Quality Assurance Manager

Location: Cambridge

Contract: Full-time and permanent

Sector: Biotechnology

Salary: c£40,000 - £60,000 depending on experience.

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 hire a QA Manager to oversee a small team to achieve cGMP compliance and develop + maintain their QMS (Quality Management System). If you are an experienced QA professional within the biotech GMP sector with prior line management experience, this may be an opportunity of interest.

The Opportunity

This is an opportunity for Quality Assurance / QA / Quality Engineer experts who have vast GMP quality assurance and QMS experience within a biological or pharmaceutical setting. This role will involve working within an established Quality team as a Manager to achieve and maintain cGMP compliance. You will be responsible for:

• Leading a small team of 2+ QA members.
• Act as a Senior Member of the QA Team – leading on new QA initiatives and ongoing management of the QMS.
• Ensuring cGMP compliance and maintaining the QMS documentation system.
• Overseeing various QA related functions including CAPAs, risk management, change control, internal / external auditing, supplier management etc.
• Leading training (group and individual) on QMS and GMP.

Skills and Experience Needed

The ideal candidate will have the following:

• BSc / MSc / PhD in a biological / biotechnology discipline (essential, or equivalent experience)
• Proven, strong career within the biological or pharmaceutical QA sector (essential)
• Previous GMP quality experience (essential)
• Previous line management 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)
• Understanding of DNA synthesis (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.