Senior QA Compliance: Data Integrity & AI Governance

Bristol Myers Squibb; Cruiserath; On-site; EUR 70,000 - 90,000; Full time

Job summary

Bristol Myers Squibb at Cruiserath Biologics seeks a Senior Specialist, QA Compliance on a one-year fixed-term basis. You will help develop and operate key site compliance programmes, including Data Integrity and AI Governance, and support supplier qualification and internal audits.

The role collaborates with global stakeholders to uphold quality culture and patient safety. The role emphasizes regulatory compliance, quality risk management and documentation control across QA systems and site

Qualifications

• Bachelor's degree in Science, Engineering, Quality, Information Technology or a related discipline.
• 3+ years experience in Quality Assurance, Quality Control, Supplier Quality or related pharma functions.
• Solid understanding of current Good Manufacturing Practice and quality systems.

Responsibilities

• Support development, implementation and maintenance of Cruiserath Data Integrity Programme.
• Review and approve Data Integrity Risk Assessments and quality documentation.
• Support AI Governance Programme and supplier qualification activities.
• Participate in internal audits, inspections and CAPA processes.
• Assist with health authority inspections and supplier oversight as required.
• Prepare documentation and participate in change controls, deviations, investigations and QA procedures.

Skills

Quality Assurance

QA Documentation

Regulatory Compliance

Audit Readiness

Cross-functional Collaboration

Education

Bachelor's degree in Science, Engineering, Quality, IT or related discipline

Job description

Bristol Myers Squibb at Cruiserath Biologics seeks a Senior Specialist, QA Compliance on a one-year fixed-term basis. You will help develop and operate key site compliance programmes, including Data Integrity and AI Governance, and support supplier qualification and internal audits.

The role collaborates with global stakeholders to uphold quality culture and patient safety. The role emphasizes regulatory compliance, quality risk management and documentation control across QA systems and site