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.
This position will focus on the batch release / review and validation side of the GMP operations.
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 QA Managers within batch release and validation.
* Taking ownership of Quality Assurance operations within the CMC, MSAT and GMP manufacturing functions of the business. This will include batch review and release activities, as well as validation activities (process, equipment, data, cleaning etc).
* As the Head of Quality, you will continuously improve the quality department through developing and implementing new quality initiatives to ensure smooth transition of products from MSAT to manufacturing.
* This will be a client facing position – you will update clients on Quality related matters.
* Supporting external quality audits and leading internal audits for quality processes.
* Working closely with other QA teams who oversee the QMS and compliance side.
* 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 pharmaceutical (sterile product, small molecule API, finished product) biotechnology / cell therapy / gene therapy organisation (essential)
* Must have the mentality to mentor and grow employees within the team (essential)
* Expert knowledge of GMP quality for pharma, biotechnology or ATMP 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)
* Expertise in batch review and release + validation sections of QA (essential)
* Experience in QMS activities, including the updating and managing of relevant documents including deviation investigation, CAPAs, change control, non-conformance etc (essential)
* Understanding of regulatory requirements for drug development GMP (MHRA, FDA, EMA 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