Location: St. John's, Newfoundland and Labrador, Canada
Type: Full Time
Salary: ($68,450 - $88,984 per annum)
SalaryHL-21 ($68,450 - $88,984 per annum)
Internal Number: 2022005413
Job Summary Reporting to the Radiopharmaceutical Sciences Manager, the Radiopharmacy Quality Assurance Manager is accountable for the comprehensive Quality Management Program within the Radiopharmaceutical Sciences (RPS). The Quality Assurance Manager is responsible for obtaining and maintaining a Drug Establishment Licence (DEL) and assisting in the generation of Clinical Trial Applications (CTA). This includes a radiopharmaceutical production program that meets Health Canada Good Manufacturing Practices (GMP) and staff safety program that meets Occupational Health & Safety, Radiation Safety, in conjunction with the Radiation Safety Officer and other applicable standards. The position is responsible for developing, implementing and auditing compliance with required production and quality control activities for the cyclotron, automated production equipment and analytical quality control instruments within Health Canada and Canadian Nuclear Safety Commission (CNSC) Standards. The position is also tasked with developing, reviewing, and maintaining policies, procedures, safety manuals and safe work practices, developing and maintaining an electronic Quality Management System and providing an education program to RPS staff. The position is also responsible for process improvement such as, root cause analysis, corrective and preventive action, out of specification investigations and follow-up and related activities.
The Quality Assurance manager collaborates with the transfer, development, validation, and routine application of methods for physical and chemical characterization of small and large molecule drug substances and drug products and ensures that methods are suitable for routine quality control and in compliance with Good Manufacturing Practices (GMP) for both investigational and clinical products.
- The Quality Assurance manager is responsible for ensuring that all performance targets and regulatory obligations to support compliance and reliability of operations and manufactured products are met under the Health Canada GMP requirements for sterile pharmaceuticals and the Annex to the GMPs for Positron Emitting Radiopharmaceuticals (PERs). - Applying a full working level of knowledge in Quality Assurance, Quality Control and Quality Management System procedures, this position is responsible for quality oversight of the entire radiopharmaceutical production facility including new and existing drug products. - The Quality Assurance manager will perform review of critical project documentation including validation protocols, standard operating procedures, user requirements, design reviews and provide GMP guidance to for routine clinical manufacturing and research & development. - Maintain a working understanding of appropriate regulatory guidance, international pharmacopeias, ICH, established business processes and protocols, and applicable standard operating procedures. - Monitor progress and ensure timely completion of investigations, non-conformances, CAPAs, and change controls. - Ensure that routine quality operations including installation/calibration/maintenance of equipment, reagent inventory, and facility housekeeping are properly maintained as well as installation/calibration/maintenance of equipment, reagent inventory, and facility housekeeping. - Provide leadership, technical guidance, supervision, and hands-on support to ensure successful translation of diagnostic and therapeutic radiopharmaceuticals as well as Day-to-day coordination and schedule of activities of assigned analysts/technologist to ensure all required daily testing is completed for pre-clinical and clinical materials.
Primarily, this position involves fostering a culture of continuous quality improvement and safety by ensuring compliance with all Health Canada (GMP), radiation (CNSC) and chemical (WHMIS) requirements and safety standards as well as occupational health & safety regulations/guidelines thus ensuring that safety for patients, residents, clients and staff is paramount in the workplace.
Job Qualifications - Bachelor's degree with a specialization in Microbiology, Chemistry, Biological Chemistry, Biotechnology, Engineering, or a related field is required. - Strong project management skills and excellent organizational skills with the ability to work independently and within a team is required. - Excellent communication skills (written and verbal) and technical writing skills is required. - Pharmaceutical Regulatory Affairs or Quality Systems diploma is an asset. - Experience in analytical techniques for chemical testing (e.g. HPLC, GC, TLC, wet chemistry, etc.) and microbiological testing (Bacterial Endotoxins, sterility, etc.), as well as material characterization is an asset. - Training and experience in radiopharmaceutical process and quality management is an asset. - Direct hands-on laboratory experience in pharma/biotech manufacturing organizations, performing method development, validation and quality control tasks is an asset.
Experience - 3 years of laboratory experience in manufacturing organizations, performing method development, validation and/or quality control analysis; preferably, in a GMP environment. - 3-5 years of experience within quality management, ideally working in a radiopharmaceutical, pharmaceutical or related GMP environment, is an asset. - Management experience is an asset.
Competencies (Knowledge, Skills & Abilities) Knowledge of good manufacturing practice guidelines, quality management and process improvement systems/tools, accreditation, and document control. Knowledge of policy development, research, and project management. Demonstrated knowledge and proficiency in the Microsoft Office Suite of applications. Exhibited leadership abilities, interpersonal and teambuilding skills. Demonstrated ability to function in a high-pressure, diverse, and changing environment. Ability to foster positive working relationships with individuals and groups, and other stakeholders at all levels of the organization. Demonstrated fiscal and resource stewardship.
Other Current or eligible for registration with Regulatory Affairs Certificate (RAC) or Canadian Association of Professionals in Regulatory Affairs (CAPRA) is an asset A satisfactory record of work performance and attendance is required.
Eastern Health is the largest, integrated health authority in Newfoundland and Labrador employing approximately 13,000 dedicated employees and serving a population of more than 300,000 people. The authority offers the full continuum of health and community services including public health, long-term care, community services, hospital care and unique provincial programs and services. At Eastern Health we pride ourselves on providing the highest quality care and service possible to the people in our communities, in our region, and in the province. To do that, we employ qualified, competent and caring individuals who are dedicated to their professions and to our vision of Healthy People, Healthy Communities.