IT Compliance manager – Polypeptide Group

We are looking for an IT Compliance Manager for Polypeptide Group!

Polypeptide Group is a one of the world’s largest and most successful companies specializing in the manufacturing of therapeutic peptides and related compounds for research and pharmaceutical applications. The peptides they produce are part of several different pharmaceutical products and through their work they are improving the quality of life for many people around the world. Polypeptide Group is constantly growing and as part of this process, they are also able to offer their employees a dynamic and stimulating workplace with great opportunities to grow.

They have 1200 engaged employees located on production facilities in Sweden, USA, Belgium, Switzerland, France and India with head office located in Zug, Switzerland.

After have gone public in 2021, now listed on the SIX, Swiss Stock Exchange, they are seeking to strengthen their Global IS/IT capabilities with someone for the position as IT Compliance Manager.

Global IS/IT is a global organization dedicated on supporting the business with everything from strategy execution to operational delivery. Global IS/IT is executing on a newly formed and approved IS/IT strategy lifting the company’s capabilities as well as contributing to the overall Strategy for Digitalization. As IT Compliance manager you will be responsible for providing quality and compliance expertise to projects and operations in support of a controlled environment and associated processes that meet both external (e.g. GAMP 5, 21 CFR part 11) and internal quality and compliance requirements of Polypeptide.

The position is based in Malmö but your responsibility will be global. You report to the CISO(Chief Information Security Officer).



MAIN RESPONSIBILITIES

- Setup and maintain Global IS/IT compliance and quality framework.
- Secure that Global IS/IT GSOPs are up to date together with departments.
- Secure that our outsourced IT partners are working according to our framework and documentation routines.
- Assuring IT compliance throughout system implementation projects, system upgrades and retirement as well as other IT projects (e.g. infrastructure, IT services).
- Act as validation lead in IT projects.
- Assist in the preparation and maintenance of clear, detailed and accurate compliance documentation, including validation documentation.
- Execute computerized system validation tasks, such as change requests and periodic reviews.
- Participate in audits and manage internal and external auditor requirements and compliance adherence.
- Collaborate with stakeholders to ensure that new IT systems meet compliance requirements before they are made operational.
- Research and interpret regulatory standards, like FDAs 21 CFR Part 11 and GAMP 5, and guidelines and apply findings to the task at hand.
- Guide and train others.
- Interface and have close collaboration with Global QA department.




PREVIOUS EXPERIENCES AND COMPETENCE THAT ARE MERITORIOUS

- Bachelor’s degree in relevant IT related field and/or equivalent experience working with quality, IT compliance within the life science industry.
- Good understanding regarding validation of computerized systems within IS/IT and IT services like SAAS, PAAS and IAAS.
- Strong experience in working with Quality Management Systems(QMS).
- Good knowledge of working with compliance tools such as Microsoft 365 E5 Compliance.
- Strong documentation skills.
- Experience in working with pharmaceutical manufacturing practices, validation methods, inspection and testing methodologies.
- Possess excellent computer skills (MS office).
- Fluent writing and editing skills in Swedish and English.
- Experience in working in a global and multinational environment.






TO BE SUCCESFULL IN THIS ROLE WE BELEIVE YOU TO HAVE THE FOLLOWING SKILLS

- High aptitude for adaptability.
- Highly initiative.
- Performance oriented.
- Dependable.
- Detail oriented.
- Self organizing.


We hope that we have caught your curiosity and look forward to your application.

OTHER INFORMATION

Start: Per agreement

Location: Malmö, Sweden

This recruitment process is handled by A-hub (https://www.a-hub.se/) and on Polypeptide´s request, all enquiries regarding this position will be handled by A-hub (https://www.a-hub.se/) and Carl Andersson (carl@a-hub.se).