QA Compliance Specialist: Data Integrity & AI Governance

Bristol Myers Squibb; Fingal; On-site; EUR 70,000 - 95,000; 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

Bristol Myers Squibb’s Cruiserath Biologics site seeks a Senior Specialist, QA Compliance on a one-year fixed-term basis. You will support Data Integrity, AI Governance, quality agreements and supplier quality, collaborating with site and global teams to uphold rigorous compliance and quality standards.

The role involves audits, inspections readiness, documentation control and continuous improvement, fostering a culture where data integrity and patient safety guide everyday decisions.

Qualifications

• Bachelor's degree in Science, Engineering, Quality, IT or related discipline.
• Minimum 3 years experience in Quality Assurance, Quality Control, Supplier Quality, Manufacturing or similar in pharma/biopharma.
• Solid understanding of current Good Manufacturing Practice requirements in pharma/biologics.
• Experience with pharmaceutical quality systems (deviations, investigations, CAPAs, change controls, QRM, controlled docs).
• Strong analytical and problem-solving skills for risk-based quality decisions.
• Ability to work independently and in cross-functional teams.
• Commitment to compliance, continuous improvement and quality culture.

Responsibilities

• Develop, implement and maintain Cruiserath Data Integrity Programme.
• Review and approve Data Integrity Risk Assessments and related docs.
• Develop and operate Cruiserath AI Governance Programme.
• Monitor AI systems and use cases per site requirements and risk management.
• Stay aligned with corporate regulatory expectations and industry developments.
• Draft and approve Quality Agreements with suppliers and external parties.
• Participate in internal audits and inspections and manage CAPAs and observations.
• Support Health Authority inspections readiness and documentation.
• Assist supplier qualification and oversight, including audits and corrective actions.
• Review/approve quality system docs: deviations, investigations, CAPAs, change controls, QRM, SOPs.
• Authorize QA procedures, guidance documents and training materials.
• Support Operational Excellence and continuous improvement within QA Compliance.
• Promote quality culture and patient safety in day-to-day decisions.

Skills

GMP knowledge

Quality systems

Audits

Documentation

Analytical skills

Cross-functional teamwork

Problem solving

Independent worker

Education

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

Job description

Bristol Myers Squibb’s Cruiserath Biologics site seeks a Senior Specialist, QA Compliance on a one-year fixed-term basis. You will support Data Integrity, AI Governance, quality agreements and supplier quality, collaborating with site and global teams to uphold rigorous compliance and quality standards.

The role involves audits, inspections readiness, documentation control and continuous improvement, fostering a culture where data integrity and patient safety guide everyday decisions.