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Device Project Manager

Zealand Pharma, a visionary and ambitious company, offers you an once-in-a-lifetime opportunity to become a major participant in the establishment of the structure and function of device development from square one, giving you a unique influence on the way devices are developed in the future.

As Device Project Manager at Zealand Pharma, you will be responsible for managing the device activities in new drug/device projects with partners and contract manufacturing organizations. Furthermore, you will report directly to VP, Commercial Manufacturing.

Your key responsibilities:

  • Ensure that device projects are progressing according to the plan
  • Ensure that quality is reviewed and evaluated for approval and implementation in a timely manner
  • Provide input to, and take ownership of, design and development of devices used for the drugs developed by Zealand Pharma
  • Coordinate and manage device-consultants to assist with device development projects
  • Ensure that all activities are conducted in compliance with relevant regulatory requirements
  • Maintain full-scope responsibility for assigned projects: ensure on-time delivery, communicate the status of projects to internal teams and vendors, execute quality assurance procedures on work produced by others, and ensure that device development projects are conducted according to specifications
  • Mature quality systems for device data generated during device development to a commercial readiness setting
  • Identify gaps, create improvements, and design work processes

Ideally, you hold a Master’s Degree in Pharmacy, Chemical Engineering or the like combined with several years of experience from working with device development and project management.

Qualifications required of the position include having relevant manufacuturing and pharmaceutical industry experience in the planning and execution of device development projects, and a proven history of effectively contributing to business plans at both the tactical and strategic levels. Moreover, you have a solid background and experience in working with external partners (CROs, CMOs and consultants) and you have extensive knowledge of GMP, ICH guidelines, FDA regulations, 21 CFR Part 11, familiarity with EMA/CHMO regulations and guidelines as well as other international regulatory guidelines. You are knowledgeable about medical device regulations, and you are comfortable managing multiple programs with competing and aggressive time lines. Finally, you can prioritize activities and work independently in a rapidly changing, not fully structured internal and external environment.

You have excellent English communication skills, both spoken and written and you are an advanced user of MS Office, Access and other relevant IT tools or systems.

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 detail 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 upper management 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 our ambitious corporate goals.

Travelling: App. 20 – 30 days a year

Domicile: Glostrup, Copenhagen

For more details about the job or the company, please contact Partner Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25. 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