QA Compliance Specialist: Data Integrity & AI

Bristol Myers Squibb; Ireland; On-site; EUR 65,000 - 85,000; 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 in Ireland is seeking a Senior Specialist, QA Compliance on a one-year fixed-term basis at the Cruiserath Biologics site. You will support the development, implementation and ongoing operation of key site compliance programmes, including Data Integrity, Quality Agreements and AI Governance.

The Senior Specialist will collaborate with site and global stakeholders to support audits, inspections, supplier quality activities and the development of a strong quality culture across

Qualifications

• Bachelor's degree in Science, Engineering, Quality, IT or related discipline.
• Minimum 3 years in Quality Assurance/Quality Control/Supplier Quality/Manufacturing in pharma/biopharma.
• Understanding of current Good Manufacturing Practice requirements.
• Experience with deviations, investigations, CAPAs, change controls, quality risk management or controlled documentation.
• Strong analytical/problem-solving and risk-based decision making.
• Ability to work independently and in cross-functional teams.
• Commitment to compliance, continuous improvement and quality culture.

Responsibilities

• Support Cruiserath Data Integrity Programme development, implementation and maintenance.
• Review, assess and approve Data Integrity Risk Assessments and manage identified risks.
• Support Cruiserath AI Governance Programme development and monitoring.
• Assist governance of AI systems and use cases at the site, with ongoing monitoring and periodic reviews.
• Draft, review and approve Quality Agreements with suppliers and external parties.
• Participate in internal audits and self-inspections, including preparation, execution and CAPA follow-ups.
• Support Health Authority inspections and inspection readiness activities.
• Support supplier qualification and oversight activities, including supplier audits and corrective actions.
• Review/approve quality system documentation (deviations/investigations/CAPAs/change controls/quality risk assessments/SOPs).
• Promote a strong quality culture across QA Compliance and the wider site.

Skills

QA Compliance

Data Integrity

Audit readiness

Cross-functional collaboration

Education

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

Job description

Bristol Myers Squibb in Ireland is seeking a Senior Specialist, QA Compliance on a one-year fixed-term basis at the Cruiserath Biologics site. You will support the development, implementation and ongoing operation of key site compliance programmes, including Data Integrity, Quality Agreements and AI Governance.

The Senior Specialist will collaborate with site and global stakeholders to support audits, inspections, supplier quality activities and the development of a strong quality culture across