James Hume is seeking a Quality Assurance professional who has experience of document control to take part in SOP committees as well as support other functions such as auditing and compliance. This opportunity has excellent longer-term career potential as this is an emerging group with expansion planned over the next 3 years, of which you can be a key part. This role will be within their Clinical Operations group where they have therapies already at phase I moving to phase II along with others due to enter the clinic in the next year.
A pioneering and ambitious Biopharmaceutical company who develop next-generation, programmed T-cell therapies to treat haematological cancers and solid tumours. The organisation has existed for 4 years and is very well funded, with a clear strategy and expansion plan for the next 3 years and beyond. Scientifically, the company has extremely exciting technologies, using a broad suite of proprietary and modular T-cell programming to engineer precisely targeted, controlled and highly active T cells. Commercially, they have a pipeline of product candidates in development (for the treatment of haematological malignancies and solid tumours) and is increasing its GMP production capacity.
The role of Quality Assurance – Document Controller is to take responsibility for this function within their clinical operations, ensuring best practice and SOP’s are followed with the QMS up to date and compliant. This is a broader role because you will be part of SOP committees where these will be reviewed to ensure they are up to date because of the changing needs of the business as trials progress. The remit of this role also includes working on Systems compliance such as Trackcel and others, with the same focus on document control and SOP adherence.
Due to the nature of the company being one that is developing quickly because of their potential you will be exposed to other areas to help with you career development. This will be part of a dynamic team where you will have authority and autonomy which in turn will give you the expertise to move to more senior or niche technical positions.
Desired Skills and Competencies
For this opportunity, you will need to have relevant Quality Assurance experience, preferably within a GxP environment, however this is not essential because GCP, or GMP are equally relevant. You will need to have experience of controlling documentation and working with an electronic QMS. Due to the focus on SOP’s you will need experience of reviewing and writing of these by working with other departments. Experience of working with clinical systems such as Trackcel is also an advantage.
Salary and Benefits
- Salary – Competitive
- 25 Days Holiday
- Pension – 5% matched contributions
- Life Assurance – 4 times base salary
- Group Income Protection
- Private Medical Insurance
- Dental Cover
- Eyecare Vouchers