Associate Director, GCP Quality – R&D QA

Does it excite you to work with pragmatic, risk-based GCP quality leadership in clinical development?, and do you have experience with Good Clinical Practice (GCP) oversight and inspection readiness? 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 Associate Director, GCP Quality in R&D QA, this role supports clinical development projects by providing hands-on quality oversight and expert guidance to ensure patient safety, data integrity, and regulatory compliance. The position partners closely with clinical trial teams, particularly during trial start-up and key milestones, to enable efficient, compliant execution. This is an individual contributor role, providing specialized functional leadership and subject matter expertise within GCP quality. The role also contributes to inspection readiness and continuous improvement of the Quality Management System (QMS) across development activities.

We offer exciting responsibilities:

• Lead quality oversight for defined clinical development projects/components in accordance with GCP and the internal QMS
• Provide pragmatic, risk-based QA guidance to clinical trial teams during trial start-up, execution, and key milestones
• Plan and conduct audits, and ensure timely, effective follow-up of audit findings
• Drive inspection readiness activities and support regulatory inspections (preparation, hosting support, and responses)
• Oversee quality events (e.g., deviations, corrective and preventive actions (CAPAs), and change controls) and support assessment/management of suspected serious breaches
• Contribute to QMS continuous improvement, including SOP governance (e.g., participation in the GCP SOP Committee) and aligned training

Your profile
This role suits a GCP quality professional with high integrity, sound judgment, and a pragmatic mindset. The ability to navigate complexity, focus on what matters most, and collaborate effectively across functions and seniority levels is important. A mentoring approach and comfort influencing without formal authority are key.

• Solid experience in clinical trial management and/or QA/compliance within clinical development
• Strong, in-depth knowledge of Good Clinical Practice (GCP); knowledge of Good Pharmacovigilance Practice (GvP) and/or Good Laboratory Practice (GLP) is an advantage
• Proven experience conducting audits, supplier qualification, and supporting regulatory inspections
• Hands-on experience managing deviations, CAPAs, and change control in a regulated environment
• Demonstrated ability to apply risk-based thinking to deliver compliant, practical solutions
• Strong communication and stakeholder management skills, with the ability to influence and lead without formal authority

Your new team
The role joins the R&D QA team, a group of experienced QA professionals supporting development activities through audits, quality event management, SOP governance, and inspection support. The team works closely with clinical trial teams and key stakeholders to strengthen quality and compliance across the development QMS and enable high-quality clinical trial execution.

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 February 15, 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 Senior Director, Head of R&D QA, Sanne Mathias and smathias@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.