Senior IT Compliance Specialist
Are you ready to begin an exciting new chapter in your career at a workplace, where you get to implement all your experience and know-how to help a successful, international medical technology organization grow and take the next steps on their IT Compliance journey?
Contura in brief
Originating from Ferrosan, Contura is an innovative medical technology company which was established in Denmark in 2000. Contura’s facility at Søborg is currently undergoing a large expansion and renewal with new factory validation set for mid 2024. Contura offers products for treatment of urinary incontinence in women as well as aesthetic augmentation and treatment of osteoarthritis in the knee joint.
When entering through the doors at the main building, you quickly notice the friendly and informal atmosphere. The entire workplace has an entrepreneurial feel to it, which goes naturally hand in hand with an almost family-like vibe, where everyone seems to know each other by their first name. You can tell that this is a workplace where colleagues meet each other at eye level.
The Søborg site currently employs 60+ employees and is expected to grow to around 100 before the end of 2023. The production of hydrogels is estimated to triple over the next 3 years. The facility, which is approved in US, Europe, Canada, Australia, etc., is designed to fulfil global regulatory requirements and deliver Contura’s entire range of hydrogel products.
Influence and responsibility as Senior IT Compliance Specialist
We are looking for an experienced IT Compliance Specialist to help Contura establish and maintain a modern IT compliance framework. The role includes evaluating existing processes and driving all new IT-compliance initiatives going forward - in accordance with GAMP 5 and Part 11. The goal is to establish a more up-to-date, mature, and digitalized process that reflect the requirements of Contura and support them on their ongoing growth journey.
During 2023/2024 Contura DK plans to implement Business Central as their brand-new ERP-platform. The project is on-going, and you are expected to play an important role during this project e.g when the system is to be validated in accordance with GxP regulations. This project in an important step on Contura’s path to further digitalize workflows.
Another exciting task is going to be the build-up of an IT-QMS. This important step will help Contura’s organization overcome common quality management challenges related to cost, complexity, compliance, and risk.
As Senior IT Compliance Specialist you are an influential capacity and thus you provide expertise and guidance to your colleagues in their System Development Lifecycle efforts to facilitate project timelines.
Furthermore, the role includes:
- Analyze business requirements by partnering with key stakeholders across the organization to develop solutions for IT Compliance and Validation purposes.
- Establish and drive IT-validation strategies and lifecycle deliverables to current regulatory requirements and company procedures.
- Participate on assigned projects in support of IT Compliance and Validation activities.
- Assess Risk level for all IT computer systems.
- Maintain and further develop GxP computerized system inventory list.
- Provide IT quality oversight of system-related issues.
- Various support related to the IT-QMS, ERP-system and Complaint handling system.
Your daily base will be Søborg, however, you will also be able to work from home.
The Culture at Contura
Contura is a growing company with dedicated people and a strong pioneer spirit. They reach their objectives through collaboration between motivated and competent colleagues in an informal working environment. The culture at Contura is best described as a close-knit team. The successes to date are a testament to a group of ambitious, talented, and like-minded colleagues.