BE THE NEW

GxP Application Manager

in a biotech company focused on the discovery, design and development of innovative peptide-based medicines

Currently, we are looking for a new GxP Application Manager, who has experience with maintenance of business applications, user training, stakeholder management and user support. If this sounds like you, and you are ready to take on a broad area of responsibilities with an independent attitude, you are a match for us.

This is a great opportunity for you to join our new and fast growing team in the IT department, “Business IT Projects and Applications”. We ensure that business applications are sourced, implemented, maintained and developed in Zealand Pharma.

You will be System Responsible for our SAS application, the safety database and our Montrium eTMF. You will be part of a fantastic team of other Application Managers and Project Managers, where team work and enthusiasm are buzz words. We currently have a portfolio of the following systems: ERP, Serialization, Safety Database, SAS, Montrium eTMF, Veeva QualityDocs, Training, eTMF and Submission, and you will work closely together with our other Application Managers, where you will back each other up.

Responsibilities

You will:

have the overall system responsibility for our SAS, Safety and Montrium eTMF systems.
be responsible for planning and implementing upgrades, bug fixes, changes etc. in close collaboration with our end-users.
be assuring good communication to and from end-users and data owners by e.g., hosting System Steering Groups.
perform daily administration i.e., user maintenance, user assistance, and problem solving.
perform Periodic System Reviews.
assure a validated and compliant system status in close collaboration with users, IT QA, System Owner and vendors throughout the system lifecycle.
ensure system governance by providing data to System Steering Committee and align with IT Committee.
present system validation during audits and Inspections.
ensure supplier management and oversight on relevant systems.

Candidate profile

3+ 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.
Excellent communication skills in English both verbally and in writing.
Can do attitude in a fast moving atmosphere, where team efforts are in focus ensuring we reach all our goals.

Bonding to innovate 
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.

Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.

We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise.

We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.

The Zealand Pharma DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.

Let’s bond and be bold 
We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our 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 https://www.zealandpharma.com/careers/zealand-as-a-workplace/

Interested? Please apply no later than April 15^th, 2024, or as soon as possible. The applications will be reviewed as they come in and interviews will be performed on a running basis.

For further information, please contact Pernelle Quist PQU@Zealandpharma.com.

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a Danish biotechnology company on a mission to change lives with next generation peptide medicines. In our effort to reach our goals bonding is at the core of everything we do. Let it be discovering and developing the best new peptide drugs for patients, engaging with partners or connecting with each other. This has led to more than 10 drug candidates invented by Zealand having 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 bond with us through LinkedIn.