Senior Quality Assurance Specialist

This role is responsible for overseeing quality assurance activities across clinical development and supply chain operations, ensuring compliance with internal standards, regulatory requirements, and relevant ISO certifications. Day-to-day tasks include developing, implementing, and maintaining quality management systems, reviewing and approving SOPs and documentation, conducting internal and external quality audits, and monitoring corrective and preventive actions (CAPA). The specialist will collaborate closely with project management, operations, regulatory, and supply chain teams to address quality-related risks, improve processes, and support inspection readiness. The role also involves training team members on quality standards and contributing to continuous improvement initiatives that enhance reliability and efficiency in clinical trial support.
Qualifications
Strong foundation in Quality Assurance and Quality Control, with experience applying these principles in clinical development, pharmaceuticals, medical devices, or related industries.
Proficiency in Quality Management systems and practices, including development, implementation, and continuous improvement of QMS frameworks.
Knowledge of Good Manufacturing Practice (GMP) and related regulatory guidelines, with the ability to interpret and apply compliance requirements to operational processes.
Experience in Quality Auditing, including planning, conducting, documenting, and following up on internal and external audits.
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or a related discipline.
Experience working in ISO-certified environments (e.g., ISO 13485, ISO 9001, ISO 27001) is highly beneficial.
Strong analytical, documentation, and problem-solving skills, with attention to detail and a structured approach.

Work arrangement
Yes