Director of Quality Assurance IT & Validation

Job summary

The Director of Quality Assurance IT & Validation will lead a team responsible for overseeing quality in GxP-regulated IT systems within a global organization. This role involves strategic leadership in IT quality, computerized system validation, and compliance with regulatory requirements, while collaborating with various departments and external vendors.

Qualifications

• Extensive experience in Quality Assurance and computerized system compliance in a regulated pharmaceutical or life sciences environment.
• In-depth knowledge of computerized system validation and familiarity with EU GMP, FDA requirements, and industry standards for GxP-relevant IT systems.
• Proven leadership and management capabilities with a strategic mindset.

Responsibilities

• Lead a team of specialists in QA IT & Validation.
• Shape the QA IT strategy and ensure compliance with global regulatory requirements.
• Oversee the implementation of major digital transformation initiatives, including Veeva and a new ERP platform.
• Act as System Owner for the electronic Quality Management System (eQMS).
• Conduct supplier audits and IT vendor qualifications.
• Drive continuous improvement initiatives and represent Quality in IT governance forums.

Skills

• Strong analytical and problem-solving skills.
• Effective communication and collaboration across Quality, IT, and business functions.
• Ability to advise stakeholders on complex compliance matters and influence cross-functional decision-making.

Education

• Relevant degree in a scientific or technical field, with additional qualifications in Quality Assurance preferred.

Tools

• Familiarity with quality management systems and validation tools relevant to the pharmaceutical industry.