QA Manager

Zealand Pharma; Søborg; On-site; DKK 800,000 - 1,100,000; Full time

Job summary

Zealand Pharma A/S is seeking a QA Manager for complaint management to strengthen our quality systems for clinical and marketed products. You will own complaint processes, collaborate with Manufacturing QA, the CMC organization, CMOs and Partners to ensure compliant and scalable workflows.

You bring a Master’s degree in life science or pharmacy, strong GMP knowledge, and hands-on eQMS experience (Veeva Vault). This role offers opportunities to drive continuous improvement across the organization.

Qualifications

• Master’s degree in life science or pharmacy.
• Experience within the life science industry.
• Experienced with complaint processing of drugs, medical devices, and/or drug-device combination products.
• Solid understanding of GMP requirements and Quality Systems within pharmaceutical development and manufacturing.
• Experience working with electronic Quality Management Systems (eQMS), ideally Veeva Vault.
• Proven ability to drive compliant, timely solutions with a structured, result-oriented, and approachable way of working.
• Strong communication skills (written and verbal), including interaction with external suppliers and partners; willingness to travel as required.

Responsibilities

• Build and strengthen our complaint competencies internally.
• Complaint management, incl. support, coordination and contact with stakeholders.
• Collaborate with Manufacturing QA, CMOs, Partners and cross-functional stakeholders on complaint-related matters.
• Maintain and continuously improve complaint and recall processes, including procedures, templates, training, and ways of working.
• Manage recall (and mock recalls) related activities.
• Contribute to the development and optimization of Veeva Quality Vault and related complaint management processes.
• Support the use of quality data, reporting, and trending to drive continuous improvement.

Skills

Quality management

Cross-functional collaboration

Strong communication

GMP knowledge

Pharma industry experience

Education

Master’s degree in life science

Tools

Veeva Vault

Job description

Does it excite you to work with Complaint Management, and do you have experience within cross-functional CMC collaboration and CMO and Partner communication? 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 our QA Manager for complaint management, you will play a crucial role in building and strengthening our complaint management systems, and handling complaint processes regarding both clinical products as well as marketed products. You will work closely with Manufacturing QA, the CMC organization internally, CMOs and Partners to ensure that the process supports both compliance and the needs of the business. The role combines hands-on complaint management with process ownership and continuous improvement of the quality systems supporting complaint handling processes for both clinical products and marketed products. This is an exciting opportunity to take ownership of an important quality process and contribute to how we develop efficient, compliant, and scalable ways of working across the organization.

We Offer Exciting Responsibilities

• Building and strengthening our complaint competencies internally
• Complaint management, incl. support, coordination and contact with stakeholders
• Collaborate with Manufacturing QA, CMOs, Partners and cross-functional stakeholders on complaint-related matters
• Maintain and continuously improve complaint and recall processes, including procedures, templates, training, and ways of working
• Manage recall (and mock recalls) related activities
• Contribute to the development and optimization of Veeva Quality Vault and related complaint management processes.
• Support the use of quality data, reporting, and trending to drive continuous improvement

Your profile

The role suits a quality-minded, collaborative professional who can balance a pragmatic approach with strong compliance judgment and clear stakeholder communication. Success requires the ability to build trusted relationships.

• Master’s degree in life science, pharmacy, or similar
• Experience within the life science industry
• Experienced with complaint processing of drugs, medical devices, and/or drug-device combination products
• Solid understanding of GMP requirements and Quality Systems within pharmaceutical development and manufacturing
• Experience working with electronic Quality Management Systems (eQMS), ideally Veeva Vault
• Proven ability to drive compliant, timely solutions with a structured, result-oriented, and approachable way of working
• Strong communication skills (written and verbal), including interaction with external suppliers and partners; willingness to travel as required

Your new team

You will join Quality Systems within QA, a team of 9 colleagues responsible for developing, maintaining, and continuously improving our Quality Management System and the digital solutions supporting it.

The team works across QA and the wider organization to ensure robust, efficient, and scalable quality processes. Our responsibilities include Quality Management System processes, quality documentation, training, process management, and the continued development of our digital Quality Systems, including Veeva Quality Vault.

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.

For further information, please contact QA Director Kamilla Vagtborg, [e-mail].

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.