IT Compliance Manager

IT Compliance Manager (f/m/d) 100% – Hørsholm, DK

We combine best-in-class capabilities from our two founding partners, including extensive know-how in developing, upscaling and manufacturing live bacteria, strong capabilities in pharma contract manufacturing, and outstanding formulation and drug delivery technologies, including the unique enTRinsic™ capsules.

Bacthera operates from its headquarters in Basel (CH) and has development and production facilities in Denmark and Switzerland. Bacthera is the first contract development and manufacturing organisation (CDMO) to provide a full supply chain that offers manufacturing of live bacteria for therapeutic use for biotech and pharma customers.

For a global position based at our site in Hørsholm (DK) we are seeking a motivated and experienced

IT Compliance Manager (f/m/d) 100%

If you’re in for the challenge this is the perfect opportunity for you to take the lead in terms of setting up and operate the global IT Compliance function, ensuring compliance with applicable regulatory and industry standards for GMP manufacturing. We’re a yet small but growing organization in the process of building a new company. This means that you will be part of forming not just the IT Compliance area but the entire IT. The distance from thought to action is short as long as the goal is to deliver good and compliant IT services. This role is expected to effectively lead and guide project teams and effectively partner with cross-functional teams.

Your Profile:

  • University degree in Computer Science or related education/experience
  • 5+ years of experience in IT Compliance
  • A good and broad IT organizational understanding
  •  A track record of Project Management and Vendor Management skills
  • Proven experience and knowledge working with(in)
    • Pharma
    • GMP/GAMP5
    • Entrepreneur spirit or high intrinsic motivation to work for a start-up
  • Comfortable with working in cross-functional global teams to effect change
  • Service minded and solution oriented
  • Willingness to travel from time to time

Role and Responsibilities:

  • Responsible (authority) for designing and maintaining IT Compliance IT domain according to regulatory requirements as well as the Bacthera business strategies and requirements
  • Responsible for GMP systems being operated in compliance with regulations
  • Ensure alignment between Line of Business, QA and IT Dept. regarding delivering Compliant IT
  • Lead IT Compliance IT Project/Tasks
  • Create and implement IT Compliance processes (design/maintain)
  • Ensure that data integrity policies and measures for IT systems and infrastructure are in place and implemented,
  • Act as subject-matter expert for internal and external audits, as well as for agency inspections and customer audits
  • In cooperation with IT/Operations and site personnel, support the evaluation of new applications and services in the field of IT Infrastructure and systems. Define qualification requirements for these projects and activities
  • Maintain (authority) IT Compliance IT Roadmap in alignment with the full IT roadmap
  • Handle the deviation- and CAPA process in relation to GMP systems
  • Responsible of GMP training in the IT Dept.
  • Drive the process towards-, during- and after GMP inspection (owner)
  • Gap analysis and follow-up (before and after GMP inspection)
  • Responsible for ad-hoc IT Compliance IT decision & operations (owner)
  • Provide overview of the IT Compliance domain, e.g. such as the operational area:
    • TrackWise (QMS, DMS etc.)
    • LIMS
    • Genome Data Handling Platform
    • cGMP production & QA laboratories systems/facilities
  • Create and maintain GMP policies and SOP’s
  • Ensure documentation
  • You report directly to the Head of IT Services and Project Delivery

Are you interested to work for an innovative, dynamic, and future oriented start-up company? Are looking for a new challenging role, where you can create things and leave your footprint, send your full application to Ms. Sandra Gamboni, Head of Human Resources;