[Hiring] QA PRODUCT RELEASE SECTION MANAGER @GRIFOLS, S.A.

Role Description

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.

• 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.

Qualifications

• Bachelor's degree in Engineering, 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.

Benefits

• Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
• Contract of Employment: Permanent.