IT Compliance Specialist (M/F)

The IT Compliance Specialist will be responsible for the ownership of all IT compliance processes by partnering with peers in IT, Quality, and

external Inspection/Audit teams to ensure our processes and solutions comply with existing and future regulations by supporting a risk driven approach to make valuable recommendations on standardization of processes and controls, and influence changes and decisions.

Main responsibilities:

• Ensure IT complies with applicable policies and procedures, training requirements, and applicable regulatory requirements;
• Interpret and communicate systems compliance regulations within the IT function, leveraging Industry learnings, guidance (GAMP), and peer benchmarks;
• Plan, facilitate the preparation/ coordination, and follow-up on audit/inspection findings and lessons learned;
• Facilitation of GMP policies, narratives, and control self-assessment documentation;
• Create and maintain IT compliance documentation and knowledge repository;
• Develop recommendations to improve the IT internal control environment;
• Responsible for ensuring that Information Technology’s systems are developed and maintained in compliance with GxP regulations, and according to industry best practice;
• Provide senior-level consultation and direction to functional areas on IT Compliance for policy, process, and procedure;
• Identify, propose, initiate, and lead significant improvement initiatives related to Compliance policy, process, and procedure.  

Profile:

• Candidate should typically have 5 or more years of experience in an IT, QA or Compliance role with a strong understanding of quality systems compliance;
• Degree in Computer Science or related technical discipline;
• Knowledge with Quality Systems
• Experience in GxP environments is a differentiator;
• Significant experience managing relationships with inspectors and auditors;
• Proven analytical and problem-solving abilities;
• Ability to effectively prioritize and execute tasks in a high-pressure environment;
• Good written, oral, and interpersonal communication skills;
• Keen attention to detail;
• Excellent Level of English (Written and Spoken)

We offer:

• Full time opportunity;
• Remuneration and social benefits adjusted to the job function and matching the experience;
• Excellent work environment, with a strong focus on quality.