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+44 208 985 0565

Director Quality Assurance


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2019-06-04 11:19:381970-01-01 Pop Science
Job Type Permanent Full Time
Location Marlow
Area South East Marlow
Sector Clinical Research
Salary £50k - 80k per year
Start Date ASAP
Job Ref 786
Job Views 404
Description

Are you a thought leader in quality assurance around software and computer system validation in clinical research? We need your help! We have a great Director role and we can consider contractors for this work too.

You will need to have a good understanding of ICH GCP and how to apply these regulations to software development and testing. Also, as this is relatively new for the company, to be able set up working practises and train and mentor teams - from sales to software development.

Here's an outline of the role:

- Participate in central operations meetings providing input to the company strategy and

- Ensure the control, coordination, planning and continuous success and improvement of systems and processes to ensure the quality of the projects conducted by the company

- To develop and maintain the company Quality Plan

- To design, implement and manage a Quality Management System

- To be responsible for supporting the external and internal auditing activities and plans, the implementation and development of GCP related quality systems if required, and training for the staff.

- To support the Information Security Officer (ISO)

- To support the quality processes and management practices that working to accredited standards, (e.g. ISO compliant practices), to ensure maintenance of existing accreditations, and lead extension of accreditations/new accreditations if appropriate.

- Offer mentoring support to the wider team and clients

- Maintain thorough knowledge of regulated and quality processes applicable to the businesses, e.g. GCP, 21CFR, FDA requirements, ABPI requirements and data protection legislation. Disseminate relevant information to the organisation, and act as senior management sponsor for the action of any required quality process changes within the company.

- Maintain an up to date knowledge of internal SOPs

- Commit to personal development and maintain a training log

- Assist with client liaison, bid and proposal development and to ensure successful project delivery.

Contact Gail or Henry for more information. +442089850565

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