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QA Manager – CMC

Work with QA in a fast growing and exciting biotech company

Zealand Pharma is entering a new exciting era with a strategy of becoming a world leader in treating specialty gastrointestinal and metabolic diseases. This entails bringing medicines for rare diseases all the way to the market through late state development and ultimately commercialization to market, all while continuing to grow the business through strong partnerships.

Development includes both drug and device products and preparation for marketing authorization of combination products, and there are several stage 3 products in the pipeline. Manufacturing of Drug Substances and Drug Products as well as Investigational Medicinal Products are all outsourced to CMOs, and hence vendor management and quality oversight remain the important factors of the daily work.

With four late stage projects in the pipeline with planned launches in the upcoming years, Zealand Pharma is looking for a QA Manager – CMC to be part of the QA team, who will join the company on this exciting journey.

As QA Manager – CMC at Zealand Pharma, you will become a part of the growing QA organization overseeing GxP activities and delivering professional guidance to ensure GxP compliance within all areas. You will be responsible for the QA oversight for the development products applying your knowledge within GMP.

The department is headed by the Vice President, Head of QA, and in addition to this position, encompasses 7 QA colleagues. You will be reporting directly to the Vice President, Head of QA.

Your key responsibilities:

QA CMC Responsible

  • Employ GxP QA expertise during the product development providing GMP compliance guidance to internal stakeholders
  • Influence the compliance of projects and programmes
  • Review and approve internal and external documentation
  • Ensure that the CMC Quality Management System at Zealand adheres to applicable regulations and guidelines by QA approval of SOPs
  • Participate in NDA readiness program within CMC
  • Ensure compliance with applicable regulations and quality standards for GMP pharmaceutical operations related to manufacturing, testing, packaging and distribution of investigational drug products, investigational API and investigational devices
  • Prepare Quality agreements for GMP vendors

QP release of IMP

  • Responsible for the review process of DP documentation and the review process of IMP documentation
  • Provide QA guidance to third party vendors to ensure quality of API DP and IMP vendors
  • Participate in relevant GMP audits

Ideally, you want to work with QA supporting the CMC area and hold a Master’s Degree within Pharmacy, Chemical Engineering or the like, with the ability to become a Qualified Person. It is crucial that you have knowledge of the following areas: aseptic preparation, drug development, GxP compliance regulations, quality terminology and techniques, and industry quality assurance.

Qualifications required of the position include having a minimum of 3 years’ experience working in a GxP environment in either the biotech or pharmaceutical industry. You have at least 2 years of experience in an applicable compliance related field and have shown good results through project planning and managing supportive capabilities, ideally from the area of aseptic filling. You have shown an excellent learning agility and might have attended an internal talent program and you are ready to take your career to the next level.

You have excellent English communication skills, both spoken and written, and you are an advanced user of MS Office.

As a person, you have a high level of drive, ambition, and passion. You take initiative, are persistent,  pay a high level of attention to details, and you are goal-oriented. You are comfortable with ambiguity and a risk-based approach to decision-making in a dynamic environment in which priorities and drivers can change rapidly. You can communicate clearly towards your stakeholders, and you are an active project player who cooperates closely with other departments at Zealand Pharma. You are a consistent high performer in your current organization and are looking to grow in your next role. Finally, you are quality driven, open-minded, robust, able to stand firm, and you like to have fun.

At Zealand Pharma, you will be part of a stimulating and informal innovative working environment, where you will interact with both colleagues and partners to deliver on ambitious corporate goals.

Domicile: Glostrup, Copenhagen

For more details about the job or the company, please contact Research Consultant Elisabeth Haun, Unique Human Capital on M +45 28 90 33 88. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
T +45 7020 6700
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cvr: 31502705
Stamholmen 157, 1. tv
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Marselis Tværvej 4
8000 Aarhus C
Unique Human Capital Poland Sp. z o.o.
+48 531 785 064
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ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland