Director, Quality Systems

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 a clinical-stage biopharmaceutical company dedicated to transforming the treatment of rare haematological diseases. Operating a fully outsourced model, Hemab advances its pipeline through strategic partnerships with contract development and manufacturing organizations (CDMOs) and clinical research organizations (CROs). As Hemab transitions from early to late stage development the Quality function plays a central role in enabling that journey.

The Opportunity

Hemab 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 supports 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. We expect you to have relevant experience from Biotech/Pharma combined with project management skills and mindset. This role will suit a candidate who enjoys building sustainable solutions and is energized by the opportunity to do so.

This is an individual contributor role with the potential to grow as Hemab expands. You will work closely with the VP of Quality, the broader Quality team, and cross-functional stakeholders across Development Operations, CMC & Manufacturing, Medical, Regulatory Affairs and IT/Digital.

Key Responsibilities

The responsibilities outlined here reflect our current priorities. As the organization matures, we expect this role to be refined, and the successful candidate will play a part in shaping that evolution.

Drive the Quality functions Digital Roadmap

• Lead the implementation and validation of new QMS IT systems
• Manage the migration from legacy or interim systems to validated, purpose-built platforms, ensuring data integrity and business continuity throughout.

QMS Ownership and Continuous Improvement

• Own the end-to-end design, implementation, and lifecycle management of Hemab's QMS, aligned with ICH Q10 principles and applicable GxP regulations (GCP, GMP, GLP, GDP).
• Maintain and evolve the QMS architecture, including the document hierarchy, process map, and quality governance structures.
• Serve as the primary business owner for QMS-related IT applications, coordinating with IT and external vendors on system requirements, validation protocols, and change management.
• Ensure systems are compliant with applicable 21 CFR Part 11, EU Annex 11, and data integrity requirements.
• Drive continuous improvement across quality processes, identifying gaps, inefficiencies, and risk areas proactively.
• Ensure the QMS remains fit-for-purpose and scalable as Hemab transitions from early to late-stage development.

Stakeholder Collaboration & Quality Culture

• Partner with cross-functional teams to embed quality processes into day-to-day operations across clinical, CMC, non-clinical, and regulatory activities.
• Provide coaching and guidance to internal stakeholders on QMS processes, compliance obligations, and continuous improvement.
• Contribute to building a strong quality culture throughout Hemab, reinforcing "tone from the top" and empowering staff to raise quality issues proactively.

Qualifications

• Bachelor's degree (or higher) in life sciences, pharmacy, engineering, or a related field.
• Experience from the pharmaceutical, biopharmaceutical, or medical device industry.
• Excellent organizational and project management skills with the ability to manage multiple workstreams simultaneously.
• Demonstrated experience designing and implementing QMS frameworks in regulated GxP environments.
• Working knowledge of 21 CFR Part 11 and EU Annex 11 (computerized systems validation).
• Strong written and verbal communication skills in English.

Preferred

• Experience supporting Phase 3 clinical programmes and/or BLA/MAA submissions.
• Familiarity with audit management and regulatory inspection preparation.
• Hands-on experience leading QMS IT system implementations or migrations (eg, Veeva Vault QualityDocs, MasterControl, TrackWise, or equivalent).
• Experience managing core quality processes: document control, deviation/CAPA management, training management, and change control.
• Prior experience in a start-up or scale-up biotech environment.

What We Offer

• The opportunity to build and shape quality infrastructure at a pivotal stage in Hemab's growth.
• A collaborative, science-driven culture with a clear sense of purpose: improving the lives of patients with rare haematological diseases.
• Competitive salary and benefits package.
• Meaningful professional development as Hemab scales into Phase 3 and toward its first marketing application.