Global QA Director, External Manufacturing

Lundbeck; København; On-site; DKK 1,005,000 - 1,382,000; Full time

Job summary

Lundbeck seeks a Director, QA External Manufacturing to lead the global quality oversight of CMOs and shape Lundbeck's governance model for external manufacturing. You will enable consistent oversight across a growing network while supporting new product introductions and lifecycle management.

You will drive QA excellence, partner across functions and geographies, and ensure GMP compliance and regulatory expectations are met in a dynamic, global environment.

Qualifications

• Extensive leadership experience and a strong execution mindset 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 governance models, operating models, or Quality Systems.
• Experience building high-performing teams and cross-functional partnerships.
• Strong business acumen balancing compliance, patient safety, and commercial priorities.

Responsibilities

• 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.

Skills

Leadership

CMO experience

GMP knowledge

Job description

Lundbeck seeks a Director, QA External Manufacturing to lead the global quality oversight of CMOs and shape Lundbeck's governance model for external manufacturing. You will enable consistent oversight across a growing network while supporting new product introductions and lifecycle management.

You will drive QA excellence, partner across functions and geographies, and ensure GMP compliance and regulatory expectations are met in a dynamic, global environment.