About the Role
This position is responsible for overseeing IT quality assurance processes, ensuring systems meet regulatory standards, supporting audits, and driving continuous improvement in quality systems across global operations.
Compensation
Competitive salary and benefits package
Work Arrangement
Remote position within Europe
Team
Global Quality Assurance team within a pharmaceutical organization
Key Responsibilities
- Lead and manage IT quality assurance activities across global systems
- Ensure compliance with regulatory requirements and industry standards
- Support internal and external audits related to IT systems
- Oversee validation of computerized systems in regulated environments
- Collaborate with cross-functional teams to implement quality practices
- Develop and maintain quality documentation and standard operating procedures
- Drive continuous improvement in IT quality processes
- Monitor performance metrics and report on quality KPIs
- Manage vendor quality oversight for IT-related services
- Ensure data integrity across quality systems
- Lead quality risk assessments for IT projects
- Support change control processes within IT environments
- Provide quality input into system development life cycles
- Ensure alignment with global quality policies
- Train teams on quality requirements for IT systems
- Respond to quality incidents involving IT systems
- Maintain oversight of electronic records and signatures compliance
- Support regulatory inspections and provide necessary documentation
- Evaluate new technologies from a quality assurance perspective
- Coordinate with regional and global stakeholders on quality matters
Qualifications
- Bachelor's degree in Computer Science, Information Systems, or related field
- Minimum of 8 years of experience in IT quality assurance
- Experience in pharmaceutical or regulated industry required
- Strong knowledge of GxP, 21 CFR Part 11, and EU Annex 11
- Proven experience in computerized system validation
- Familiarity with quality management systems
- Project management experience in IT environments
- Experience with audit support and regulatory inspections
- Proficiency in quality risk assessment methodologies
- Strong understanding of data integrity principles
- Experience with electronic records and signatures compliance
- Knowledge of change control and deviation management
- Ability to lead cross-functional teams
- Excellent documentation and communication skills
- Fluency in English, written and spoken
- Problem-solving skills with attention to detail
- Ability to work in a global, matrixed environment
- Experience with cloud-based systems validation
- Working knowledge of quality tools and software
- Certifications in quality or IT (e.g., CQA, CQE, CISSP) preferred
What We Offer
- Flexible remote working arrangement
- Opportunity to work in a global organization
- Exposure to diverse IT and quality projects
- Professional development and training opportunities
- Inclusive and collaborative work culture
- Health and wellness benefits
- Pension or retirement savings plans
- Paid time off and holidays
- Support for work-life balance
- Access to digital collaboration tools
Not applicable; role based in Europe
