Mississauga Change Control Manager 1 ON

Job description

Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions. Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Position title: Supply and Audit Director Reports to: Quality Senior Director Position Summary: The Supply and Audit Director provides Quality Assurance leadership for GMP audit programs, supplier qualification, and regulatory inspections, ensuring compliance with Canadian regulations, cGMP requirements, FDA and European standards. The individual oversees risk-based audit strategies, auditor development, quality agreements, supplier performance, and quality system effectiveness to identify risks, drive continuous improvement, and maintain product quality and regulatory compliance. Position Objective: The Supply and Audit Director provides leadership and oversight for Quality Assurance (QA) GMP audit activities, including the development and maintenance of a risk-based audit program, as well as the training and ongoing development of GMP auditors within a matrix organization. This role is responsible for assessing and reporting GMP risks, quality trends, and the effectiveness of quality systems across Grifols Canada Plasma. As the primary Quality representative, the Supply and Audit Director supports and leads interactions during third-party audits and inspections conducted by Health Authorities. The role also evaluates critical suppliers in accordance with established procedures, using audit results and key performance indicators (KPIs) to assess cGMP compliance, product quality, and service performance. Through these activities, the position helps ensure continued supplier qualification, regulatory compliance, and overall quality excellence. Key Responsibilities: Develop, manage and oversee a global risk-based audit program to ensure effective QA oversight of Grifols Canadian Plasma GMP activities, internally and externally. Participate in execution of risk-based GMP internal and external audits for Grifols Canadian Plasma activities, following the audit plan. Lead the design and implementation of auditing and supplier qualification personnel training and development programs. Oversee and provide feedback to Quality Audit specialists to discuss findings, emerging risks and identify actions to address identified risks, ensuring formal feedback is provided to senior management on a regular basis. Provide quality direction in relation to regulatory updates as it impacts on the Grifols Canadian Plasma GMP audit program, ensuring continual compliance with policies and procedures. Participate in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements. Participate in and support Regulatory inspections and aspect of notified body audits, as well as other external audits. Establish an internal audit program to ensure that all areas in the company are in compliance with Canadian Regulation, cGMP requirements and in accordance with FDA and European standards, in order to ensure the quality and safety of final product according to the licenses approved by Health Authorities. Ensure that supplier change notifications assessed with the support of each related areas. Maintain and supervise Quality Agreements with critical suppliers. Site certification (operational license, GMP, IQPP,…), new or renewal, management. Required Skills, Qualifications and Experience: Bachelor ‘s Degree in Health-related Sciences, preferably in Pharmacy. Post-Graduate Certification in Quality Management. Proven experience in GMP auditing within a Pharmaceutical Company is preferred. Knowledge of GMP requirements preferred. Auditor certification. Typically requires a minimum of 10 years of general experience with 6 years performance quality audits in GMP environment within the pharmaceutical industry. Proficiency with computers using Microsoft Office. Organized and able to manage time effectively. Ability to work within a highly regulated, labor-intensive environment. Analytical and enquiring mind with the ability to interpret data and facts. Excellent oral and written communication skills to produce clear and concise factual findings and the ability to present effectively to groups. Effective organizational and planning skills with the ability to meet deadlines required. The salary range for this position is currently being assessed and will be disclosed upon completion of the compensation review process, in accordance with applicable transparency requirements. 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