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Job #03281

About our client Our client’s expertise is in manufacturing and marketing generic pharmaceutical products. They are into over-the-counter and prescription products. They have offices in Israel, Canada and the US. Since 1984, our client's Canadian office has manufactured and marketed high-quality medications sold by prescription and available over-the-counter across the world. They produce two-thirds of our client's global volume and boast the largest topical product R&D Team in Canada. Due to expansion, they are seeking a VP of Quality Assurance to head up their quality division. This is an executive role that will direct the company's quality management program including implementation and maintenance of the quality management principles and tools to promote continuous improvement of systems, product and service quality. The candidate will lead the oversight and integrity of Quality Assurance, Quality Control and Compliance for the company. Position Location Vice President of Quality Assurance GTA, Ontario Salary Highly competitive package, commensurate with experience Responsibilities 1) Establish and drive product quality as well as compliance strategies 2) Ensure quality compliance at the Canadian manufacturing site 3) Lead, mentor, and develop the Quality organization 4) Liaise with the company, its customers, and various governmental agencies 5) Provide global vision and leadership for the Quality organization as well as determine quality objectives and link those objectives to the manufacturing site and corporate objectives 6) Develop, establish, and maintain QA programs, policies, processes, procedures, and controls 7) Ensure that performance and quality of products conform to the established company and governmental regulatory standards as well as agency guidelines and customer satisfaction 8) Maintain compliance with corporate Quality Management System 9) Ensure effective quality processes are maintained including procedures, documentation systems, tools, metrics, and measurable improvements that are required to meet the quality system standards 10) Manage and maintain effectiveness of the Quality Management System 11) Represent the site to outside regulatory bodies 12) Provide a monthly report summarizing trend analysis on the defined and applicable quality system as well as corresponding quality objectives 13) Facilitate the awareness of regulatory and customer requirements throughout the organization 14) Create and effectively communicate regulations/standards 15) Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to ensure compliance as well as assist the organization in driving the implementation of standards 16) Determine and establish assigned Quality organizational structure and supervisory relationships with direction and support from the US office 17) Collaborate with multiple cross-functional teams to ensure achievement of the standards and regulations during product development and commercialization activities 18) Establish goals to improve efficiency and output 19) Propose and execute initiatives to optimize resource utilization 20) Ensure that operations are as per FDA and Health Canada standards and maintain associated certifications as well as positive audit results 21) Provide supervision to internal and external audits, CAPA, proper document, and record control 22) Review key investigations for non-conforming products, materials, and components 23) Coach, develop, and mentor quality department employees 24) Allocate internal and external resources (as required) 25) Manage employee-related activities (hiring, training, performance management, recognition, and motivation) Requirements 1) BS/BA in a scientific discipline (Master’s or Ph. D. preferred) 2) Minimum 15 years of quality management experience in the pharmaceutical industry 3) Extensive knowledge of FDA, cGMPs, ICH guidelines, and Canada Health regulations 4) Knowledge of post-marketing complaint handling, reporting, field corrections, CAPA, change controls, investigations, and quality metrics 5) Demonstrated record of achievement in managing quality systems and organizations as well as success in commercializing products on-time and within budget 6) Proven ability to devise strategy and execute effectively 7) Commitment to organizational goals and to escalating unresolved issues or concerns regarding product quality 8) Ability to effectively lead and manage, maximize employee performance, provide recognition, constructive feedback, and build cooperation 9) Ability to multi-task with excellent organizational, communication (written and oral), and decision-making skills as well as follow-up practices 10) Ability to give clear direction and communicate effectively with all levels of management and employees 11) Strong focus on flexibility and attention to detail