Key Skills

Job Description

The Company Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety. Job Description As a Senior Quality Systems Specialist, you will manage and improve GMP Quality Systems, focusing on Change Control, Deviations, CAPA and Material Review processes. You will collaborate with cross-functional teams to ensure compliance with EU GMP and ICH Q10, support audits and inspections, and drive continuous improvement across quality processes. Key Responsibilities Manage and oversee key quality systems at the site level, including Change Control, Deviations, CAPA, and Material Review Board processes Deliver training on these systems and act as a backup chair for related governance meetings, such as the Change Control Review Board and Deviations Board Ensure compliance with regulatory requirements and internal quality policies Support preparation for regulatory inspections and audits Maintain and approve cGMP documentation and ensure accuracy of the Quality Management System Review and approve change proposals, deviations, CAPA records, and other quality documents Track and report key metrics, supporting continuous improvement initiatives Requirements At least 3 years’ experience in Quality Assurance within a GMP environment (Drug Substance or Drug Product) Strong knowledge of GMP regulations, EU GMPs, and ICH Q10 standards Experience with Change Control, CAPA, Deviations, Internal Audits, and Material Review Boards Technical background in Chemistry, Microbiology, Engineering, or similar discipline (Bachelor’s degree or higher) Proficiency with MS Word, Excel, PowerPoint, Smartsheet, Power BI, Power Automate, and Quality Management Systems Knowledge of aseptic manufacturing processes Other Information Apply to our vacancy for more information. We look forward to hearing from you!

Core Responsibilities

Manage and improve site-level GMP quality systems, including change control, deviations, CAPA, and material review processes. Ensure regulatory compliance, support audits and inspections, maintain quality documentation, deliver training, report metrics, and drive continuous improvement.

Requirements

Requires at least three years of Quality Assurance experience in a GMP environment and strong knowledge of GMP regulations, EU GMP, and ICH Q10. A bachelor’s degree or higher in a relevant technical discipline, experience with core quality systems and audits, proficiency with specified office and quality tools, and knowledge of aseptic manufacturing are required.