Quality Assurance Director – Gene Therapy

If you’re a highly experienced quality assurance leader with a strong background in gene / cell therapy and you’re open minded about a new role we really need to be talking about a fantastic opportunity I’m recruiting for.

I’m working with a company who are operating at the cutting edge of gene therapy. They’re building out a full business to take novel therapeutic products to patients with unmet needs and as part of that expansion they’re investing heavily in their quality function.

I’m looking for someone to take overall responsibility for quality assurance for the organisation across all GxP disciplines. The main focus in the short terms will be around GLP and GMP with additional expertise in GCP and GDP being of value.

Due to the nature of the organisation and their size I’m looking for someone who’s happy and able to tackle a wide breadth of responsibilities across leadership, strategic and hands on operational areas. I’m looking for someone with a dynamic, entrepreneurial mindset who would be really drawn to a start up, high tech organisation.

Examples of responsibilities of the role include (but are far from limited to)

Leadership

Defining and driving strategy for the organisation’s approach to quality.

Building and managing a lean, highly effective team of quality professionals that ensure a top tier quality culture in the business.

Acting as the go to person in the organisation for all quality related to quality and being recognised as highly credible expert.

Specific Quality Requirements

Full oversight of GxP requirements including creating and training around SOPs.

Managing and conducting a broad range of internal and external audits

Training across the business and where necessary with suppliers and external collaborators.

Full oversight of quality metrics and management of CAPA findings

I have some specific ‘have to have’ requirements for this role

Extensive QA leadership experience across multiple GxP disciplines. Certainly GLP and GMP, GDP and GCP would be ideal also.

A strong, established background in Cell / Gene Therapy and ATMPs. This is essential and I regret that even the strongest QA candidates not meeting this requirement cannot be considered.

Strong leadership skills with the proven ability to strategise, influence and formally lead a team.

Some nice to haves would include

Designation as a QP or being on track for this. This is not a formal requirement and very solid support can be offered for well qualified applicants who are working towards becoming a QP.

Oncology experience

Start up company experience.

In return my client offers the opportunity to join one of the most exciting businesses I’ve ever worked with. The short, medium and long term opportunities for professional development are huge. You’d also be working for a company that has a deep and serious commitment to bringing life changing therapies to patients.

If this sounds like you and you’d like to know more I’d love to hear from you – please get in touch and I’ll give you a full brief on the company and role.

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How to apply

If this position is of interest please send us your CV here, or you can call Andrew Wise direct on 01892 507 135 to discuss this and other vacancies that may suit.

Andrew Wise

Managing Consultant - Pharma
Email: andrew.wise@bluepelican.com
My recruitment career started 18 years ago and for the last 11 and a half years I've been catering to life science busin...