Director, Qualified Person (QP) for IMP

Requistion ID: 5325

Location:

Copenhagen, Danish Capital Region, DK

Director, Qualified Person (QP) for IMP

Do you dream of being Qualified Person (QP) and people manager for at team of QP delegates responsible for certifying Investigational Medicinal Product (IMP), while supporting development of new treatments for brain diseases by ensuring patient safety and GMP compliant IMP to clinical trials? Then this is a unique opportunity to join CMC Development QA in a newly established team, with a great opportunity to streamline the QP certification processes across modalities of biologic and small molecules. The QP delegate team will have a central role and collaborate with multiple stakeholders leveraging your professional and personal competencies.

We offer an exciting job with a broad variety in your daily work ensuring compliance for IMP from early to late phase pipeline projects.

Your new role – why is this a great opportunity?

You will be heading up a newly established team of 3 QP-delegates. As the QP you are responsible for the QP competencies of the QP-delegates and you will be responsible for bringing in new requirements and ensuring interpretation of these into the CMC Development QA organization.

You will be responsible for the IMP QP certification, recall, complaint and QP register processes. You will be responsible for QP assessment of potential quality or regulatory impact for deviations and laboratory deviations while leveraging on your solid experience in cGMP for IMP.

You thrive in driving continuous improvements and will be motivated by streamlining the certification process by a compliant modality agnostic approach. As our pipeline includes combination products you will also be accountable for implementation of QP-release requirements for combination products.

You will join a growing department with an exciting future ahead with expected upcoming purchase off new drug candidates. The job offers great opportunities to grow your competencies and knowledge and to widen your duties and responsibility as you develop in the role.

Your future team

The CMC Development QA organization consists of approximately 20 employees based in Copenhagen and Seattle, US who together are responsible for efficient and compliant quality processes in support of the development of Small Molecule and Biologics drug candidates including device activities. The most of the manufacturing activities in CMC are outsourced to CMO´s.

You will be working from Headquarter located in Valby, Copenhagen and will be working primarily inDK time zone but with ad hoc meetings with peers from Seattle primarily in the timeslot from 16.00-18.00.

As an experienced leader you will support the development of an engaged and empowered team by setting the direction, taking risk-based decisions founded on your solid experience.

You work closely with peers in QA and collaborate with competent stakeholders across the CMC area all with the aim of developing new innovative treatments. We enjoy learning every day and thrive in the dynamic CMC environment. We offer a unique position for you to build upon your experiences and professional development.

What you bring to the team

• You hold a master’s degree in pharmacy or similar qualifications to meet the requirements of a QP

• You have experience as either a QP or a QP delegate

• Experience from a management position

• Solid understanding of cGMP requirements for development

• Understanding of biologic manufacturing

• Experience in small molecules or combination products is preferred.

• You are fluent in English

Our promise to you

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn or Instagram (@h_lundbeck).

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. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Director CMC Development QA – Charlotte Ullits Houlbjerg via phone +45 3083 21 69. Applications must be received by 01-jun-2024 2024. Relevant candidates will be invited for interviews as applications are received.

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and 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 .

About Lundbeck

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.

About Lundbeck

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.