QA Manager - GCP, Consultancy

JOB DESCRIPTION - Quality Consultant (Title to be confirmed depending on final candidate)

 The Quality Consultant (the “consultant”) will provide QA consultancy support to our clients. The successful candidate will be based at our offices in Cambridgeshire.

Qualifications and Experience

The Consultant will have the minimum qualifications of a life science degree (BSc), and will have relevant experience from working in clinical drug development with some involvement in GCP Quality management systems and an understanding of the regulatory environment for conducting clinical trials.

The Consultant will have competent word processing skills (including use of standard MS Office applications).

 Reporting Lines

The Consultant will report to the Director & Head of Quality for all technical issues and also for personnel matters.

Technical roles and responsibilities

Outlined here are the tasks that will generally be the responsibility of the Consultant, but they may be delegated to other staff where appropriate:

-               supporting clients as QA Consultant; facilitating periodic QMS meetings with client teams

-               preparation of SOPs for clients and support for client QMS management; including provision of technical QA support for clients.

-               support maintenance of the internal Quality Management Systems and SOPs, including provision of ad hoc QA support for internal processes

-               conduct of QC reviews of essential documents

-               speaking at external meetings and conduct of client training seminars

-               training and mentoring of staff

General responsibilities:

-               to be involved with business development activities to promote the company; preparation of proposals

-               to be involved with invoice preparation and budget oversight for assigned projects

-               to maintain and promote the reputation of the company as an ethical and expert consultancy company

-               to maintain the confidentiality of clinical trial subjects, the client and other company information

-               to maintain good professional relationships with all external parties in contact with us, including; clients, suppliers, consultants and clinical trial investigators

-               to maintain good working relationships with colleagues and to enable a team spirit within the company

-               to contribute ideas on matters affecting the running of the company

-               to maintain an awareness of the business of the company and of all ongoing projects

-               to be organised in the planning of personal workload

-               to ensure that personal development is maintained through continuous training assessment

-               to maintain technical expertise as appropriate

-               to be conversant with our Standard Operating Procedures

Candidate Profile:

We are looking for an experienced GCP professional, either with direct experience working in QA/SOP management or with a clinical project management background, looking to move into quality.