary.• Initiated new receipts into LIMS, checked documents for accuracy, and verified supplier CofAs for locations, nomenclature, lot numbers, etc.• Printed weekly SAP stability reports to determine which raw materials expired or were due for retest.• Performed Near-Infared (NIR) testing for material drum identification using Brimrose Luminar Acquire and Predict software programs. Scanned new materials to NIR library for future use.• Assisted department of 4 QA techs in reducing sampling throughput from 4 to 3 days by improving process efficiency.• Created Kanban ordering system for Fisher Scientific supplies, reducing warehouse storage for sampling by 60% and increasing ordering efficiency.• Improved laboratory safety awareness by adding the NFPA/HMIS codes to raw material sample containers.

• Led shift team of 4 operators. Delegated projects and spread workload among co-workers to increase output. • Utilized schedule board for priorities and department communication. Updated schedule daily as production met or surpassed targets. • Weighed raw materials and performed manufacturing operations for liquids and semi-solids. Operated mechanical and electronic equipment during production. Monitored operation processes to ensure high quality. Detected rare equipment malfunctions to prevent losses or materials or batches. • Trained new operators as needed to replace or increase staff dependent on demand.• Revised operating procedures to increase compliance and efficiency. • Designed and implemented visual logbook system for documentation of clean and use of equipment. Organized department procedures for point-of-use access while maintaining document control.

• Weighed raw materials and performed granulation and blending operations. • Provided support in tablet compression and worked on R&D projects for film coating. • Operated equipment, trained new operators, and revised procedures as needed.