Wesley E. Davis Email & Phone Number

Wilmington, DE, US

Wilmington, Delaware, United States

• While retaining all responsibilities of prior role, additional functions and accomplishments in strategic QA include:
• Lead a team to provide Quality and compliance for U.S. and Canadian markets related to small molecule drug manufacturing, and small and large molecule packaging and distribution, and Incyte customer complaints.
• Drive significant process efficiency and improvement to closure processes and Veeva enhancement tools resulting in improved closure rates to >55% (from <5% in ’22)
• Lead 3 new vendor qualification efforts, hosted US inspection for Pharmacy distribution, launch of 2 new products, and strategic planning for 2 new products pertaining to QA distribution and QA secondary packaging.
• Leverage lean tools to reduce complaint handling time by >270 hours, while implementing a reporting suite for tracking and trending of LOEs
• Collaborate with cross-function teams, such Supply Chain US, BioScience Canada, and R&D to ensure seamless integration of the quality process into new and existing systems

Wilmington, Delaware, United States

• Lead a team to provide Quality and compliance for U.S. and Canadian markets, while acting as a backup for EU activities
• Lead Risk Management and streamline initiatives for CMO and Distribution network
• Develop and maintain Critical Process Indictors (KPIs) dashboards for CMO and Distribution partners
• Manage and Streamline Complaint process for U.S. and EU markets
• Schedule, perform, and conduct Audit activities for Suppliers, CMOs, and distributors
• Work in cross-functional team with Supply Chain, QC, CMC, and Regulatory Affairs to ensure product is develop, manufactured, and distributed with quality oversight

Wilmington, Delaware, United States

• Monitor performance of external manufacture systems to ensure effectiveness and efficiency to meet regulatory and company policies.
• Communicate supplier information to all relevant organizational departments, outside vendors, or contractors.
• Audit and inspect subcontractor facilities including external laboratories.
• Manage supplier program related to internal and external manufacturing, performing supplier audits and oversight of 3rd party auditors for global operations
• Responsible for oversight of Quality IT systems for quality management, documentation, and training
• Write and update quality and specification agreements for contracted vendors

Wilmington, Delaware, United States

• Manage team of eight Quality Assurance Specialists who are responsible for batch records, product release, raw materials, validation and investigations
• Led cross functional team to improve batch log ‘right first time’ rates by 15% resulting in a 4-day decrease in cycle times
• Develop a quality risk registry by identifying and working with cross functional teams to close potential compliance gaps
• Review and approve process validation studies
• Provide oversight, approval, and administration of CAPA, Change Controls, Events and Deviations in the Quality Management System
• Approve master batch logs, specifications, and SOPs in document management systems

• Fostered effective collaboration with Contract Manufacturing to streamline product release process and create effective data exchanges to meet reliable and consistent product delivery
• Oversaw contractor lab for sampling and testing to ensure GMP compliance
• Provided front-room and back-room support for FDA and corporate audits
• Served as lead for internal quality audits, noted for expeditious mitigation of identified compliance gaps
• Conducted new hire training related to batch record review, product release, event writing, approvals and internal audit preparation
• Developed and implemented streamlined paperless process to reduce sampling time by over 50%

Malvern, Pennsylvania, United States

• Prioritized compliance with safety and environmental practices, cGMP’s and OSHA regulations in a pharmaceutical setting
• Executed critical site testing to ensure specifications are met for release of final product
• Proficient in writing SOPs, Alert Action Notifications, Out-of-Specification reports, Invalid Assays and Deviation Investigations
• Provided oversight of water and environmental methods for processing in Manufacturing
• Developed training module for site initiative to reduce contamination
• Responsible for training Quality and Manufacturing associates on aseptic technique and Quality assays

Malvern, Pennsylvania, United States

• Performed various laboratory activities in a GMP and GLP chemical lab
• Conducted water analysis tests, including conductivity, pH, alkalinity, acidity, nitrates, and chlorine
• Recorded and analyzed testing data, effectively communicated results with management

Master Of Business Administration - Mba, Global Challenges And Strategic Innovation In Businesses, 3.7

Activities and Societies: Strategic Leadership & Management Certificate, University of Illinois Global Challenges in Business Certificate.

Bachelor Of Science - Bs