Replimune is pioneering a new generation of cancer treatments called oncolytic immunotherapies. These cleverly designed therapeutics combine multiple mechanisms of action, enhancing the ability of viruses to replicate in and kill cancer cells, generating a powerful patient-specific, systemic immune response.
Summary of job description:
Reporting into the Manager, Clinical Quality Assurance, the Senior Associate, Clinical Quality Assurance will support and ensure that all systems and processes are compliant with good clinical practice (GCP) guidelines, standards, and regulations (FDA, MHRA, EMA, ICH). The Senior Associate, Clinical Quality Assurance will be responsible for assisting GCP QA and Quality Systems with Training, Document Control, tracking GCP elements of the Quality Management System (QMS), logistical support for Inspection Readiness activities, Project and clinical trial support, Vendor oversight; including audit support and audit closeout. The Senior Associate, Clinical Quality Assurance will ensure that all processes contributing to the performance of a clinical trial are established and conducted compliantly, troubleshoot escalated clinical trial issues, manage and maintain databases for the quality system, as well as prepare and assist in preparing annual reports and quality trending reports.
Experience and skill requirement:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.