Senior Specialist - Research Laboratory Quality Systems

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. This 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. Key responsibilities include developing Quality Manuals, annual reports, quarterly reviews, managing documentation, conducting internal audits, ensuring regulatory compliance, driving continuous improvement, managing risk, participating in corporate policy committees, and serving as a collaborative partner with the cores’ end users to ensure harmonized quality practices and to meet stakeholder expectations across all facilities. 

Laboratory Quality Management System Implementation and Maintenance

• Implements and maintains the integrated Quality Management System (QMS) across the research core facilities under the direction of the Executive Director of Core Facilities, keeping day-to-day laboratory operations aligned with ISO 9001, ISO 15189, ISO 17025, ISO 20387, CAP, and GLP requirements, as applicable.

• Tracks and version-controls the QMS documentation set for each core (Quality Manuals, SOPs, work instructions, forms, and records), and reviews and harmonizes end-user and laboratory documentation across cores for accuracy and compliance.

• Maintains personnel competency, training, and proficiency records, and tracks CPD and CME attainment against an annual training plan.

• 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.

• Maintains equipment calibration, maintenance, qualification (IQ/OQ), and environmental monitoring records, coordinating with biomedical engineering, procurement, and vendors.

• Processes non-conformances and CAPA, logs and responds to customer complaints and feedback, and tracks continuous-improvement actions across the cores.

• Applies ISO 20387 controls for biobanking operations, covering specimen traceability, chain of custody, storage conditions, and handling.

• 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.

Accreditation, Auditing, and Regulatory Readiness

• Keeps the core facilities inspection-ready and coordinates the internal audit program and external accreditation activities for laboratory standards (CAP, ISO 15189, ISO 17025, ISO 20387), separate from hospital-wide accreditation.

• 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.

• Maintains continuous readiness for certification, accreditation, and regulatory inspection by keeping documentation and document control current.

• Acts as the coordination point with external audit and certification bodies, prepares the cores for on-site assessments, and tracks accreditation status, fee payments, and required submissions.

• Qualifies and monitors external laboratories, reagent suppliers, and equipment vendors against the applicable standards, including ISO 20387 for biobanking providers.

• 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.

• Ensures confidentiality is maintained at all times, for example concerning issues of business sensitivity, personnel information and patient confidentiality.

General

• Provides regular reporting to the leadership of Core Facilities regarding quality system performance, compliance status across all applicable standards, audit findings, CAPA effectiveness, accreditation status, customer satisfaction metrics, risk assessments, and quality improvements.

• Undertakes any other duties applicable to the grade/post as required.

• Ensures records and documents are controlled and well organized

• Adhere to Sidra’s standards as they appear in the Code of Conduct and Conflict of Interest policies.

• Adhere to and promote Sidra’s Values.

   

In view of the evolving needs and opportunities within Sidra, this position may be required to perform other duties as assigned and reporting relationships may vary.