QA GCP Manager

Job title : QA GCP Manager
Location : London
Job type : Permanent
Salary : Negotiable
Contact name : John Swift
Contact email : john.swift@secpharma.com
I am working with a full-service clinical contract research organization (CRO). They provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Their mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, and CNS.

Due to a very exciting transitional period within the company, they are now seeking a Quality Assurance Manager who can be located in one of their European offices. You will be an integral part of the teams growth and will manage QA Auditors as well as aspects of projects, investigative site audits and/or business segments as needed. You will develop and oversee employee training. You will also help plan and maintain the annual audit schedule in conjunction with Department Director, including proposing and developing audit plans for new projects. You will work directly with the Clients, as needed.

Responsibilities
Independently coordinate the conduct of all types of audits and ensure completion of QA department responsibilities identified by SOPs;
Oversee and manage auditor capacity planning and audit reporting requirements per procedure;
Provide line management responsibilities and development for multiple QA Auditors
Assisting the QA Director with coordinating and conducting internal system audits and external vendor audits for central laboratory and CRO operational functions
Participate in audits by Sponsors and/or Regulatory Inspectors
Identify areas of risk and provide input on an effective QA oversight plan to mitigate the identified risk;
Proactively identify and resolve non-compliance issues within Medpace lines of business;
Create and revise departmental SOPs and guidelines.

Please contact me on 07392 865 321 or john.swift@secpharma.com for more information.