Head of Quality - Pharma/Biotech

• Lead and develop QA&QC team and Quality Systems from industrial scaling phase|Biotech company, manufacturing of high performance growth factors and enzymes

Biotech company, manufacturer of high performance growth factors and enzymes, with high-development project and strong industrial deployment in Bilbao surroundings.

Reporting to COO, the Head of Quality will lead QA and QC teams, from the final phase of industrial facility in Bilbao (GMP standards) to later daily management, and also suport the implementation of the general Quality Sustems according to established policies and procedures. Upon completion, this individual is expected to be responsible for operating and leading the Quality Area as Technical Quality Director, for the liberation of the produced batches.

The main functions will be:

• Management and maintenance of the Quality System implemented in the company, both in the industrial manufacturing plant and in the R&D center.


• Implementation of qualification and validation programs, including cleaning and technology and process transfer processes.


• Implementation and promotion of the company's quality policies in terms of a standardized documentation system, training, internal, customer and regulatory authority audits, management of quality events such as Change Controls, Deviations, Complaints, CAPA actions, management risks, etc.


• Implementation and monitoring of quality indicators.


• Suppliers management.


• Lead and coordinate teams in the QA and QC departments.


• Represent the company in activities related to clients and authorities on issues involving quality.


• Collaborate with other areas and departments to support them in the implementation of their processes under regulatory and quality requirements.


• Ensure the training of all company personnel in terms of quality.

Real career opportunity in a solid and high-growth project in Bilbao area.

• Bachelor's degree in a scientific or engineering discipline.


• Minimum of 6 years experience managing Quality departments in a healthcare or biopharmaceutical environment, in pharmaceutical, biological or food production plants.


• Previous experience in managing a Quality System under GMP requirements for the manufacture of cGMP products.


• Experience in managing QA and QC departments.


• Fluent in Spanish; proficient in English


• Familiarity with biological and/or purification processes and equipment.


• Knowledge of EU and FDA regulatory requirements for cGMP production.


• Leadership, proactivity and team management skills, as well as readiness to perform in a high growth start-up environment