Arlene Sanchez

Senior Manager Quality @Cipher Pharmaceuticals Inc. (TSX: CPH) (OTCQX:CPHRF)

Mississauga, ON, CA

Establishes and maintains a highly functional GMP/GLP quality management system • Oversees the establishment and maintenance of compliant and efficient QA review systems. • Be responsible for all compliance requirements pertaining to document and data management, including administration, storage, and archiving of documents. • Acts as the Key QA contact and Subject Matter Expert (SME) for all internal, customer, and regulatory audits. • Participates in corporate and group cross-functional meetings on an ongoing basis across the organization. • Leads all the post approval quality changes in compliance with product manufacturers including manufacturing changes when proposed. • Establishes & implements compliance & efficiency improvements to product development and manufacturing process, evaluates the quality impact, and revises QA procedures, as needed. Initiate, review, and approve, as applicable change control and deviation quality records. • Performs control of Narcotic Products and regulatory requirements. • Oversees QMS for importer/distributor regulatory requirements that may include maintenance and implementation of standard operating procedures to comply with HC and FDA GMP/GLP requirements. • Improves the efficiency of QA activities while ensuring compliance with Cipher’s SOPs, Health Canada, and FDA GMP/GLP requirements. • Responsible for managing quality-related responsibilities with respect to change management, event management, product development, and approval process. • Leads investigations using root cause analysis tools with multi-functional groups, analyzes processes and systems, identify vulnerabilities/gaps/root cause, and where applicable, leads implementation activities. • Responsible for Quality approval of documents. • Performs on-site and off-site QA audits on external partners (domestic or international). • Responsible for monthly reporting of key quality indicators, KPIs, and trends for continuous improvement

University of Santo Tomas

Bachelor of Science (BS), Pharmacy