Senior QA Compliance: Data Integrity & AI Governance

Bristol-Myers Squibb Co; Cruiserath; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym

Life assurance

Job summary

BMS Cruiserath Biologics is seeking a Senior Specialist, QA Compliance on a one-year fixed-term basis. This role supports the Cruiserath Data Integrity Programme, AI Governance, and supplier quality activities, collaborating with site and global stakeholders to uphold quality and regulatory expectations.

The successful candidate will help coordinate internal audits, inspections, and corrective actions, while ensuring robust quality systems including deviations, CAPAs, and change controls are in

Qualifications

• Bachelor’s degree in Science, Engineering, Quality, IT or related discipline.
• 3+ years in Quality Assurance, Quality Control, Supplier Quality, Manufacturing or similar.
• Understanding of GMP in pharma/biologics.
• Experience with QA systems (deviations, investigations, CAPAs, change controls).
• Strong analytical and risk-based decision skills.

Responsibilities

• Support Cruiserath Data Integrity Programme development and maintenance.
• Review and approve Data Integrity Risk Assessments.
• Support Cruiserath AI Governance Programme development and operation.
• Monitor regulatory expectations and industry developments for Data Integrity and AI Governance.
• Draft and approve Quality Agreements with suppliers and external partners.
• Participate in internal audits, inspections, and CAPA follow-up.
• Assist with Health Authority inspections readiness and documentation.
• Support supplier qualification, audits, and follow-up actions.
• Review and approve quality system documentation (DVs, CAPAs, changes, QRA, SOPs).
• Promote continuous improvement within QA Compliance and the site.

Skills

Quality assurance

Analytical thinking

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree in Science/Engineering/Quality/IT

Job description

BMS Cruiserath Biologics is seeking a Senior Specialist, QA Compliance on a one-year fixed-term basis. This role supports the Cruiserath Data Integrity Programme, AI Governance, and supplier quality activities, collaborating with site and global stakeholders to uphold quality and regulatory expectations.

The successful candidate will help coordinate internal audits, inspections, and corrective actions, while ensuring robust quality systems including deviations, CAPAs, and change controls are in