Director of Quality Assurance

5 days ago

Copenhagen, Copenhagen, Denmark Skills Alliance Full time 120,000 - 180,000 per year

Senior Director Quality Assurance

Location:
Denmark, Hybrid

The Company

A rapidly expanding European CDMO specializing in the development and GMP manufacturing of biologics and advanced therapies. The site partners with leading global biotech and pharmaceutical companies to deliver high-quality clinical and commercial products in compliance with international regulatory standards.

Position Overview

The Quality Director will lead all Quality Assurance activities on-site, ensuring that manufacturing operations, documentation systems, and product releases meet the highest GMP and regulatory standards. The role will provide strategic and operational leadership to the QA organization, supporting continued site growth, successful client audits, and global regulatory inspections.

Key Responsibilities

  • Lead and develop the site QA team, overseeing batch release, QMS, deviation/CAPA management, change control, and audit readiness.
  • Ensure full compliance with EU, FDA, and ICH GMP guidelines for biologics manufacturing.
  • Serve as the Quality representative on the site leadership team, contributing to strategy and continuous improvement initiatives.
  • Partner cross-functionally with MSAT, Manufacturing, QC, and Regulatory Affairs to ensure alignment between operations and compliance objectives.
  • Support client quality interactions, ensuring timely communication and resolution of quality topics.
  • Lead and host regulatory and customer audits, maintaining a culture of quality excellence and inspection readiness.
  • Drive continuous improvement across the Quality Management System to support scalability and operational excellence.

Candidate Profile

  • 10–15 years' experience in Quality Assurance within a biopharmaceutical or CDMO environment.
  • Proven leadership experience managing QA teams in GMP manufacturing for biologics (mAbs, recombinant proteins, viral vectors).
  • Strong understanding of EU GMP Part I & II, Annex 1, and relevant regulatory frameworks.
  • Experience with client audits, regulatory inspections, and commercial product release.
  • Collaborative, pragmatic leader with excellent stakeholder communication skills.

Please apply directly to this job posting if this position sounds of interest

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