Senior QA Manager

Zealand Pharma A/S; Gladsaxe Kommune; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Zealand Pharma A/S is seeking a Senior QA Manager, GLP & GCP to lead GLP quality assurance across non-clinical development programs and grow in GCP quality oversight.

The role focuses on GLP audits of contract research laboratories with opportunities to expand into GCP and clinical trial quality oversight.

Qualifications

• Solid, hands-on GLP auditing experience — study audits, facility audits, and raw data reviews.
• Strong knowledge of OECD GLP Principles and/or FDA 21 CFR Part 58.
• Familiarity with computerized system requirements (21 CFR Part 11, ICH E6(R3), GAMP5).
• GCP experience in clinical QA, clinical operations, or audit roles is an advantage — not a requirement.
• Experience managing quality events, deviations, CAPAs, and change control in a regulated environment.
• Experience supporting regulatory inspections is an advantage.

Responsibilities

• Plan and execute our risk-based audit program covering GLP test facilities, non-clinical studies, and GCP service providers — including computerized system elements
• Conduct and report GLP audits, including study and facility audits at contract research laboratories, assessing data integrity and GLP compliance
• Support GCP audits at clinical trial service providers as you build your GCP expertise
• Advise clinical trial teams on protocol compliance and service provider oversight
• Manage quality events from GCP activities — including serious breaches, deviations, CAPAs, and change control — driving timely root cause analysis
• Establish and maintain QA relationships, quality agreements, and oversight plans with service providers and contract laboratories

Skills

GLP auditing

GCP awareness

Data integrity

Risk-based QA

Regulatory inspections experience

Tools

Computerized systems

Job description

Are you excited by pragmatic, risk-based quality assurance and do you bring solid, hands-on GLP auditing experience of contract research laboratories? If you're also ready to grow into GCP and clinical trial quality, we'd love to hear from you. 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 QA Manager, GLP & GCP, you will lead GLP quality assurance across our non-clinical development program, while building your expertise in GCP and clinical trial quality oversight. The role is primarily GLP-focused — covering test facility and study audits at contract research laboratories — with GCP audit support as an area you will grow into. You'll combine hands‑on QA oversight with a risk-based, pragmatic approach, where inspection readiness, quality event management, and cross‑functional partnering are central. We offer exciting responsibilities:

• Plan and execute our risk‑based audit program covering GLP test facilities, non‑clinical studies, and GCP service providers — including computerized system elements
• Conduct and report GLP audits, including study and facility audits at contract research laboratories, assessing data integrity and GLP compliance
• Support GCP audits at clinical trial service providers as you build your GCP expertise
• Advise clinical trial teams on protocol compliance and service provider oversight
• Manage quality events from GCP activities — including serious breaches, deviations, CAPAs, and change control — driving timely root cause analysis
• Establish and maintain QA relationships, quality agreements, and oversight plans with service providers and contract laboratories

Your profile You bring a strong GLP auditing background, paired with the curiosity and drive to develop in GCP. A team player with a pragmatic, solution‑oriented approach to QA, you translate compliance requirements into workable, proportionate solutions. GCP experience and familiarity with computerized systems are an advantage — not a requirement. What matters most is solid GLP expertise, a risk‑based mindset, and the motivation to grow into a broader GxP auditor role.

• Solid, hands‑on GLP auditing experience — study audits, facility audits, and raw data reviews — in a pharma or biotech setting
• Strong knowledge of OECD GLP Principles and/or FDA 21 CFR Part 58
• Familiarity with computerized system requirements (21 CFR Part 11, ICH E6(R3), GAMP5) is an advantage
• GCP experience in clinical QA, clinical operations, or audit roles is an advantage — not a requirement
• Experience managing quality events, deviations, CAPAs, and change control in a regulated environment
• Experience supporting regulatory inspections is an advantage

Your new team You'll join the R&D QA team, supporting development activities through audits, quality event management, SOP governance, and inspection readiness. The team partners closely with clinical trial teams, non‑clinical scientists, and IT QA functions. Your specialist depth in GLP will meaningfully expand the team's capabilities and reach.

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.

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. #LI-Onsite Since our founding in 1998, Zealand Pharma has built a core expertise in the discovery, design, and development of therapeutic peptides. This expertise has led to an R&D pipeline of innovative investigational candidates designed to address a broad range of disease areas. We have four therapeutic focus areas: obesity, rare diseases, chronic inflammation, and type 1 diabetes. In obesity, our peptide capabilities place us in a unique position to address a vast global health challenge and positively impact hundreds of millions of lives. Within rare diseases, we have a long‑standing commitment to deliver new treatments to patients living with congenital hyperinsulinism and short bowel syndrome. For chronic inflammatory diseases, we are progressing peptide programs focused on high‑profile targets shown to be difficult to address with small molecules and antibodies. For type 1 diabetes, we aspire to change the management of this disease. Our strategy is to pursue global co‑development and commercialization partnerships that complement and extend our capabilities across the value chain to deliver new peptide therapies to people who need them.

For further information, please contact Senior Director, R&D QA, Sanne Mathias, [e-mail].