Senior IT QA & Compliance Specialist (Healthcare, Remote)

Job summary

This role focuses on ensuring compliance within the Digital, Data & IT organization, particularly in the context of supporting medical device operations. The position involves working with a specialized team to meet regulatory demands and enhance operational efficiency.

Qualifications

• Master's degree in IT, Life Sciences, or a related field
• Several years of experience in quality assurance or regulatory compliance
• Familiarity with audit processes
• Knowledge of quality assurance practices in the life sciences sector

Responsibilities

• Ensure adherence to regulatory requirements and industry standards
• Facilitate both paper and on-site audits for the Digital, Data & IT team
• Plan, conduct, and report on internal audits
• Collaborate with cross-functional teams to address validation issues
• Perform risk assessments and create risk mitigation strategies
• Provide training on validation requirements and best practices
• Develop and maintain validation documentation, including protocols and standard operating procedures

Skills

• Strong organizational and planning abilities
• Technical knowledge in IT
• Effective stakeholder management skills
• Ability to work collaboratively and independently
• Fluent in English, both written and spoken (Danish is a plus)

Education

• Master's degree in a relevant field

Tools

• Experience with quality assurance and compliance tools relevant to the healthcare industry