emagine is looking for an IT Compliance Lead for a pharma client
Description:
The client is seeking a highly skilled and experienced IT Compliance Lead to define and execute validation and qualification strategies for innovative IT solutions. The ideal candidate will possess a deep understanding of compliance regulations and methodologies, specifically within the context of GxP (Good Practices). As an integral part of our team, you will engage with our clients, ensuring their systems meet all regulatory requirements.
Main Responsibilities:
The IT Compliance Lead will:
Define and implement validation strategies for our Genetic Analysis Platform and other upcoming solutions.
Deliver comprehensive documentation and reports.
Conduct various assessments, including Supplier, IT risk, and data integrity assessments.
Ensure compliance with both internal and external regulatory requirements.
Participate in audits and inspections, identifying and resolving compliance gaps.
Key Requirements:
Proven experience with pharma procedures.
Strong understanding of IT systems management and digital solutions.
Expertise in IT Risk Assessment and Vendor IT Assessment.
Solid background in compliance documentation and regulatory frameworks.
Excellent communication skills and attention to detail.
Nice to Have:
Experience in the biotechnology or pharmaceutical sector.
Familiarity with GxP regulatory requirements.
Prior experience in audits and inspections.
Start: Beginning of March
Duration: 12 months + possibility for extension
Workload: Fulltime
Location: Måløv, hybrid
