§ Development of GXP (GLP, GMP, GCP) Quality systems consistent with FDA, EMA & ICH Guidelines. 21 CFR Parts 210, 211, 820 & 312. ICH guidelines, EU Directives and other global regulatory requirements
§ Participate and crucial experience ensuring compliance with regulatory requirements from early clinical development – Phase III and commercialization
§ Significant expertise in development and management of operations through CDMO contractors
§ Vendor audit capabilities ensuring vendor qualification
§ Able to work with facility design from concept through validation of systems, (H20, HVAC, Compressed Air, Analytical set up) creating a customer ready audit package
§ Support for Quality Control (QC) microbiology requirements throughout the manufacturing process. From the start of the development process through completion of drug product fill and stability study management
§ Participate in the development of required process, testing and vendor audit for biologics or small molecule products from early clinical phase through commercialization
§ Ensure products and product development are produced consistently with global GxP regulatory expectations. Key expertise with working with CDMO operations
§ Aseptic Processing
§ Able to create and support start to finish document control. Including set up of SharePoint document meta data tracking
§ Create, implement and manage document control ensuring SOP writing, approval and training
§ Start to finish document management software, with full Part 11 validation GxP services to the Biologics and Pharmaceutical Industry
§ Ensure 100% retrievability of essential documents to support product development through commercialization
§ Implement and validate electronic software to create paperless document management
§ Work with Development CMC teams managing QA functions to ensure process development, analytical validation, method development and cGMPs are adhered to while also meeting timelines, budget allowances and appropriate early to late stage clinical trial supplies
§ Work closely with CDMO partners to collaboratively direct manufacturing, QC testing and disposition of product. Manage CDMO deviations, change controls, investigations, OOS events. Stage product and work with Quality Person (QP) for EU disposition of product
§ Ensure labeling, packaging and product disposition is conducted in controlled batch record approved CDMOs. Work with Clients to ensure serialization for track and trace is implemented
§ Work with Clinical groups to ensure GCP regulations are adhered too, that product is appropriately staged for shipment to clinical settings. Manage GCP compliance during the clinical phase. Work as clinical support as QA un-blinded representative
§ Ensuring Vendor Qualification whether quality questionnaire, on-site audits, for-cause audits or staging for PAI readiness is conducted appropriately meeting industry requirements. Work cohesively to ensure quality agreement approval
