Quality Manager

Oxford Genetics, a leader in synthetic biology, is a specialised contract research organisation offering services to support the discovery, development and production of biologics, with a particular focus on viral vectors for gene therapy applications. A unifying theme across the portfolio is expertise in DNA design, expression system optimisation, cell line development and engineering of viral delivery systems. We are located within purpose-fitted laboratories at the Oxford Science Park, just South of Oxford.  

We are in a phase of rapid expansion and are seeking highly motivated and enthusiastic scientists and engineers to join the team and help facilitate the next stage of our development as a company. We aim to be both innovative and entrepreneurial in everything we do – join us and contribute to this exciting journey! 

Role Overview:

An opportunity has arisen for an experienced Quality Manager at Oxford Genetics. This position requires previous experience in a related environment, and ideally in developing and implementing quality management systems within an expanding company setting.

The appointee will take overall responsibility for all quality related activities within the company, by working with the existing lab management staff, informatics group and senior management. Quality is central to all of our functions, and this role will help ensure and streamline processes to enable this throughout our product and service portfolio. Along with ensuring adherence to set standards (the company is ISO9001 accredited and operates laboratories to GLP standards), the Manager will facilitate audits of the site as appropriate, and be the main point of contact for interaction with regulatory authorities (MHRA, EMEA, FDA). 

This position will interface with other Managers within the company, in particular the leads for the Cell Line Development, Informatics and Process Development teams. The position will report to the Chief Technology Officer. 

Key Responsibilities:

•    Day to day management of and responsibility for all quality related activities 
•    Direct line management of Lab management group 
•    To work closely with internal and external stakeholders to define project goals and deliverables, in line with planned project objectives
•    To keep up-to date with the scientific and regulatory legislation in the field
•    To ensure that all managers and staff maintain and uphold their quality related activities as part of the QMS
•    Manage and develop quality KPIs across the business
•    Provide project summaries and reporting to Senior Leadership Team, in relation to quality KPIs
•    To champion best practice within the company and a continuous improvement mindset
•    To ensure established quality standards are strictly adhered to, across all on-going activities

Criteria:

•    BSc., MSc. or Ph.D in a relevant subject, along with a minimum 3-4 years industry experience in a quality management role
•    Extensive knowledge of subject area, and ideally a strong network within industry groups
•    Highly developed interpersonal, written and verbal skills, including the ability to give presentations and to speak to groups 
•    High-level attention to detail
•    Experience in managing teams, both via direct line management and through matrix management 
•    Ability to work under demanding conditions, and to cope with shifting priorities
•    Experience of leading quality management system development, ideally in biotechnology related area
•    Understanding of relevant legislation and regulatory standards 
•    Experience of process mapping and introduction
•    Understanding and previous utilization of LIMS systems within a regulated environment
•    Experience of data analysis and using outputs to drive continuous improvement. 

Job Type: Permanent
Hours: full time 
Salary: £35,000 – 45,000 per annum

Applicants must be eligible to work in the UK without sponsorship.

We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.

Please apply online with your CV and covering letter stating ref no 0134.

Please check your email for confirmation that your application has been received and to follow further instructions if applicable.