Job Overview :
The individual in this role is leading Covance requirements for Central Lab Services (CLS) QA team with the management support to assure all systems, processes, and their outcomes comply with standards that meet applicable international and national regulations, guidelines and fulfill client and Covance requirements for Central Lab Services (CLS).
Standard expectations of this role include leadership of their direct reports, and the wider QA team; accountability for implementation and management of audit program;
accountability for maintaining constructive and effective relationships with external regulatory contacts (both clients and national regulatory bodies);
maintaining organizational awareness of regulatory developments and requirements in a timely manner.
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
Manage a QA team
Provide education, training and experiences for the QA team to ensure that they are appropriately qualified to perform their role.
Perform / Support Internal / Vendor audits when necessary
Interprets regulatory requirements and quality standards and influences changes in processes to ensure compliance.
Creates training material and delivers training to operational departments
Creates new global procedures
Hosts client and regulatory audits / inspections
Train and mentor other members of the team
Quality Issue support
Identify process improvement opportunities and lead associated initiatives
Other essential job duties as assigned by management
Education / Qualifications :
Bachelor's Degree or equivalent experience Science related field preferred.
Experience : Minimum Required :
Minimum of 5 Years of experience in the job discipline or other related roles.
Demonstrated understanding of Quality Assurance in a regulated CAP / GCP / CLP environment
Preferred working experience in in any of the following :
Good Clinical Practices (GCP).
College of American Pathologists (CAP)
Quality Management System (QMS)