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.
• 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.
• 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.
• 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.
• 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

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.
• 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.
• 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.
• 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.
• 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.

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.
• 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.
• 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.
• Monitored and managed validation projects budgets and progress and ensured that projects are implemented as per the agreed scope and timelines.

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.
• 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.
• Managed multiple cross-functional teams, client resources, and direct reports to ensure successful completion of projects based on client timelines and budget

• 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.

• 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