Qulaity Assurance Executive

This role involves supporting and monitoring quality systems across clinical supply chain operations to ensure compliance with internal SOPs, ISO standards, and relevant regulatory requirements. Day-to-day responsibilities include reviewing documentation, conducting internal audits, supporting vendor and site qualification activities, and assisting in deviation, CAPA, and change control processes. The Quality Assurance Executive will collaborate closely with cross-functional teams such as operations, project management, regulatory, and supply chain to identify risks, improve processes, and maintain consistent quality standards. The role also includes preparing quality reports, supporting training initiatives, and contributing to continuous improvement projects within the organization.
Qualifications
Strong foundation in quality management systems, including experience with ISO standards (e.g., ISO 9001, ISO 13485, ISO 27001) and good documentation practices.
Experience with clinical trial or pharmaceutical/biotech environments, including familiarity with regulatory and compliance requirements for medical devices, equipment, and clinical supplies.
Skills in internal auditing, risk assessment, deviation and CAPA management, and process improvement within a regulated setting.
Proficiency in documentation review, SOP development and maintenance, and record-keeping for quality-related activities.
Strong analytical, problem-solving, and organizational skills, with attention to detail and ability to manage multiple tasks and timelines.
Effective written and verbal communication skills, with the ability to collaborate across multidisciplinary and geographically dispersed teams.
Comfort with hybrid work arrangements, including use of digital tools for remote collaboration, reporting, and document control.

Work arrangement
Yes