Jessica Villavicencio

• Led URS, FAT, SAT, Qualification, CSV and GMP compliance. • Managed Quality System processes including Deviations, CAPAs, Change Controls and Risk Assessments. • Coordinated multidisciplinary Engineering & Calibration teams supporting GMP critical systems. • Designed the qualification strategy for a new Facility (520+ qualification documents) • Coordinated multidisciplinary teams across Engineering, Manufacturing, Validation, Procurement and Quality throughout complex engineering programmes.

• Supervised Quality Assurance/Quality Control operations within ISO 13485 and cGMP-certified manufacturing facility. • Managed SOP lifecycle, Deviations, OOS, CAPAs, Complaints, Internal & Supplier Audits and Inspection Readiness. • Led the site Validation Master Plan, including CSV, Process, Cleaning and Analytical Methods. • Implemented a risk-based periodic review strategy, optimizing the qualification lifecycle. • Led Operational Excellence initiatives using Lean Six Sigma and Quality Risk Management.

• Coordinated WHO Prequalification activities for a contraceptive medicine, supporting product eligibility for United Nations procurement programmes. • Managed regulatory gap assessments, coordinating technical actions across Germany, Mexico and Ecuador. • Supported successful international tender with UNFPA by integrating regulatory, sustainability and quality documentation. • Collaborated with multidisciplinary international teams to align technical documentation across multiple manufacturing sites.