Director, Quality Systems & GxP Digital Transformation

Hemab Therapeutics; København; On-site; DKK 1,300,000 - 2,000,000; Full time

Benefits offered by this job

Competitive salary and benefits

Professional development

Culture of quality

Job summary

Hemab Therapeutics is seeking a Director, Quality Systems to build and shape quality infrastructure and processes at a pivotal stage in Hemab's growth. You will build, implement, and continuously improve the systems and processes that support Hemab as the company scales.

If you can plan and drive projects in close collaboration with internal colleagues and external service providers, we would love to hear from you.

Qualifications

• Bachelor’s degree (or higher) in life sciences, pharmacy, engineering, or related field.
• Experience in pharma/biopharma or medical device industries.
• Strong organizational and project management skills across multiple streams.
• Experience designing and implementing QMS in regulated GxP environments.
• Working knowledge of 21 CFR Part 11 and EU Annex 11.
• Excellent written and verbal English communication.

Responsibilities

• Drive the QMS digital roadmap and validation of IT systems.
• Own end-to-end QMS design, lifecycle management, and governance.
• Collaborate with IT, external vendors, and cross-functional teams.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and data integrity.
• Advise on continuous improvement and risk management.

Skills

Project management

QMS design

GxP compliance

21 CFR Part 11 knowledge

EU Annex 11 knowledge

English communication

Education

Bachelor's degree or higher in life sciences, pharmacy, engineering, or related field

Tools

Veeva Vault QualityDocs

MasterControl

TrackWise

Job description

Hemab Therapeutics is seeking a Director, Quality Systems to build and shape quality infrastructure and processes at a pivotal stage in Hemab's growth. You will build, implement, and continuously improve the systems and processes that support Hemab as the company scales.

If you can plan and drive projects in close collaboration with internal colleagues and external service providers, we would love to hear from you.