Senior Executive, Division of Pharmacy

Job Detail

We are seeking a highly motivated and dynamic candidate to support the establishment, implementation and continuous improvement of quality systems, validation activities and clinical laboratory services. You will play a key role in developing and operationalising new clinical laboratory services, quality management systems and digital workflows, while ensuring compliance with regulatory and accreditation requirements. The role involves close collaboration with clinicians, pharmacists, laboratory professionals, IT teams and external partners to drive service development, validation and quality initiatives. You will be responsible for: Supporting the establishment, implementation and maintenance of Quality Management Systems (QMS) in accordance with ISO 15189, HCSA and other applicable regulatory requirements. Coordinating laboratory accreditation, licensing and inspection readiness activities, including internal audits, gap assessments, CAPA management and external quality assurance programmes. Planning and implementing validation and verification activities for laboratory assays, instruments, workflows, software applications and laboratory-developed tests. Developing, reviewing and maintaining quality documentation, including SOPs, validation protocols, reports, risk assessments and quality manuals. Working with multidisciplinary stakeholders to design and implement new clinical laboratory services and operational workflows. Supporting implementation and optimisation of laboratory IT systems, middleware, electronic medical record integrations and digital solutions that enhance laboratory operations. Collecting, analysing and interpreting data required for validation, quality monitoring and continuous improvement initiatives. Coordinating procurement, vendor engagement, project administration and financial processes related to laboratory operations and service development. Supporting risk management, training coordination, biosafety and regulatory compliance activities within the laboratory. Staying updated on industry regulations, accreditation standards, quality management practices and emerging healthcare technologies.