Quality Manager - Biotech

Quality Manager - Biotech

Job Title: Quality Manager - Biotech
Contract Type: Permanent
Location: Oxford
Salary: Up to £45000 plus benefits
Start Date: 2017-06-28
Reference: 15488 JH
Contact Name: James Hume
Contact Email:
Job Published: June 28, 2017 17:34

Job Description

  • Job Title: Quality Manager
  • Salary: Up to £50,000 D.o.E. plus benefits
  • Location: Oxford
  • Excellent Opportunity to Join a Cutting Edge Synthetic Biology Company Developing Solutions for the Cell and Gene Therapy industries.
  • The Quality Manager is an Influential Role which will Operate at a Senior Level and is Key in Supporting their Expansion by Maintaining Compliance to Regulatory Standards.
Job Summary:
This is an influential role that will have an impact as the company goes through a sustained growth period to take control of the Quality systems and continue to develop these as to meet the changing business needs of this Biotech with great potential.  They are pioneers in the use of synthetic biology and its application to transform the discovery, development and manufacture of biologics, cell & gene therapies.  Based in state-of-the-art laboratories on the outskirts of Oxford they are at the cutting edge of research in this field, which has huge potential to deliver solutions for the production of complex, high value products.  

The Company
The company are at the cutting edge of the exciting field of synthetic biology after developing their unique platform which enables them to offer solutions to the discovery, development and manufacture of biologics, cell & gene therapies.  They currently offer a range of custom and platform services, specialising in DNA design, optimisation of protein and viral expression systems, and cell line development technologies. 

A strong focus is placed on R&D activities and further developing platform technologies, as supported by the recent receipt of multiple grants awards from Innovate UK.  Which will enable them to realise their potential and have a positive impact on the cell and gene therapy sectors.

The Opportunity:
The Quality Manager will take control of all quality related activities ensuring these meet regulatory requirements and work with departmental managers to ensure standards are met across the company.  They are going through a period of expansion due to the potential of their technology which means they need someone who can improve their systems to continue to be compliant to meet changing regulatory requirements during this time.  They are currently at ISO9001:2008, operating to GLP standards, and working towards ISO:2015.

As the Quality Manager both internal and external auditing will be your responsibility working with the relevant internal and external stakeholders.  Responding to any findings, implementing changes and keeping in contact with relevant regulatory bodies to maintain compliance.  You will also work closely with other departmental managers to set KPI’s to monitor compliance and take action should any issues arise.  The management of the QMS and LIMS will be your responsibility to ensure this is updated and maintained correctly company wide.  There is a small team who will assist you with administrative and other functions as required

Desired Skills and Experience:
They are seeking a Quality Manager who can bring their own ideas and experience with them to shape the quality systems and drive their improvement.  You will need to have demonstrable experience of managing quality systems in a similar environment (Biotech, Pharma, CRO, CMO etc.) to at least ISO 9001 standards. Knowledge of or direct experience of working to GMP is advantageous to your application.  You will need to have experience of leading the development of quality standards to meet higher level qualifications such as ISO9001:2015 and changing business needs as they grow.  In addition you will need to have experience of working with a LIMS system in a similar environment.

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