Responsible for organizational quality, regulatory and compliance program. Maintain working knowledge of applicable regulations for the application of development, implementation, ensuring adherence to company policies, standard operating procedures, compliance tools, Working Instruction Documents (WID) and local requirements and regulations. Provide training and supervision to direct reports. Direct communications with governmental agencies (e.g. FDA, NRC, DEA. Review and support submissions of Investigational New Drug applications, clinical trial protocols prior to submission. Identify gaps and implement process improvement initiatives in collaboration with team to optimize existing SOP/WID’s. Review and approve procedures, protocols, reports, and other GXP documents. Oversight for companywide Quality Management System (QMS). Review and approve responses to regulatory inspections and client audits. Manage regulatory inspections and client audits, and responses to observations from these inspections/audits until their final resolution, and maintain all records and reports, including CAPAs and resolution reports. Other duties as assigned by the General Manager, US or VP, Quality Assurance.

• Generate and maintain all aspects of the quality program as required by cGMPs and FDA guidelines• Ensure quality testing is in compliance with current regulatory requirements• Serve as document control supervisor• Responsible for administering, updating, maintaining, and documenting Excite’s training program and ensuring all personnel have had the appropriate training according to their job duties• Periodically perform internal audits of internal practices and procedures as they apply to cGMP compliance and internal SOP requirements• Oversee the quality aspects of manufacturing- including batch record conformance to requirements, cleaning procedures are in place, etc.• Liaison for government and client inspections• Participate in annual Management Reviews• Support the validation of processes including approval of sampling protocols, process protocols, and reports• Support the qualification of rooms and equipment including approval of user requirements, protocols, and reports• Oversee the Vendor Qualification process, including conducting on-site audits if needed• Monitor the Quality Management System for trends and provide necessary changes for continual improvement and compliance• Review and approve investigations and deviations as necessary• Disposition of finished product• Coordinate and oversee complaint investigations• Responsible for the management of the QC laboratory• Draft and negotiate quality agreements• Serve as a member of the executive management committee to determine policy, create plans to address current and future business needs or issues, and provide overall guidance to the company

• Generate and maintain all aspects of the quality program as required by ISO, cGMP, and FDA guidelines• Develop and maintain specifications for raw materials and raw material suppliers• Establish quality parameters and specifications for in-process and finished products and packaging• Ensure all quality testing is in compliance with current regulatory requirements• Perform and/or review quality assurance tests on raw materials, in-process, finished products, and packaging where applicable• Serve as document control manager, including maintenance of current and archived controlled documents, issuance of controlled documents, and management of document change requests• Generate Certificates of Analysis for finished goods• Management representative for ISO• Responsible for administering, updating, maintaining, and documenting Ioditech’s training program and ensuring all personnel have had the appropriate training according to their job duties• Periodically perform internal audits of internal practices and procedures as they apply to cGMP compliance and ISO certification

• Serve as the focal point for ce2l quality control (QC) and quality assurance (QA) program and be responsible for the oversight of QC/QA activities. This includes implementing, maintaining, and improving the quality system:• Ensuring all personnel understand their contributions to the quality system;• Ensuring communication takes place at all levels within the laboratory regarding the effectiveness of the quality system.• Evaluating the effectiveness of training;• Developing and updating a comprehensive quality assurance manual (QAM) for the laboratory;• Preparation, review, and/or approval of laboratory Standard Operating Procedures (SOPs);• Coordinating laboratory accreditation activities;• Coordinating external audits;• Assessing the adequacy of quality control (QC) activities within the laboratory and keeping managers informed of their effectiveness;• Validating laboratory generated data with respect to established QC criteria; and to provide training for data review personnel;• Performing or coordinating internal technical and system audits;• Preparing annual reports to management;• Coordinating the analysis of performance testing (PT) samples and communicating PT sample results to appropriate laboratory staff; and initiating/coordinating associated corrective action efforts;• Communicating corrective action reports to regulatory agencies;• Performing secondary or final reviews of data, when required;• Coordinating and/or assisting clients in the preparation and approval of Quality Assurance Project Plans (QAPPs); and • Identifying staff training needs.• Using available tools, such as audit and surveillance results, control charts, proficiency testing results, data analysis, corrective and preventative actions, customer feedback, and management reviews in efforts to monitor trends and continually improve the quality system.

