We’re working on behalf of the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. The organization targets diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. The company is laser focused on advancing therapies that are the first or best of their kind.
We seek candidates with extensive knowledge of GLP /GCP regulations and 10+ years of experience within a regulated health environment for the role of Senior Audit Manager, GLP/GCP. This is a role that can be worked remotely or on-site. The person in this role will play a key role in executing the company’s GxP Compliance Program. The overall purpose of this program is to ensure continuous compliance with applicable global GxP regulations and company quality requirements through periodic assessments of internal operations; domestic and international third parties (i.e. testing facilities, contract research organizations, analytical laboratories) responsible for conducting non-clinical laboratory studies intended to support research and marketing of products regulated by government agencies. The primary responsibility of the position is the planning and execution of GCP /GLP audits to assess ongoing compliance with government regulations and corporate standards of the company’s internal sites and external third parties.
Candidates must have a Bachelor's degree preferred in related scientific field and ten or more years' experience in a role of GCP auditor, including leading audits and understanding a risk-based model. Must have working knowledge of drug development and clinical research, including extensive knowledge of US FDA regulations and ICH GCP, as well as working knowledge of global regulatory requirements. Must have knowledge of electronic systems as the auditor and as a user, including document management systems. Candidates must have a high level of initiative, self-motivation, and organization.
The role offers highly competitive compensation and excellent benefits. This is an excellent opportunity to join a global, high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. For more information call 941.739.1400 or submit your resume now by clicking on the button below that says “Apply Now.”
Edge Recruitment Solutions
888.666.2450 or 941.739.1400