Senior Quality Assurance Specialist (Biopharmaceutical, Denmark)

Job summary

This role involves overseeing Supplier Management within the Quality Assurance department of a biopharmaceutical organization. The Senior Specialist will coordinate the Supplier Quality Management System and collaborate with various stakeholders to enhance processes and training related to supplier and vendor management.

Qualifications

• Relevant academic degree, preferably a Master’s or equivalent.
• 5-10 years of experience in Quality Assurance, particularly in the medicinal products sector.
• Strong understanding of quality processes and global regulations.
• Extensive experience in supplier lifecycle management.
• Familiarity with Veeva QMS or similar electronic Quality Management Systems.
• Experience in Risk Management and stakeholder reporting.

Responsibilities

• Maintain and enhance the Supplier and Vendor lifecycle management process.
• Own the Supplier Quality Management System within the organization’s QMS.
• Support stakeholders in managing supplier quality processes.
• Provide training and development for users of the Supplier Quality Management System.
• Manage GxP document control processes.
• Lead GxP process improvement initiatives across the organization.

Skills

• Strong communication skills, proficient in English (written and spoken).
• Excellent presentation abilities for diverse audiences.
• Outgoing and pragmatic approach, capable of working with all organizational levels.
• Detail-oriented, self-motivated, and able to work independently.

Education

• Master’s degree or equivalent in a relevant field.

Tools

• Veeva QMS or similar electronic Quality Management Systems.
• Risk Management tools.