Product Quality Lead, CMC Development Quality

Product Quality Lead, CMC Development Quality 

Lundbeck is advancing a strong pipeline of small molecule and biologic therapies to address significant unmet needs in brain disorders. As part of our ambition to become a more data- and digitally enabled organization, we are increasingly leveraging advanced analytics and AI to strengthen decision-making across development and quality.

We are expanding our Product Quality Lead (PQL) capabilities and are looking for an experienced quality leader to partner with our small molecule development programs. In this role, you will bring both technical expertise and a pragmatic, risk-based approach to quality, supporting cross-functional teams as molecules progress from clinical development into commercialization.

Your new role

As a Product Quality Lead, you will act as the primary quality representative for your assigned program(s), working closely with colleagues across development, manufacturing, regulatory, and external partners. You will contribute to quality oversight across development, helping teams navigate complexity, manage risk, and align with global health authority expectations.

This is a senior individual contributor role in a matrix environment, where success depends on your ability to build trust, provide clear guidance, and support balanced decision-making across functions. You are comfortable working in evolving environments and contributing to how quality is integrated into development teams.

As a Product Quality Lead, you will:

• Act as the primary quality point of contact for the project, engaging relevant QA experts as needed


• Support science- and risk-based evaluation of complex process and product quality data


• Contribute to patient-focused strategies that balance quality, compliance, and business needs


• Identify and anticipate quality and health authority risks early and support development of pragmatic mitigation approaches


• Support alignment of development documentation with health authority expectations


• Contribute to the transition of products from clinical development to commercial manufacturing


• Work with internal stakeholders and external CMOs to support alignment on quality expectations


• Use data, digital tools, and emerging AI capabilities, to support quality oversight and risk-based decision-making.

Some travelling, up to 4 trips per year, is estimated in this role.

Your future team

You will report to Senior Director CMC Development Quality Assurance and join a collaborative, global team based in Copenhagen, Denmark and Seattle, USA.

The team consists of Product Quality Leads and Quality Systems and works closely with other CMC Development QA functions, including QP/QP delegates and vendor management. You will be part of a cross-functional environment where perspectives are shared and balanced to support program progression.

As our team is located both in Copenhagen and Seattle, it is necessary to accommodate to the time zone difference for meetings. We aim to reduce late meetings to a minimum by maintaining a primary meeting band in the calendar and by applying a geographical proximity, when working with our global CMOs.

The position is based in Copenhagen, Denmark.

What you bring to the team

• Degree in chemistry, biochemistry, or a related pharmaceutical sciences field (advanced degree preferred)


• Typically 8–12+ years of experience in a regulated environment, with increasing responsibility across quality, development, manufacturing, or regulatory functions


• Experience in small molecule development across one or more of the following areas: quality, analytical development, process development, manufacturing or regulatory


• Strong knowledge of cGMP and global health authority requirements, and the ability to apply these in complex, evolving development contexts


• Experience working in cross-functional teams and contributing to quality-related decision making


• A pragmatic, risk-based mindset and the ability to balance quality, compliance, and business needs


• Experience collaborating with external partners such as CMOs is an advantage


• Comfort working with data and digital tools, and interest in applying emerging AI capabilities in a quality and development context


• Strong communication skills and ability to work effectively across functions and cultures

Experience with biologic drug development is an advantage

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: 786 000 - 1 081 300 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.

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 Shannon Carstens ([email protected])

Applications must be received by 24 June 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.