Head Of Quality Assurance

Location: Cambridgeshire

Head of Quality Assurance

Location:

Cambridge

Contract:

Full-time and permanent - onsite

Sector:
Biotechnology and gene therapy

Salary: c £70,000 - £90,000 depending on experience and interview performance

Our client is an innovative biotechnology company based outside of the centre of Cambridge. They have built a platform to synthesise DNA, providing 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 expand their Quality Assurance team by hiring a Head of Quality (reporting to the VP of Quality).

If you are an experienced QA Lead within the biotech MSAT and CMC GMP sector, this may be an opportunity of interest.

The Opportunity

This is an opportunity for a proven Quality Assurance leader with 5+ years’ of management experience within a biotechnology / gene therapy / cell therapy GMP setting. You will have experience in CMC, MSAT and tech transfer to manufacturing. This role will involve the following:

* Managing the Quality Operations team, including a QA Manager and other staff members.

* Taking ownership of Quality Assurance operations for all CMC, MSAT and manufacturing functions of the business. You will also develop and implement new quality initiatives to ensure smooth transition of products from R&D to manufacturing.

* Acting as point of contact for clients with respect to GMP quality and FDA / EU regulatory related queries. This will be a client facing position.

* Supporting external quality audits and leading internal audits for quality processes.

* Overseeing and managing the GMP QMS, designing and implementing new processes; alongside promoting best practices and suggesting improvements.

* Training of staff within the Quality Operations team.

Skills and Experience Needed

The ideal candidate will have the following:

* BSc / MSc / PhD in a life science discipline (essential, or equivalent experience)

* Must have several years of experience in leading Quality Operations (leading both teams and operations) for a biotechnology / cell therapy / gene therapy organisation. Must have the mentality to mentor and grow employees within the team (essential)

* Expert knowledge of GMP quality for biotechnology or gene therapy operations built over many years’ experience (essential)

* Must have proven experience in Quality assurance for Chemistry Manufacturing Control (CMC) and Manufacturing, Science & Technology (MSAT) and Tech Transfer + Process Development operations (essential)

* Experience in creating, maintaining and updating a Quality Management System (QMS) and relevant documents including deviation investigation, CAPAs, change control, non-conformance etc (essential)

* Understanding of regulatory requirements for APIs in drug development (MHRA, FDA etc) (essential)

* High attention to detail, the drive to be a complete finisher and highly organised (essential)

* Good communication skills (essential)

* Prior lead auditor experience (desired)

* Must have full, long-term right to work in the UK (essential)

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 and share incentives