Peniel Ortega PMP PharmAllies

Peniel Ortega is the Managing Director of PharmAllies, a leading consultancy specializing in commissioning, qualification, and validation (CQV), data integrity, computer software assurance (CSA), operational excellence, and project management for the pharmaceutical, biopharmaceutical, and medical device industries. With over 20 years of experience, Peniel is a Certified Six Sigma Black Belt (CSSBB) and a Project Management Professional (PMP), recognized for delivering risk-based, compliance-driven solutions that enhance efficiency and promote regulatory adherence. A recognized expert in Data Integrity, CSA, and risk-based Computer System Validation (CSV), Peniel helps organizations mitigate compliance risks while leveraging digital transformation to optimize operations. His leadership in quality risk management, project management, operational excellence, and QMS harmonization has driven measurable success across global manufacturing networks. Before leading PharmAllies, Peniel served as Associate Director of Engineering at Merck, overseeing high-impact projects and cross-functional teams in regulated environments. His ability to integrate Lean Six Sigma methodologies with regulatory best practices makes him a trusted advisor and sought-after speaker in the life sciences industry. Guided by excellence, integrity, and relationship-building, Peniel is dedicated to helping companies navigate evolving regulations, implement risk-based validation strategies, and ensure long-term compliance and operational success.