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 companies specializing in the manufacturing of therapeutic peptides and related compounds for research and pharmaceutical applications.

After recently have gone public, listed on the SIX, Swiss Stock Exchange, they are now seeking to strengthen their IT capabilities in recruiting someone for the role as IT Compliance manager. You will be part of a newly formed team within Global IS/IT responsible for compliance and cyber security and reporting to CISO (Chief Information Security Officer).

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.

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

Other: Some international travel will be required.

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