Sr. Manager, GxP Quality

Job Title: Sr. Manager, GxP Quality

Job Number: 89527

Location: , US

Job Description

A new opportunity is available for a Sr. Manager, GXP Quality (GCP/GLP/GVP). This role involves ensuring the quality and compliance of development programs with applicable regulatory requirements (FDA/EMA) and internal standards. The position will also assist the non-clinical team in maintaining compliance for GLP studies. The role reports to the Director of Clinical Quality & Compliance.

Responsibilities

* Provide GCP/GLP/GVP QA oversight and support to cross-functional teams. * Assist in developing the annual audit schedule for GCP/GLP/GVP. * Conduct and oversee audits, ensuring compliance with global regulations, guidance, and internal procedures. Audits may include clinical sites, CROs/vendors, processes, systems, study projects, and documentation. * Track and report on audit deviations and trends. * Identify, investigate, escalate, and resolve quality issues internally and externally. * Coordinate with QA counterparts at CROs and vendors. * Assist in preparing for and hosting regulatory inspections. * Conduct QA reviews of clinical trial documents, including protocols, informed consent forms (ICFs), and clinical study reports (CSRs). * Review GLP reports and validation plans. * Perform other duties as required.

Required Skills

* Bachelor’s degree in a scientific discipline; advanced degree preferred. * 7+ years in the pharmaceutical industry, with 5+ years in GCP QA. * Strong understanding of GCP, GLP, and GVP regulations and guidelines. * Experience with US and international clinical studies. * Excellent verbal and written communication skills. * Experience reviewing clinical documents. * Strong organizational skills and ability to work independently. * Collaborative problem-solver. * Ability to travel domestically and internationally (approximately 25%).

Application Deadline: 2025-02-03