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QA specialist with biological QP experience - Corporate Product Quality Biologics

Requistion ID:  1447

Copenhagen, N/A, DK

Date:  06-Nov-2020

<span style="font-family:"Arial",sans-serif">QA specialist with biological QP experience – Corporate Product Quality Biologics


<span style="font-family:"Arial",sans-serif">Are you passionate about quality assurance and would you like to have an integral role in assuring quality and patient safety for Lundbeck’s commercial biopharmaceutical products? We are looking for a QA specialist to function as a QP deputy for biological products in the newly established Corporate Product Quality Biologics (CPQB) department within the Corporate Product Quality (CPQ) organization with focus on release of drug substance (DS), drug product (DP), and final product (FP) to global markets. This open position holds the unique opportunity to be part of designing and shaping the way CPQ works with commercial biopharmaceuticals across the organization in Valby, Lundbeck Seattle Biopharmaceuticals (Lu-SBP) and CPQ North America (CPQ NA).


<span style="font-family:"Arial",sans-serif">You will be joining a group of highly competent colleagues in CPQB and collaborate with colleagues across the entire CPQ organization. The CPQ biopharmaceutical operations covers multiple sites across Valby, Seattle and New Jersey with all manufacturing and analyses being outsourced to CMO/CROs.


<span style="font-family:"Arial",sans-serif">The CPQ organization is responsible for QA and QC oversight of all activities related to release of commercial products within the entire Lundbeck supply chain, from starting materials to release of FP to all global markets and currently comprises approximately 175 employees. In addition, CPQ has a wide range of responsibilities amongst other:

  • <span style="font-family:"Arial",sans-serif">Assuring compliance and continuous development of the quality system
  • <span style="font-family:"Arial",sans-serif">Internal and external audits of commercial CROs/CMOs as well as partners
  • <span style="font-family:"Arial",sans-serif">Handling of complaints and recalls of commercial biopharmaceutical products globally


<span style="font-family:"Arial",sans-serif">Your job and key responsibilities

  • <span style="font-family:"Arial",sans-serif">Acting as a QP deputy releasing biopharmaceutical FP in close collaboration with the designated QP of commercial Biologics
  • <span style="font-family:"Arial",sans-serif">Reviewing/approving documentation related to manufacturing and analysis of biopharmaceutical DS, DP and FP e.g. master batch records, batch documentation, product specification, deviations and change requests
  • <span style="font-family:"Arial",sans-serif">Advising on quality matters related to GMP compliance in commercial production of biopharmaceuticals
  • <span style="font-family:"Arial",sans-serif">Daily contact with subject matter experts in CPQ in Valby as well as colleagues in Lu-SBP
  • <span style="font-family:"Arial",sans-serif">Participating in designing how the commercial quality organization works with biopharmaceuticals on a global scale
  • <span style="font-family:"Arial",sans-serif">Participating in internal and external audits of partners, CROs and CMOs in EU (approx. 15 days/year)


<span style="font-family:"Arial",sans-serif">We offer

<span style="font-family:"Arial",sans-serif">An exciting job opportunity in a newly established area with many different responsibilities supporting the commercial biopharmaceutical quality department. You will have the opportunity to set the course for quality assurance of biopharmaceuticals in the commercial quality department. Furthermore, you will have a broad collaboration with colleagues in both Valby, Seattle and New Jersey, solving significant quality matters related to the commercial biopharmaceuticals. The possibility of expanding job content depending on interest and competencies.


<span style="font-family:"Arial",sans-serif">Qualifications and competencies

<span style="font-family:"Arial",sans-serif">You are self-driven, professional individual who likes working in an informal team setting with the following professional qualifications:

  • <span style="font-family:"Arial",sans-serif">Relevant academic background – Master’s degree in biochemistry, pharmacy or equivalent
  • <span style="font-family:"Arial",sans-serif">More than 10 years of work experience from the pharmaceutical industry within quality assurance Experience with qualified person obligation within biopharmaceuticals is strongly desired
  • <span style="font-family:"Arial",sans-serif">Extensive experience with GMP requirements for release of biopharmaceutical products
  • <span style="font-family:"Arial",sans-serif">Biopharmaceutical audit experience is desirable
  • <span style="font-family:"Arial",sans-serif">Strong quality mind-set with the ability to find the right solutions together with your colleagues
  • <span style="font-family:"Arial",sans-serif">Positive, team-player and a good sense of humor


<span style="font-family:"Arial",sans-serif">Further information

<span style="font-family:"Arial",sans-serif">For further information please contact Senior Vice President of CPQ Lene Andersen on +45 30832471. We also recommend that you have a look at our website www.lundbeck.com.


<span style="font-family:"Arial",sans-serif">Your applications

<span style="font-family:"Arial",sans-serif">Please click on the link below to apply for the job. Applications must be received no later than 1st of December 2020. The first interviews will start during the application period.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
Read more at www.lundbeck.com/global/about-us/progress-in-mind. 
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.