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QA Director

Alphalyse A/S
Odense M

Would you like to lead the evolution of quality and GMP excellence in a biotech CRO in transformation?

Alphalyse seeks an experienced QA Director to advance our established Quality Management System, embed quality ownership across the organization, and mentor teams in regulatory compliance and GMP practice as we scale our operations.

About the role

As QA Director, you will take ownership of our evolving QA function, with the opportunity to build and lead a QA team as the organization scales. A key part of this role is to translate regulatory requirements into practical guidance and build quality ownership across the organization. You will support the transition from research to GMP-focused operations, balancing quality rigor with the operational realities of a 50-person CRO where GMP and non-GMP activities share space and equipment.

Your responsibilities

  • Review and sign off on QA-critical documents and laboratory records as part of daily operations
  • Take ownership of our Quality Management System and advance quality frameworks while ensuring continued compliance with GMP, FDA, and ICH regulations
  • Build quality awareness across the organization through GMP training, mentoring, and practical guidance on data integrity and compliance
  • Lead risk assessments, deviation management, and investigations while driving continuous improvement
  • Oversee quality in both GMP and non-GMP operations, developing fit-for-purpose solutions for shared resources
  • Prepare for and support client audits and regulatory inspections
  • Apply strong risk-based thinking when supporting implementation of new analytical technologies and defining appropriate control strategies
  • Collaborate with Operations, QC, and Research to align quality standards and support business growth

Who you are

You are a confident QA leader with deep GMP expertise and a passion for teaching and cultural change. You communicate clearly with scientists, technicians, and leadership alike, explaining the why behind compliance. You balance rigor with flexibility, building trust through transparency. You stay calm under pressure, see challenges as opportunities, and take ownership of systems while remaining solution oriented.

Professional Qualifications

Required:

  • MSc in life sciences, pharma, chemistry, or engineering
  • 8-10+years of QA/Compliance experience in pharma, biotech, or medical devices
  • Deep knowledge of GMP, FDA, and ICH guidelines
  • Proven experience developing, implementing and maturing QA systems
  • Demonstrated ability to lead cross-functional quality initiatives
  • Strong communication, coaching, and leadership in English

Preferred:

  • CRO or contract laboratory background
  • Experience supporting client audits and regulatory inspections
  • Knowledge of analytical method validation, data integrity (21 CFR Part 11), or GMP analytical work
  • Familiar with LC-MS analysis

What we offer

  • A senior leadership role with authority to shape quality strategy and governance, scaling our QA systems and GMP readiness as the organization grows
  • Close collaboration with scientific, operational, and leadership teams in a company where quality has visible business impact
  • The chance to work at the intersection of advanced protein analysis, GMP operations, and biopharmaceutical development in a growing CRO
  • The opportunity to define and implement quality frameworks for novel analytical technologies entering regulated environments

Are you interested?

To apply, please send your letter of motivation, CV, and relevant diplomas to pilely@alphalyse.com no later than June 8, 2026. We encourage you to apply as soon as possible.

If you have questions about the role, please contact COO Katrine Pilely at +45 63 10 65 07.

About Alphalyse

Alphalyse is a Danish contract research laboratory founded in 2002. We use our passion for protein analysis to help clients develop safe and effective biopharmaceuticals. An innovative approach has made us world leaders in quantifying Host Cell Proteins using a unique mass spectrometry method. Our technical experts make the analysis results accessible to understand and use, and they take pride in building strong and rewarding relationships with our clients. Our most important asset is our team of highly skilled employees, and we encourage a work environment that is exciting, challenging, and fun. Learn more at www.alphalyse.com

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