Does it excite you to lead IT Quality Assurance for GxP computerized systems, and do you have experience building compliant, scalable frameworks across the product lifecycle? Proven people leadership is essential in this role. 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
Be the new Director, Head of IT QA in a biotech company bonding to discover, design and develop innovative peptide-based medicines. This role leads the IT QA function, setting the quality framework and direction for GxP computerized systems across the product lifecycle. The position partners closely with IT, QA, Clinical, and external vendors/CROs to ensure robust compliance and data integrity. It combines strategic leadership with hands-on oversight of validation, audits, and inspection readiness to enable compliant, scalable growth.
We offer exciting responsibilities:
- Lead, coach, and develop the IT QA team; foster a strong quality and compliance culture across the organization
- Define, implement, and maintain the quality framework for GxP computerized systems (e.g., 21 CFR Part 11, EU GMP Annex 11, GAMP 5) and data integrity
- Provide QA oversight for implementation, validation, change control, and periodic review of regulated IT systems
- Own and execute the IT supplier/CRO audit program, including planning, conduct, reporting, and CAPA follow-up
- Drive inspection readiness and represent the area during authority inspections; ensure timely remediation of findings
- Collaborate with IT, Quality, and Clinical to risk-assess processes, improve ways of working, and deliver training and guidance
Your profile
A seasoned quality leader who builds trust and alignment, balances pragmatism with regulatory expectations, and communicates clearly with technical and non-technical stakeholders. Thrives in a dynamic, growth-oriented setting and enjoys developing people and processes to a consistently high standard.
- Degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field
- Extensive experience in pharma/biotech IT QA or computerized systems validation in GxP-regulated environments
- Deep knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and data integrity principles
- Proven people leadership with the ability to build, mentor, and empower high-performing teams
- Hands-on expertise in CSV, risk management, audits/inspections, and quality management processes
- Strong stakeholder management and communication skills across IT, Quality, Clinical, and external partners
Your new team
Join a dynamic QA department with a can-do attitude that works on projects and provides oversight and advice to colleagues. The IT QA team proactively sets quality standards and follows through on initiatives to secure data integrity in IT systems supporting clinical trials and product quality, enabling products to reach patients. The organization is growing, with high demands for oversight of both internal GxP IT systems and those at Contract Research Organizations. In QA there are four teams covering IT QA, GMP QA, GCP QA, and Quality Systems, and the department is located in Søborg. A workday here includes relationship building, documentation review, audits, training, and daily leadership. You will be part of an experienced and supportive QA Management team, reporting to the Vice President for Quality Assurance, and helping to build the quality foundation for the years to come, with the opportunity to further develop leadership competencies.
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 October 28, 2025, 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 Senior Vice President for Quality Assurance, Morten Urhøj Palm and MPalm@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 the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a team in the U.S. For more information about Zealand Pharma's business and activities, please visit www.zealandpharma.com.
