Chemistry, Manufacturing and Control (CMC)
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.
Contract Manufacturing Operations (CMO) Management
Work closely with CMO partners to collaboratively direct manufacturing, QC testing and disposition of product. Manage CMO 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 CMOs. 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.
Vendor Qualification Programs
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.
Essential Document Skills
Essential Skills in document management systems, ensuring robust document repository, SOP initiation and approval, retrievability of documents for ease of submission updates. Software management, Share Point, Egnyte, Drop Box, Box, Share file, e-rooms, electronic signatures.