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Alphalyse A/S
Odense M
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Senior QC Manager

Would you like to join us at Alphalyse to push the boundaries of biologics development and quality control using advanced LC-MS analytical methods? Alphalyse now seeks a Senior QC Manager to develop, implement, and maintain our quality systems and contribute to groundbreaking solutions for improved impurity control, shaping the future of biologics.

About the role

As an experienced and proactive Senior QC Manager you will take ownership of our Quality Management System (QMS) and ensure compliance within a regulated environment. You will play a central role in maintaining high-quality standards while collaborating with teams across the organization. You will have significant professional influence in a collaborative and quality-driven environment where accountability, quality, and teamwork are essential.

Your responsibilities

  • Lead and guide colleagues during quality initiatives and problem-solving activities.
  • Develop, maintain, and improve quality documentation in compliance with GMP and ISO standards.
  • Collaborate closely with the Head of QC, QA, and QC teams to maintain GMP compliance.
  • Coordinate with other departments to align quality standards and improvement initiatives across GMP and non-GMP processes.
  • Promote a culture of quality by sharing knowledge and delivering QMS training.
  • Drive internal projects to enhance the QMS and QC services.
  • Manage risk assessments, deviations, and laboratory investigations to ensure timely and effective resolution.
  • Prepare for and host client audits and regulatory inspections, ensuring timely closure of findings and corrective actions.

Who you are

You take ownership of systems and processes, ensuring top-quality standards. You are structured and detail-oriented, and you keep the big picture in mind while driving compliance in a pragmatic, collaborative way.

You communicate clearly across all levels, stay calm under pressure during audits and deviations, and proactively make improvements to enhance efficiency. Building trust and strong relationships across QA, QC, and the wider organization comes naturally to you. In this role, success depends on strong personal and team-oriented skills, as it involves collaboration, leadership, and influencing quality across the organization.

Professional Qualifications

Required:

  • MSc, BSc, or equivalent in life sciences, chemistry, or engineering
  • At least 3-5 years of proven experience within QC/QA in a regulated environment (pharma, biotech, or medical devices)
  • Strong regulatory knowledge and interest, including GMP and ICH guidelines
  • Experience with quality documentation and quality systems
  • Skilled in risk assessment and problem-solving
  • Ability to balance quality, speed, and business priorities
  • Structured and analytical with sound decision-making skills
  • Strong organizational and project management skills

Preferred:

  • Experience from a similar position
  • Experience with laboratory operations
  • Experience preparing for client audits and regulatory inspections.
  • Experience with LIMS and digitalization, preferably in GMP areas
  • Understanding of method lifecycle management
  • Understanding of FDA 21 CFR Part 11, and data integrity principles.

What we offer

  • A key role with significant professional influence
  • A collaborative and quality-driven work environment
  • Opportunities for professional and personal development
  • A role where accountability, quality, and teamwork are essential

Are you interested in the position?

Please send your application as soon as possible or no later than January 26, 2026, to thyssen@alphalyse.com. Include a Letter of motivation, CV, and relevant diplomas.

For more information, contact Head of QC Department, Stine Thyssen or Head of Characterization & Data-Driven Innovation, 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 Protein 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 about Alphalyse at www.alphalyse.com

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