Senior Specialist - Research Laboratory Quality Systems

Role Overview

Senior Specialist - Research Laboratory Quality Systems at Sidra Medicine, reporting to the Executive Director of Core Facilities. This role is based at Sidra Medicine's research facilities.

Company Overview

Sidra Medicine operates multiple research core facilities requiring integrated quality management and regulatory compliance across all centers.

Role Purpose

Develop, implement, and maintain an integrated Quality Management System across multiple research core facilities while ensuring compliance with ISO 9001, ISO 17025, ISO 15189, ISO 20387, CAP, GLP, ISO 19011, and ISO 31000 standards, and adhering to corporate GREC requirements to meet stakeholder expectations and harmonize quality practices.

Key Responsibilities

Laboratory Quality Management System Implementation and Maintenance

• Implement and maintain the integrated Quality Management System across research core facilities, keeping day-to-day laboratory operations aligned with ISO 9001, ISO 15189, ISO 17025, ISO 20387, CAP, and GLP requirements as applicable.
• Track and version-control the QMS documentation set for each core, including Quality Manuals, SOPs, work instructions, forms, and records.
• Review and harmonize end-user and laboratory documentation across cores for accuracy and compliance.
• Maintain personnel competency, training, and proficiency records, and track CPD and CME attainment against an annual training plan.
• Run routine quality controls, internal quality assurance, external quality assessment, proficiency testing, and measurement-uncertainty records as required by ISO 15189, ISO 17025, and CAP.
• Maintain equipment calibration, maintenance, qualification (IQ/OQ), and environmental monitoring records, coordinating with biomedical engineering, procurement, and vendors.
• Process non-conformances and CAPA, log and respond to customer complaints and feedback, and track continuous-improvement actions across the cores.
• Apply ISO 20387 controls for biobanking operations, covering specimen traceability, chain of custody, storage conditions, and handling.
• Maintain the quality risk register using ISO 31000 and compile quality metrics, audit results, and KPIs to support management review.

Accreditation, Auditing, and Regulatory Readiness

• Keep core facilities inspection-ready and coordinate the internal audit program and external accreditation activities for laboratory standards (CAP, ISO 15189, ISO 17025, ISO 20387), separate from hospital-wide accreditation.
• Plan and conduct 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.
• Maintain continuous readiness for certification, accreditation, and regulatory inspection by keeping documentation and document control current.
• Act as the coordination point with external audit and certification bodies, prepare the cores for on-site assessments, and track accreditation status, fee payments, and required submissions.
• Qualify and monitor external laboratories, reagent suppliers, and equipment vendors against applicable standards, including ISO 20387 for biobanking providers.
• Maintain core-facility emergency and continuity procedures and align quality procedures with Health and Safety and biosafety requirements alongside the Laboratory Biological Safety Officer and Facility Safety Officer.
• Ensure confidentiality is maintained at all times concerning business sensitivity, personnel information, and patient confidentiality.

Governance and Reporting

• Provide 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.
• Ensure 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.

General

• Undertake any other duties applicable to the grade and post as required.
• Perform other duties as assigned in view of evolving needs and opportunities within Sidra.

Qualifications & Experience

• Bachelor's degree in Biomedical Sciences, Engineering, or a related field.
• 7 or more years of experience in a relevant field.
• Exceptions to the experience requirement may be granted for Qatari nationals (internal and external candidates), with a reduction of up to two years.
• Formal training or certification in Quality Management Systems or other Quality standard including Auditing.
• Preferred: Master's Degree in a related field.
• Preferred: Certification with a third-party certification body for ISO 9001, ISO 19011, ISO 14001, or ISO 17025.
• Preferred: International Register of Certificated Auditors eligibility (CQI/IRCA).

Skills & Competencies

• Strong understanding of healthcare and quality.
• Excellent communication and interpersonal skills.
• Strong cultural intelligence and teamwork competencies.
• Ability to keep and retrieve records.
• Proficiency with Microsoft Office suite.
• Fluency in written and spoken English.
• Arabic speaking.

Additional Information

• Reporting relationships may vary in view of evolving needs and opportunities within Sidra.