Job Overview

Cambridge, England
Job Type
Full Time
£45,000 - £60,000 Per Year
Date Posted
5 days ago

Additional Details

Job ID
Job Views

Job Description

Quality Team Lead

Location: Cambridge

Contract: Full-time and permanent

Sector: Biotechnology

Salary: Up to £60,000 DOE

Our client is an innovative biotechnology company based outside of the centre of Cambridge. They have built a platform to synthesis DNA which provides exciting possibilities for ensuring cheaper, faster and more accurate DNA / gene constructs than traditional plasmid-based methods. In a key phase of their growth, our client is looking to build a robust and driven Quality team to implement a new QMS (Quality Management System) which will be compliant with various ISO and GMP standards. They are looking for Quality Lead to oversee the newly formed Quality Team and implement a new QMS on a full-time and permanent basis.

The Opportunity

This is an opportunity for highly experienced Quality Assurance / QA / Quality Engineer professionals who have at least 5 years’ of experience within a GMP and pharmaceutical (or biotechnology) setting. This role will involve overseeing a newly formed Quality team where you will lead the design and implementation and development of a new Quality Management System (QMS). You will be involved in:

  • Managing and overseeing the Quality team, setting work schedules, milestones and timetables.
  • Leading the development of the new QMS.
  • Lead the writing of quality system SOPs as well as reviewing, rewriting and validating the documentation.
  • Writing technical SOPs relating to DNA synthesis.
  • Leading internal quality audits and overseeing external audits.
  • Support the training of other staff on GMP policies
  • Investigating deviations, implementing CAPAs and change control.
  • Working on continuous improvement projects.

Skills and Experience Needed

The ideal candidate will have the following:

  • BSc / MSc / PhD in a biological / biotechnology discipline (essential)
  • At least 5 years of previous QA / Quality Assurance / Quality Engineer experience within a GMP and pharmaceutical or biotech environment (essential)
  • Previous GMP quality experience (essential)
  • Experience in maintaining and updating a Quality Management System (QMS) and relevant documents including deviation investigation, CAPAs, change control etc (essential)
  • Good communication skills (essential)
  • Strong understanding of ISO 9001, ISO 13485 (desired)
  • Understanding of DNA synthesis (desired)
  • Previous team leadership experience (highly beneficial)
  • Previous experience in designing a QMS from scratch (desired)

The Package

As an up-and-coming Cambridge Biotech, our client is able to offer a competitive salary, progression options and benefits package including private pension.


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