QA PRODUCT RELEASE SECTION MANAGER

Grifols, S.A; Barcelona; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Grifols, S.A in Barcelona is seeking a QA Product Release Section Manager to oversee product release activities for manufactured and distributed products. The role ensures compliance with regulatory requirements and quality standards.

The ideal candidate will have a Bachelor’s degree in Engineering or Health Sciences, at least 3 years of experience in Quality Assurance or Regulatory Affairs, and strong analytical skills. A flexible schedule is offered, emphasizing a diverse, inclusive workplace.

Formación

• At least 3 years of experience in Quality Assurance or Regulatory Affairs.
• Experience in regulated environments under ISO13485 and/or IVDR.
• C1 level in English.

Responsabilidades

• Manage product release activities and ensure compliance.
• Coordinate communications with Health Authorities regarding import/export.
• Act as internal auditor and participate in supplier audits.

Conocimientos

Attention to detail

Analytical ability

Collaborative work

Technical judgement

Educación

Bachelor's degree in Engineering or Health Sciences

Herramientas

ISO13485

IVDR

Descripción del empleo

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.

In our Technical Area Department, we are looking for a QA Product Release Section Manager to manage product release activities for both manufactured and distributed products, ensuring compliance with Technical Direction guidelines and applicable regulatory requirements.

What your responsibilities will be

• Manage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines.
• Participate in the configuration of systems related to product release.
• Coordinate communications with Notified Bodies, reference laboratories and related stakeholders.
• Manage documentation storage, control and retrieval, including externally archived documentation.
• Handle document management quality notifications, ensuring proper tracking and workflow.
• Approve quality notifications after evaluating their impact on batch release and product status.
• Monitor the status of materials affected by quality notifications.
• Coordinate communications with Health Authorities (e.g., AEMPS) and Pharmacy Inspection regarding import/export activities.
• Issue and manage authorizations and official letters required for import/export processes.
• Ensure compliance with applicable regulations such as ISO 13485, IVDR and MDSAP.
• Act as internal auditor and participate in supplier audits.
• Participate in continuous improvement of the Quality Management System.

Who you are

• Bachelor's degree in Enigneering, Health Sciences or similar.
• At least 3 years of experience in Quality Assurance or Regulatory Affairs.
• Experience in regulated environments under ISO13485 and/or IVDR.
• Experience in team management.
• Experience in audits.
• Cross‑functional and collaborative work with multiple departments.
• Attention to detail and compliance.
• Analytical ability and technical judgement in impact assessments.
• English level is C1.

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.

Grifols is an equal opportunity employer.

Flexible schedule

Monday‑Thursday 7‑10 to 16‑19h and Friday 8‑15h (with the same flexible start time).