Coordinate with vendors any quality related activities such as changes to methods, specifications, batch records, protocols, and method transfers, etc.Support the validation of processes including approval of sampling protocols, process protocols, and reportsManage change controls including QA evaluation and approval, approval/ rejection of vendor change controls, monitoring completion of action items, and routing for final approvalParticipate in FDA inspectionsParticipate in global health authority inspections at vendorPerform batch record reviewApprove Master Batch RecordsDisposition finished product for multiple regions and countries, including evaluation of compliance with specifications and regulatory requirementsDevelop scope, conduct audit, write reports, approve corrective action plans for internal auditsDevelop agendas, conduct GMP audit, write reports, approve corrective action plans for external auditsCoordinate and oversee complaint investigations including approval of vendor investigations and communications with the complainantReview and approve investigations and deviations as necessaryAuthor and review SOPsParticipate in cross functional teams for US, EU, and international submissions such as CMC section of NDA and dossiers, CBE30, and responses to questions Generate, review, and approve specifications, methods, transfer validation protocols and reportsManage stability testing including selection of the lot, coordination of the pull, approval of protocols, and evaluating and trending resultsManage reserve sample program including determination of required amount and review of annual examination reportsAuthor Annual Product Quality Reviews including compilation of data and results, evaluation of results, determination of corrective actionsDevelop and maintain product technical filesDraft and negotiate Quality AgreementsManage and train contract staff

Review and approve non-conformance/ deviation reportsPerform root cause analysisResponsible for the Corrective and Preventive Action program and related processes and the implementation of a coordinated approach to systems improvementAssure that corrective and preventive actions are completed as requiredResponsible for the maintenance of databasesResponsible for trend analysis including evaluation of effectiveness, report generation, and participation in monthly meetings with various functional groupsParticipate in client and internal audits as necessaryParticipate in global quality teams as necessaryPerform external audits as required

Perform batch record review and finished product release dispositions, including accept/reject decisionsPerform dispositions of incoming drug substances, raw materials, components, and in-process materials and finished drug productPerform internal and external audits including developing scope, conducting audit, writing reports, and approving corrective action plansAuthor annual product reviews including compilation of data and results, evaluation of results, determination of corrective actionsResponsible for cGMP complianceParticipate in FDA inspectionsEnsure compliance with policies and proceduresPerform and/or review/approve investigations/deviationsConduct CAPA investigations including root cause analysis, evaluation of effectiveness, and conclusionsResponsible for conducting product complaint investigations and handling of returned goodsParticipate in vendor and supplier certificationOversee personnel training, label control, and retain programQA liaison for manufacturing and packaging operations to assist in resolving processing difficulties, documentation issues, and cGMP complianceSupervision of assigned personnel

Conduct qualification of cleaning processes, equipment, facilities, lab instruments, and computer systems Conduct process validation for products manufactured by Martec Conduct change controls of qualified equipment Implement, review, and update SOPs governing validation Implement, review, and update master validation plans Coordinate the environmental monitoring activities Manage contract validation personnel Participate in FDA inspections

Determine case report form requirements in accordance with study protocol, project plan, and guidance from PRA and clientDevelop data management plan by providing professional input and drafting sections as assignedParticipate in the validation of the clinical databaseProcess and review CRF dataGenerate and resolve queriesPerform and document quality control tasks of data reviews and DCF replies

Assure the quality of products by monitoring compliance with global, site, and unit guidelines Provide quality perspective to the technology transfer and development of new products at the KC SiteInvestigation of customer complaintsDevelop and conduct trainingReview and approve procedures and change control documentationPerform and/or review/approve investigations/deviations Conduct internal and external auditsSupport the qualification of equipment and validation of processesParticipate in cross functional teams for FDA submissions such as CMC section of NDA, CBE30, and responses to questionsProvide support to a third party manufacturer of in-process materials including review and approval of validation protocols and deviationsWork with planning, purchasing, manufacturing, and technology to carry out daily activities such as batch release, problem resolution, cGMP compliance, document review, and approval of batch deviations

• Investigate and resolve production problems, characterize raw materials, respond to customer complaint samples• Responsible for the safety training for the laboratory associates as the Chemical Hygiene Officer in 2001

Perform release testing on routine production and stability samples and enter the data into the SQL-LIMS systemPerform review of laboratory documentation including hardcopy data and data entered into SQL-LIMS Coordinate with manufacturing the swabbing and testing of samples after equipment cleans

Perform generic and failure analyses on coatings using FTIR microscopyPerform elemental analysis on paint chips