Joy Weakley

Background

About Joy Weakley

Quality-focused operations leader and project manager, with 14+ years of commercial GMP manufacturing experience and exceptional ability to balance production scheduling needs while adhering to industry compliance standards and streamlining processes to control costs and maximize efficiency. Known as a collaborative team player who works well cross-functionally. Experience and accomplishments include- GMP Systems, Requirements, Operations & Facilities - In-depth experience and understanding of what it takes to successfully produce commercial drugs under the strictest regulations in GMP biotechnology facilities. Skilled at crafting and implementing policies to meet standards; knows how to validate processes. Proven results in: Change Control | Validation | Deviation | CAPA Document Control | System Implementation | Contract Oversight - Production Processes - Extensive experience developing, validating, data trending and managing production processes and support activities: Preparative Scale HPLC | Low-Pressure Ion Exchange | Aseptic Manipulation Buffer Compounding via Automated Skid Module system | CIP|SIP | Autoclave - FDA Regulations & Licensing Process – Well developed knowledge of compliance standards and FDA licensing requirements. Background embraces experience as a key team member in successful FDA licensure process for a new biotech facility which resulted in successful Pre-Approval Inspection audit of the product and facility, involving: Process Transfer Validation | Conformance Run Process Validation Common Technical Document (CTD) Generation and Review in Support of the Submission - Audits – Strong results working directly with FDA and WSBOP auditors through participation as a Production SME in over 10 agency audits. Experience overseeing pre-inspection prep for internal and regulatory agency audits. Knows how audits are structured and how to craft responses and CAPA.