Ensure quality assurance on a strategic level to maintain compliance with ISO 13485.  Review and approve relevant quality system documents Review and approve change requests Review and approve quality records e.g. qualification and validation documents Ensure an appropriate audit program is implemented and maintained Oriel STAT A MATRIX Exemplar Global Certified Qualified Lead Auditor: ISO 9001:2015, inclusive of ISO13485:2016.  Lead the front room and manage the back room with requests of regulatory authorities during inspections and inspections of contract service providers Ensure that developed procedures and specifications are appropriate and followed, including those used by firms under contract to the manufacturer Identify and/or assist in the resolution of potential or existing quality issues that may jeopardize cGXP compliance or regulatory position Review and determine the acceptability of non-conformances and proposed corrective and preventive action plans for product Training of new personnel in both general and specific QA processes Participate in assessing the effectiveness of the quality management system as well as process performance and product quality Ensure continual improvement Ensure risk management procedures are in place Maintain company quality and safety standards

Ensure quality assurance on a strategic level to maintain compliance with ISO 9001, including business development. Assume overall responsibility for Quality Assurance and Quality Control teams and ensure that resource and training requirements are met. Review and approve relevant quality system documentation such as change controls, CAPAs, change requests, qualification protocols, validation protocols, deviations, and product specifications.  Sets objectives to align with broader organizational goals, and breaks down the objectives into appropriate initiatives and milestones. Responsible for assessing the effectiveness and continual improvement of the Quality Management System as well as process performance and product quality. Assist in the coordination and compliance with requests of regulatory authorities during inspections and inspections of contract service providers. Ensure Risk Management and Audit programs are implemented and effective. Identify and assist in the resolution of potential or existing quality issues that may jeopardize cGXP compliance or regulatory position. Ensure that developed procedures and specifications are appropriate and followed, including those used by firms under contract to the manufacturer.  Ensure comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and GMP test laboratories. Responsible for Quality Management Review and the reporting/trending of quality metrics.

 Manage and monitor quality assurance systems, processes and facilities by ensuring regulatory compliance in the manufacture of mammalian cell culture products. Manage and monitor training program by ensuring training requirements for employees align with established training curricula and support job descriptions. Ensure comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and GMP test laboratories relating to raw material, in-process and product release. Manage and monitor final batch disposition of manufactured products. Participate in investigations and corrective action identification and implementation process for OOS, OOT and Exceptions. Manage review of various validation and technical documents to comply with regulatory requirements. Manage and monitor on-time closure of corrective action/preventive action items. Implement GMP training program for company employees, in collaboration with the Training department. Manage the activities of direct reports in the conduct of their duties. Maintain trending program for quality metrics including CAPA and PPQE. Facilitate periodic Quality Management Review (QMR) meetings.

 Manage and monitor quality assurance systems, processes and facilities by ensuring regulatory compliance in the manufacture of medical device. Manage and monitor training program by ensuring training requirements for employees align with established training curricula and support job descriptions. Ensure comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and GMP test laboratories relating to raw material, in-process and product release. Manage and monitor final batch disposition of manufactured products. Participate in investigations and corrective action identification and implementation process for OOS, OOT and Exceptions. Manage review of various validation and technical documents to comply with regulatory requirements.

 Review documentation for accuracy and compliance to procedures. Maintain quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products. Review and approve SOPs, change management requests and change controls for quality impact and compliance. Review and approve item masters and product specifications. Perform technical and administrative review of batch and analytical data for accuracy and compliance to procedures for raw material, in-process, and product release. Review and approve QC product testing documentation supporting batch release. Perform and manage exception report, corrective and preventive action, and batch record review. Review and approve level II exception reports. Perform and document CAPA effectiveness checks. Participate in internal and external audits. Track and trend quality metrics, CAPA, PPQE.

 Log test results, complete lab submission forms, post requests to contractor site, and forward request to third party labs.  Complete results entry step in AdminLIMS for physical, dimensional, and analytical results. Compile lot data package, provide initial technical review of data, and collaborate with GPTD final reviewer/verifier. Change Initiator and Executer for change controls in the Trackwise system and Lead Investigator with Root Cause Analysis training for any events. Technical contact for GPTD engineers for specification migration from Penguin to Regulus.  Key technical contact between GPTD and incoming QC labs for packaging components.  Support packaging-related data management and GPTD laboratory initiatives as necessary.

 Management and oversight of Quality Assurance – Exubera Device Packaging Operations for GLP, GMP, FDA and ISO 13485 compliance. Acted as final release authority of all incoming and finished good lots of Exubera Inhalers, Chambers, and Insulin Release Units. Served as the main contact in Quality Assurance within Terre Haute operations and with our contract manufacturers and clinical operations. Exubera Product Complaint Investigations. Authored and revised numerous SOPs, Protocols, Quality Agreements, and Quality Action Reports with Corrective and Preventive Actions. Production Order and Batch Record Review and Approval. Participated in FDA and ISO audits as subject matter expert for Quality. Performed various duties on lot management systems (AS400, MAPS, LRS, LIMS, RCS) such as initiating and coordinating testing of all the medical devices, data verification, stage approval, and status disposition.