Manager - Quality Systems

Description

We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. We have built a pipeline of novel therapeutic product candidates that have the potential to address the significant morbidity and mortality that remains for patients suffering from cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease.

Reporting to the Vice President – Head of Quality, the Manager – Quality Systems is responsible for executing the requirements of the Cardurion Quality Systems for GxP Document Management and the GxP Training Program, as well as for providing general support for the development, implementation, and maintenance of the required Cardurion Quality Systems.

The position provides support to the various GxP functions within Cardurion in facilitating the development, review, approval, issuance, and maintenance of Quality System Policies and Procedures and provides technical and administrative support for electronic quality management system (eQMS) users. The position also has responsibility for the administration of the GxP Training Program through the eQMS, including the management of training curricula and reporting on training compliance.

As the internal subject matter expert, the incumbent works directly with the Cardurion Quality Team and members of the various GxP functional groups to ensure effective execution of the Cardurion Quality System requirements and compliance with the applicable GxP regulations, guidelines, and industry standards regarding GxP Document Management and GxP Training.

In addition, the position contributes to the development, performance monitoring, and continuous improvement initiatives related to the company’s Quality Systems and their associated processes, policies, and procedures.

This role is required to be onsite in Burlington office 3 days a week.

• Ensuring the eQMS is maintained in a validated state and in compliance with the Cardurion Documentation Management Quality System requirements and procedures.
• Develops and maintains standard operating procedures, work practices, and user guides related to the use of the eQMS. Develops training materials and provides training and troubleshooting support to eQMS users as required to ensure proper use of the system.
• As needed, assists users in facilitation of the document lifecycle (drafting, review, approval, issuance) for Cardurion Quality Policies and Procedures using the eQMS.
• Continually explores opportunities to optimize and improve the document management processes and procedures. Actively manages use of the eQMS to identify and implement changes and functionality that enhances GxP compliance and user efficiency.
• Collaborates with Information Technology to evaluate and implement eQMS changes and improvements.
• Fulfills GxP documentation requests from internal functional groups, business partners, and regulatory agencies, as appropriate. Supports regulatory inspections through document preparation and retrieval, as required.
• Remains current in the regulatory and industry requirements and trends for GxP document management, GxP training, and pharmaceutical quality systems.

• Ensuring the GxP Training Program is maintained in compliance with the Cardurion Training Quality System…