Director QA External Manufacturing

H. Lundbeck A/S; København; On-site; DKK 1,005,000 - 1,382,000; Full time

Job summary

H. Lundbeck A/S seeks a visionary Director, QA External Manufacturing to lead global QA oversight of CMOs and strengthen governance frameworks. You will shape how Lundbeck partners with external manufacturers, drive quality excellence, and enable business growth while maintaining product integrity.

Based in Denmark with international travel, you will oversee a team of QA professionals, advance scalable processes, and ensure timely batch release and risk management across the network of CMOs.

Qualifications

• Extensive leadership experience in QA for external manufacturing.
• Strong knowledge of GMP and pharmaceutical manufacturing.
• Proven ability to build governance models and scalable processes.
• Experience with CMOs and external manufacturing networks.
• Ability to drive cross-functional partnerships and strategic quality initiatives.

Responsibilities

• Lead, coach, and develop the QA External Manufacturing organization.
• Strengthen QA governance for CMOs and ensure clear accountability.
• Develop robust, efficient, and scalable processes for a global CMO network.
• Oversee day-to-day QA operations including batch release, deviations, and changes.
• Drive harmonization of Quality Systems, risk management, and supplier oversight.

Skills

Leadership

Quality Assurance

GMP Knowledge

Program Governance

Job description

Director, QA External Manufacturing
At Lundbeck, our purpose is to restore brain health so every person can be their best. As our portfolio continues to grow and new products are introduced to patients around the world, External Manufacturing is becoming an increasingly important priority for our business.

We are therefore looking for an experienced Director, QA External Manufacturing to lead our global quality oversight of Contract Manufacturing Organizations (CMOs). This is a unique opportunity to shape how Lundbeck collaborates with external manufacturing partners by strengthening governance, building scalable quality processes, and ensuring that quality and compliance continue to enable business growth.

If you can develop organizations, build strategic partnerships, and drive quality excellence in a global CMO environment, we would love to hear from you.

Your new role

As Director, QA External Manufacturing, you will play a pivotal role in shaping one of Lundbeck's key strategic capabilities. Beyond ensuring GMP compliance and product quality, you will lead the continued development of Lundbeck's global quality governance model for External Manufacturing, enabling consistent oversight across an expanding network of manufacturing partners while supporting new product introductions and future business growth.

Your responsibilities will include:

• Lead, coach, and develop the QA External Manufacturing organization.
• Strengthen Lundbeck's QA governance model for CMOs, ensuring clear accountability, decision-making, and effective quality oversight.
• Develop robust, efficient, and scalable processes and ways of working that support a growing global CMO network.
• Lead the day-to-day operations in QA External Manufacturing ensuring timely batch release, deviation and change control handling while supporting projects involving CMOs.
• Drive harmonization and continuous improvement of Quality Systems, risk management, supplier oversight, and governance across external manufacturing.
• Build strong strategic partnerships with CMOs based on collaboration, transparency, accountability, and continuous improvement.
• Support new product introductions, technology transfers, lifecycle management, and network expansion.
• Provide leadership in managing quality risks, critical quality issues, and complex cross-functional decisions.
• Ensure compliance with global GMP requirements, Lundbeck Quality Standards, and regulatory expectations.

Your future team

You will lead the QA External Manufacturing organization within Corporate Product Quality (CPQ) and be responsible for a team of 10 highly skilled QA professionals supporting Lundbeck's global network of CMOs.

You will collaborate closely with colleagues across Pharmaceutical- and bioproduction, Supply Chain, Regulatory Affairs, Product Development, Procurement, and Commercial Operations. Externally, you will build trusted relationships with key manufacturing partners around the world. Lundbeck is engaged with CMOs in Europe, Asia and North America which require flexibility due to shifting meeting hours.

The position is based in Valby, Denmark. Some international travel is required, approximately 10-20 days per year.

What you bring to the team

You are a collaborative and inspiring leader with a passion for quality, people, and continuous improvement. You thrive in complex global organizations and enjoy balancing strategic development with daily operations.

We imagine that you bring:

• Extensive leadership experience and a strong execution mindset with the ability to get things done and deliver results in a complex, fast-moving environment.
• Significant experience working with CMOs and external manufacturing.
• Deep knowledge of GMP and pharmaceutical manufacturing throughout the product lifecycle.
• Demonstrated experience building or strengthening governance models, operating models, or Quality Systems within External Manufacturing.
• Experience developing and leading high-performing teams and building strong partnerships across complex stakeholder landscapes.
• Strong business acumen with the ability to balance compliance, patient safety, operational performance, and commercial priorities.

It would be an advantage if you also have:

• Qualified Person (QP) experience or eligibility.
• Experience supporting global product launches, technology transfers, or manufacturing network expansion.
• Experience interacting with regulatory authorities and supporting health authority inspections.

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: (1 005 000 - 1 381 600) 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.

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.