Sr. Manager, GxP Quality

Job Title: Sr. Manager, GxP Quality

Job Number: 35675

Location: , 

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%).