Melanie Little

Oversee quality organization, including the setting of quality goals and managing and improving all aspects of the quality system and product quality. Develop, implement, manage, audit and maintain GMP quality systems to support commercial and development activities for the Company.

Responsibilities include: • Plans, schedules, coordinates and conducts client audits. Records findings to prepare responses. • Assures the competence of client audit team members including subject matter experts, selects appropriate audit support teams and assigns roles and responsibilities, trains staff including subject matter experts to conduct or assist with audits. • Responds to questions and information requests from clients and regulatory authorities, completes questionnaires, tracks client quality agreement status and maintains audit program records. • Initiates CAPA in response to client and regulatory audit observations and conducts periodic follow-up with responsible parties. Drafts the overall audit response for review by management. • Leads in the development of a site-wide climate of quality and safety • Participates on process improvement projects, mock audits and investigations. • Acts as a company auditing resource when required. • Monitors the performance and effectiveness of the quality support activities for client services. • Prepares reports on KPIs and CAPA status based on the overall achievements of the audit program • Ensures compliance to all regulatory, compendial, internal and client-specific requirements.

Responsible for Release of Finished Drug Product (CTM and Commercial), Manage Manufacturing and Packaging issues, Responsible for Drug Product Shipments, Raw Materials, API, Component, Labeling and Cleaning Verification Releases, Change Control, Deviations, CAPA, Approve Annual Product Review, Customer Complaints and CTM Investigations. Support release process for EU criteria. Host onsite client audits. Assist with FDA inspections.