Matthew Cousens, P.Eng Email & Phone Number

Hamilton, Ontario, Ca

San Diego, Ca, Us

• Balanced validation department workload based on client timelines and business needs between 2 direct reports and 9 indirect reports; mentored, coached, delegated, managed and provided personnel management guidance for direct reports • Provided technical oversight and decision-making for validation activities related to commercial and clinical-stage parenterals, on matters relating to validation, technical capabilities, personnel capacity and quality requirements• Led multiple cross-functional teams for time sensitive qualification of new & modified facility/equipment, including filling and capping lines, facility modifications, computer systems, testing equipment, bioreactors, smoke studies, media fills, autoclave cycle development, utilities (WFI, clean steam, purified water, HVAC) etc• Introduced Agile methodology to the site, via Jira Project Management, via the Validation department, resulting in improved resource planning, cross-functional coordination, activity prioritization and on-time delivery of qualified systems to the end-user• Revised the cleaning validation, autoclave load assessment, and parts washer / CIP programs to reflect current best practices• Led the investigation into biological indicator and media fill failures, and identified root causes & process improvements necessary to return the associated systems to compliance• Devised and managed multiple compliance and process improvements (e.g. pre-use glove qualification, master data management, validation techniques, quality metrics) resulting in fewer deviations, faster qualifications, and lower overhead costs

Oakville, Ontario, Ca

• Plan workload and distribute equitably to 6 direct reports; mentor, coach, train, manage and provide performance feedback for direct reports and implement Quality Assurance procedures as per regulatory/client/internal requirements • Host and lead customer auditing executions for client audits and regulatory health authority inspections; involve in auditing contract manufacturers against FDA, Health Canada, and other international regulatory requirements• Organize, schedule, and conduct internal audits for the various programs and departments to ensure client requirements (e.g., procedural steps, operational reports, and AE reporting, etc.) comply with company policies and procedures • Ensure program/department audits and internal process/system audits are scheduled in advance and reflected in the QA audit calendar; analyze and evaluate available data and prepare or review written reports of audit findings and observations• Conduct periodic Quality Management Review (QMR) meetings with Management Teams and related functional areas to review key quality metrics, discuss trends/issues, and coordinate quality improvement initiatives• Manage the controlled documents (Policies, SOPs, WIs, and Forms) request, review, and issuance workflow by actively liaising with each program/department management as assigned, and coordinating with the respective programs/department managers or designates to ensure the controlled documents are generated and finalized in a timely manner• Understand program/project roadmap, and key milestones regarding criticality, downstream impact if dates are missed and determine alternative/mitigating actions; lead the budgeting and capital goods acquisition for Quality Assurance department• Provide timely, concise communications to functional and executive leadership regarding project status and pending issues• Review quality data and determine if all products and processes are aligned with regulatory, internal, and customer specifications

Montréal, Québec, Ca

• Supported the validation and quality engineering of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas and assured the equipment/system and validation programs are compliant with the client's global/site standards and industry practice• Analyzed information, draw the right conclusions, and worked effectively with different groups across the site to determine status, gaps, and corrective actions• Revised and developed SOPs as required to assure that all needs are addressed, and compliance and industry standards are incorporated; carried out all aspects of a validation project for pharmaceutical, biopharmaceutical, and medical device manufacturing clients• Involved in screening and interviewing of candidates for employment as validation and compliance specialists• Performed equipment risk assessments to assess the impact of system functionality and control on product quality and troubleshoot equipment/system when errors occur to provide recommended corrective and/or preventive actions (CAPA) to the client• Monitored and managed validation projects budgets and progress and ensured that projects are implemented as per the agreed scope and timelines.• Authored the validation deliverables including VMP, URS, FAT, SAT, IQ, OQ, PQ, Traceability Matrix, Functional Risk Assessments, User Acceptance Test Design, and User Acceptance Test Cases• Maintained up-to-date knowledge of validation requirements, practices, and procedures and coach other members of the team participating in validation activities• Ensured compliance with current GP (Good Practices, e.g., GMP/GLP) regulations, guidelines within North America (Health Canada, US Food & Drug Administration)

Mississauga, Ontario, Ca

• Developed, implemented, maintained and continually assessed a regulatory and quality assurance function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements• Developed and maintained systems for procedures, work instructions, standard operating procedures (SOPs), and forms• Used incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and respond to process and service issues• Implemented performed and oversaw internal quality auditing (including applicable vendors or subcontractors), customer quality audit response, and other quality management system activities• Represented quality assurance function and quality management system and related processes in connection with internal or external audits, inspections, monitoring visits, and new business development, sales, activities, and assisted with quality-related information related to client assessments, RFPs, contracts, and other documentation• Managed multiple cross-functional teams, client resources, and direct reports to ensure successful completion of projects based on client timelines and budget• Mentored and trained supervisors, project leaders, associates, and coordinators on effective execution of work (OOS/production investigations, quality agreement negotiation, software operation, change controls, and metric reporting)• Maintained current knowledge base of regulations, corporate policies, and standards to ensure that the regulatory and quality assurance function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements

• Designed the implementation of a reduced testing program for APIs, excipients, and packaging components resulting in a time savings of 20,000 lab hours per year• Involved in the creation and negotiation of quality agreements with third parties, including manufacturers, packagers, raw material suppliers, contract labs, and sterilization service providers• Developed key performance and quality metrics related to personnel, supplier, and quality system performance• Developed quality systems, including Validation Master Plans, IQ/OQ/PQ and validation protocols, SOPs and associated documentation, for compliance to the drug, NHP, Dietary supplement, and medical device cGMPs and business requirements

• Managed qualification and validation activities to ensure new equipment was commissioned on schedule• Implemented innovative data analysis procedure to determine the root cause of EM program failures, resulting in a 70% decrease in excursions