The Sr. GMP QA Specialist develops and maintains quality systems to meet US and EU requirements, including, but not limited to deviations, investigations, change controls, batch disposition, external and internal auditing, to support the Development Quality Organization and ensuring compliance to Good Manufacturing Practice (GMP). Provide support for review and approval of COAs, Change Controls, SOPs, and other GMP controlled documents as required.
Work with Clinical Trial Supplies and Global supply chain groups (US and UK sites) on a day-to-day basis to review and approve study supply strategy documents, packaging/labeling plans, label text, and participate in the resolution of packaging/labeling CMO operational issues.
Additionally, the Sr. GMP QA Specialist manages the compliance of secondary packaging and labeling CMO’s to ensure manufactured product meets GMP and Eisai requirements including writing and/or reviewing quality agreements, review and approval of CMO deviations, change controls and investigations, review and approval of all documentation covering packaging/labeling operations, track quality related issues, maintaining effective working relationships with multiple external partners, and participate in CMO business meetings as required
The ability to be an independent decision maker for assessing suitability for use of IMP/NIMP drug product for human clinical trials
Develop, implement and maintain processes and procedures to support quality systems specific to the DQA organization; Ensure processes and procedures are adhered to and consistent with GMPs as well as Eisai requirements
Write, review and implement Standard Operating Procedures (SOPs) to support CMO operations for labeling and packaging
Review and approve deviations, investigations, and change controls affecting both internal and externally approved process and products. Approve all appropriate documentation, corrective action recommendations and final actions
Review and evaluate existing Development Quality Systems for effectiveness and efficiency pertaining to the day to day function of CMO operations; seek and incorporate feedback from peers;
Review and approve study strategies, packaging/labeling plans, and label text, as well as participate in the resolution of packaging and labeling CMO operational issues.
Ensure CMO compliance to GMPs and Eisai expectations. Review and approve packaging/labeling CMO batch records
Support Internal / External Audit functions as required
• B.S./B.A. in Science related field (or equivalent)
• Minimum 3 years of drug/biotech experience
• Minimum 3 years of quality auditing in GLP, GMP and/or ICH/GCP environment
• Experience with Contact Manufacturing Organizations (CMO) relating to packaging/labeling of clinical trial materials preferred
• Knowledge and experience with all aspects of Quality System Management, lot disposition, deviation and investigations, CMC participation, training, and auditing
• Thorough working knowledge of regulated GMP systems