Quality Assurance Director Cdmo

Are you a Quality Assurance expert with leadership experience in GMP environments?Do you want to make a real impact on regulatory submissions for the U.S. FDA?

At BioRecruit, we're partnering withGMP Healthcare, a leading UK-based consultancy, to find a QA Director to support one of their key clients in Valencia, Spain.

Please note that this is a 6-month contract to lead a strategic QA project onsite.

The role

You'll be working directly with one of GMP Healthcare's clients focused on chemical processes involving polymers, APIs, excipients, and pharmaceutical substances.

Your mission : to lead the QA team, prepare for PPQ, and ensure full compliance with FDA and GMP standards.

In a nutshell, your main responsibilities in this role will be :

Leading a QA team in a CDMO environment.

Overseeing regulatory compliance and quality control activities.

Supporting a key client in preparing a PPQ for FDA submission.

Ensuring compliance with current GMP regulations.

Qualifications

To thrive and succeed in this role we would expect you to have :

Strong QA experience in the pharmaceutical industry.

It will be an advantage if you have experience in chemical processes involving polymers, APIs, excipients, and pharmaceutical substances.

Background working with clients in clinical and development phases.

Solid understanding of regulatory processes, especially with the FDA.

Proven leadership skills to manage multidisciplinary teams in dynamic settings.

Fluency in both Spanish and English.

Additionally, we would need you to be available onsite in Valencia (relocation support available for the right candidate).

Contact

For any questions regarding the position, do not hesitate to contact us at

We are reviewing applicants on an ongoing basis.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.

To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We look forward to receiving your application