QA Compliance Lead – Data Integrity & AI Governance

Bristol Myers Squibb UK & Ireland; Ireland; On-site; EUR 75,000 - 100,000; 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 in Ireland is seeking a Senior Specialist, QA Compliance for a 12-month fixed-term contract. You will support data integrity, AI governance, and supplier quality activities across the site, collaborating with cross-functional teams to ensure regulatory compliance and continuous improvement.

Reporting to the Senior Manager, QA Compliance, you will review risk assessments, develop quality agreements, prepare for authority inspections, and contribute to a strong quality

Qualifications

• Bachelor’s degree in Science, Engineering, Quality, Information Technology or a related discipline.
• Minimum of 3 years experience in Quality Assurance, Quality Control, Supplier Quality, Manufacturing or similar within pharma/biopharma.
• Strong understanding of current Good Manufacturing Practice requirements and their application.
• Experience with pharmaceutical quality systems (deviations, investigations, CAPAs, change controls, QRM, etc.).
• Strong analytical and problem-solving skills with risk-based decision making.
• Ability to work independently and in cross-functional teams with a commitment to compliance.

Responsibilities

• Support development, implementation and maintenance of Cruiserath Data Integrity Programme.
• Review and approve Data Integrity Risk Assessments and document risks.
• Support Cruiserath AI Governance Programme development and monitoring.
• Govern AI systems and use cases and perform ongoing reviews.
• Monitor regulatory expectations and assess applicability to site operations.
• Draft, review and approve Quality Agreements with suppliers and external parties.
• Participate in internal audits and inspections, including preparing observations and CAPAs.
• Assist with Health Authority inspections and inspection readiness activities.
• Support supplier qualification and oversight, including supplier audits and corrective actions.
• Review and approve quality system documents (deviations, investigations, CAPAs, changes, QA procedures).
• Contribute to Operational Excellence and continuous improvement within QA Compliance.

Skills

Quality Assurance

Data Integrity

AI Governance

Regulatory compliance

Audit support

Cross-functional collaboration

Education

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

Job description

BMS Cruiserath Biologics in Ireland is seeking a Senior Specialist, QA Compliance for a 12-month fixed-term contract. You will support data integrity, AI governance, and supplier quality activities across the site, collaborating with cross-functional teams to ensure regulatory compliance and continuous improvement.

Reporting to the Senior Manager, QA Compliance, you will review risk assessments, develop quality agreements, prepare for authority inspections, and contribute to a strong quality