Quality Assurance Consultant

Provides expertise and guidance in interpreting existing and emerging governmental regulations, agency guidelines and internal policies to assure compliance

Establish quality systems for start-up pharmaceutical companies

Develop quality agreements for specified suppliers and CMOS

Establish supplier/vendor qualification program for CMOs,

Perform batch records reviews and approve drug substance, drug product release/disposition, contractor manufacturing labeling, and packaging documents,

Develop and manage audit programs and perform audits of suppliers, contractors, GMP and GLP study reports, and regulatory documents, communicate evaluations to management, monitor follow-up action

Review and approve primary component specifications and their sampling and inspection requirements

Provide QA representation, guidance, leadership, and direction to CMO’s, process development, analytical development, and external operations teams for biologics drug substance and drug product in commercial environments

Lead/support investigations associated with major deviations, non-conformance, change control, and CAPA

Manage quality metrics reporting