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QA, Vendor Manager

Zealand Pharma is entering a new exciting era – with a strategy of becoming a fully integrated visionary biotech company with full ownership of own product candidates through late stage development and ultimately commercialization to market.

Development includes both drug and device in parallel and preparation for marketing authorization of combination products. All GxP activities are outsourced to CROs/CMOs – such as pre-clinical studies, bioanalyses and PK studies, manufacturing of Drug Substances and Drug Products as well as Fininished Products, Investigational Medicinal Products, and Clinical Trial Management.

In order to meet the requirements, Zealand Pharma is looking for a QA, Vendor Manager to be a part of this exciting journey.

As QA, Vendor Manager at Zealand Pharma, you will be responsible for the overall Vendor Management Oversight Program. The QA area at Zealand Pharma is now professionalizing to ensure GxP compliance within all areas: you, your skill-set and knowledge, in cooperation with the QA team, are needed on this journey. In the role as QA, Vendor Manager you will also be part of the QA Management team. You will be reporting directly to Vice President, Head of QA.

Your key responsibilities:

  • Design and maintain processes and systems for vendor selection, management, transfer and oversight
  • Secure vendor oversight according to procedures
  • Plan and coordinate internal and external audits
  • Set up training courses and perform training
  • Assign and collaborate with external lead auditors
  • Prepare and execute regulatory inspections
  • Review and approve requests for information, vendor assessment reports, audit reports etc.
  • Handle vendor notifications and CAPAs
  • Coordination and alignment of the vendor mangement program with the development projects
  • Coordination and alignment of the vendor mangement program with Legal and Supply Chain departments

Ideally, you hold a Master’s Degree in Pharmacy, Chemical Engineering or the like, combined with experience of working in a GxP environment, as well as having experience from a vendor management role.

Qualifications required of the position include having a minimum of 5 years of experince working in a GxP environment in either the biotech or pharmaceutical industry. You have at least 2 years working experience in the Vendor Oversight role, where you have demonstrated experience in designing and maintaining processes and systems for vendor selection, management, transfer and oversight. Furthermore, you have experience in contract design and negotiations. You thrive in a role with many different internal and external stakeholders and you know the importance of good stakeholder management. It is expected that you have demonstrated good oral and written communication skills and experience with multicultural collaboration with international vendors.

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 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. 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 Senior Consultant Jannie Jensen, Unique Human Capital on M: +45 29 72 78 86. All applications must be in English and are treated confidentially.

 

Zealand Pharma offers an exciting, interdisciplinary and challenging job at a workplace, which encourages continuous learning at work and sharing of best practices. They have an inclusive corporate culture where they believe in development of their employees. All employees at Zealand benefit from a combined remuneration package including pension scheme and health insurance as well as lunch plan, massage, fitness room, and social clubs. 

Read more at www.zealandpharma.com

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Unique Human Capital A/S
cvr: 31502705

Stamholmen 151
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
T +45 7020 6700
Marselis Tværvej 4
8000 Aarhus C
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
Poland
T + 48 22 291 32 20