Be the new
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S is a Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence the U.S. as well.
Zealand is seeking an Application Manager, to join our team QA Computerized Systems within the QA department. The Application Manager will be responsible for our eTMF, safety database and SAS system.
The successful candidate will be responsible for:
The applicant will be part of a collaborative team that holds system responsibility for many GxP IT Systems, so back up and assistance with other internal GxP systems e.g. (Serialization, ERP and EDMS/QMS) will be needed.
Our team also focuses on further developing the system governance and quality system on the use and maintenance of GxP systems in Zealand Pharma.
In the QA department, you will be a part of a dedicated group of people with a positive and structured mindset. Here, we collaborate closely and are in close dialogue with our other colleagues and partners while we ensure and secure compliance in the organization. You will be welcomed as a part of our ambitious and passionate Zealand family working seamlessly and effectively in a fast-paced environment providing life changing medicines.
The successful candidate will have most or all the below qualifications:
- Planning for and implementing upgrades, bug fixes, changes etc. in close collaboration with users
- Assuring good communication to and from end-users and data owners by e.g., hosting System Steering Groups
- Daily administration i.e., user maintenance, user assistance, and problem solving
- Performing Periodic System Reviews
- Assuring a validated and compliant system status in close collaboration with users, System Owner and vendors throughout the system lifecycle
- Ensuring system governance by providing data to System Steering Committee and align with IT Committee
- Present system validation during audits and Inspections
What we offer
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Our work environment is characterized by strong cross functional teamwork, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined compensation package which includes a base salary, pension, bonus, and an attractive employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities. To find out more about working at Zealand, visit www.zealandpharma.com.
Please apply no later than February 15, 2023. We review applications on a rolling basis.
For further information, please contact Associate Director, Head of Computerized Systems, Pernelle Quist on firstname.lastname@example.org
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.
- 3+ years in experience with GxP IT systems and infrastructure in the pharmaceutical/biotech industry
- Practical experience with FDA 21CFRpart 11, EU Annex 11, and GAMP 5
- Strong practical knowledge of GxP and authority inspections
- Excellent communication skills in English both verbally and in writing.