Quality Systems Specialist

Company: A leading organization dedicated to advancing healthcare through innovative and quality-driven solutions. Their mission is to support the development and manufacturing of life-saving therapies, focusing on improving patient outcomes worldwide.

Job Description: The Quality Systems Specialist plays a vital role in supporting the deployment and management of the company’s quality systems. This position involves ensuring compliance, facilitating cross-site collaboration, and maintaining high standards in quality assurance activities related to regulated pharmaceutical processes.

Responsibilities: Oversee the maintenance, training, and continuous improvement of core quality systems such as Change Control, Deviations, CAPA management, and Material Review Board processes. Support site and cross-site compliance with regulatory requirements and quality policies. Facilitate training sessions and act as a backup chair for the EU Change Control Review Board, Deviations, and Material Review Board. Assist in regulatory inspections and audits, ensuring proper documentation and adherence to cGMP standards.

Manage the review and approval of changes, deviations, CAPA records, and related documentation. Track and report metrics to identify opportunities for process improvements and support management reviews. Support multidisciplinary teams in startup activities and process improvements. Maintain the company’s Quality Management System and ensure timely approval of documents. Act as a backup support for the Senior Manager of Quality Systems and contribute to ongoing quality initiatives.

Perform other related duties as required to uphold quality standards.

Requirements: At least 5 years of GMP Quality Assurance experience in a pharmaceutical environment (Drug Substance or Drug Product). Strong knowledge of GMP regulations, ICHQ10 standards, and relevant pharmaceutical law. Hands-on experience with Change Control, CAPA, Deviations, Internal Audits, and Material Review Boards. Knowledge of aseptic manufacturing processes. Proficiency in MS Word, Excel, PowerPoint, Smartsheet, Power BI, Power Automate, and quality management systems.

A bachelor’s degree in technical fields such as Chemistry, Microbiology, Engineering, or similar.

Preferred: Certifications such as ASQ, Black Belt/Green Belt, and experience with ATMPs.

Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.