Associate Director, GCP Quality – R&D QA

Are you passionate about providing pragmatic, risk-based quality leadership that enables high quality clinical development? Do you have solid expertise in Good Clinical Practice (GCP) and enjoy guiding teams through complex development challenges? If so, this could be your opportunity to join Zealand Pharma as Associate Director, GCP Quality in R&D QA.

Your new position

As Associate Director, GCP Quality in R&D QA, you will play a vital role in supporting midsized development projects and providing specialized leadership across key components of clinical development programs. You will combine hands-on quality oversight with strategic judgment to protect patient safety, data integrity, and regulatory compliance.

You will lead defined segments of projects—often within Phase 1 or 2 clinical development—and act as a recognized subject matter expert within Clinical quality. Through close collaboration with clinical trial teams and Compliance, Outsourcing, Legal , QMS QA and IT QA, particularly during trial startup and critical milestones, you will ensure compliant, efficient execution of clinical audits and contribute to inspection readiness and continuous improvement of the Quality Management System (QMS).

Key responsibilities

Quality leadership and oversight

• Lead quality oversight for specific clinical development projects or defined components, ensuring alignment with GCP and internal QMS requirements
• Provide expert, risk-based QA guidance to clinical trial teams, particularly during trial startup and execution of critical milestones
• Serve as a key resource and mentor for QA Managers within your area of expertise
• Drive and support GCP training for Development organization

Audits, inspections, and compliance

• Plan, conduct, and oversee audits (e.g., GCP, GvP, GLP) and ensure timely, effective follow-up of audit findings
• Support and contribute to inspection readiness activities and regulatory inspections, including preparation, hosting support, and responses
• Lead or support assessment and management of suspected serious breaches related to clinical trials, including escalation and documentation
• Drive cooperation with our preferred service providers QA functions according to established Clinical Quality Agreements.

Quality events and continuous improvement

• Oversee and drive quality events such as deviations, CAPAs, and change controls, applying sound judgment to resolve complex issues
• Lead continuous improvement initiatives within the development QMS, incorporating industry trends and regulatory expectations
• Lead and/or contribute to the GCP SOP Committee, ensuring high quality, consistent QMS documentation and aligned training

Collaboration and decision-making

• Engage effectively with internal and external stakeholders to ensure cohesive execution of project objectives and strategic goals
• Make impactful decisions within defined project components or functional areas, addressing complex problems with structured methodologies

Your profile

You are a highly skilled GCP quality professional with strong integrity, sound judgment, and a pragmatic mindset. You thrive in complex environments, balancing detailed analysis with a clear focus on what matters most. You are recognized for your expertise and your ability to guide, mentor, and collaborate across functions and seniority levels.

• Solid experience in clinical trial management and/or QA/compliance within clinical development. Typically, 10+ years of industry experience within clinical development and preferably at least 2+ years in QA/Compliance roles.
• Strong, in-depth knowledge of GCP; familiarity with GvP and/or 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, pragmatic solutions
• Strong communication and stakeholder management skills, with the ability to influence and lead without formal authority

Your new team

You will join the R&D QA team, a group of experienced QA professionals who work as one integrated team to support development activities through audits, quality event management, SOP governance, and inspection support. We actively use each other’s expertise to discuss and navigate GCP grey areas, fostering open dialogue, shared learnings, and consistent decision‑making. The team works closely with clinical trial teams and key stakeholders to strengthen quality and compliance across the development QMS and to enable high‑quality clinical trial execution.

Let’s bond and be bold

At Zealand Pharma, our culture is built on strong collaboration, curiosity, and the courage to challenge conventional thinking. We foster an environment that supports innovation, teamwork, and continuous advancement—and we expect our leaders to actively contribute to this culture.

Making bonds is at the core of everything we do: with patients, partners, and each other. Join us, and help shape the future of peptide‑based medicines. Let’s bond and be bold.

Interested in bonding with us?
Please apply no later than 23 Mar 2026, or as soon as possible. Applications will be reviewed on an ongoing basis. While a cover letter is not required, please include a few sentences in your CV describing your motivation for applying.

For further information, please contact Senior Director, R&D QA, Sanne Mathias at smathias@zealandpharma.com.

We are committed to an inclusive recruitment process and welcome applications from all qualified candidates.

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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