Be the new
Application Manager (GxP Systems)
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a fast-growing, fully integrated Copenhagen-based biotechnology company with a highly attractive pipeline. With two products on the market and three candidates in late-stage development, Zealand is a unique success story in Danish biotech. 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. In addition to the Søborg Headquarters, Zealand is also located in the United States in Boston (MA), Marlborough (MA), and New York (NY).
Zealand is looking for an Application Manager/System Responsible for the Zealand Electronic Document Management System (EDMS) also containing modules for Training and Quality Management processes such as Events, Deviations, CAPAs and Complaints. The candidate will be part of a great team of four in the department; QA Computerized Systems which supports the business with GxP computerized system implementation and operation, IT QA resources and archiving.
The applicant will be system responsible for our MasterControl system.
System responsibility includes:
The applicant will be part of a team that holds system responsibility for many GxP IT Systems, so back up and assistance with other internal GxP systems e.g. (eTMF, Serialization, IRT, safety database) will be needed, just as system responsibility for new systems may occur. Our team also focuses on further developing the system governance and quality system on the use and maintenance of GxP systems in Zealand Pharma.
The successful candidate will have most or all of the below qualifications:
- Assure good communication to and from end-users and data owners by e.g. hosting user groups (all Zealand sites)
- Daily administration i.e. user maintenance, user assistance, and problem solving
- Plan for and implement upgrades, bug fixes and new modules
- Collaborate with end-users on the configuration and perform system configurations
- Plan and implement changes and improvements to system in close collaboration with users
- Perform end-user training and improve and develop procedures, training material and user guides
- Assure a validated and compliant system status in close collaboration with users, system owner and vendors throughout the system lifecycle
- Ensure system governance by providing data to system steering Committee and align with IT committee.
- 5+ years in experience with GxP IT systems 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.
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.
- Pragmatic and yet compliant quality mindset
- Structure is an integrated part of your work
- High standards for ethics and integrity
- Strong communication skills
- Ability to work effectively in a fast-paced environment
- Like to be in a great team and achieve things together
- Fluent in English (company language), Danish is a plus.
Our work environment is characterized by strong cross functional team-work, 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 October 31, 2021. Applications will be reviewed and interviews scheduled on a rolling basis.
For further information, please contact Pernelle Quist
at +45 5060 3621 or firstname.lastname@example.org
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: 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.