Gerle Peña Email & Phone Number

Engaging Quality Management professional with extensive experience in global Quality Management Systems (QMS) and manufacturing operations in regulated environments. 20+ years of technical and global leadership experience in medical devices, Pharma, and food industry as a Quality professional, with a high performance demonstrated by the ongoing career development across the years.Some elements in my background experience include:★ Pharmaceutical products manufacturing site operations such as solids, liquids, parenteral and injectables.★ Medical Device manufacturing site operations such as components subassembly, final product assembly and serialized medical devices.★ Commissioning of installation and star up of class II complex imaging and radiological medical devices used for cancer diagnostic and therapies.★ Integration of Medical Device and Pharma procedures into harmonized Quality Systems procedures. ★ Strict compliance with all corporate policies and procedures, as well as regulatory requirements governing the manufacturing of Pharma o and medical devices.★Demonstrated ability to lead complex project teams, drive cross-functional collaboration within a team environment, and deliver results.★ Extensive experience with regulations and standards such as 21CFR parts 4, 820, 806, 804, 11, 58, 210, 211, ISO13485, MDD, as well as with the Medical Device Single Audit Program (MDSAP). ★ Successful implementation of audit preparation plans and hosting inspections/audits conducted by FDA and Notified Bodies (BSI, NSAI, TUV).Specialties: ●Quality Management ●Strategic Planning & Management ●Six Sigma Black Belt ●Certified Quality Manager ●Quality Systems and Standards ●Good Manufacturing Practice (GMP) ●Supplier Quality Engineering ●Audit Readiness ●FDA 483 Remediation ●Risk Analysis ●Root Cause Analysis ●Process Validation ●People Development / Training ●Cross-Functional Leadership ●Project Management ●NPI ●Product Launch.

Listed skills include Six Sigma, 21 Cfr, Lean Manufacturing, Statistical Sampling, and 26 others.