Reporting to the Radiopharmaceutical Sciences Manager, the Radiopharmacy Quality Manager is accountable for a comprehensive Quality Management Program within the Radiopharmaceutical Sciences Section of the Diagnostic Imaging Program. The position closely liaises with the Manager, Radiochemist, Lead Radiopharmacy Technologist, Cyclotron Engineer, Radiation Safety Officer and technical staff of the Radiopharmaceutical Sciences Program as well as regulatory agencies and accreditation bodies.
The Manager is accountable for developing, implementing, maintaining, reviewing and monitoring the Radiopharmaceutical Sciences Quality Program including obtaining and maintaining a Drug Establishment Licence (DEL). This includes a radiopharmaceutical production program that meets Health Canada Good Manufacturing Practices (GMP) and a staff safety program that meets Radiation Safety, Occupational Health & Safety 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; developing, reviewing and maintaining policies, procedures, safety manuals and safe work practices; developing and maintaining an electronic Quality Management System; maintaining WHMIS information and providing an annual education program to RPS staff. The position is also responsible for process improvement, root cause analysis, corrective and preventive action, out of specification investigations and follow-up and related activities.
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.
By applying for this job, you acknowledge an understanding that regular requirements and demands of this job include (but are not limited to):
Occasionally moves or lifts objects between 1- 5 lbs. such as pens, paper, file folders, or boxes. Constantly sits at a desk performing paper/computer work, answering a telephone or emails; occasionally walks or stands to observe or to consult with other staff or sits conducting interviews. Regularly performs fine finger/precision computer work requiring steadiness and accurate movement/control. Visual and hearing concentration is required to observe or consult with staff, to work on documents or to listen to staff on the telephone or in person.
Bachelor’s degree with a specialization in microbiology or a related field is required.
Pharmaceutical Regulatory Affairs or Quality Systems diploma is required.
Training and experience in radiopharmaceutical process and quality management is an asset.
Three years of experience within the last five in quality management is required, ideally working in a radiopharmaceutical, pharmaceutical or related manufacturing GMP environment.
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.
Current or eligible for registration with Regulatory Affairs Certificate (RAC) or Canadian Association of Professionals in Regulatory Affairs (CAPRA)
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 Hea...lth 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.