QA PRODUCT RELEASE SECTION MANAGER

Grifols Shared Services North America, Inc; Parets del Vallès; Presencial; EUR 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible schedule

Permanent contract

Descripción de la vacante

Grifols is seeking a QA Product Release Section Manager in Parets del Vallès to lead product release activities and ensure compliance with ISO 13485, IVDR, and regulatory requirements. You will coordinate with Notified Bodies, reference laboratories, and Health Authorities while overseeing documentation control and quality notifications.

The role requires a Bachelor’s degree in Engineering or Health Sciences, 3+ years in QA or Regulatory Affairs, audits experience, and English at C1 level.

Formación

• Bachelor's degree in engineering, health sciences or similar.
• At least 3 years of experience in QA or regulatory affairs.
• Experience in ISO13485 and/or IVDR environments.
• Strong communication and cross-functional collaboration skills.
• English proficiency at C1 level.

Responsabilidades

• Manage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines.
• Coordinate communications with Notified Bodies, reference laboratories and related stakeholders.
• Manage documentation storage, control and retrieval, including externally archived documentation.
• Approve quality notifications after evaluating their impact on batch release and product status.
• Coordinate communications with Health Authorities (e.g., AEMPS) and Pharmacy Inspection regarding import/export activities.

Conocimientos

Quality Assurance

Regulatory Affairs

Audits

Team management

Educación

Bachelor's degree in Engineering or Health Sciences

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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).

• 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.

• Excellent communication skills.

• 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.

Information about Grifols is available at www.grifols.com.

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).

Contract of Employment: Permanent

Location: Parets del Vallès

www.grifols.com

Learn more about Grifols (http://www.grifols.com/es/web/international/home)

Type: Indefinido tiempo completo