Senior QP Delegate (Specialist)

Senior QP Delegate (Specialist)

Do you want to be part of bringing new treatments for brain diseases to patients by securing GMP‑compliant investigational medicinal products for clinical trials?

This opportunity offers a broad and highly impactful quality role, supporting outsourced DS, DP, and IMP development across Lundbeck’s global pipeline. The position provides significant exposure to complex development activities, cross-functional collaboration, and quality oversight in a dynamic environment. It also offers the possibility to contribute meaningfully to patient-focused development programs while helping ensure robust quality and compliance standards across a diverse and evolving portfolio.

Your new role

As Senior QP Delegate in CMC QA Release you are responsible for ensuring compliance with applicable GMP and GDP requirements for investigational medicinal products used in clinical trials. The role holds accountability for batch certification, assessment of deviations, and oversight of external vendors, while actively supporting the continuous improvement of quality systems within CMC activities.

As Senior QP Delegate you independently assess and guide resolution of deviations, complaints, and potential recall situations, with a strong focus on patient safety, product quality, and regulatory impact, while mentoring and coaching colleagues in risk assessment and quality decision‑making.

In addition, you serve as process owner for defined workstreams, ensuring regulatory compliance, robust governance, and effective implementation across the organization.

Your future team

You will join a team of 4 headed by the Qualified Person. We work closely together, support and challenge one another, and value a collaborative environment with room for both professionalism and enjoyment.

The team has a strong opportunity to influence and streamline current ways of working while supporting an expanding and increasingly complex development portfolio.

Your primary workplace will be at Lundbeck’s headquarters in Valby and should therefore live within commuting distance of the Valby headquarters.

CMC QA Release is part of the CMC Development QA organization, comprising approximately 20 colleagues based in Copenhagen and Seattle. The organization is responsible for ensuring efficient, compliant quality processes that support the development of small-molecule and biologic drug candidates, including device-related activities.

In this role, you will work closely with Product Quality Leads, as well as key stakeholders across CMC, manufacturing, supply chain, and quality. You will play an important role in supporting product lifecycle activities, batch release processes, deviation management, change controls, and continuous quality oversight.

What you bring to the team

• At least 5 years of experience as a QP delegate, preferably within CMC
• A minimum of 10 years of experience in a GMP-regulated environment within Quality Assurance, Manufacturing, or Quality Control
• Solid expertise in QA processes, including deviation management, change control, and complaint handling.
• Proficient in batch record review and approval for both biologics and small molecule products.
• Experience with vendor oversight processes, including quality agreements, vendor qualification, and ongoing performance evaluation.
• Excellent problem solving and decision-making skills, with a strong focus on continuous improvement.
• Demonstrated ability to exercise sound, experience-based judgment and to independently assess product quality and patient safety in complex QA/QP deviation or complaint cases.
• Strong risk-based decision-making capabilities, with experience overseeing and governing quality processes.
• Ability to support complex and advanced projects with the appropriate level of maturity, prioritization, and pace.

Our promise to you  

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

Annual base salary range: 687 000 - 944 900 DKK gross

At Lundbeck, we are committed to fair and transparent pay. Please note that the final base salary within the stated range will be based on relevant qualifications, skills, competencies, and level of proficiency as well as internal pay equity.

Apply now

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience

If you have questions, please contact Director, Qualified Person - Malene Brandt-Larsen at mlba@lundbeck.com

Applications must be received by June 17th, 2026.

Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.