Clinical QA Auditor

Job title : Clinical QA Auditor
Location : New York, USA
Job type : Permanent
Salary : US$110000 - US$125000 per annum + Competitive
Contact name : John Swift
Contact email : john.swift@secpharma.com

I have partnered with my innovative and scientifically driven client to find an experienced Clinical QA Auditor for their New York office.

The overview of the position is below;

Effectively plan and perform regular and random QA audits of clinical trials including but not limited to investigator site audits, audits of company vendors, internal Operational audits in order to assure compliance with company SOPs, study protocols, ICH GCP guidelines, relevant regulations and EN ISO 14155 requirements
Manage and maintain databases for the quality system
Be involved, when required, in project audit management and staff training and contribute to the review of company systems and procedures as appropriate
Maintain a thorough knowledge of all relevant company SOPs, GXP and ISO requirements and appropriate regulations and guidelines
Develops company Quality Management System - focusing on implementing Clinical Operations into QMS
Evaluate/Manage quality issues, CAPAs, and complaints
Participate in Inspection Readiness activities including hosting of Regulatory Inspections and external audits
Ensure that audit results are appropriately recorded and reported and that corrective/preventive actions are properly completed and documented
Assist with the development of project audit procedures.

They are an oncology company pioneering a novel therapy for solid tumors and have experienced 40% revenue growth over in 2019.

Please contact me asap for a full job spec and more information on john.swift@secpharma.com