Supporting FDA Regulated companies to prepare for certification and licensing with regulated bodies (e.g. FDA, ISO, etc.)

● Creation and maintenance of site Quality Policy and Plan inclusive of strategic, continuous improvement, remediation, and cost improvement initiatives.
● Oversight of 4 direct managers and 80+ indirect QA/QC reports (Quality Systems/Compliance, Quality Operations, QC Microbiology and QC Bioassay
● Introduced Quality Planning and Internal Auditing focused on all elements of the business’ quality system
● Building quality specific partnerships with other Dendreon locations

● Senior leader for the site with operations, facility, warehouse, and safety function reporting into the role.
● Responsible for ensuring resourcing to meet the demands of the production schedule.
● Accountable for building a Great Place to Work culture at the site.
● Oversight of backfilling >15 open manufacturing roles, cross-training, streamlining training, overtime incentives in less than 8 weeks to meet Q1 and Q2 production demands
● Ensuring manufacturing success of > 99.5%

● Responsible for $1.7MM capital improvement in solution mix area to simplify and reduce setup time and mitigate operator safety hazard.
● Reduced the changeover days for the manufacturing process of a new product by 50% and reduced waste in the manufacturing process
● Identified contamination mitigation in component pass-thru process by exploring UV, Ozone, and VHP technologies
● Implemented a Cost of Quality program at the Greenville Solution Facility to focus on cost reduction

● Manager of validation team of 7 directs. Responsible for maintaining validated state of Equipment, Aseptic Processes, Products, Sterilization, Cleaning processes, and Software systems in the Greenville Solutions Plant. Provided validation support and technical expertise to Milan, Italy lens care solutions site
● Remediated legacy equipment, validation, and documentation for 35-year-old facility thus improving quality performance rating from ‘needs improvement' to ‘good’ rating

● Validation Leader for Philadelphia PA site and the team of 5 direct reports. Responsible for equipment, process, cleaning, and computer validation.
● Validation subject matter expert for routine customer audits and regulatory surveillance audits.

Provided equipment and process validation services for solid dosage clients

Provided validation support for various pharmaceutical, medical device and biotech clients.

Build and led Validation Program at the Allendale NJ site