Senior Specialist - Research Laboratory Quality Systems
by Sidra Medicine in Healthcare & Medical Services
The Senior Specialist - Research Laboratory Quality Systems reports to the Executive Director of Core Facilities and is responsible for developing, implementing, and maintaining an integrated Quality Management System across multiple research core facilities. The role ensures compliance with ISO 9001, ISO 17025, ISO 15189, ISO 20387, CAP, GLP, ISO 19011, and ISO 31000 standards while adhering to corporate GREC requirements. The position implements and maintains the integrated Quality Management System (QMS) across research core facilities and keeps day-to-day laboratory operations aligned with ISO 9001, ISO 15189, ISO 17025, ISO 20387, CAP, and GLP requirements, as applicable. The role tracks and version-controls the QMS documentation set for each core, including Quality Manuals, SOPs, work instructions, forms, and records, and reviews and harmonizes end-user and laboratory documentation across cores for accuracy and compliance. It maintains personnel competency, training, and proficiency records and tracks CPD and CME attainment against an annual training plan. The position runs routine quality controls, internal quality assurance, external quality assessment, proficiency testing, and measurement-uncertainty records as required by ISO 15189, ISO 17025, and CAP. It maintains equipment calibration, maintenance, qualification (IQ/OQ), and environmental monitoring records while coordinating with biomedical engineering, procurement, and vendors. The role processes non-conformances and CAPA, logs and responds to customer complaints and feedback, and tracks continuous-improvement actions across the cores. It applies ISO 20387 controls for biobanking operations, including specimen traceability, chain of custody, storage conditions, and handling. It maintains the quality risk register using ISO 31000 and compiles quality metrics, audit results, and KPIs to support the management review led by the Executive Director. The position keeps core facilities inspection-ready and coordinates the internal audit program and external accreditation activities for laboratory standards including CAP, ISO 15189, ISO 17025, and ISO 20387, separate from hospital-wide accreditation. It plans and conducts the internal audit schedule across the cores following ISO 19011, ensuring auditor independence, documenting findings, and monitoring corrective actions through to closure against CAP checklists and GLP principles. It maintains continuous readiness for certification, accreditation, and regulatory inspection by keeping documentation and document control current. It acts as the coordination point with external audit and certification bodies, prepares cores for on-site assessments, and tracks accreditation status, fee payments, and required submissions. It qualifies and monitors external laboratories, reagent suppliers, and equipment vendors against applicable standards, including ISO 20387 for biobanking providers. It maintains core-facility emergency and continuity procedures and aligns quality procedures with Health and Safety and biosafety requirements alongside the Laboratory Biological Safety Officer and Facility Safety Officer. The role ensures confidentiality is maintained at all times, including business sensitivity, personnel information, and patient confidentiality. It provides regular reporting to Core Facilities leadership regarding quality system performance, compliance status across all applicable standards, audit findings, CAPA effectiveness, accreditation status, customer satisfaction metrics, risk assessments, and quality improvements. The role also ensures records and documents are controlled and well organized, adheres to Sidra’s standards as they appear in the Code of Conduct and Conflict of Interest policies, and adheres to and promotes Sidra’s Values. The position may be required to perform other duties as assigned and reporting relationships may vary in view of the evolving needs and opportunities within Sidra. Essential qualifications include a Bachelor’s degree in Biomedical Sciences, Engineering, or a related field, 7+ years of experience in the relevant field, and formal training or certification in Quality Management Systems or other Quality standard including Auditing. Exceptions to the experience requirement may be granted for Qatari nationals, with a reduction of up to two years, while DHP licensable roles must strictly follow Department of Healthcare Professions experience requirements and defined scope of practice. Preferred qualifications include a Master’s Degree in a related field, the last 7 years of related professional experience, preferred certification with a 3rd party certification body for ISO9001, ISO 19011, ISO 14001, or ISO17025, eligibility for the International Register of Certificated Auditors (CQI/IRCA), Arabic speaking ability, and proficiency with Microsoft Office suite. The role requires strong understanding of healthcare and quality, excellent communication and interpersonal skills, strong cultural intelligence and teamwork competencies, ability to keep and retrieve records, and fluency in written and spoken English.
