GxP Application Manager, Zealand Pharma

GxP Application Manager

Are you passionate about GxP computer validation and system lifecycle management?

Zealand Pharma is now seeking an Application Manager, to join our team QA Computerized Systems within the QA department. The Application Manager will be System Responsible for our eTMF, safety database and SAS system. Furthermore, you will be responsible for the following:

• 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

You will be part of a dynamic team that holds system responsibility for many GxP IT Systems, so back up and assistance with the other internal GxP systems 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 join a group of dedicated 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.

Candidates Profile

We imagine you will bring along most or all the below qualifications:

• 3+ years in experience with GxP IT systems and infrastructure in the pharmaceutical/biotech industry
• Practical experience with FDA 21 CFR part 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.

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.

About Zealand Pharma

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.