Senior GCP Manager in R&D QA

Are you passionate about working with pragmatic, risk-based QA support that enables high-quality clinical development, and do you have experience with Good Clinical Practice (GCP) quality/compliance? 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 Senior GCP Manager in R&D QA, responsibilities will cover quality oversight across our development activities with a strong focus on clinical trials. The position combines hands-on, detail-oriented work with the ability to assess risk and protect patient safety and data integrity. Close collaboration with trial teams will be central—especially during trial start-up—to enable compliant, efficient execution. The role will contribute to inspections readiness and continuous improvement of the Quality Management System (QMS).

We offer exciting responsibilities:

• Plan and conduct audits (e.g., GCP, Good Pharmacovigilance Practice (GvP), and Good Laboratory Practice (GLP)) and drive timely follow-up actions
• Manage quality events including deviations, Corrective and Preventive Actions (CAPAs), and change cases in line with internal processes and applicable regulations
• Support clinical trial teams with pragmatic, risk-based QA guidance—particularly in trial start-up and critical milestones
• Contribute to inspection readiness and support regulatory inspections, including preparation, hosting support, and responses/follow-up
• Lead and/or contribute to the GCP SOP Committee, ensuring consistency across development QMS documentation and training alignment
• Handle suspected serious breaches related to clinical trials, including assessment, escalation, documentation, and coordination with relevant stakeholders

Your profile
The ideal candidate is a collaborative team player with a pragmatic mindset and strong integrity. The candidate thrives deep diving into complex topics while maintaining the overview needed to focus on what is most critical. Strong stakeholder management skills and clear communication are essential, as the role interfaces broadly across clinical development and quality. Curiosity, structure, and a continuous-improvement mindset will help succeed in this position.

• Experience from clinical trial management and/or from compliance/quality assurance within clinical development
• Solid knowledge of GCP; familiarity with GvP and/or GLP is an advantage
• Experience conducting audits, pre-qualification of suppliers and/or supporting inspection readiness and regulatory inspections
• Hands-on experience managing deviations, CAPAs, and change control in a regulated environment
• Ability to apply risk-based thinking to balance compliant solutions with operational practicality
• Strong communication skills and proven ability to collaborate effectively across functions and seniority levels

Your new team
You will join the R&D QA team, consisting of QA Managers who support 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, with a particular focus on enabling high-quality 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 15 February 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, R&D QA, Sanne Mathias on [email protected].

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.