Quality Assurance Manager & Qualified Person (Biotech Start-up)

Barcelona - Spain

Monthly Salary: Not Disclosed

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

Actual Talent is the talent acquisition consultancy that offers Executive Search RPO and Talent Solutions.

Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people diversity and inclusion innovation and cutting-edge technology.

About the Project: We are partnering with a high-growth Biotechnology company (global scale-up phase.) that is currently disrupting its therapeutic area with the global launch of an innovative biological drug.

We are seeking an entrepreneurial autonomous and technically rigorous professional to take on the role of Quality Assurance Manager & Qualified Person. Your mission will be to ensure that the global expansion of our product meets the highest quality standards by supervising external manufacturing and leading the batch release process to the market.

Your Key Challenges:

Act as the Qualified Person (QP) taking legal responsibility for the certification and release of every manufactured batch (GMP/GDP).
Lead the technical relationship with international CMOs ensuring that external production consistently adheres to the companys quality standards.
Supervise the entire product lifecycle: from manufacturing changes to resolving quality incidents deviations and OOS.
Ensure regulatory compliance across the new markets where the drug is being deployed globally.
Represent the company before Health Authorities (inspections audits and official communications).

What We Are Looking For:

Education: Bachelors Degree in Pharmacy (legal requirement for the QP role). A Masters degree in the Pharmaceutical Industry is a plus.
Experience: At least 3-5 years in QA departments with proven previous experience acting as a Qualified Person (QP).
Expertise: Solid experience with biological products biotechnological drugs or sterile injectables (aseptic processing Annex 1).
Languages: Advanced level of English (essential for daily communication with international suppliers and stakeholders).
Mindset: We are looking for someone who thrives in dynamic environments with strong decision-making skills and a high orientation toward quality and detail.

What This Project Offers:

The chance to be a key player in the success of an expanding Biotech with a global footprint.
Direct responsibility over a high-complexity scientific product.
A professional agile and internationally focused work environment.

Actual Talent is the talent acquisition consultancy that offers Executive Search RPO and Talent Solutions.Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals wh...

Actual Talent is the talent acquisition consultancy that offers Executive Search RPO and Talent Solutions.

Your Key Challenges:

Act as the Qualified Person (QP) taking legal responsibility for the certification and release of every manufactured batch (GMP/GDP).
Lead the technical relationship with international CMOs ensuring that external production consistently adheres to the companys quality standards.
Supervise the entire product lifecycle: from manufacturing changes to resolving quality incidents deviations and OOS.
Ensure regulatory compliance across the new markets where the drug is being deployed globally.
Represent the company before Health Authorities (inspections audits and official communications).

What We Are Looking For:

Education: Bachelors Degree in Pharmacy (legal requirement for the QP role). A Masters degree in the Pharmaceutical Industry is a plus.
Experience: At least 3-5 years in QA departments with proven previous experience acting as a Qualified Person (QP).
Expertise: Solid experience with biological products biotechnological drugs or sterile injectables (aseptic processing Annex 1).
Languages: Advanced level of English (essential for daily communication with international suppliers and stakeholders).
Mindset: We are looking for someone who thrives in dynamic environments with strong decision-making skills and a high orientation toward quality and detail.

What This Project Offers:

The chance to be a key player in the success of an expanding Biotech with a global footprint.
Direct responsibility over a high-complexity scientific product.
A professional agile and internationally focused work environment.