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Director, Qualified Person (qp) For Imp, Copenhagen

Denmark, Denmark, Copenhagen
Udgivet 2024-06-08
Udløber 2024-06-12
ID #2186083916
Free
Director, Qualified Person (qp) For Imp, Copenhagen
Denmark, Denmark, Copenhagen,
Udgivet June 8, 2024

Beskrivelse

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 c GMP 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 in DK 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 c GMP 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.

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 30-jun-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 .

#Every Brain In The Game 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.

Joboplysninger

Jobtype: Fuld tid
Kontrakttype: Permanent
Løn type: Månedlige
Beskæftigelse: Director, qualified person (qp) for imp

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