Manager, Quality Systems & Operations
The Manager, Quality Systems & Operations (QSO) at eClinical Solutions is responsible for leading the day-to-day operation, governance, and continuous improvement of the organization's Quality Management System (QMS) within a regulated clinical technology environment. This role serves as the operational backbone of the Quality & Compliance function, ensuring that quality processes are efficient, inspection-ready, risk-based, and aligned with the needs of a clinical trial software and technology-enabled services organization.
Key responsibilities include overseeing core quality system processes such as document control, Standard Operating Procedure (SOP) lifecycle management, training administration and effectiveness support, quality events and Corrective and Preventive Actions (CAPA) management, quality metrics, and management reporting. The Manager, QSO will also lead cross-functional process improvement initiatives and partner closely with various departments, including Product, Engineering, Information Security, Operations, Client Services, Audits & Assurance, and Systems & Regulatory Compliance, to support Good Clinical Practice (GxP) expectations, customer requirements, and operational excellence.
The ideal candidate will have a strong background in quality management within a regulated clinical technology environment, with experience in managing QMS processes and leading cross-functional teams. Proficiency in document control, training administration, quality event management, and CAPA processes is essential. Strong analytical skills, attention to detail, and the ability to identify and implement process improvements are also critical for success in this role.
eClinical Solutions offers a dynamic work environment with opportunities for professional growth and development. Employees are encouraged to take initiative and contribute to the continuous improvement of processes and systems. The company values collaboration, innovation, and a commitment to quality, providing a supportive atmosphere for individuals looking to make a meaningful impact in the clinical technology industry.