Senior QA Manager

Senior QA Manager Apply locations Søborg, Denmark time type Full time posted on Posted 2 Days Ago job requisition id JR324 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. Interested in bonding with us? Then please apply no later than 31 August 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, [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 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