QA Manager, Drug Substance

Does it excite you to work with GMP Quality Assurance for Drug Substance in an outsourced development set-up, and do you have experience with QA oversight of CMOs and cross-functional CMC collaboration? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.

Your new position
As our QA Manager – Drug Substance, you will provide QA oversight and compliant quality guidance for drug substance development and GMP manufacturing performed at external CMOs and in close collaboration with partners. You will help ensure robust GMP execution, and timely quality decisions. The role also includes drug substance release activities and may involve occasional travel to support effective oversight and collaboration with external sites. You will join Manufacturing QA in an outsourced business model where strong collaboration and clear quality judgment are key.

We offer exciting responsibilities:

• Provide QA oversight and timely quality guidance for drug substance development activities and GMP manufacturing at CMOs
• Collaborate closely with internal development functions and external CMOs and partners to ensure alignment, compliance, and effective issue resolution
• Participate in CMC project teams, providing operational QA input to plans, deliverables, and risk assessments
• Perform drug substance release activities, including review and approval of relevant GMP documentation in accordance with procedures and agreements
• Maintain and continuously improve the Quality Management System within the GMP area (processes, templates, training, and ways of working)
• Support preparation for and participation in Health Authority inspections and partner audits, including readiness activities and documentation review

Your profile
The role suits a quality-minded, collaborative professional who can balance a pragmatic approach with strong compliance judgment and clear stakeholder communication. Success requires the ability to build trusted relationships while maintaining appropriate QA oversight of suppliers and partners in an outsourced set-up.

• Master’s degree in life science, pharmacy, or similar
• Several years of experience with drug substance GMP operations in the pharmaceutical industry
• Experience with Quality Assurance work supporting drug substance development and manufacturing in an outsourced set-up
• Solid understanding of GMP requirements and Quality Systems within pharmaceutical development and manufacturing
• Proven ability to drive compliant, timely solutions with a structured, result-oriented, and approachable way of working
• Strong communication skills (written and verbal), including interaction with external suppliers and partners; willingness to travel as required

Your new team
You will join Manufacturing QA, which provides QA support and oversight across manufacturing-related activities in an outsourced business model. The team works closely with internal development stakeholders as well as external CMOs and partners to ensure compliant execution, robust quality decisions, and readiness for inspections and partner interactions. The position reports to Martin Wallin, QA Director.

Let's bond and be bold
We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture.

Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let's bond and be bold.

Interested in bonding with us? Then please apply no later than June 7th, 2026, or as soon as possible. The applications will be reviewed as they come in. While a cover letter is not required, please include a few sentences in your CV explaining your motivation for applying.

For further information, please contact QA Director Martin Wallin; mwallin@zealandpharma.com.

We are committed to an inclusive recruitment process and welcome applications from all job applicants.

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data-driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma-invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.

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