PNI specializes in enabling mRNA development including both technology and parenteral formulation development and manufacturing process design and implementation at small, intermediate, and large/commercial scales. This enables the manufacturing of complex lipid-based formulations of therapeutic agents for preclinical and clinical testing as well as transfer of drug product manufacturing to both internal and external commercial facilities. We are currently in the process of developing the first Canadian mRNA Covid vaccine and building a state-of-the-art clinical/manufacturing facility.The Head of Quality is critical to helping PNI move from an R&D environment to a state-of-the-art GMP manufacturing operation. This role is as much about cultural transformation as it is about technical improvement and business growth, specifically building, leading, and engaging the entire PNI team along its quality evolution.The Head of Quality is responsible for developing and executing a quality assurance vision for PNI that incorporates best in class quality assurance standards, testing approaches, as well as purchasing strategies and frameworks. Unique to this role is the diversity of implementing one quality system to support:Establish departmental goals and effectively communicate direction, objectives, and results as needed to the department, plant site, and staff.Develop and actively manage team conformance to departmental budget and drive improved efficiencies in departmental operations.Develop, implement and continuously improve the quality system procedures that are effective and compliant to applicable standards.Establish cGMP training systems and perform on-site staff training.Ensure PNI meets business and customer requirements with respect to the development and transfer of testing methods for raw materials, in-process controls, and intermediate and final products.Complete new client questionnaires as required by the sales teams to support the development of new customer projects and products.Coordinate and host customer audits and develop audit responses as required by the respective auditing customer.Coordinate and host regulatory agency audits, coordinate follow-up communication and supervise necessary corrective actions on site.Ensure compliance with all commitments (to customers or authorities) in conjunction with regulatory approvals of products and processes.Establish and manage QA tracking and trending of essential performance measures and the preparation of periodic reports for management review.Chair the Management Review meetings.Qualifications and Experience:We will send you the most recent job openings picked directly from top job sites and company websites.
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