• Manage corporate document control department, supporting Toxicology and Biologics Testing Divisions overseeing more than 1300 SOPs and in excess of 900 controlled batch records• Responsible for GXP compliance of corporate archives and storage of regulated documents in excess of 1000 studies per month• Focus on process enhancements and procedures and continuous improvement• Responsible for regulatory compliance within the operational and support departments

o Oversight of compliance of cGMP laboratories with US and foreign regulationso Lead regulatory inspectionso Supported client submission filings and BioReliance US facility registrationso Managed the timely review of facility and utility monitoring records and supported data to assure completeness, traceability, accuracy, and compliance to cGMP requirementso Ensured quality standards were met and issues were resolved promptly and effectivelyo Provided review and input for generation of new or revised SOPs, Master Batch Records and other controlled documentationSpecial business improvement projects:o Serving as the QA delegate on a project to transition a Trackwise-based investigation process to SAPo Developed a harmonized quality agreement template for use at all BioReliance sites globallyo Represented QA on a cross-functional committee that developed a cross-contamination risk assessment and associated FMEAo Functioned as the BioReliance liaison to Sigma Aldrich training group, responsible for transition of paper-based training documentation to an electronic learning management system (eLMS)

• Evaluated the suitability of suppliers via audit and on-going quality management. Led internal audits of BioReliance’s quality systems and facility inspections of the laboratories, and supported areas in accordance with GxP regulations and established company policies and procedures.• Supervised and coordinated the execution of internal and external quality system audits. Determined compliance to GLP/GMP regulatory requirements during internal, facility and supplier audits by interpreting regulations against procedures and records. Performed SOP reviews, document reviews, generation of the audit reports, and follow-up of audit responses.• Scheduled and performed supplier qualification audits in accordance with established practices and procedures• Scheduled and hosted customer quality assurance audits of BioReliance laboratories and support areas. Coordinated with the operations group to prepare responses to customer audits.• Responsible for regulatory compliance within the operational and support departments• Ensured quality manual, drug master files and letters to regulatory agencies were developed and provided as required. Supported any BioReliance maintenance of an up-to-date CAPA database and supported closure of action items.• Supported client and regulatory audits, customer quality surveys, and responses to audit reports• Ensured harmonization of procedures throughout Biologics Testing operations and between the US and UK sites• Taught Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP) classes.

• Managed quality compliance within the operational and support departments• Authored and maintained cross-departmental standard operating procedures and supported individual groups in generating, updating and coordinating their SOPs, batch records, and other controlled templates• Maintained CAPA database and provided support for closure of action items• Participated in activities related to client and regulatory audits, customer quality surveys, and responses to audit reports• Trained and mentored quality system audit staff